Conditions: Meningococcal Vaccine
Keywords: Meningococcal Vaccine Invasive Meningococcal Disease Meningococcal Serogroups A, B, C W and Y MenABCWY Vaccine
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 326
Healthy volunteers: yes

Brief summary:
The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Detailed description:

Arms:
arm 1: Group 1 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 (2 primary vaccinations and a booster dose) schedule, and given Prophylactic Liquid Paracetamol (PLP) during primary vaccinations. arm 2: Group 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule arm 3: Group 3 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP or Scheduled Liquid Pracetamol (SLP) during primary vaccinations. arm 4: Group 4 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule arm 5: Group 5 - Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations. arm 6: Group 7 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given SLP during primary vaccinations. arm 7: Group 8 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations arm 8: Group 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule arm 9: Group 11 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with Therapeutic Liquid Paracetamol (TLP) during primary vaccinations. arm 10: Group 13 - Participants 2 months of age vaccinated with MenABCWY and placebo on a 2+1 schedule, with a determined ratio of participants given SLP or TLP during primary vaccinations. arm 11: Group 14 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule with a determined ratio of participants given PLP or TLP during primary vaccinations.

Interventions: intervention 1: MenABCWY intervention 2: Bivalent rLP2086 (60-µg Dose) intervention 3: Bivalent rLP2086 (120-µg Dose) intervention 4: Bexsero intervention 5: Prophylactic Liquid Paracetamol (PLP) intervention 6: Nimenrix intervention 7: Placebo intervention 8: Scheduled Liquid Paracetamol (SLP) intervention 9: Therapeutic Liquid Paracetamol (TLP)
Intervention descriptions: intervention 1: Neisseria meningitis groups A, B, C W, and Y vaccine intervention 2: Trumenba (half dose) - Meningococcal Group B vaccine intervention 3: Trumenba - Meningococcal Group B vaccine intervention 4: Bexsero - Meningococcal Group B vaccine intervention 5: PLP administration during primary vaccinations 1 and 2 intervention 6: Nimenrix - Meningococcal Group A, C, W and Y vaccine intervention 7: Normal Saline intervention 8: SLP administration after primary vaccinations 1 and 2. intervention 9: TLP administration after primary vaccinations 1 and 2

Protocol document:
Prot_000.pdf: 
PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511002
Protocol Amendment 2, 13 September 2021
PFIZER CONFIDENTIAL
Page 1
A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND 
IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS 
OF AGE
Study Intervention Number:
PF-06886992
Study Intervention Name:
Neisseria meningitidis Group A, B, C, W, and Y 
Vaccine (MenABCWY)
US IND Number:
N/A
EudraCT Number:
ClinicalTrials.gov ID:
NCT04645966
Protocol Number:
C3511002
Phase:
2b
Short Title: A Phase 2b Study to Describe the Safety and Immunogenicity of 
MenABCWY in Healthy Infants 2 and 6 Months of Age
This document and accompanying materials contain confidential information belonging to Pfizer.  Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.
CCI


PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511002
Protocol Amendment 2, 13 September 2021
PFIZER CONFIDENTIAL
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Protocol Amendment Summary of Changes Table
Document History
Document
Version 
Date
Summary and Rationale for Changes
Amendment 2
13 September
2021

Protocol amendment 2 implemented 
EDMC recommendations that resulted 
from an analysis of available fever and 
safety data and a review of paracetamol 
regimens following completion of 
enrollment to sentinel Group 5 
(Trumenba 120 µg + Nimenrix + PLP). 
This resulted in:

A data-driven adjustment to the 
paracetamol regimens aimed at 
mitigation of unnecessary medical 
interventions occurring due to fever.
Added SLP and TLP in 
Section 8.2.1.2.

Updates to the open-label sentinel-
cohort stage, the open-label 
expanded-enrollment stage, and the 
blinded expanded-enrollment stage 
to progress sequentially as follows:
o
2-Month-old participants 
receiving MenABCWY + SLP in 
the sentinel stage, followed by
o
2-Month-old participants 
receiving MenABCWY + TLP in 
the open-label expanded-
enrollment stage, followed by
o
2-Month-old participants 
receiving MenABCWY + SLP or 
TLP or Bexsero + Nimenrix + 
PLP or TLP in the blinded 
expanded-enrollment stage.


PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511002
Protocol Amendment 2, 13 September 2021
PFIZER CONFIDENTIAL
Page 3
Document History
Document
Version 
Date
Summary and Rationale for Changes

Elimination of Group 6 for receiving 
120 µg rLP2086 + Nimenrix without 
PLP and Group 9 for receiving 
MenABCWY without PLP in the 
open-label sentinel-cohort stage 
based on the EDMC’s 
recommendation.

Elimination of Group 12 for 
receiving Bexsero + Nimenrix ± PLP
in the open-label expanded-
enrollment stage.

Updated Section 3 to reflect group 
changes and the paracetamol regimen 
changes.

Specified the vaccine volumes for 
injection at the vaccination visits in 
Section 8.11.

Increased the number of participants to 
37 in Group 3 and up to 100 in both 
Group 7 and Group 11. 

Updated the numbers of participants to 
be enrolled for each stage of the study 
and the total participant number for the 
study.

Updated Section 9 Statistical 
Considerations to reflect the changes
made in Section 3.

Incorporated changes per PACL dated 
05 March 2021.

Replaced the term SRM with ISF 
throughout the protocol as the term 
SRM is no longer used.


PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511002
Protocol Amendment 2, 13 September 2021
PFIZER CONFIDENTIAL
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Document History
Document
Version 
Date
Summary and Rationale for Changes

Added Appendix 7: Alternative 
Measures During Public Emergencies
per new template.
Amendment 1
28 January 
2021

Addition of observer-blind expanded-
enrollment stage to allow further safety 
evaluation while minimizing potential 
bias.  Addition of corresponding 
safety/immunogenicity objectives and 
analysis triggering enrollment into this 
stage.

Addition of a planned analysis 1 month 
after the booster vaccination in the 
open-label expanded-enrollment stage 
in lieu of the prior final analysis.

Separated Bexsero randomization 
groups (Groups 8 and 10) from 
sentinel-cohort stepdown structure to 
allow enrollment into these groups at 
any time during the sentinel stage as 
vaccine assigned in these groups 
represents standard of care.  Removed 
enrollment restrictions from these 
groups and applied fewer stopping 
rules.

In order to allow for sufficient numbers 
of participants for the planned analysis 
preceding the observer-blind expanded-
enrollment stage, adjustments were 
made to:  

Increase the number of participants 
from 25 to 50 in Groups 5, 7, 8, 9,
and 10.

Decrease the number of participants 
in Group 11 from 150 to 50 and in 
Group 12 from 150 to 100.


PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Protocol Amendment 2, 13 September 2021
PFIZER CONFIDENTIAL
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Document History
Document
Version 
Date
Summary and Rationale for Changes

Added confirmation that serum 
obtained from participants enrolled in 
the open-label stages may be used for 
exploratory analysis and 
meningococcal assay development as a 
priority over the analysis shown in the 
study estimands, based on availability 
of serum volume.  

Removal of defined titers from all 
exploratory estimands.

Inclusion of flowchart in Section 1.2
showing study progression and decision 
points.

Inclusion of edits from administrative 
letter dated 16 November 2020.
Original protocol
19 June 2020
N/A
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities, IRBs/ECs, and any protocol administrative clarification 
letter.


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Protocol C3511002
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PFIZER CONFIDENTIAL
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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................11
LIST OF FIGURES .................................................................................................................12
1. PROTOCOL SUMMARY...................................................................................................13
1.1. Synopsis ..................................................................................................................13
1.2. Schema ....................................................................................................................19
1.2.1. Study Progression Flowchart......................................................................19
1.2.2. Study Intervention Overview......................................................................20
1.3. Schedule of Activities .............................................................................................23
2. INTRODUCTION ...............................................................................................................27
2.1. Study Rationale .......................................................................................................27
2.2. Background .............................................................................................................30
2.2.1. Background of the Disease and Medical Need...........................................30
2.2.2. Clinical Overview.......................................................................................30
2.3. Benefit/Risk Assessment.........................................................................................31
2.3.1. Risk Assessment.........................................................................................33
2.3.2. Benefit Assessment.....................................................................................39
2.3.3. Overall Benefit/Risk Conclusion................................................................39
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS ...........................................................40
3.1. Open-Label Sentinel-Cohort and Expanded-Enrollment Stages.............................40
3.2. Blinded Expanded-Enrollment Stage......................................................................48
4. STUDY DESIGN.................................................................................................................51
4.1. Overall Design.........................................................................................................51
4.1.1. Open-Label Sentinel-Cohort Stage.............................................................51
4.1.1.1. Cohorts 1 to 4............................................................................52
4.1.1.2. Sentinel-Control Cohort ............................................................53
4.1.2. Open-Label Expanded-Enrollment Stage...................................................53
4.1.3. Blinded Expanded-Enrollment Stage .........................................................56
4.1.4. Approximate Duration of Participation for Each Participant .....................56
4.1.5. Approximate Number of Participants.........................................................56
4.2. Scientific Rationale for Study Design.....................................................................56
4.3. Justification for Dose ..............................................................................................58


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4.4. End of Study Definition ..........................................................................................58
5. STUDY POPULATION......................................................................................................59
5.1. Inclusion Criteria.....................................................................................................59
5.2. Exclusion Criteria....................................................................................................60
5.3. Lifestyle Considerations..........................................................................................61
5.4. Screen Failures ........................................................................................................61
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study 
Intervention Administration ......................................................................................61
5.5.1. Criteria for Temporarily Delaying Vaccine Administration ......................61
5.5.2. Criteria for Temporarily Delaying Immunogenicity Blood Draw..............62
6. STUDY INTERVENTION..................................................................................................62
6.1. Study Intervention(s) Administered........................................................................63
6.1.1. Administration............................................................................................65
6.1.2. Medical Devices .........................................................................................65
6.2. Preparation/Handling/Storage/Accountability ........................................................66
6.2.1. Preparation and Dispensing........................................................................67
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................68
6.3.1. Allocation to Study Intervention ................................................................68
6.3.2. Blinding During the Open-Label Stages.....................................................68
6.3.3. Blinding During the Blinded Expanded-Enrollment Stage ........................68
6.3.3.1. Blinding of Study Staff .............................................................68
6.3.3.2. Blinding of the Sponsor.............................................................69
6.3.3.3. Breaking the Blind ....................................................................69
6.4. Study Intervention Compliance...............................................................................70
6.5. Concomitant Therapy..............................................................................................70
6.5.1. Prohibited During the Study.......................................................................71
6.5.2. Permitted During the Study ........................................................................71
6.5.3. Prior Vaccinations and Treatments.............................................................72
6.5.4. Prohibited Prior Treatments........................................................................72
6.6. Dose Modification...................................................................................................72
6.7. Intervention After the End of the Study..................................................................72
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................72


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7.1. Discontinuation of Study Intervention ....................................................................72
7.2. Participant Discontinuation/Withdrawal From the Study.......................................73
7.2.1. Withdrawal of Consent...............................................................................74
7.3. Lost to Follow-up....................................................................................................74
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................75
8.1. Efficacy Assessments and/or Immunogenicity Assessment ...................................75
8.1.1. MenA, MenC, MenW, and MenY Serum Bactericidal Assays..................76
8.1.2. MenB Serum Bactericidal Assays ..............................................................76
8.1.3. Biological Samples.....................................................................................76
8.2. Safety Assessments .................................................................................................76
8.2.1. Electronic Diary..........................................................................................78
8.2.1.1. Local Reactions.........................................................................79
8.2.1.2. Systemic Events ........................................................................80
8.2.1.3. Use of Antipyretic/Pain Medications ........................................83
8.2.2. Open-Label Safety Assessment ..................................................................84
8.2.2.1. Sentinel-Cohort Safety Assessment ..........................................84
8.2.2.2. Expanded-Cohort Safety Assessment .......................................85
8.2.3. Blinded Phase Safety Assessment ..............................................................85
8.2.4. Study Pause.................................................................................................85
8.2.4.1. Stopping Rules ..........................................................................85
8.2.4.2. Resuming Enrollment and Vaccination After a Study 
Pause..................................................................................................87
8.3. Adverse Events and Serious Adverse Events..........................................................87
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......88
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................90
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................90
8.3.2. Method of Detecting AEs and SAEs ..........................................................90
8.3.3. Follow-up of AEs and SAEs.......................................................................91
8.3.4. Regulatory Reporting Requirements for SAEs...........................................91
8.3.5. Exposure During Pregnancy or Breastfeeding via Occupational 
Exposure ..........................................................................................................91
8.3.5.1. Exposure During Pregnancy......................................................91
8.3.5.2. Exposure During Breastfeeding ................................................93


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Protocol Amendment 2, 13 September 2021
PFIZER CONFIDENTIAL
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8.3.5.3. Occupational Exposure .............................................................93
8.3.6. Cardiovascular and Death Events...............................................................93
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................94
8.3.8. Adverse Events of Special Interest.............................................................94
8.3.8.1. Lack of Efficacy........................................................................94
8.3.9. Medical Device Deficiencies......................................................................94
8.3.9.1. Time Period for Detecting Medical Device Deficiencies .........94
8.3.9.2. Follow-up of Medical Device Deficiencies...............................94
8.3.9.3. Prompt Reporting of Device Deficiencies to Sponsor ..............95
8.3.9.4. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................95
8.3.10. Medication Errors.....................................................................................95
8.4. Treatment of Overdose............................................................................................96
8.5. Pharmacokinetics ....................................................................................................96
8.6. Pharmacodynamics..................................................................................................97
8.7. Genetics...................................................................................................................97
8.8. Biomarkers ..............................................................................................................97
8.9. Immunogenicity Assessments.................................................................................97
8.10. Health Economics .................................................................................................97
8.11. Study Procedures...................................................................................................97
8.11.1. Visit 1 (Day 1): Primary Vaccination 1....................................................97
8.11.2. Visit 2 (28 to 42 Days After Visit 1): Safety Telephone Contact...........101
8.11.3. Visit 3 (63 to 77 Days After Visit 1): Primary Vaccination 2................102
8.11.4. Visit 4 (28 to 42 Days After Visit 3): Follow-up After Primary 
Vaccination 2 .................................................................................................105
8.11.5. Visit 5 (365 to 386 Days of Age): Booster Vaccination.........................106
8.11.6. Visit 6 (28 to 42 Days After Visit 5): Follow-up After Booster 
Vaccination ....................................................................................................108
8.11.7. Visit 7 (168 to 196 Days After Last Study Vaccination): Final 
Telephone Contact .........................................................................................109
8.12. Unscheduled Visits..............................................................................................110
9. STATISTICAL CONSIDERATIONS ..............................................................................110


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9.1. Estimands and Statistical Hypotheses...................................................................111
9.1.1. Estimands..................................................................................................111
9.2. Sample Size Determination...................................................................................112
9.2.1. Open-Label Sentinel-Cohort and Expanded-Enrollment Stages ..............112
9.2.2. Blinded Expanded-Enrollment Stage .......................................................113
9.3. Analysis Sets .........................................................................................................114
9.4. Statistical Analyses ...............................................................................................116
9.4.1. Immunogenicity Analyses ........................................................................116
9.4.1.1. Open-Label Sentinel-Cohort and Open-Label Expanded-
Enrollment Stages............................................................................116
9.4.1.2. Blinded Expanded-Enrollment Stage......................................120
9.4.2. Safety Analyses ........................................................................................121
9.4.2.1. Open-Label Sentinel-Cohort and Expanded-Enrollment 
Stages...............................................................................................121
9.4.2.2. Blinded Expanded-Enrollment Stage......................................123
9.5. Interim Analyses ...................................................................................................124
9.5.1. Analysis Timing........................................................................................124
9.6. Data Monitoring Committee or Other Independent Oversight Committee...........125
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS........................................................................................................126
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations.............126
10.1.1. Regulatory and Ethical Considerations ..................................................126
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.......................................................................126
10.1.2. Financial Disclosure ...............................................................................127
10.1.3. Informed Consent Process ......................................................................127
10.1.4. Data Protection .......................................................................................128
10.1.5. Dissemination of Clinical Study Data ....................................................128
10.1.6. Data Quality Assurance ..........................................................................130
10.1.7. Source Documents..................................................................................131
10.1.8. Study and Site Start and Closure ............................................................131
10.1.9. Publication Policy...................................................................................132
10.1.10. Sponsor’s Qualified Medical Personnel ...............................................133


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10.2. Appendix 2: Clinical Laboratory Tests ...............................................................133
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ....................................................................134
10.3.1. Definition of AE .....................................................................................134
10.3.2. Definition of an NDCMC.......................................................................135
10.3.3. Definition of SAE...................................................................................135
10.3.4. Recording/Reporting and Follow-up of AEs and/or SAEs.....................137
10.3.5. Reporting of SAEs..................................................................................140
10.4. Appendix 4: Contraceptive Guidance .................................................................140
10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments ......141
10.6. Appendix 6: Medical Device Adverse Events, Adverse Device Effects, 
Serious Adverse Events, and Device Deficiencies: Definition and Procedures 
for Recording, Evaluating, Follow-up, and Reporting............................................143
10.6.1. Definition of AE and ADE .....................................................................143
10.6.2. Definition of SAE, SADE, and Unanticipated Serious Adverse 
Device Effect .................................................................................................144
10.6.3. Definition of Device Deficiency.............................................................144
10.6.4. Recording/Reporting and Follow-up of AEs and/or SAEs and 
Device Deficiencies .......................................................................................145
10.6.5. Reporting of SAEs..................................................................................147
10.6.6. Reporting of SADEs...............................................................................148
10.7. Appendix 7: Alternative Measures During Public Emergencies ........................149
10.7.1. Telehealth Visits.....................................................................................149
10.7.2. Home Health Visits.................................................................................150
10.7.3. Adverse Events and Serious Adverse Events.........................................151
10.8. Appendix 8: Abbreviations .................................................................................152
11. REFERENCES ................................................................................................................155
LIST OF TABLES
Table 1.
Study Intervention Administration Schedule and SRSDs ........................65
Table 2.
Grading of Redness and Swelling.............................................................79
Table 3.
Grading of Tenderness..............................................................................80
Table 4.
Scale for Fever..........................................................................................80


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Table 5.
Protocol-Assigned Paracetamol Dosages and Schedules .........................82
Table 6.
Grading of Other Systemic Events ...........................................................83
Table 7.
Summary of AE Data Collection..............................................................89
Table 8.
Vaccine Groups and Descriptions ..........................................................111
Table 9.
Expected Half-Width of One-Sample 95% CIs for Different 
Scenarios of Percentage of Participants Achieving an hSBA Titer ≥
LLOQ for Each Test Strain.....................................................................112
Table 10.
Probability of Observing at Least 1 Event by Assumed True Event 
Rates .......................................................................................................113
Table 11.
Expected Half-Width of One-Sample 95% CIs for Different 
Scenarios of Percentage of Participants Achieving an hSBA Titer ≥
LLOQ for Each Test Strain.....................................................................114
Table 12.
Probability of Observing at Least 1 Event by Assumed True Event 
Rates .......................................................................................................114
LIST OF FIGURES
Figure 1.
Enrollment Strategy and Study Progression in Sentinel-Cohort 
Stage .........................................................................................................55


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PFIZER CONFIDENTIAL
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1. PROTOCOL SUMMARY
1.1. Synopsis
The purpose of the study is to describe the safety, tolerability, and immunogenicity of 
MenABCWY in healthy infants, beginning with infants 6 months of age and progressing to 
infants 2 months of age. The investigational pentavalent MenABCWY is composed of
licensed vaccines Trumenba® (serogroup B; bivalent rLP2086) and Nimenrix® (groups A, C, 
W-135, and Y; MenACWY-TT).
Cumulatively, 12,411 pediatric participants have been exposed to Nimenrix in clinical trials 
(4525 of whom received Nimenrix coadministered with other vaccines), with an acceptable 
safety profile in participants from 6 weeks of age. 
Bivalent rLP2086 has been evaluated in participants 1 through 25 years of age, where 120 µg 
of bivalent rLP2086 was shown to be safe and well tolerated and elicited a robust immune 
response. Bivalent rLP2086 was initially evaluated in the infant population in 
Study B1971008 where infants 2 months of age were to receive the final formulation at 20-, 
60-, 120-, or 200-µg dose levels coadministered with other routine vaccines. An initial 
sentinel cohort of 22 infants 2 months of age received 20 μg of bivalent rLP2086 and 64% of 
the infants experienced mild to moderate fever. Thereafter, the study progressed to the next 
sentinel cohort, in which infants 2 months of age received 60 μg of bivalent rLP2086. This 
study was prematurely terminated after 10 infants had received a first dose of 60 μg of 
bivalent rLP2086, as 9 of the 10 infants experienced mild to moderate fever. The design of 
this study did not include the administration of paracetamol prophylaxis and, at the time, a 
90% rate of fever was judged to be unacceptably high. Because of the current better 
understanding and acceptance of the higher incidence of fever seen with MenB vaccines and 
the impact of prophylactic paracetamol in reducing the occurrence of fever in infants, along 
with the acceptable safety profile of 120 μg of bivalent rLP2086 seen in toddlers 12 months 
of age, Pfizer has reconsidered the benefit/risk of evaluating bivalent rLP2086 in infants.
As 120 μg of bivalent rLP2086 is considered safe in toddlers 12 months of age, yet high rates 
of fever were observed in infants 2 months of age, this study will evaluate 120 μg of bivalent 
rLP2086 as part of MenABCWY (concomitantly with Prevenar 13® [13-valent 
pneumococcal conjugate vaccine] and Vaxelis [a hexavalent DTPa-HBV-IPV-Hib]) in an 
initial sentinel cohort of infants 6 months of age, after which a stepwise progression to 
infants 2 months of age will occur if supported by the safety findings in preceding cohorts. 
In infants 2 months of age, an initial sentinel cohort will receive 60 μg of bivalent rLP2086
and Nimenrix (concomitantly with Prevenar 13 and Vaxelis), after which, if supported by the 
safety findings, this age group will receive 120 μg of bivalent rLP2086 and Nimenrix
(concomitantly with Prevenar 13 and Vaxelis), and then 120 μg of bivalent rLP2086 as part 
of MenABCWY (concomitantly with Prevenar 13 and Vaxelis). Study progression will be 
dictated by safety data assessed by participant age, bivalent rLP2086 dose level, and 
protocol-assigned paracetamol regimen.


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During the conduct of the open-label sentinel stage, a stopping rule event triggered an 
evaluation of the protocol-assigned paracetamol regimen. This evaluation was reviewed by 
the IRC and EDMC, and the result was a data-driven adjustment to the paracetamol regimens
based on fevers observed in the study at the time. This adjustment was aimed at mitigating
unnecessary medical interventions occurring due to fever and has been implemented with 
protocol amendment 2.
In this study, the protocol-assigned paracetamol regimens will be used only in the primary 
series of vaccinations, which include the prophylactic liquid paracetamol regimen (PLP) with
3 required doses of paracetamol administered with the first dose starting 30 minutes before 
vaccination, the scheduled liquid paracetamol regimen (SLP) with an initial dosing schedule 
of 4 or 5 paracetamol doses starting no later than 8 hours after vaccination, and the 
therapeutic liquid paracetamol regimen (TLP) with an initial dosing schedule of 4 or 5
paracetamol doses given as treatment only when fever or other reactogenicity symptoms arise 
within 48 hours after the primary series vaccinations and require treatment (if no symptoms 
are experienced, no paracetamol will be given). These paracetamol dosing schedules can be 
modified at the discretion of the IRC based upon data obtained in the study.  The exact 
schedules of the different protocol-assigned paracetamol regimens will be provided in the 
paracetamol dosing instructions.
The inclusion of a licensed comparator is essential in a development program. Bexsero is a 
MenB vaccine currently approved for use in infants in Europe.  It is standard of care in some 
countries and will be used as the MenB component comparator in this study.
The study will be conducted in 3 stages as follows:

An open-label sentinel-cohort stage, aimed at demonstrating that 120 μg of 
bivalent rLP2086 as a separate injection or as part of MenABCWY is safe and 
immunogenic when administered to infants 2 months of age;

An open-label expanded-enrollment stage, aimed at obtaining additional safety 
and immunogenicity data when open-label MenABCWY is administered to 
infants 2 months of age;

A blinded expanded-enrollment stage, aimed at obtaining additional safety and 
immunogenicity data when MenABCWY is administered to infants 2 months of 
age in a blinded manner.
Objectives
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Primary Immunogenicity Objectives

To describe the immune response for MenA, MenC, MenW, and MenY induced by 
MenABCWY compared to the immune response induced by Nimenrix after 
2 primary vaccinations and after a booster dose.


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
To describe the immune response for MenB induced by MenABCWY compared to 
the immune response induced by Bexsero after 2 primary vaccinations and after a 
booster dose.

To describe the immune response for MenB induced by 60 µg and 120 µg of bivalent 
rLP2086 after 2 primary vaccinations and after a booster dose.
Primary Safety Objective

To describe the safety profile of MenABCWY after primary vaccinations, by 
protocol-assigned paracetamol regimen, and after a booster dose.
Secondary Immunogenicity Objective

To further describe the immune response for MenB induced by 60 µg and 120 µg of 
bivalent rLP2086 after 2 primary vaccinations and after a booster dose.
Secondary Safety Objective

To describe the safety profile of 60 µg and 120 µg of bivalent rLP2086 after primary 
vaccinations, with and without a protocol-assigned paracetamol regimen, and after a 
booster dose.
Blinded Expanded-Enrollment Stage
Primary Immunogenicity Objectives

To describe the immune response for MenA, MenC, MenW, and MenY induced by 
MenABCWY compared to the immune response induced by Nimenrix after 
2 primary vaccinations and after a booster dose.

To describe the immune response for MenB induced by MenABCWY compared to 
the immune response induced by Bexsero after 2 primary vaccinations and after a 
booster dose.
Primary Safety Objective

To describe the safety profile of MenABCWY after primary vaccinations, by 
protocol-assigned paracetamol regimen, and after a booster dose.


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Overall Design
This is a Phase 2b multicenter trial that will enroll up to 1272 healthy infants, beginning 
with infants 6 months of age, then on to infants 2 months of age.  The study will be 
conducted in 3 stages: an open-label sentinel-cohort stage, an open-label 
expanded-enrollment stage, and a blinded expanded-enrollment stage.  Approximately up 
to 472 participants will be enrolled in the open-label stages and up to 800 participants 
will be enrolled in the blinded expanded-enrollment stage of the study.  Participants will 
be randomized to receive 1 of the following:

MenABCWY,

Bivalent rLP2086 (60-µg or 120-µg dose level) and Nimenrix, or

Bexsero and Nimenrix. 
The safety, tolerability, and immunogenicity of MenABCWY will be evaluated in 
comparison with the licensed vaccines Bexsero and Nimenrix.
The open-label sentinel-cohort stage will comprise 5 cohorts (Cohorts 1 to 4 and a 
sentinel-control cohort) and 8 groups based on age, protocol-assigned paracetamol use,
and vaccine(s) to be administered.  During the open-label sentinel-cohort stage, for the 
primary vaccination series starting at 2 months of age, PLP will be used for all 
participants receiving 120 µg rLP2086, whereas SLP will be used for all 2-month-old 
participants receiving MenABCWY following the recommendations from the EDMC.
PLP or SLP will be used only in the primary series of vaccinations. These paracetamol 
dosing schedules can be modified at the discretion of the IRC based upon data obtained 
in the study. During this stage, approximately 50 participants 6 months of age and up to 
322 participants 2 months of age will be randomized. MenABCWY, 60 µg of bivalent 
rLP2086, 120 µg of bivalent rLP2086, Bexsero, and Nimenrix will be administered on a 
2 (primary doses) +1 (booster dose) schedule. Prevenar 13 and Vaxelis will be 
concomitantly administered to all sentinel-cohort participants during primary 
vaccinations. See Section 1.2 for each group’s vaccination and blood collection 
schedule.
For sentinel Cohorts 1 to 4, enrollment will be initiated in each cohort sequentially, 
starting with Cohort 1 (see Figure 1).  Enrollment in each of these cohorts will be 
restricted to 3 participants per day until the first 9 participants have been enrolled. A 
Pfizer IRC will review and evaluate the 7-day post–primary vaccination 1 safety data of 
each cohort and will control the study enrollment and progression. Stopping rules will 
apply to participants in sentinel Cohorts 1 to 4 for the 7-day safety period following 
primary vaccination 1 only. The study will progress to the open-label
expanded-enrollment stage following IRC review of post–primary vaccination 1 safety 
data from Cohort 4.


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Enrollment into the sentinel-control cohort, which will comprise randomization groups of 
participants receiving Bexsero and Nimenrix (with or without PLP), may occur at any 
time during the sentinel-cohort stage without IRC review of data from Cohorts 1 to 4.
In the open-label expanded-enrollment stage, approximately 50 to 100 participants 
2 months of age will be enrolled into 1 group (Group 11). The participants will receive 
MenABCWY with TLP as treatment only if fever or reactogenicity symptoms arise
within 48 hours after primary series vaccinations and require treatment (if no symptoms
are experienced, no paracetamol will be given). Enrollment of participants receiving
MenABCWY with TLP will be restricted to 3 participants per day until 9 participants 
have been enrolled. Seven days after the first 25 participants have received primary 
vaccination 1, e-diary and AE data from this group will be summarized, as well as e-diary 
and AE data from prior cohort(s) in the sentinel-cohort stage, for review by the sponsor’s 
IRC. Continuation with the enrollment of participants receiving MenABCWY with TLP 
into Group 11 and primary vaccination 2 for the participants already enrolled in Group 11
will not be permitted until IRC review of these safety data are complete and these data 
are found acceptable. With the IRC’s approval, enrollment will be continued, such that 
up to approximately 50 to 100 participants 2 months of age will be enrolled. At any point 
during the study conduct of Group 11, the IRC may determine that the remaining 
participants will be enrolled to receive MenABCWY with SLP, based on the safety data 
gathered. TLP or SLP administration in this group will be associated only with primary 
series vaccinations. These paracetamol dosing schedules can be modified at the 
discretion of the IRC based upon data obtained in the study.
MenABCWY, Bexsero, and Nimenrix will be administered on a 2+1 schedule. 
Prevenar 13 and Vaxelis will be concomitantly administered to all expanded-enrollment 
stage participants during primary vaccinations. See Section 1.2 for each group’s 
vaccination and blood collection schedule.
In the blinded expanded-enrollment stage, up to 800 participants will be enrolled and will 
receive the same study vaccinations as in the open-label expanded-enrollment stage, with 
participants randomized to receive MenABCWY additionally receiving placebo at each 
vaccination visit to maintain the study blind (Section 1.2.2). Enrollment will be stratified 
by protocol-assigned paracetamol use, either SLP or TLP for MenABCWY-receiving 
participants and PLP or TLP for Bexsero-receiving participants. The proportion of 
participants receiving each regimen being set by the sponsor is based on safety data 
gathered during the study. The protocol-assigned paracetamol use is only applicable to 
primary series vaccinations. The exact schedules of protocol assigned paracetamol 
regimens will be at the discretion of the IRC, may be adjusted as safety data become 
available, and will be described in the protocol-assigned paracetamol dosing instructions.


PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Data Monitoring Committee or Other Independent Oversight Committee
A Pfizer IRC will review and evaluate post–primary vaccination 1 safety data of each 
cohort in the open-label sentinel-cohort stage and the post–primary vaccination 1 safety 
data from the first 25 participants enrolled to the open-label expanded-enrollment stage
and will also perform other ad-hoc reviews of data as required for the purpose of study
enrollment and progression. In both the open-label and blinded expanded-enrollment 
stages, the exact schedules of protocol-assigned paracetamol regimens will be at the 
discretion of the IRC and may be adjusted as safety data become available. An EDMC 
will be informed of the IRC’s determinations. Enrollment and vaccination may proceed 
at the discretion of the IRC. The IRC will also review safety data after all open-label 
sentinel-cohort stage participants have completed primary vaccination 2, and when all 
open-label expanded-enrollment stage participants have completed primary vaccination 
2.
The EDMC will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter. Recommendations made by the EDMC will be forwarded 
to Pfizer for final decision making.
Statistical Methods
This is not a hypothesis-testing study; an estimation approach will be used to assess the 
immunogenicity and safety objectives in this study. All immunogenicity data will be 
summarized descriptively.  For all binary endpoints (including primary endpoints), 
counts, percentages, and 2-sided 95% CIs using the Clopper-Pearson method will be 
calculated.  For hSBA titer results, geometric means and 2-sided 95% CIs based on the 
t-distribution will be computed.  Statistical analyses will be carried out when the final 
data for the specified analyses are available (see Section 9.5.1).
The primary immunogenicity objectives will be evaluated by descriptive summary 
statistics for the percentages of participants achieving hSBA titers ≥LLOQ 1 month after 
primary vaccination 2 and 1 month after the booster vaccination.  Additionally, hSBA 
GMTs and the RCDCs of the hSBA titers will be provided for the specified time points to 
provide further characterization of the immune response.
The primary safety objective will be evaluated by descriptive summary statistics for local 
reactions, systemic events, and AEs, including SAEs, MAEs, and NDCMCs.


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1.2. Schema
1.2.1. Study Progression Flowchart
Open-Label Sentinel-Cohort Stage (Groups 1-5, 7, 8, and 10)
Cohorts 1-4
Sentinel-Control Cohort
Progression through Cohorts 1-4 based on 
IRC review of 7-day post–vaccination 1 
safety data
Enrollment into the sentinel-control cohort may 
occur at any time during the sentinel-cohort stage 
without IRC review of data from Cohorts 1-4.
Progression to the open-label expanded-enrollment stage based on
IRC review of 7-day post–vaccination 1 safety data from Cohort 4
Open-Label Expanded-Enrollment Stage (Group 11)
IRC review of 7-day post–vaccination 1 safety data for the first 25 participants and other ad-hoc data 
reviews to determine the enrollment progression into Group 11
Progression to the blinded expanded-enrollment stage based on IRC review of 
post–vaccination 2 or 3 immunogenicity data from Groups 5, 8, and 10
and all safety data available at the time of this analysis.  At a minimum, 
this will include safety data from all sentinel-cohort groups (Groups 1-5, 7, 8, and 10) and 7-day post–
vaccination 1 safety data from Group 11
The enrollment progression and the stratification of protocol-assigned paracetamol regimen use in the 
blinded expanded-enrollment stage will be at the discretion of IRC based on safety data review
Blinded Expanded-Enrollment Stage (Groups 13 and 14)


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1.2.2. Study Intervention Overview
Open-Label Sentinel-Cohort Stage:
Visit Description
Primary 
Vaccination
1
Safety 
Telephone
Contact
Primary 
Vaccination
2
Follow-up After 
Primary 
Vaccination 2
Booster
Vaccination
Follow-up After 
Booster 
Vaccination
Final
Telephone
Contact
Visit Identifier
1
2
3
4
5
6
7
Approximate Month of Agea
6
7
8
9
12
13
18
Cohort 1
Group 1 (n ~ 25)
MenABCWY + PLP
MenABCWY + PLP
MenABCWY
Cohort 2
Group 2 (n ~ 25)
MenABCWY
MenABCWY
MenABCWY
Approximate 
Months of Age
2
3
4
5
12
13
18
Group 3
(n ~ 37)
60 µg rLP2086 
+ Nimenrix + PLPb
60 µg rLP2086
+ Nimenrix + PLP
60 µg rLP2086 
+ Nimenrix
Cohort 3
Group 4
(n ~ 25)
60 µg rLP2086 
+ Nimenrix
60 µg rLP2086 
+ Nimenrix
60 µg rLP2086 
+ Nimenrix
Group 5
(n ~ 50)
120 µg rLP2086 
+ Nimenrix + PLP
120 µg rLP2086 + 
Nimenrix + PLP
120 µg rLP2086
+ Nimenrix
Cohort 4
Group 7
(n ~ 50-100)
MenABCWY + SLPc
MenABCWY + SLP
MenABCWY
Sentinel-
Control 
Cohortd
Group 8
(n ~ 55)
Bexsero +
Nimenrix + PLP
Bexsero +
Nimenrix + PLP
Bexsero + 
Nimenrix
Group 10
(n ~ 55)
Bexsero +
Nimenrix
Bexsero +
Nimenrix
Bexsero +
Nimenrix
Blood Draw
5 mL
5 mL
Abbreviations: bivalent rLP2086 = bivalent recombinant lipoprotein 2086 vaccine; EDMC = external data monitoring committee; IRC = institutional review board; 
PLP = prophylactic liquid paracetamol regimen; SLP = scheduled liquid paracetamol regimen.
Note: “rLP2086” refers to bivalent rLP2086.
Groups 6 and 9 were removed in protocol amendment 2 based on the EDMC’s recommendation.
a.
Participants 6 months of age (Groups 1 and 2) will receive Prevenar 13 and Vaxelis at 6 months of age (Visit 1). Participants 2 months of age (Groups 3-5, 7, 8 and 10) will 
receive Prevenar 13 and Vaxelis at 2 and 4 months of age (Visits 1 and 3).
b.
Protocol amendment 2 added 12 additional participants to Group 3 that will receive SLP for primary vaccinations.
c.
Group 7 will receive SLP as described in Section 8.2.1.2.
d.
Enrollment into the sentinel-control cohort may occur at any time during the sentinel-cohort stage without IRC review of data from Cohorts 1-4.


PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Open-Label Expanded-Enrollment Stage:
Visit Description
Primary 
Vaccination 1
Safety 
Telephone 
Contact 
Primary 
Vaccination 2
Follow-up After 
Primary 
Vaccination 2
Booster
Vaccination
Follow-up After 
Booster 
Vaccination
Final 
Telephone 
Contact
Visit Identifier
1
2
3
4
5
6
7
Approximate
Months of Agea
2
3
4
5
12
13
18
Group 11
(n ~ 50 to 100)
MenABCWY
+ TLPb
MenABCWY
+ TLP
MenABCWY
Blood Draw
5 mL
5 mL
Abbreviations: IRC = institutional review board; SLP = scheduled liquid paracetamol regimen; TLP = therapeutic liquid paracetamol regimen.
a.
Participants will receive Prevenar 13 and Vaxelis at 2 and 4 months of age (Visits 1 and 3).
b.
The protocol-assigned paracetamol regimen for Group 11 may be subject to change at the discretion of the IRC, and instead of TLP, some participants may 
receive SLP. See details in Section 8.2.1.2.


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Blinded Expanded-Enrollment Stage:
Visit Description
Primary 
Vaccination 1
Safety 
Telephone 
Contact 
Primary 
Vaccination 2
Follow-up After 
Primary 
Vaccination 2
Booster
Vaccination
Follow-up After 
Booster 
Vaccination
Final 
Telephone 
Contact
Visit Identifier
1
2
3
4
5
6
7
Approximate
Month of Agea
2
3
4
5
12
13
18
Group 13
(n = up to 400)b
MenABCWY
+ placebo + SLP or 
TLP
MenABCWY
+ placebo + SLP 
or TLP
MenABCWY
+ placebo
Group 14
(n = up to 400)b
Bexsero
+ Nimenrix
+ PLP or TLP
Bexsero
+ Nimenrix
+ PLP or TLP
Bexsero
+ Nimenrix
Blood Draw
5 mL
5 mL
Abbreviations: SLP = scheduled liquid paracetamol regimen; TLP = therapeutic liquid paracetamol regimen.
a.
Participants will receive Prevenar 13 and Vaxelis at 2 and 4 months of age (Visits 1 and 3).
b.
Up to 400 participants will be enrolled in Groups 13 and 14. See details in Section 4.1.3.   


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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant.
Primary 
Vaccination 1
Safety 
Telephone 
Contact 
Primary 
Vaccination 2
Follow-up 
After Primary 
Vaccination 2
Booster 
Vaccination
Follow-up 
After Booster 
Vaccination
Final Telephone 
Contact
Visit
1
2
3
4
5
6
7
Approximate Months of 
the Study
0
1
2
3
6a/10b
7a/11b
12a/16b
Approximate Months of 
Age:
Participants 6 Months 
of Age at 
Randomization
6
7
8
9
12
13
18
Participants 2 Months 
of Age at 
Randomization
2
3
4
5
12
13
18
Visit Window
Day 1
28 to 42 Days 
After Visit 1
63 to 77 Days 
After Visit 1
28 to 42 Days 
After Visit 3
365 to 386 
Days of Age
28 to 42 Days 
After Visit 5
168 to 196 Days 
After Last Study 
Vaccination
Informed consent
X
Review eligibility criteria
X
Demography
X
Confirm continued 
eligibility
X
X
X
X
X
Medical history and 
physical examination
X
Record previous 
PRP-OMP vaccinations
X


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Primary 
Vaccination 1
Safety 
Telephone 
Contact 
Primary 
Vaccination 2
Follow-up 
After Primary 
Vaccination 2
Booster 
Vaccination
Follow-up 
After Booster 
Vaccination
Final Telephone 
Contact
Visit
1
2
3
4
5
6
7
Approximate Months of 
the Study
0
1
2
3
6a/10b
7a/11b
12a/16b
Approximate Months of 
Age:
Participants 6 Months 
of Age at 
Randomization
6
7
8
9
12
13
18
Participants 2 Months 
of Age at 
Randomization
2
3
4
5
12
13
18
Visit Window
Day 1
28 to 42 Days 
After Visit 1
63 to 77 Days 
After Visit 1
28 to 42 Days 
After Visit 3
365 to 386 
Days of Age
28 to 42 Days 
After Visit 5
168 to 196 Days 
After Last Study 
Vaccination
Brief physical examination
X
X
Axillary temperature
X
X
X
Randomization
X
Obtain blood sample
5 mL
5 mL
Administer PLP before 
vaccination (PLP
participants only)c
X
X
Dispense protocol-assigned 
paracetamol to 
parent(s)/legal guardian 
(PLP, SLP, and TLP
participants only)
X
X
Investigational product 
administration and 
observationd
X
X
X
Record nonstudy 
vaccinations
X
X
X
X
X


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Primary 
Vaccination 1
Safety 
Telephone 
Contact 
Primary 
Vaccination 2
Follow-up 
After Primary 
Vaccination 2
Booster 
Vaccination
Follow-up 
After Booster 
Vaccination
Final Telephone 
Contact
Visit
1
2
3
4
5
6
7
Approximate Months of 
the Study
0
1
2
3
6a/10b
7a/11b
12a/16b
Approximate Months of 
Age:
Participants 6 Months 
of Age at 
Randomization
6
7
8
9
12
13
18
Participants 2 Months 
of Age at 
Randomization
2
3
4
5
12
13
18
Visit Window
Day 1
28 to 42 Days 
After Visit 1
63 to 77 Days 
After Visit 1
28 to 42 Days 
After Visit 3
365 to 386 
Days of Age
28 to 42 Days 
After Visit 5
168 to 196 Days 
After Last Study 
Vaccination
Provide provisioned 
e-diary or ensure diary app 
downloadede
X
X
X
Provide caliper, measuring 
tape/ruler, and 
thermometer, if necessary
X
X
X
Assess reactogenicity and 
record use of antipyretic 
medication
Days 1 to 7
Days 1 to 7
Days 1 to 7
Collect e-diary (if device 
provided)
X
X
Collect protocol-assigned 
paracetamol from 
parent(s)/legal guardian for 
accountability (PLP, SLP,
and TLP participants only)
X
X
Provide parent(s)/legal 
guardian a contact card
X
Provide parent(s)/legal 
guardian a memory aid
X
X
Complete Study 
Visit/Telephone Contact 
AE Checklist
X
X
X
X
X
X


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Primary 
Vaccination 1
Safety 
Telephone 
Contact 
Primary 
Vaccination 2
Follow-up 
After Primary 
Vaccination 2
Booster 
Vaccination
Follow-up 
After Booster 
Vaccination
Final Telephone 
Contact
Visit
1
2
3
4
5
6
7
Approximate Months of 
the Study
0
1
2
3
6a/10b
7a/11b
12a/16b
Approximate Months of 
Age:
Participants 6 Months 
of Age at 
Randomization
6
7
8
9
12
13
18
Participants 2 Months 
of Age at 
Randomization
2
3
4
5
12
13
18
Visit Window
Day 1
28 to 42 Days 
After Visit 1
63 to 77 Days 
After Visit 1
28 to 42 Days 
After Visit 3
365 to 386 
Days of Age
28 to 42 Days 
After Visit 5
168 to 196 Days 
After Last Study 
Vaccination
Record concomitant 
medications used to treat 
AEs
X
X
X
X
X
X
X
(S)AE collection 
appropriate for the visit
X
X
X
X
X
X
X
Abbreviations: e-diary = electronic diary; PLP = prophylactic liquid paracetamol regimen; PRP-OMP = polyribosylribitol phosphate oligosaccharide of 
Haemophilus influenzae type b conjugated to outer membrane protein; SLP = scheduled liquid paracetamol regimen; TLP = therapeutic liquid paracetamol
regimen.
a.
Approximate months of the study for participants in Groups 1 and 2.
b.
Approximate months of the study for participants in Groups 3 through 14.
c.
Record the first dose of PLP administration in the PLP participant’s e-diary.
d.
During blinded expanded-enrollment stage, study vaccines to be administered by unblinded administrator only.
e.
Ensure functionality of the provisioned e-diary device or the downloaded diary application.


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2. INTRODUCTION
Pfizer is developing a pentavalent meningococcal vaccine (MenABCWY) by combining 
Trumenba® (serogroup B; bivalent rLP2086) and Nimenrix® (groups A, C, W-135, and Y; 
MenACWY-TT), 2 commercially available vaccines, into a single vaccine to prevent 
invasive disease caused by the 5 major meningococcal serogroups: A, B, C, W, and Y. 
Trumenba is composed of 2 recombinant lipidated fHBP variants from serogroup B, one 
from fHBP subfamily A (A05) and one from subfamily B (B01), and is approved for active 
immunization of individuals 10 through 25 years of age in the United States and individuals 
10 years of age and older in Europe to prevent invasive disease caused by 
Neisseria meningitidis serogroup B.
Nimenrix is composed of capsular polysaccharides from each of the A, C, W-135, and Y 
groups of N meningitidis conjugated to tetanus toxoid. It is approved in Europe and other 
locations for active immunization of individuals 6 weeks of age and older against IMD
caused by N meningitidis groups A, C, W-135, and Y and is included as a comparator in this 
study.
MenABCWY is a pentavalent meningococcal vaccine composed of bivalent rLP2086 
(120 µg of meningococcal group B vaccine) and Nimenrix (5 µg of each of the 4
meningococcal polysaccharides from groups A, C, W-135, and Y conjugated to 44 µg of 
tetanus toxoid).
Bexsero is another MenB vaccine that is approved for active immunization of individuals 10 
through 25 years of age in the United States and individuals 2 months of age and older in 
Europe to prevent invasive disease caused by N meningitidis group B and is included as a 
comparator in this study.
2.1. Study Rationale
MenABCWY is composed of bivalent rLP2086 (120 µg of meningococcal group B vaccine) 
and Nimenrix (5 µg of each of the 4 meningococcal polysaccharides A, C, W-135, and Y 
conjugated to 44 µg of tetanus toxoid).
Nimenrix is a licensed vaccine currently approved in a 2+1 schedule for infants 6 weeks to 
less than 6 months of age, in a 1+1 schedule for infants 6 to 12 months of age, and as a single 
dose thereafter. Cumulatively, 12,411 pediatric participants have been exposed to Nimenrix
in clinical trials (4525 of whom received Nimenrix coadministered with other vaccines), with 
an acceptable safety profile.
Trumenba was initially evaluated in the infant population in Study B1971008 where infants 
2 months of age were to receive the final formulation of bivalent rLP2086 at 20-, 60-, 120-, 
or 200-µg dose levels coadministered with other routine vaccines. An initial sentinel cohort 
of 22 infants 2 months of age received 20 μg of bivalent rLP2086, and 64% of the infants 
experienced mild to moderate fever.  Thereafter, the study progressed to the next sentinel 
cohort, in which infants 2 months of age received 60 μg of bivalent rLP2086. This study was 
prematurely terminated after 10 infants had received a first dose of 60 μg of bivalent 


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rLP2086, as 9 of the 10 infants experienced mild to moderate fever. The design of this study 
did not include the administration of paracetamol prophylaxis and, at the time, a 90% rate of 
fever was judged to be unacceptably high.
The bivalent rLP2086 clinical development program also evaluated adolescents where 
bivalent rLP2086 at a dose of 120 µg was shown to be safe and well tolerated and elicited a 
robust immune response. Bivalent rLP2086 at a dose of 60 µg was also evaluated in 
adolescents, showing a safety profile comparable to the 120-µg dose; however, the 120-µg 
dose exhibited higher immunogenicity for more MenB test strains, maximizing the breadth of 
coverage. Following evaluation in adolescents and young adults, 120 µg of bivalent rLP2086 
was evaluated in toddlers and children 1 to <10 years of age, where it was shown to be safe 
and well tolerated and elicited a robust immune response.
Several years after the termination of Study B1971008, Bexsero (another MenB vaccine) was 
licensed in Europe for use in infants. High rates of mild to moderate fever (up to 70%) were 
also reported in clinical trials evaluating Bexsero when administered alone and even higher 
rates when coadministered with routine vaccination. However, rates of fever were shown to 
be reduced with the administration of prophylactic paracetamol, particularly fever ≥39.0°C.1
After the approval of Bexsero in the EU, some European countries instituted MenB routine 
vaccination programs as standard of care where the primary series is initiated in infants 2 or 
3 months of age. The use of prophylactic paracetamol was also introduced as standard of 
care in some European countries as a measure to reduce rates of fever experienced in infants 
receiving Bexsero.
Because of the better understanding and acceptance of the higher incidence of fever seen 
with MenB vaccines and the impact of prophylactic paracetamol in reducing the occurrence 
of fever in infants, along with the acceptable safety profile of 120 μg of bivalent rLP2086 
seen in toddlers 12 months of age, Pfizer decided to reconsider the evaluation of bivalent 
rLP2086 in infants. As 120 μg of bivalent rLP2086 is considered safe in toddlers 12 months 
of age, yet high rates of fever were observed in infants 2 months of age, it was determined 
appropriate to initiate this study evaluating 120 μg of bivalent rLP2086 as part of 
MenABCWY (concomitantly with Prevenar 13® [13-valent pneumococcal conjugate 
vaccine] and Vaxelis [a hexavalent DTPa-HBV-IPV-Hib]) in an initial sentinel cohort of 
infants 6 months of age, after which progression would occur stepping down to infants 
2 months of age. In infants 2 months of age, an initial sentinel cohort will receive 60 μg of 
bivalent rLP2086 and Nimenrix (concomitantly with Prevenar 13 and Vaxelis), after which, 
if supported by the safety findings, this age group will receive 120 μg of bivalent rLP2086
and Nimenrix (concomitantly with Prevenar 13 and Vaxelis), and then 120 μg of bivalent 
rLP2086 as part of MenABCWY (concomitantly with Prevenar 13 and Vaxelis). Study
progression will be dictated by safety and immunogenicity data assessed by participant age, 
bivalent rLP2086 dose level, and protocol-assigned paracetamol use.


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During the conduct of the open-label sentinel stage, a stopping rule event triggered an 
evaluation of the paracetamol regimen. This evaluation was reviewed by the IRC and 
EDMC, and the result was a data-driven adjustment to paracetamol regimens based on fevers 
observed in the study at the time. This adjustment aimed to mitigate unnecessary medical 
interventions occurring due to fever and has been implemented with protocol amendment 2.
In this study, the protocol-assigned paracetamol regimens will be used only in the primary 
series of vaccinations, which include the prophylactic liquid paracetamol regimen (PLP) with 
3 required doses of paracetamol administered with the first dose starting 30 minutes before 
vaccination, the scheduled liquid paracetamol regimen (SLP) with an initial dosing schedule 
of 4 or 5 paracetamol doses starting no later than 8 hours after vaccination, and the 
therapeutic liquid paracetamol regimen (TLP) with an initial dosing schedule of 4 or 5
paracetamol doses given as treatment only when fever or other reactogenicity symptoms arise 
within 48 hours after the primary series vaccinations and require treatment (if no symptoms 
are experienced, no paracetamol will be given). These paracetamol dosing schedules can be 
modified at the discretion of the IRC based upon data obtained in the study. The exact 
schedules of the different protocol-assigned paracetamol regimens will be provided in the 
paracetamol dosing instructions.
The inclusion of a licensed comparator is essential in a development program. Bexsero is 
another MenB vaccine currently approved for use in infants in Europe and will be used as the 
MenB component comparator. Bexsero is licensed in infants 2 months of age and is standard 
of care in some EU countries as a 2- or 3-dose primary series plus a booster dose
administered between 12 and 15 months of age (2+1 or 3+1). This study will evaluate 
MenABCWY in infants 2 months of age using a 2+1 dosing schedule and will be conducted 
in 3 stages as follows:

An open-label sentinel-cohort stage, aimed at demonstrating that 120 μg of 
bivalent rLP2086 as a separate injection or as part of MenABCWY is safe and 
immunogenic when administered to infants 2 months of age;

An open-label expanded-enrollment stage, aimed at obtaining additional safety 
and immunogenicity data when open-label MenABCWY is administered to 
infants 2 months of age;

An blinded expanded-enrollment stage, aimed at obtaining additional safety and 
immunogenicity data when MenABCWY is administered to infants 2 months of 
age in a blinded manner.


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2.2. Background 
2.2.1. Background of the Disease and Medical Need
N meningitidis is an obligate human pathogen that colonizes the upper respiratory tract,
which, in some individuals, can cause serious, life-threatening IMD, which clinically 
presents as septicemia, meningitis, or both.2 IMD is rare in EU/EEA countries, but is a 
severe and life-threatening disease. The greatest burden is in infants and young children,
with a relatively high case fatality and up to one-fifth of all survivors suffering from 
long-term sequelae.3 N meningitidis groups A, B, C, W-135, and Y are 5 of the 6 
meningococcal serogroups that cause the vast majority of meningococcal disease globally,4
and disease incidence is highest in infants and young children.3 In Europe, meningococcal 
disease is primarily caused by group B, followed by groups W and C.3
In Europe, the peak of disease in infants occurs around 5 to 6 months of age.5,6 Current 
preventive vaccination strategies require separate immunizations at different times for a 
MenACWY conjugate vaccine as well as a separate group B vaccine. In Europe, MenB has 
become the most common cause of IMD over the past several years and MenB now exceeds 
all other serogroups in incidence, accounting for 70% of IMD among children under the age 
of 1 year, with groups C, W, Y, and other serogroups, including A, accounting for the other 
30%.3 These data show that all 5 serogroups causing the majority of meningococcal disease 
globally also contribute to disease in infants and that a multivalent vaccine incorporating 
group B would have significant public health utility. These data also show that initiating
immunization at 2 months of age would provide protection to the age groups with the highest 
disease burden.
Given that meningococcal groups B, C, W, and Y cause disease in infants through early 
adolescence and young adulthood, with unacceptable mortality and morbidity outcomes with 
a high contribution of group B to IMD in this age group, a safe and effective pentavalent 
vaccine, which is currently not available, would fulfill an unmet need for broad protection 
against IMD that is more durable in the setting of the disease’s changing epidemiology.
2.2.2. Clinical Overview
Cumulatively, 12,411 pediatric participants from 6 weeks of age and older have received
Nimenrix in clinical trials (4525 of whom received Nimenrix coadministered with other 
vaccines), with an acceptable safety profile.
The Trumenba clinical development program evaluated adolescents and adults for whom
Trumenba at a dose of 120 µg was shown to be safe and well tolerated and elicited a robust 
immune response. Trumenba at a dose of 60 µg was also evaluated in adolescents, showing 
a safety profile comparable to the 120-µg dose; however, the 120-µg dose exhibited higher 
immunogenicity for more MenB test strains, maximizing the breadth of coverage. Following 
evaluation in adolescents and young adults, 120 µg of bivalent rLP2086 was evaluated in 
toddlers and children 1 to <10 years of age, where it was shown to be safe and well tolerated
and elicited a robust immune response. In Study B1971008, infants 2 months of age were to 
receive the final formulation of Trumenba at 20-, 60-, 120-, or 200-µg dose levels 
coadministered with other routine vaccines. 


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An initial sentinel cohort of 22 infants 2 months of age received 20 μg of bivalent rLP2086,
and 64% of infants experienced mild to moderate fever. Thereafter, the study progressed to 
the next sentinel cohort of infants 2 months of age, who received 60 μg of bivalent rLP2086. 
This study was prematurely terminated after 10 infants had received a first dose of 60 μg of 
bivalent rLP2086, as 9 of the 10 infants experienced mild to moderate fever. 
In Study B1971057, an FIH and POC study for MenABCWY, 543 participants between 
10 and 25 years of age received MenABCWY on a 0- and 6-month schedule.  Results from 
Study B1971057 indicated that in adolescents and adults, MenABCWY is well tolerated,
with an acceptable safety profile, and also provides a high degree of protective immune 
responses without interference among all 5 serogroup components. 
2.3. Benefit/Risk Assessment
As previously described, the greatest burden of IMD is in infants and young children, with a 
relatively high case fatality and up to one-fifth of all survivors suffering from long-term 
sequelae. Current preventive vaccination strategies require separate immunizations at 
different times for vaccines against the different serogroups. A safe and effective pentavalent 
vaccine, which is currently not available, would fulfill an unmet need for broad protection 
against 5 serogroups causing IMD in these populations.
Trumenba and Nimenrix were proven to be immunogenic and to have an acceptable safety 
profile in children above 1 year of age, adolescents, and adults. Nimenrix was also proven to 
be immunogenic and safe in infants above the age of 6 weeks. Consequently, Bexsero and 
Nimenrix are standards of care in some EU countries. Study B1971008, which evaluated 
Trumenba in infants 2 months of age, was prematurely terminated after 10 infants had 
received a first dose of 60 μg of bivalent rLP2086, as 9 of the 10 infants experienced mild to 
moderate fever. The design of this study did not include the administration of paracetamol
prophylaxis and, at the time, a 90% rate of fever was judged to be unacceptably high. This 
initial perception of unacceptable fever rates has changed over time after the evidence of 
Bexsero’s showing high rates of fever (up to 70%) that were reduced with the use of 
prophylactic paracetamol.1
In the FIH Study B1971057, MenABCWY provided a high degree of immunologic
protection against IMD caused by N meningitidis groups A, B, C, W, and Y in adolescents 
and young adults. MenABCWY was statistically noninferior to Trumenba for the MenB 
component and to MenACWY-CRM for the MenA, MenC, MenW, and MenY components 
in participants who had received a prior vaccination with a MenACWY-containing vaccine
as well as those naïve to a MenACWY vaccine. No new safety events were identified in this 
study. 
This Phase 2b study is one of several studies in the MenABCWY development program, 
which, if successful, could provide a broadly protective, safe, comprehensive, and 
first-in-class meningococcal vaccine that could contribute significantly to a simplified 
vaccination program for the prevention of IMD.


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Trumenba and Nimenrix are licensed vaccines. Common AEs noted after vaccination are 
primarily related to reactogenicity, including local reactions and systemic events. See more 
details in Section 2.3.1.
As with any vaccine, an allergic reaction may occur. Symptoms of an allergic reaction can
include swelling of the lips, mouth, and throat, which may cause difficulty in swallowing or
breathing; skin rash; swelling of the hands, feet, and ankles; dizziness; and fainting. A severe
allergic shock (anaphylactic shock) may occur. There may also be additional risks related to
the vaccines administered in the study that are unknown at this time. 
Risks that may be associated with study procedures include risk from blood sampling, such
as fainting, tenderness, swelling, bruising, and infection in the vicinity of the vein from 
where blood is taken.
Safety assessments described in this protocol and ongoing safety data reviews by the
investigator, and the sponsor’s global medical monitor, the internal safety data review
subcommittee, the internal risk management committee, and the EDMC will serve to monitor 
and mitigate these risks.
More detailed information about the known and expected benefits and risks and reasonable 
expected AEs of MenABCWY may be found in the MenABCWY IB, which is the SRSD for 
MenABCWY for this study. Detailed safety information for Nimenrix, Bexsero, 
Prevenar 13, Vaxelis, and paracetamol can be found in their SmPCs, and detailed safety 
information for bivalent rLP2086 (60-µg and 120-µg doses) can be found in the Trumenba 
IB (Table 1). The SmPC of paracetamol is the Lithuanian SmPC for Panadol 
(120 mg/5 mL).


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2.3.1. Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s): Vaccinations With MenABCWY, Trumenba, Nimenrix, Bexsero, Prevenar 13, Vaxelis, and Paracetamol
Potential risks that may be associated with 
MenABCWY in adolescents and young 
adults based on clinical trial experience with 
bivalent rLP2086, Nimenrix, and 
MenABCWY include the following: 
headache, nausea, diarrhea, vomiting, 
myalgia, arthralgia, injection site pain, 
fatigue, chills, injection site swelling, 
injection site redness, fever, loss 
of/decreased appetite, irritability, insomnia, 
crying, drowsiness, hypoesthesia, dizziness, 
rash, pruritus, pain in extremity, injection 
site hematoma, malaise, and injection site 
reaction (including induration, pruritus, 
warmth, and anesthesia).
Potential risk of medical evaluations and/or 
diagnostic procedures due to reactogenicity 
fever in infants. 
Potential risks that may be associated with 
MenABCWY in infants based on clinical 
trial experience with Nimenrix include the 
following: loss of/decreased appetite, 
irritability/fussiness, insomnia, crying, 
drowsiness, diarrhea, nausea, vomiting, rash, 
injection site pain, injection site swelling, 
injection site redness, fever, injection site 
hematoma, malaise, and injection site 
reaction (including induration, pruritus, 
warmth, and anesthesia).
Potential risks that may be associated with 
MenABCWY based on postmarketing 
experience with bivalent rLP2086 and 
The potential risks that may be reported 
with MenABCWY are based on the known 
safety profiles of the component vaccines,
bivalent rLP2086 and Nimenrix, as 
presented in the MenABCWY IB (based on 
the bivalent rLP2086 CDS and Nimenrix 
CDS).
Eligibility criteria have been selected to ensure that only 
appropriate healthy participants are included in the study 
(see Section 5).
Enrollment will be initiated in each numbered cohort 
sequentially in the sentinel-cohort stage. Enrollment in 
Cohorts 1 to 4 will be restricted to 3 participants per day until 
the first 9 participants have been enrolled.
In the sentinel stage, the vaccine will be initially given to
infants 6 months of age, and then to infants 2 months of age, 
along with protocol-assigned paracetamol administration 
during primary vaccinations. 
E-diary and AE data will be monitored daily by the 
investigator (or designee) and the sponsor during the first 7 
days (including nonbusiness days) after primary vaccination 1
(Section 8.2.1). The IRC determines the study enrollment and 
progression upon review and evaluation of the 7-day safety 
data.
Fever management procedures will be followed as described 
(Section 8.2.1.2.2).
Stopping rules are clearly defined for safety management and 
study progression control (Section 8.2.4.1). 
Protocol amendment 2 implemented EDMC recommendations 
based on the evaluation of the paracetamol regimens and 
resulted in a data-driven adjustment to the paracetamol 
regimen based on fevers observed in the study at the time. This 
adjustment aimed at mitigating unnecessary medical 
interventions occurring due to fever.


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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Nimenrix are as follows: extensive limb 
swelling at the injection site, frequently 
associated with erythema, sometimes 
involving the adjacent joint or swelling of 
the entire injected limb; lymphadenopathya;
allergic reactions; and syncope.
The risks associated with Trumenba 
observed in adolescents and young adults 10 
years of age and older based on clinical trial 
experience with bivalent rLP2086 are as 
follows: headache, nausea, diarrhea, 
vomiting, myalgia, arthralgia, injection site 
pain, fatigue, chills, injection site swelling, 
injection site redness, and fever. 
The risks associated with Trumenba in 
toddlers 12 to <24 months of age based on 
clinical trial experience with bivalent 
rLP2086 are as follows: drowsiness, 
irritability (fussiness), loss of/decreased 
appetite, injection site pain, injection site 
swelling, injection site redness, and fever.
In clinical studies, fever occurred more 
frequently as participant age decreased.
The risks associated with Trumenba based on 
postmarketing experience are as follows: 
allergic reactions and syncope.
Potential risk of medical evaluations and/or 
diagnostic procedures due to reactogenicity 
fever in infants. 
The potential risks are based on the known 
safety profile of Trumenba as presented in 
the Trumenba IB (based on the bivalent 
rLP2086 CDS).
Eligibility criteria have been selected to ensure that only 
appropriate healthy participants are included in the study (see
Section 5).
Enrollment will be initiated in each cohort sequentially in the 
sentinel-cohort stage. Enrollment in Cohorts 1 to 4 will be 
restricted to 3 participants per day until the first 9 participants 
have been enrolled.
In the sentinel stage, the vaccine will be initially given to 
participants at half of the full dose (60 µg), and then the full 
dose (120 µg), with or without protocol-assigned paracetamol
administration during primary vaccinations. 
E-diary and AE data will be monitored daily by the 
investigator (or designee) and the sponsor during the first 7 
days (including nonbusiness days) after primary vaccination 1
(Section 8.2.1). The IRC determines the study enrollment and 
progression upon review and evaluation of the 7-day safety 
data.
Fever management procedures will be followed as described
(Section 8.2.1.2.2).  
Stopping rules are clearly defined for safety management and 
study progression control (Section 8.2.4.1). 
Protocol amendment 2 implemented EDMC recommendations 
based on the evaluation of the paracetamol regimen and 
resulted in a data-driven adjustment to the paracetamol 
regimen based on fevers observed in the study at the time. 


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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
This adjustment aimed at mitigating unnecessary medical 
interventions occurring due to fever.
The risks associated with Nimenrix in 
individuals 6 weeks up to 55 years of age 
based on clinical trial experience include the 
following: loss of/decreased appetite, 
irritability, insomnia, crying, drowsiness, 
headache, hypoesthesia, dizziness, diarrhea, 
vomiting, nausea, pruritus, rash, myalgia, 
pain in extremity, fever, injection site pain, 
injection site swelling, injection site redness, 
fatigue, injection site hematoma, malaise, 
and injection site reaction (including 
induration, pruritus, warmth, and anesthesia).
The risks associated with Nimenrix based on 
postmarketing experience are as follows:
extensive limb swelling at the injection site, 
frequently associated with erythema, 
sometimes involving the adjacent joint or 
swelling of the entire injected limb;
lymphadenopathy.
The risks are based on the known safety 
profile of Nimenrix in infants as presented 
in the product labeling Nimenrix SmPC.
Eligibility criteria have been selected to ensure that only 
appropriate healthy participants are included in the study (see 
Section 5).
Individuals with significant reactions after the first vaccination 
or AEs considered by the investigator to present increased risk 
to the participant if rechallenged with the second vaccination,
or who develop exclusionary conditions during the conduct of 
the study, will be excluded from further vaccinations.
The risks associated with Bexsero observed
in infants and children up to 10 years of age 
based on clinical trial experience include the 
following:
Very common and common: eating 
disorders, sleepiness, unusual crying, 
headache, diarrhea, vomiting, rash,
arthralgia, fever (≥38°C), injection site 
tenderness, injection site erythema, injection 
site swelling, injection site induration, and 
irritability.
Uncommon: seizure (including febrile 
seizure), pallor, eczema, and fever (≥40°C).
Rare: Kawasaki syndrome and urticaria.
The risks are based on the known safety 
profile of Bexsero in infants and children up 
to 10 years of age as presented in the 
Bexsero SmPC.
Eligibility criteria have been selected to ensure that only 
appropriate healthy participants are included in the study 
(see Section 5).
In the sentinel stage, the vaccine will be given to participants 
initially with PLP administration during primary vaccinations. 
E-diary and AE data will be monitored daily by the 
investigator (or designee) and the sponsor during the first 7 
days (including nonbusiness days) after primary vaccination 1
(Section 8.2.1). The IRC determines the study enrollment and 
progression upon review and evaluation of the 7-day safety 
data.


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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
The risks associated with Bexsero in infants 
and children up to 10 years of age based on 
postmarketing experience include the 
following: allergic reactions (including 
anaphylactic reactions), hypotonic-
hyporesponsive episode, meningeal irritation 
(signs of meningeal irritation, such as neck 
stiffness or photophobia), and injection site 
reactions (including extensive swelling of the 
vaccinated limb, blisters at or around the 
injection site, and injection site nodule,
which may persist for more than 1 month).
Potential risk of medical evaluations and/or 
diagnostic procedures due to reactogenicity 
fever in infants.
Fever management procedures will be followed as described 
(Section 8.2.1.2.2).
Stopping rules are clearly defined for safety management and 
study progression control (Section 8.2.4.1). 
The risks associated with Prevenar 13
observed in infants and children 6 weeks to 
5 years of age based on clinical trial 
experience include the following:
hypersensitivity reaction including facial
edema, dyspnea, and bronchospasm; 
convulsions (including febrile convulsions); 
hypotonic-hyporesponsive episode; 
decreased appetite; vomiting; diarrhea; rash; 
urticaria or urticaria-like rash; pyrexia, 
irritability, injection site tenderness,
erythema, and swelling; somnolence, poor-
quality sleep; pyrexia >39°C; and 
vaccination site movement impairment (due 
to pain).
The risks associated with Prevenar 13 in 
infants and children 6 weeks to 5 years of 
age based on postmarketing experience are
as follows: lymphadenopathy (localized to 
the region of the vaccination site);
The risks are based on the known safety 
profile of Prevenar 13 in infants and 
children 6 weeks to 5 years of age as 
presented in the product labeling (SmPC).
Eligibility criteria have been selected to ensure that only 
appropriate healthy participants are included in the study (see 
Section 5).
Individuals with significant reactions after the first vaccination 
or AEs considered by the investigator to present increased risk 
to the participant if rechallenged with the second vaccination,
or who develop exclusionary conditions during the conduct of 
the study, will be excluded from further vaccinations.


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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
anaphylactic/anaphylactoid reaction 
including shock; angioedema; erythema 
multiforme; vaccination site urticaria; 
vaccination site dermatitis; vaccination site 
pruritus; flushing; and apnea in very 
premature infants (≤28 weeks of gestation).
The common and very common risks
associated with Vaxelis in infants from 6 
weeks of age based on clinical trial 
experience include the following:
decreased appetite, somnolence, vomiting, 
diarrhea, crying, irritability, injection site 
erythema, injection site pain, injection site 
swelling, pyrexia, injection site bruising, 
injection site induration, and injection site 
nodule.
The risks associated with Vaxelis in infants 
from 6 weeks of age based on postmarketing 
experience are as follows: 
hypotonic-hyporesponsive episode.
The risks are based on the known safety 
profile of Vaxelis (diphtheria, tetanus, 
pertussis [acellular, component], hepatitis B 
(rDNA), poliomyelitis [inactivated], and 
Haemophilus influenzae type b conjugate 
vaccine [adsorbed]) in infants and toddlers 
as presented in the product labeling (SmPC).
Eligibility criteria have been selected to ensure that only 
appropriate healthy participants are included in the study (see 
Section 5).
Individuals with significant reactions after the first vaccination 
or AEs considered by the investigator to present increased risk 
to the participant if rechallenged with the second vaccination 
or who develop exclusionary conditions during the conduct of 
the study will be excluded from further vaccinations.
The risks associated with paracetamol 
120-mg/5-mL oral suspension based on 
postmarketing experience include the 
following:
Very rare: thrombocytopenia, anaphylaxis, 
increased skin sensitivity reactions 
(including skin rash, angioedema, Stevens-
Johnson syndrome, and toxic epidermal 
necrolysis), hepatic impairment, and 
bronchospasm in patients with 
hypersensitivity to acetylsalicylic acid and 
other NSAIDs. 
Cases of hepatic impairment (failure) have 
been reported in patients with glutathione 
deficiency. Paracetamol should be 
The risks are based on the known safety 
profile as presented in the product labeling 
of paracetamol 120-mg/5-mL oral 
suspension (Lithuanian SmPC for Panadol).
Eligibility criteria have been selected to ensure that only 
appropriate healthy participants are included in the study. In 
addition, individuals with prior adverse reactions to 
paracetamol use, including allergic reactions, will be excluded 
(see Section 5).
Individuals with significant reactions after oral administration 
of paracetamol or AEs considered by the investigator to 
present increased risk to the participant will be excluded from 
the study.
Parent(s)/legal guardian will be instructed to administer 
protocol-assigned paracetamol according to the protocol. 
Parent(s)/legal guardian will be instructed not to coadminister 
other paracetamol-containing medications during the period of 
protocol-assigned paracetamol use.


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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
administered with caution to patients with 
renal and hepatic impairment. Paracetamol 
usage with other medicines containing 
paracetamol may cause an overdose. 
Paracetamol overdose may lead to liver 
failure, which may require a liver 
transplantation, or may cause death. 
Paracetamol oral suspension containing 
maltitol and sorbitol should not be used in
patients with hereditary fructose intolerance.
E-diary and AE data will be monitored daily by the 
investigator (or designee) and the sponsor during the first 7 
days (including nonbusiness days) after primary vaccination 1 
(Section 8.2.1). The IRC determines the study enrollment and 
progression upon review and evaluation of the 7-day safety 
data.
Fever management procedures will be followed as described 
(Section 8.2.1.2.2).  
Stopping rules are clearly defined for safety management and 
study progression control (Section 8.2.4.1).
Study Procedures: Venipuncture
There is the risk of bleeding, bruising, 
hematoma formation, and infection at the 
venipuncture site.
Venipuncture is required to collect 
immunogenicity data from participants.
Only qualified nurses, physicians, nurse practitioners, 
physician’s assistants, phlebotomists, or medical assistants 
certified or otherwise authorized to draw blood per the 
standards and procedures of the investigative site as allowed 
by institutional, local, and country guidance will be allowed to 
draw blood, to minimize local complications.
a.
Lymphadenopathy is included in the SmPC for Nimenrix but is not listed in the CDS as its causality is not clear.


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2.3.2. Benefit Assessment
Based on the known degree of protective immunogenicity afforded by the licensed vaccines
Trumenba, Nimenrix, and Bexsero, as well as data for the investigational vaccine 
MenABCWY from the FIH Study B1971057, the potential benefits of participation in this 
study and receipt of all vaccination doses include protection against IMD caused by 
N meningitidis groups A, B, C, W, and Y after receipt of all scheduled vaccinations.
The potential benefits of participation in this study also include protective immunity afforded 
by licensed vaccines Prevenar 13 and Vaxelis for prevention of invasive disease caused by 
13 S pneumoniae serotypes, and diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and 
Hib, respectively.
Other benefits to the individual participant may include physical examination by a medical
provider at the start of the study and prior to each study vaccination, a thorough review of the
participant’s vaccination status, and evaluations and management of some illnesses (AEs) 
that occur during participation in the study as part of protocol-specified scheduled and 
unscheduled assessments. 
2.3.3. Overall Benefit/Risk Conclusion
Taking into account that Bexsero and Nimenrix are standards of care in some EU countries 
and the measures implemented to minimize risk to participants in this study, the potential 
risks of vaccination with MenABCWY, Trumenba, Nimenrix, and Bexsero (which primarily 
include transient, mild to moderate local reactions and systemic events and the potential risks 
for minor complications from intramuscular injections or venipuncture) are justified by the 
anticipated benefits (protective immunity against IMD) that participants may receive.


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3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS
3.1. Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Sera obtained from participants enrolled in the open-label stages may be used for exploratory analysis and meningococcal assay 
development as a priority over the analysis as shown in the estimands below, based on availability of serum volume.
Objectives
Estimands
Endpoints
Primary Immunogenicity:
Primary Immunogenicity:
Primary Immunogenicity:
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by MenABCWY compared 
to the immune response induced by 
Nimenrix after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group combinations:
Groups 7+11 (MenABCWY recipients) 
Groups 8+10 (Nimenrix recipients)
The percentage of participants achieving an hSBA titer ≥LLOQ for each MenA, 
MenC, MenW, and MenY test strain 1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:
The percentage of participants achieving an hSBA titer ≥LLOQ for each MenA, 
MenC, MenW, and MenY test strain 1 month after the booster vaccination.
hSBA titer for each of the 
MenA, MenC, MenW, and 
MenY test strains.
To describe the immune response for 
MenB induced by MenABCWY 
compared to the immune response 
induced by Bexsero after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group combinations:
Groups 7+11 (MenABCWY recipients)
Groups 8+10 (Bexsero recipients)
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.
hSBA titer for each of the MenB 
test strains (TBD).


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Objectives
Estimands
Endpoints
To describe the immune response for 
MenB induced by 60 µg and 120 µg 
of bivalent rLP2086 after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group or combination:
Groups 3+4 (60 µg bivalent rLP2086 recipients)
Group 5 (120 µg bivalent rLP2086 recipients)
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.
hSBA titer for each of the MenB 
test strains (TBD).
Primary Safety:
Primary Safety:
Primary Safety:
To describe the safety profile of 
MenABCWY after primary 
vaccinations, by protocol-assigned 
paracetamol regimen, and after a
booster dose.
In participants receiving at least 1 dose of investigational product, expressed by 
protocol-assigned paracetamol regimen and irrespective of protocol-assigned 
paracetamol regimen receipt, in the following group combinations:
Groups 7+11 (MenABCWY recipients with SLP or TLP) 
Groups 8+10 (Bexsero + Nimenrix recipients with or without PLP)
The percentage of participants reporting local reactions, systemic events, and use 
of antipyretic medication within 7 days after each primary vaccination. 
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
During the primary series follow-up phase (from Visits 4-5).
Throughout the primary series stage (from Visits 1-5).
The percentage of participants reporting at least 1 AE during the following time 
periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
Local reactions (tenderness, 
redness, and swelling). 
Systemic events (fever, 
increased sleep, decreased 
appetite, and irritability).
Use of antipyretic medication.
AEs, SAEs, MAEs, NDCMCs, 
and immediate AEs.


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Objectives
Estimands
Endpoints
The percentage of participants reporting at least 1 immediate AE after each 
primary vaccination.
In participants who completed primary vaccinations and received a booster dose, 
expressed in the same group combinations as above, regardless of protocol-
assigned paracetamol regimen receipt during the primary vaccination series:
The percentage of participants reporting local reactions, systemic events, and use 
of antipyretic medication within 7 days after the booster vaccination. 
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:
During the booster vaccination phase (from Visits 5-6).
During the booster follow-up phase (from Visits 6-7)
Throughout the booster stage (from Visits 5-7).
The percentage of participants reporting at least 1 AE during the following time 
period:
During the booster vaccination phase (from Visits 5-6).
The percentage of participants reporting at least 1 immediate AE after the booster 
vaccination.
Secondary Immunogenicity:
Secondary Immunogenicity:
Secondary Immunogenicity:
To further describe the immune 
response for MenB induced by 60 µg 
and 120 µg of bivalent rLP2086 after 
2 primary vaccinations and after a 
booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group or combination:
Groups 3+4 (60 µg bivalent rLP2086 recipients)
Group 5 (120 µg bivalent rLP2086 recipients)
hSBA GMTs for each of the MenB test strains 1 month after primary vaccination 
2.
In participants who completed primary vaccinations and received a booster dose,
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:
hSBA GMTs for each of the MenB test strains 1 month after the booster 
vaccination.
hSBA titer for each of the MenB 
test strains (TBD).


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Objectives
Estimands
Endpoints
Secondary Safety:
Secondary Safety:
Secondary Safety:
To describe the safety profile of 60 
µg and 120 µg of bivalent rLP2086 
after primary vaccinations, by
protocol-assigned paracetamol
regimen, and after a booster dose.
In participants receiving at least 1 dose of investigational product, expressed by 
protocol-assigned paracetamol regimen and irrespective of protocol-assigned 
paracetamol regimen receipt, in the following groups:
Group 3 (60 µg bivalent rLP2086 + Nimenrix + PLP recipients)
Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients)
Group 5 (120 µg bivalent rLP2086 + Nimenrix + PLP recipients)
The percentage of participants reporting local reactions, systemic events, and use 
of antipyretic medication within 7 days after each primary vaccination.
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
During the primary series follow-up phase (from Visits 4-5).
Throughout the primary series stage (from Visits 1-5).
The percentage of participants reporting at least 1 AE during the following time 
periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
The percentage of participants reporting at least 1 immediate AE after each 
primary vaccination.
In participants who completed primary vaccinations and received a booster dose, 
expressed in the same groups as above, regardless of protocol-assigned 
paracetamol regimen receipt during primary vaccinations:
The percentage of participants reporting local reactions, systemic events, and use 
of antipyretic medication within 7 days after the booster vaccination. 
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:
During the booster vaccination phase (from Visits 5-6).
During the booster follow-up phase (from Visits 6-7).
Throughout the booster stage (from Visits 5-7).
Local reactions (tenderness, 
redness, and swelling). 
Systemic events (fever, 
increased sleep, decreased 
appetite, and irritability).
Use of antipyretic medication.
AEs, SAEs, MAEs, NDCMCs, 
and immediate AEs.


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Objectives
Estimands
Endpoints
The percentage of participants reporting at least 1 AE during the following time 
period:
During the booster vaccination phase (from Visits 5-6).
The percentage of participants reporting at least 1 immediate AE after the booster 
vaccination.
Tertiary/Exploratory 
Immunogenicity:
Tertiary/Exploratory Immunogenicity:
Tertiary/Exploratory 
Immunogenicity:
To further describe the immune 
response for MenA, MenC, MenW, 
and MenY induced by MenABCWY 
compared to the immune response 
induced by Nimenrix after 2 primary 
vaccinations and after a booster dose.  
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group combinations: 
Groups 7+11 (MenABCWY recipients) 
Groups 8+10 (Nimenrix recipients)
hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:
hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after the booster vaccination.
hSBA titer for each of the 
MenA, MenC, MenW, and 
MenY test strains.
To further describe the immune 
response for MenB induced by 
MenABCWY compared to the 
immune response induced by 
Bexsero after 2 primary vaccinations 
and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group combinations: 
Groups 7+11 (MenABCWY recipients) 
Groups 8+10 (Bexsero recipients)
hSBA GMTs for each of the MenB test strains 1 month after primary vaccination 
2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the following group combinations as above:
hSBA GMTs for each of the MenB test strains 1 month after the booster 
vaccination.
hSBA titer for each of the MenB 
test strains (TBD).


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Objectives
Estimands
Endpoints
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by 2 doses of MenABCWY 
compared to the immune response 
induced by 2 doses of Nimenrix, by 
protocol-assigned paracetamol 
regimen.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed by protocol-
assigned paracetamol regimen and irrespective of protocol-assigned paracetamol 
regimen receipt, in the following group combinations:
Groups 7+11 (MenABCWY recipients with SLP or TLP)  
Groups 8+10 (Nimenrix recipients with or without PLP)
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenA, MenC, MenW, and MenY test strains 1 month after primary vaccination 2.
hSBA titer for each of the 
MenA, MenC, MenW, and 
MenY test strains.
To describe the immune response for 
MenB induced by 2 doses of 
MenABCWY compared to the 
immune response induced by 2 doses 
of Bexsero, by protocol-assigned 
paracetamol regimen.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed by protocol-
assigned paracetamol regimen and irrespective of protocol-assigned paracetamol 
regimen receipt, in the following group combinations:
Groups 7+11 (MenABCWY recipients with SLP or TLP)  
Groups 8+10 (Bexsero recipients with or without PLP)
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.
hSBA titer for each of the MenB 
test strains (TBD).
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by MenABCWY after 2 
primary vaccinations and after a 
booster dose in healthy infants 6 
months of age at study entry.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group combination:
Groups 1+2 (MenABCWY recipients) 

The percentage of participants achieving an hSBA titer ≥ LLOQ for each 
MenA, MenC, MenW, and MenY test strain 1 month after primary 
vaccination 2.

hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combination as above:
The percentage of participants achieving an hSBA titer ≥ LLOQ for each MenA, 
MenC, MenW, and MenY test strain 1 month after the booster vaccination.
hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after the booster vaccination.
hSBA titer for each of the 
MenA, MenC, MenW, and 
MenY test strains.


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Objectives
Estimands
Endpoints
To describe the immune response for 
MenB induced by MenABCWY after 
2 primary vaccinations and after a 
booster dose in healthy infants 6 
months of age at study entry.
In participants receiving primary vaccinations 1 and 2, who are in compliance 
with the key protocol criteria (evaluable participants), expressed in the following 
group combination:
Groups 1+2 (MenABCWY recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each of 
the MenB test strains 1 month after primary vaccination 2.

hSBA GMTs for each of the MenB test strains 1 month after primary 
vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combination as above:
The percentage of participants achieving an hSBA titer ≥ LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.
hSBA GMTs for each of the MenB test strains 1 month after the booster 
vaccination.
hSBA titer for each of the MenB 
test strains (TBD).
Tertiary/Exploratory Safety:
Tertiary/Exploratory Safety:
Tertiary/Exploratory Safety:
To describe the safety profile of 
MenABCWY after primary 
vaccinations with and without PLP, 
and after a booster dose in 
participants 6 months of age.
In participants receiving at least 1 dose of investigational product, expressed with, 
without, and irrespective of PLP receipt during primary vaccinations, in Groups 1 
and 2:
Group 1 (MenABCWY + PLP recipients)
Group 2 (MenABCWY recipients)
The percentage of participants reporting local reactions, systemic events, and use 
of antipyretic medication within 7 days after each primary vaccination.
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
Throughout the primary series stage (from Visits 1-5).
The percentage of participants reporting at least 1 AE during the following time 
periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
Local reactions (tenderness, 
redness, and swelling).
Systemic events (fever, 
increased sleep, decreased 
appetite, and irritability).
Use of antipyretic medication.
AEs, SAEs, MAEs, NDCMCs, 
and immediate AEs.


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Objectives
Estimands
Endpoints
The percentage of participants reporting at least 1 immediate AE after each 
primary vaccination.
In participants who completed primary vaccinations and received a booster dose, 
expressed in Groups 1 and 2 as above, regardless of PLP receipt during primary 
vaccinations:
The percentage of participants reporting local reactions, systemic events, and use 
of antipyretic medication within 7 days after the booster vaccination. 
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:
During the booster vaccination phase (from Visits 5-6).
During the booster follow-up phase (from Visits 6-7).
Throughout the booster stage (from Visits 5-7).
The percentage of participants reporting at least 1 AE during the following time 
period:
During the booster vaccination phase (from Visits 5-6).
The percentage of participants reporting at least 1 immediate AE after the booster 
vaccination.


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3.2. Blinded Expanded-Enrollment Stage
Objectives
Estimands
Endpoints
Primary Immunogenicity:
Primary Immunogenicity:
Primary Immunogenicity:
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by MenABCWY compared to 
the immune response induced by 
Nimenrix after 2 primary vaccinations 
and after a booster dose.
In participants receiving primary vaccinations 1 and 2 who are in compliance with 
the key protocol criteria (evaluable participants) expressed in the following group 
combinations:
Group 13 (MenABCWY recipients)
Group 14 (Nimenrix recipients)
The percentage of participants achieving an hSBA titer ≥ LLOQ for each MenA, 
MenC, MenW, and MenY test strain 1 month after primary vaccination 2.
hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 1 month 
after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, and 
who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:
The percentage of participants achieving an hSBA titer ≥ LLOQ for each MenA, 
MenC, MenW, and MenY test strain 1 month after the booster vaccination.
hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains after the 
booster vaccination.
hSBA titer for each of the MenA, 
MenC, MenW, and MenY test 
strains.
To describe the immune response for 
MenB induced by MenABCWY 
compared to the immune response 
induced by Bexsero after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2 who are in compliance with 
the key protocol criteria (evaluable participants) expressed in the following group 
combinations:
Group 13 (MenABCWY recipients)
Group 14 (Bexsero recipients)
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.
hSBA GMTs for each of the MenB test strains 1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, and 
who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:
The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.
hSBA GMTs for each of the MenB test strains after the booster vaccination.
hSBA titer for each of the MenB 
test strains (TBD).


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Objectives
Estimands
Endpoints
Primary Safety:
Primary Safety:
Primary Safety:
To describe the safety profile of 
MenABCWY after primary 
vaccinations, by protocol-assigned 
paracetamol regimen, and after a 
booster dose.
In participants receiving at least 1 dose of investigational product, expressed by 
protocol-assigned paracetamol regimen receipt in the following groups:
Group 13 (MenABCWY recipients with SLP or TLP) 
Group 14 (Bexsero + Nimenrix recipients with PLP or TLP)
The percentage of participants reporting local reactions, systemic events, and use of 
antipyretic medication within 7 days after each primary vaccination. 
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at least 1 
NDCMC during the following time periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
During the primary series follow-up phase (from Visits 4-5).
Throughout the primary series stage (from Visits 1-5).
The percentage of participants reporting at least 1 AE during the following time 
periods:
30 Days after each primary vaccination.
30 Days after any primary vaccination.
During the primary series vaccination phase (from Visits 1-4).
The percentage of participants reporting at least 1 immediate AE after each primary 
vaccination.
In participants who completed primary vaccinations and received a booster dose, 
expressed by protocol-assigned paracetamol regimen receipt in the same groups as 
above, during the primary vaccination series:
The percentage of participants reporting local reactions, systemic events, and use of 
antipyretic medication within 7 days after the booster vaccination. 
The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at least 1 
NDCMC during the following time periods:
During the booster vaccination phase (from Visits 5-6).
During the booster follow-up phase (from Visits 6-7).
Throughout the booster stage (from Visits 5-7).
Local reactions (tenderness, 
redness, and swelling). 
Systemic events (fever, increased 
sleep, decreased appetite, and 
irritability).
Use of antipyretic medication. 
AEs, SAEs, MAEs, NDCMCs, 
and immediate AEs.


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Objectives
Estimands
Endpoints
The percentage of participants reporting at least 1 AE during the following time 
period:
During the booster vaccination phase (from Visits 5-6).
The percentage of participants reporting at least 1 immediate AE after the booster 
vaccination.


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4. STUDY DESIGN
4.1. Overall Design
This is a Phase 2b multicenter trial that will enroll up to 1272 healthy infants, beginning with 
infants 6 months of age and progressing to infants 2 months of age. All participants will be 
naive to any meningococcal vaccines prior to enrollment.  The study will be conducted in 
3 stages: an open-label sentinel-cohort stage, an open-label expanded-enrollment stage, and a 
blinded expanded-enrollment stage.  Approximately up to 472 participants will be enrolled in 
the open-label stages and up to 800 will be enrolled in the blinded expanded-enrollment stage 
of this study.  An overview of study progression through these stages is shown in 
Section 1.2.1.
During each stage, participants will receive coadminstered Prevenar 13 and Vaxelis per the 
national immunization schedule for a primary series. Local reactions, systemic events, and 
use of antipyretic/pain medications will be collected by e-diary for 7 days following primary 
vaccinations 1 and 2 and the booster vaccination (Section 8.2.1).
During the conduct of the open-label sentinel stage, a stopping rule event triggered an 
evaluation of the protocol-assigned paracetamol regimen. This evaluation was reviewed by 
the IRC and EDMC, and the result was a data-driven adjustment to the paracetamol timing 
based on fevers observed in the study at the time. This adjustment aimed to mitigate 
unnecessary medical interventions occurring due to fever and has been implemented with 
protocol amendment 2.
4.1.1. Open-Label Sentinel-Cohort Stage
The sentinel-cohort stage will comprise 5 cohorts (Cohorts 1 to 4 and a sentinel-control 
cohort) and 8 groups based on age, protocol-assigned paracetamol use, and vaccine(s) to be 
administered (see Section 1.2). Protocol-assigned paracetamol will be applicable only to 
vaccinations in the primary series. Approximately 50 participants 6 months of age and up to 
322 participants 2 months of age will be randomized into the following cohorts/groups, with 
randomization groups containing Bexsero and Nimenrix being enrolled at any time (Groups 8 
and 10):

Cohort 1
o
Group 1 (n~25): infants 6 months of age will receive MenABCWY with PLP

Cohort 2
o
Group 2 (n~25): infants 6 months of age will receive MenABCWY without PLP
o
Group 3 (n~37): infants 2 months of age will receive 60 µg of bivalent rLP2086 
and Nimenrix with PLP or SLP


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
Cohort 3 
o
Group 4 (n~25): infants 2 months of age will receive 60 µg of bivalent rLP2086 
and Nimenrix without PLP
o
Group 5 (n~50): infants 2 months of age will receive 120 µg of bivalent rLP2086 
and Nimenrix with PLP

Cohort 4
o
Group 7 (n~50-100): infants 2 months of age will receive MenABCWY with SLP 
(the exact schedule of the protocol-assigned paracetamol regimen will be at the 
discretion of the IRC, may be subject to change on an ongoing basis as data 
become available, and will be described in the protocol-assigned paracetamol 
dosing instructions).

Sentinel-control cohort
o
Group 8 (n~55): infants 2 months of age will receive Bexsero and Nimenrix with 
PLP
o
Group 10 (n~55): infants 2 months of age will receive Bexsero and Nimenrix 
without PLP
MenABCWY, 60 µg bivalent rLP2086, 120 µg bivalent rLP2086, Bexsero, and Nimenrix
will be administered on a 2 (primary doses) + 1 (booster dose) schedule.
Prevenar 13 and Vaxelis will be concomitantly administered to all sentinel-cohort
participants during primary vaccinations. Participants 6 months of age (Groups 1 and 2) will 
receive Prevenar 13 and Vaxelis at 6 months of age (Visit 1). Participants 2 months of age 
(Groups 3-10) will receive Prevenar 13 and Vaxelis at 2 and 4 months of age (Visits 1 and 3). 
4.1.1.1. Cohorts 1 to 4
For Cohorts 1 to 4, enrollment will be initiated in each cohort sequentially, starting with 
Cohort 1. Enrollment in each of these cohorts will be restricted to 3 participants per day until 
9 participants have been enrolled.  Seven days after the last participant in each cohort has 
received primary vaccination 1, e-diary and AE data from that cohort will be summarized, as 
well as e-diary and AE data from prior cohort(s) (if applicable), for review by the sponsor’s 
IRC. Primary vaccination 2 in the corresponding cohort and enrollment into the subsequent 
cohort will not be permitted until IRC review of these safety data are complete and these data 
are found acceptable (see Figure 1). Stopping rules will apply to participants in Cohorts 1 to 
4 for the 7-day safety period following primary vaccination 1 only (Section 8.2.4.1). The 
number of participants in a specific group may be increased by up to 25% by the sponsor, as 
needed, if more safety data for that group is deemed beneficial.


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The study will progress to the open-label expanded-enrollment stage following IRC review 
of post–primary vaccination 1 safety data from Cohort 4. A summary of study progression 
through the sentinel-cohort stage is shown in Figure 1.
In order to provide ongoing oversight of participant safety, 7 days after all the sentinel-cohort 
stage participants have completed primary vaccination 2, reactogenicity and AE data from all 
participants available at the time will be summarized for review by the IRC.
4.1.1.2. Sentinel-Control Cohort
Enrollment into the sentinel-control cohort may occur at any time during the sentinel-cohort 
stage without IRC review of data from Cohorts 1 to 4.  Enrollment into the sentinel-control 
cohort will not be subject to enrollment restrictions imposed on Cohorts 1 to 4, and fewer 
stopping rules will apply to participants in this cohort (Section 8.2.4.1).
During the IRC review of reactogenicity and AE data from participants in Cohorts 1 to 4
(post-vaccination 1 and 2), available reactogenicity and AE data from participants in the 
sentinel-control cohort will also be reviewed.
A planned analysis will be conducted after Groups 5, 8, and 10 participants have completed 
Visit 4, 1 month after primary vaccination 2.  This analysis will include immunogenicity data 
from Groups 5, 8, and 10 up to 1 month after vaccination 2, and all safety data available at 
that time which, at a minimum, will include safety data from all sentinel-cohort groups 
(Groups 1-5, 7, 8, and 10). See Section 9.5.1.  The study will progress to the blinded stage if 
the safety and immunogenicity data from this analysis are deemed acceptable by the sponsor, 
or if safety and immunogenicity data from the equivalent analysis 1 month after the booster 
vaccination are deemed acceptable. 
4.1.2. Open-Label Expanded-Enrollment Stage
The open-label expanded-enrollment stage will include 1 additional treatment group (Group 
11) with approximately 50 to 100 participants (see Section 1.2) that will receive 
MenABCWY and TLP as treatment only if fever or other reactogenicity symptoms arise
within 48 hours after primary series vaccinations (if no symptoms are experienced, no 
paracetamol will be given). Enrollment of participants receiving MenABCWY with TLP
will be restricted to 3 participants per day until 9 participants have been enrolled. Seven days 
after the first 25 participants have received primary vaccination 1, e-diary and AE data from 
this group will be summarized, as well as e-diary and AE data from prior cohort(s) in the 
sentinel-cohort stage, for review by the sponsor’s IRC. Continuation with the enrollment of 
participants receiving MenABCWY with TLP into Group 11 and primary vaccination 2 for 
the participants already enrolled in Group 11 will not be permitted until IRC review of these 
safety data are complete and these data are found acceptable. With the IRC’s approval, 
enrollment will be continued such that up to approximately 50 to 100 participants 2 months 
of age will be enrolled as below. At any point during the study conduct of Group 11, the IRC 
may determine that the remaining participants will be enrolled to receive MenABCWY with 
SLP, based on the safety data gathered. TLP or SLP administration in this group will be 
associated only with primary series vaccinations. Group 11 (n~50 to 100): infants 2 months 


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of age will receive MenABCWY with TLP (the exact schedule of the protocol-assigned 
paracetamol regimen will be at the discretion of the IRC, may be subject to change on an 
ongoing basis as data become available, and will be described in the protocol-assigned 
paracetamol dosing instructions).
MenABCWY will be administered on a 2+1 schedule. Prevenar 13 and Vaxelis will be 
concomitantly administered to all expanded-enrollment stage participants during primary 
series vaccinations. Participants 2 months of age will receive Prevenar 13 and Vaxelis at 2 
and 4 months of age (Visits 1 and 3). 
In order to provide ongoing oversight of participant safety, 7 days after all 
expanded-enrollment stage participants have completed primary vaccination 2, reactogenicity 
and AE data from all participants available at the time will be summarized for review by the 
IRC.  
A planned analysis of safety and immunogenicity data will be conducted after all 
expanded-enrollment stage participants have completed Visit 4, 1 month after primary 
vaccination 2. A further planned analysis of safety and immunogenicity data will be 
conducted after all open-label stage participants have completed Visit 6, 1 month after the 
booster vaccination (see Section 9.5.1).


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Figure 1.
Enrollment Strategy and Study Progression in Sentinel-Cohort Stage


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4.1.3. Blinded Expanded-Enrollment Stage 
The following groups will be included in the blinded phase (see Section 1.2):

Group 13 (n = up to 400): infants 2 months of age will receive MenABCWY + placebo
with SLP or TLP

Group 14 (n = up to 400): infants 2 months of age will receive Bexsero + Nimenrix with 
PLP or TLP
The study vaccination schedule, including that for Prevenar 13 and Vaxelis, will be the same 
as for the expanded-enrollment stage, but participants in Group 13 will receive both 
MenABCWY and placebo, rather than MenABCWY alone, in order to maintain the study 
blind.
In the blinded stage, enrollment will be stratified by protocol-assigned paracetamol use, with 
the proportion of participants receiving each regimen being set by the sponsor based on 
safety data gathered during the study. The protocol-assigned paracetamol use is only 
applicable to primary series vaccinations. Participants enrolled in Groups 13 and 14 and 
assigned TLP will follow a double-blind design. Participants in Groups 13 and 14 who are 
assigned SLP and PLP, respectively, will follow a single-blind design due to the differences 
in the paracetamol regimens. The exact number of participants to be enrolled into each group
and each stratum for protocol-assigned paracetamol use, enrollment speed, and exact 
schedules of protocol-assigned paracetamol regimens will be at the discretion of the IRC,
may be subject to change as safety data become available, and will be described in the 
protocol-assigned paracetamol dosing instructions.
Planned safety analysis based on the numbers of participants enrolled per protocol-assigned 
paracetamol regimen following the double-blind and single-blind design will be detailed in 
the SAP.
4.1.4. Approximate Duration of Participation for Each Participant
Participants enrolled at 6 months of age will be in the study for approximately 12 months. 
Participants enrolled at 2 months of age will be in the study for approximately 16 months.  
4.1.5. Approximate Number of Participants
Up to 1272 participants will be enrolled, with approximately up to 472 participants in the 
open-label stages and up to 800 in the blinded expanded-enrollment stage.
4.2. Scientific Rationale for Study Design
The aim of the study is to assess the safety, tolerability, and immunogenicity of 
MenABCWY in healthy infants, initially 6 months of age, and then going down in age to 
infants 2 months of age. MenABCWY is composed of 2 vaccines already licensed in 
Europe, Trumenba (120 µg bivalent rLP2086) and Nimenrix (MenACWY-TT). 


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The MenACWY component of MenABCWY, Nimenrix (MenACWY-TT), is a licensed 
vaccine currently approved in a 2+1 schedule for infants 6 weeks to less than 6 months of 
age, in a 1+1 schedule for infants 6 to 12 months of age, and as a single dose thereafter. 
Clinical studies of Nimenrix in the pediatric population have demonstrated an acceptable 
safety profile. 
The MenB component of MenABCWY, bivalent rLP2086, was initially evaluated in the 
infant population in Study B1971008 where infants 2 months of age were to receive the final 
formulation of bivalent rLP2086 at 20-, 60-, 120-, or 200-µg dose levels coadministered with 
other routine vaccines. An initial sentinel cohort of 22 infants 2 months of age received 
20 μg of bivalent rLP2086, and 64% of the infants experienced mild to moderate fever.  
Thereafter, the study progressed to the next sentinel cohort of infants 2 months of age, who
received 60 μg of bivalent rLP2086. This study was prematurely terminated after 10 infants 
had received a first dose of 60 μg of bivalent rLP2086, as 9 of the 10 infants experienced 
mild to moderate fever. The design of this study did not include the administration of 
paracetamol prophylaxis and, at the time, a 90% rate of fever was judged to be unacceptably 
high.
The bivalent rLP2086 clinical development program also evaluated adolescents where 
bivalent rLP2086 at a dose of 120 µg was shown to be safe and well tolerated and elicited a 
robust immune response. Bivalent rLP2086 at a dose of 60 µg was also evaluated in 
adolescents showing a safety profile comparable to the 120-µg dose; however, the 120-µg 
dose exhibited higher immunogenicity for more MenB test strains, maximizing the breadth of 
coverage. Following evaluation in adolescents and young adults, 120 µg of bivalent rLP2086 
was evaluated in toddlers and children 1 to <10 years of age, where it was shown to be safe 
and well tolerated and elicited a robust immune response. 
Several years after the termination of Study B1971008, Bexsero (another MenB vaccine) was 
licensed in Europe in infants. High rates of mild to moderate fever (up to 70%) were also 
reported in clinical trials evaluating Bexsero when administered alone with higher rates when 
coadministered with routine vaccination. However, rates of fever were shown to be reduced 
with the administration of prophylactic paracetamol, particularly fever ≥39.0°C.1 After the 
approval of Bexsero in the EU, some European countries instituted MenB routine vaccination 
programs where the primary series is initiated in infants 2 or 3 months of age. The use of 
prophylactic paracetamol was also introduced as standard of care in some European countries 
as a measure to reduce rates of fever experienced in infants receiving Bexsero.
Because of the better understanding and acceptance of the higher incidence of fever seen 
with MenB vaccines and the impact of prophylactic paracetamol in reducing the occurrence 
of fever in infants, along with the acceptable safety profile of 120 μg of bivalent rLP2086 
seen in toddlers 12 months of age, Pfizer has reconsidered the benefit and risk of evaluating
bivalent rLP2086 in infants. As 120 μg of bivalent rLP2086 is considered safe in toddlers 
12 months of age, yet high rates of fever were observed in infants 2 months of age, this study 
will evaluate 120 μg of bivalent rLP2086 as part of MenABCWY (concomitantly with 
Prevenar 13 and Vaxelis) in an initial sentinel cohort of infants 6 months of age, after which 
a stepwise progression to infants 2 months of age will occur if supported by the safety 


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findings. In infants 2 months of age, an initial sentinel cohort will receive 60 μg of bivalent 
rLP2086 and Nimenrix (concomitantly with Prevenar 13 and Vaxelis), after which, if 
supported by the safety findings, this age group will receive 120 μg of bivalent rLP2086 with 
Nimenrix (concomitantly with Prevenar 13 and Vaxelis), and then 120 μg of bivalent 
rLP2086 as part of MenABCWY. Throughout the sentinel stage, the study progression will 
be dictated by safety data assessed by participant age, bivalent rLP2086 dose level, and 
protocol-assigned paracetamol use.
The inclusion of a licensed comparator is essential in a development program. Bexsero is a 
MenB vaccine currently approved in infants in Europe and will be used as the MenB 
component comparator. Bexsero is licensed in infants 2 months of age as a 2- or 3-dose 
primary series plus a booster dose administered between 12 and 15 months of age (2+1 or 
3+1). This study will evaluate MenABCWY in infants 2 months of age using a 2+1 dosing 
schedule.
4.3. Justification for Dose
Trumenba (120 µg of bivalent rLP2086) is supplied as a 0.5-mL dose PFS, while Nimenrix is 
supplied as a lyophilized powder in a single-dose vial and a solvent in a PFS to be 
reconstituted for injection.
MenABCWY consists of 120 µg of bivalent rLP2086, supplied as a high-fill-volume PFS, 
which is used to reconstitute Nimenrix, and 0.5 mL of the resultant MenABCWY is 
administered via intramuscular injection. 
Trumenba (120 μg of bivalent rLP2086) is considered safe in toddlers 12 months of age, yet 
high rates of fever were observed in infants 2 months of age; therefore, it was determined 
appropriate to initiate this study evaluating 120 μg of bivalent rLP2086 as part of 
MenABCWY (concomitantly with Prevenar 13 and Vaxelis) in an initial sentinel cohort of 
infants 6 months of age, after which progression would occur stepping down in age to infants 
2 months of age. In infants 2 months of age, an initial sentinel cohort will receive 60 μg of 
bivalent rLP2086 and Nimenrix (concomitantly with Prevenar 13 and Vaxelis), after which 
this age group will receive 120 μg of bivalent rLP2086 and Nimenrix (concomitantly with 
Prevenar 13 and Vaxelis), and then 120 μg of bivalent rLP2086 as part of MenABCWY
(concomitantly with Prevenar 13 and Vaxelis). Study progression will be dictated by safety 
data assessed by participant age, bivalent rLP2086 dose level, and protocol-assigned 
paracetamol use.
4.4. End of Study Definition
A participant is considered to have completed the study if he/she has completed all phases of 
the study, including the last scheduled procedure shown in the SoA.
The end of the study is defined as the date of the last scheduled procedure shown in the SoA
for the last participant in the trial globally.


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5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled.  The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate.  All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a particular participant is suitable for this 
protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Male and female participants:

Open-label sentinel-cohort stage: 2 months of age (≥60 to ≤98 days) or 6 months of 
age (≥150 to ≤210 days) at the time of randomization.

Open-label expanded-enrollment stage and blinded expanded-enrollment stage: 
2 months of age (≥60 to ≤98 days) at the time of randomization.
Type of Participant and Disease Characteristics:
2. Participant’s parent(s)/legal guardian who are willing and able to comply with all 
scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Participant is available for the entire study period and the participant’s parent(s)/legal 
guardian can be reached by telephone.
4. Healthy participant as determined by medical history, physical examination, and 
judgment of the investigator.
Weight
5. Body weight ≥4 kg for participants 2 months of age at the time of randomization.
Informed Consent:
6. Participants whose parent(s)/legal guardian are capable of giving signed informed 
consent as described in Appendix 1, which includes compliance with the requirements 
and restrictions listed in the ICD and in this protocol.


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5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Prior adverse reaction to paracetamol use, including allergic reactions.
2. Participant was born prematurely (<37 weeks of gestation).
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would 
contraindicate intramuscular injection.
5. A known or suspected defect of the immune system that would prevent an immune 
response to the vaccine, such as participants with congenital or acquired defects in B-cell 
function, those receiving chronic systemic (oral, intravenous, or intramuscular) 
corticosteroid therapy, or those receiving immunosuppressive therapy. Please refer to the 
ISF for additional details.
6. History of microbiologically proven disease caused by N meningitidis or 
Neisseria gonorrhoeae.
7. Significant neurological disorder or history of seizure (including simple febrile seizure).
8. Any neuroinflammatory or autoimmune condition, including, but not limited to, 
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
9. Other acute or chronic medical or psychiatric condition or laboratory abnormality that 
may increase the risk of study participation or, in the investigator’s judgment, make the 
participant inappropriate for the study.
Prior/Concomitant Therapy:
10. Previous vaccination with any meningococcal vaccine. Written vaccination history must 
be obtained prior to randomization.
11. For participants 2 months of age, prior vaccination with any of the following licensed or 
investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or 
its component, except for the birth dose of hepatitis B vaccine. 
12. Participants receiving any allergen immunotherapy with a nonlicensed product or 
receiving allergen immunotherapy with a licensed product and are not on stable 
maintenance doses.
13. Receipt of any blood products, including immunoglobulin, before the first study 
vaccination.


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14. Current chronic use of systemic antibiotics.
Prior/Concurrent Clinical Study Experience:
15. Participation in other studies involving investigational drug(s) or investigational 
vaccine(s) within 28 days prior to study entry and/or during study participation.
Diagnostic Assessments:
Not applicable.
Other Exclusions:
16. Children or grandchildren of investigator site staff or Pfizer employees directly involved 
in the conduct of the study.
5.3. Lifestyle Considerations
No restrictions are required.
5.4. Screen Failures
Screen failures are defined as participants whose parent(s)/legal guardian consent to allow 
their participation in the clinical study but are not subsequently enrolled in the study. Screen 
failure data are collected and remain as source and are not reported to the clinical database.
Individuals who do not meet the criteria for participation in this study (screen failure) may 
not be rescreened. 
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study Intervention 
Administration
5.5.1. Criteria for Temporarily Delaying Vaccine Administration
The following conditions are temporary or self-limiting and a participant may be vaccinated 
once the conditions have resolved and the participant is eligible for vaccination:
1. Current febrile illness (temperature ≥38.0°C [≥100.4°F]) or other acute illness within 
48 hours before investigational product administration.
2. Participant has received any nonlive vaccine (or intramuscular/sublingual allergen 
immunotherapy) or rotavirus vaccine within 14 days, or any live vaccine (other than a 
rotavirus vaccine) within 28 days, before investigational product administration.
3. Participant is less than 5 days into a course of systemic antibiotic therapy.
4. Participant has received systemic (oral, intravenous, or intramuscular) corticosteroid 
therapy within the previous 28 days.


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5. Participant has received antipyretic medications and/or other pain medications on the day 
prior to planned vaccination other than that assigned per the study protocol.
If a participant meets any delay criteria for vaccination, all study procedures, including blood 
sample collection relating to that visit, should be delayed until the day of vaccination. Blood 
samples must always be collected prior to and on the same day as vaccination.
5.5.2. Criteria for Temporarily Delaying Immunogenicity Blood Draw
The following condition is temporary or self-limiting and blood may be drawn once the 
condition has resolved and the participant is eligible for blood collection:
1. Participant has received systemic antibiotic therapy within the last 5 days (must have a 
full 5-day interval between the date of the last dose and the date of blood collection).
6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, medical device(s), or study procedure(s) intended to be administered to a study 
participant according to the study protocol.
For the purposes of this protocol, study intervention refers to the investigational products 
listed in Section 6.1.


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6.1. Study Intervention(s) Administered
Vaccine or Drug 
Name
MenABCWY
Bivalent 
rLP2086 (60-µg 
Dose)
Bivalent 
rLP2086 
(120-µg 
Dose)
Nimenrix
Bexsero
Prevenar 13
Vaxelis
Paracetamola
Placebo
(Normal Saline)
Group(s)
1, 2, 7, 11, and 
13
3 and 4
5 
3, 4, 5, 8, 10,
and 14
8, 10, and 14
1, 2, 3-5, 7, 8, 
10, 11, 13, and 
14
1, 2, 3-5, 7, 8, 
10, 11, 13, and 
14
1, 3, 5, 7, 8, 11, 13,
and 14
13
Dose 
Formulation
Nimenrix will 
be reconstituted 
with bivalent 
rLP2086, 
supplied as a 
high-fill-
volume PFS.
0.5-mL PFS;
appropriate 
volume to be 
withdrawn from 
0.5-mL PFS to 
administer a 
dose of 0.25 mL
0.5-mL PFS
Nimenrix is 
supplied as a 
lyophilized 
powder in a 
single-dose 
vial and a 
solvent in a 
PFS to be 
reconstituted 
for injection.
0.5-mL PFS
0.5-mL PFS
0.5-mL PFS
120-mg/5-mL 
suspension
0.5-mL PFS
Dosage Level(s)
0.5-mL dose at 
Visits 1, 3, and 
5
0.25-mL dose at 
Visits 1, 3, and 
5
0.5-mL dose 
at Visits 1, 3,
and 5
0.5-mL dose at 
Visits 1, 3, and 
5
0.5-mL dose at 
Visits 1, 3, and 
5
0.5-mL dose at 
Visit 1 for 
Groups 1 and 
2; Visits 1 and 
3 for Groups 3-
5, 7, 8, 10, 11,
13, and 14
0.5-mL dose at 
Visit 1 for 
Groups 1 and 2; 
Visits 1 and 3 
for Groups 3-5, 
7, 8, 10, 11, 13,
and 14
5-mL dose for 
Group 1;
2.5-mL dose for 
Groups 3, 5, 7, 8,
11, 13, and 14
0.5-mL dose at 
Visits 1, 3, and 5
Route of 
Administration
Intramuscular
Intramuscular
Intramuscula
r
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Oral
Intramuscular
IMP or NIMP
IMP
IMP
IMP
IMP
IMP
NIMP
NIMP
IMP
IMP
Sourcing
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
Packaging and 
Labeling
Each 
MenABCWY 
kit will consist 
of a vial of 
Nimenrix, 
bivalent 
rLP2086 high-
fill-volume 
PFS, and vial 
adaptor. Kits 
will be 
packaged in a 
carton and
labeled as 
required per 
country 
requirement.
Study 
intervention will 
be provided in a 
single-dose PFS.
Each syringe
will be 
packaged in a 
carton and 
labeled as 
required per 
country 
requirement.
Study 
intervention 
will be 
provided in a 
single-dose 
PFS.  Each 
syringe will 
be packaged 
in a carton 
and labeled 
as required 
per country 
requirement.
Study 
intervention 
will be 
provided as a 
lyophilized 
powder in a 
single-dose
vial and a 
solvent in a 
PFS. The vial
and PFS will 
be packaged in 
a carton and 
labeled as 
required per 
country 
requirement.
Study 
intervention will 
be provided in a 
single-dose 
PFS.  Each 
syringe will be 
packaged in a 
carton and 
labeled as 
required per 
country 
requirement.
Kits provided 
for the blinded
phase will 
include a 
blinded label 
Study 
intervention 
will be 
provided in a 
single-dose 
PFS.  Each 
syringe will be 
packaged in a 
carton and 
labeled as 
required per 
country 
requirement.
Study 
intervention 
will be provided 
in a single-dose 
PFS.  Each 
syringe will be 
packaged in a 
carton and 
labeled as 
required per 
country 
requirement.
Study intervention 
will be provided in a 
bottle. Each bottle 
will be packaged in 
a carton and labeled 
as required per 
country requirement.
Study 
intervention will 
be provided in a 
single-dose PFS.  
Each syringe 
will be packaged 
in a carton and 
labeled as 
required per 
country 
requirement. 
Kits provided 
will include a 
blinded label and 
a tamper-evident 
seal. .


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Vaccine or Drug 
Name
MenABCWY
Bivalent 
rLP2086 (60-µg 
Dose)
Bivalent 
rLP2086 
(120-µg 
Dose)
Nimenrix
Bexsero
Prevenar 13
Vaxelis
Paracetamola
Placebo
(Normal Saline)
Kits provided 
for the blinded
phase will 
include a 
blinded label 
and a 
tamper-evident 
seal. 
Kits provided 
for the blinded
phase will 
include a 
blinded label 
and a tamper-
evident seal. 
and a 
tamper-evident 
seal.
a.
See details of protocol-assigned paracetamol dosages and schedules in Table 5.
The sentinel-cohort stage and the expanded-cohort stage will be open-label.  The blinded phase will use blinded labels for 
MenABCWY, Nimenrix, Bexsero, and placebo.


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6.1.1. Administration
Participants will receive the investigational products in accordance with the study’s SoA.
See Table 1.
Table 1.
Study Intervention Administration Schedule and SRSDs
Investigational 
Product
Group(s)
Visit(s)
Injection 
Location
SRSD
MenABCWY
1, 2, 7, 11, and 13
Visits 1, 3, and 5
Left thigh
MenABCWY IB
Trumenba
(60-µg dose)
3 and 4
Visits 1, 3, and 5
Left thigh
Trumenba IB
Trumenba
(120-µg dose)
5 
Visits 1, 3, and 5
Left thigh
Trumenba IB
Nimenrix
3, 4, 5, 8, 10, and 14
Visits 1, 3, and 5
Right thigh
SmPC
Bexsero
8, 10, and 14
Visits 1, 3, and 5
Left thigh
SmPC
Placebo
13
Visits 1, 3, and 5
Right thigh
N/A
Prevenar 13
1 and 2
Visit 1 
Right thigh
SmPC
3-5, 7, 8, 10, 11, 13, and 
14
Visits 1 and 3
Right thigh
Vaxelis
1 and 2
Visit 1
Right thigh
SmPC
3-5, 7, 8, 10, 11, 13, and 
14
Visits 1 and 3
Right thigh
Paracetamola
1, 3, 5, 7, 8, 11, 13, and
14
Visits 1 and 3 
N/A
Lithuanian SmPC
for Panadol (120 
mg/5 mL)
Abbreviations: IB = investigator’s brochure; N/A = not applicable; SmPC = summary of product 
characteristics; SRSD = single reference safety document.
a.
See details of protocol-assigned paracetamol dosages and schedules in Table 5.
Standard vaccination practices must be observed and vaccine must not be injected into blood 
vessels.  Appropriate medication and other supportive measures for management of an acute 
hypersensitivity reaction should be available in accordance with local guidelines for standard 
immunization practices.
Administration of study interventions should be performed by an appropriately qualified, 
GCP-trained, and vaccine-experienced member of the study staff (eg, physician, nurse, 
physician’s assistant, nurse practitioner, pharmacist, or medical assistant) as allowed by 
local, state, and institutional guidance. 
Study intervention administration details will be recorded on the CRF.
6.1.2. Medical Devices
1. The Pfizer-manufactured medical devices (or devices manufactured for Pfizer by a third 
party) provided for use in this study are the vial adaptor and PFS for MenABCWY, and 
the PFS for Trumenba, Nimenrix, placebo, and Prevenar 13.
2. Other medical devices (not manufactured by or for Pfizer) provided for use in this study 
are the PFS for Bexsero and Vaxelis.


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3. Instructions for medical device use are provided in the IP manual.
4. All medical device deficiencies (including malfunction, use error, and inadequate 
labeling) shall be documented and reported by the investigator throughout the clinical 
investigation (see Section 8.3.9) and appropriately managed by the sponsor.
6.2. Preparation/Handling/Storage/Accountability
1. The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study interventions received and any discrepancies are 
reported and resolved before use of the study intervention.
2. Study intervention will be shipped to the study site after required regulatory and legal 
documents have been received by the sponsor. The investigational vaccines/placebo will 
be shipped at +2°C to +8°C.  Upon receipt at the study site, the investigational
vaccines/placebo should be immediately transferred to a +2°C to +8°C temperature-
monitored refrigerator for storage. Liquid paracetamol will be shipped and stored per the 
product leaflet.
3. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study interventions
must be stored in a secure, environmentally controlled, and monitored (manual or 
automated recording) area in accordance with the labeled storage conditions with access 
limited to the investigator and authorized site staff.  At a minimum, daily minimum and 
maximum temperatures for all site storage locations must be documented and available 
upon request.  Data for nonworking days must indicate the minimum and maximum 
temperatures since previously documented for all site storage locations upon return to 
business.
4. Any excursions from the study intervention label storage conditions should be reported to 
Pfizer upon discovery along with any actions taken.  The site should actively pursue 
options for returning the study intervention to the storage conditions described in the 
labeling, as soon as possible.  Once an excursion is identified, the study intervention must 
be quarantined and not used until Pfizer provides permission to use the study 
intervention.  Specific details regarding the definition of an excursion and information the 
site should report for each excursion will be provided to the site in the IP manual.
5. Receipt of materials, door opening and closing, and other routine handling operations 
where the products are briefly out of the temperature range described in the labeling are 
not considered excursions.
6. Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the label.
7. Study interventions should be stored in their original containers.


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8. Site staff will instruct participants on the proper storage requirements for take-home 
study intervention, eg, liquid paracetamol.
9. See the IP manual, package insert, or equivalent for storage conditions of the study 
intervention once reconstituted.
10. The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records), such as the IPAL or 
sponsor-approved equivalent. All study interventions will be accounted for using a study 
intervention accountability form/record. Used needles and syringes should be disposed of 
according to local practice.  Empty outer study intervention containers must be retained 
until reviewed by the sponsor's representative and then may be destroyed after the 
sponsor’s representative has performed accountability.  Study intervention 
return/destruction must be documented on the accountability log. Protocol-assigned 
paracetamol will be accounted for as outlined in the IP manual. The protocol-assigned 
paracetamol bottle that is taken home by the participant’s parent/legal guardian needs to 
be returned to the investigator by the participant’s parent(s)/legal guardian on the 
following study site visit. 
11. Further guidance and information for the final disposition of unused study interventions 
are provided in the IP manual. All destruction must be adequately documented.  If 
destruction is authorized to take place at the investigator site, the investigator must ensure 
that the materials are destroyed in compliance with applicable environmental regulations, 
institutional policy, and any special instructions provided by Pfizer.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP manual.
Additional details about accountability, storage, destruction, and excursion reporting can be 
found in the IP manual.
6.2.1. Preparation and Dispensing
See the IP manual, package insert, or equivalent for instructions on how to prepare the study 
intervention for administration.  Study intervention should be prepared and dispensed by 
appropriately qualified and experienced members of the study staff (eg, physician, nurse, 
physician’s assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as 
allowed by local, state, and institutional guidance. A second staff member will verify the 
dispensing.
In addition to the above, during the blinded expanded-enrollment stage, study staff preparing, 
dispensing, and administering the study intervention will be unblinded, and all participants 
will remain blinded to whether they received MenABCWY + placebo or Bexsero + Nimenrix 
throughout this stage of the study.  


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6.3. Measures to Minimize Bias: Randomization and Blinding
6.3.1. Allocation to Study Intervention
Allocation (randomization) of participants to vaccine groups will proceed through the use of 
an IRT system (IWR) that is accessible 24 hours a day, 365 days a year.  The site personnel 
(study coordinator or specified designee) will be required to enter or select information 
including but not limited to the user’s ID and password, the protocol number, and the 
participant number.  The site personnel will then be provided with a vaccine assignment, 
randomization number, and DU or container number when study intervention is being 
supplied via the IRT system.  The IRT system will provide a confirmation report containing 
the participant number, randomization number, and DU or container number assigned. The 
randomization number and the date on which the randomization number was assigned will be 
recorded on the CRF.  The confirmation report must be stored in the site’s files. 
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
During both the open-label and blinded stages, the specific study intervention dispensed to 
the participant will be assigned using an IRT. The site will contact the IRT prior to the start 
of study intervention administration for each participant. The site will record the study 
intervention assignment on the applicable CRF, if required. Study intervention will be 
dispensed at the study visits summarized in the SoA. 
During the open-label stages, the investigator’s knowledge of the vaccine assignment should 
not influence the decision to enroll a particular participant or affect the order in which 
participants are enrolled.
Returned study intervention must not be redispensed to the participants.
6.3.2. Blinding During the Open-Label Stages
All study staff and sponsor personnel will be unblinded during the open-label stages.
6.3.3. Blinding During the Blinded Expanded-Enrollment Stage
6.3.3.1. Blinding of Study Staff
During the blinded expanded-enrollment stage, the study staff dispensing, preparing, and 
administering study vaccines will be unblinded.  For participants assigned to receive TLP, all 
other study and site staff, including the investigator, investigator staff, participants, and 
participants’ parent(s)/legal guardian, will be blinded to whether these participants have 
received MenABCWY + placebo or Bexsero + Nimenrix throughout the blinded expanded-
enrollment stage.  In particular, the individuals who evaluate participant safety will be 
blinded.  Because these study interventions are different in physical appearance, the 
MenABCWY, placebo, Bexsero, and Nimenrix study vaccine syringes will be administered 
in a manner that prevents the study participants’ parent(s)/legal guardian from identifying the 
vaccine type based on its appearance (see Section 6.1).  For participants assigned to receive 
PLP or SLP, participants’ parent(s)/legal guardian will be blinded to whether these 


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participants have received MenABCWY + placebo or Bexsero + Nimenrix throughout the 
blinded expanded-enrollment stage.  All other study and site staff, including the investigator
and investigator staff, will not be blinded to whether these participants have received 
MenABCWY + placebo or Bexsero + Nimenrix throughout the blinded expanded-enrollment 
stage.  
All study staff will be unblinded to the use of protocol-assigned paracetamol regimen, 
Prevenar 13, and Vaxelis throughout the blinded expanded-enrollment stage. Participants’
parent(s)/legal guardian will be blinded to the association of the use of protocol-assigned 
paracetamol regimens with specific investigational vaccines throughout the blinded
expanded-enrollment stage. For participants assigned to receive PLP or SLP, the feasibility 
of blinding the participants’ parent(s)/legal guardian to the association of the use of protocol-
assigned paracetamol with specific investigational vaccines will be reassessed by the Sponsor 
prior to study progression to the blinded expanded-enrollment stage. The participants’
parent(s)/legal guardian may not be blinded to the use of protocol-assigned paracetamol for 
participants assigned to receive PLP or SLP if blinding is deemed not feasible.
The responsibility of the unblinded dispenser and administrator must be assigned to an 
individual or individuals who will not participate in the evaluation of any study participants.  
Contact between the unblinded dispenser and study participants and unblinded administrator 
and study participants should be kept to a minimum during the blinded expanded-enrollment
stage.  The remaining study staff must not know whether a participant has been assigned to 
receive MenABCWY + placebo or Bexsero + Nimenrix.
6.3.3.2. Blinding of the Sponsor
Those study team members who are involved in ensuring that protocol requirements for 
study intervention preparation, handling, allocation, and administration are fulfilled at the site 
will be unblinded for the duration of the study (eg, unblinded study manager, unblinded 
clinical research associate).  An unblinded clinician who is not a direct member of the study 
team will review unblinded protocol deviations.  For participants assigned to receive TLP, all 
other study team members will remain blinded to whether participants have been assigned to 
MenABCWY + placebo or Bexsero + Nimenrix during the blinded expanded-enrollment
stage until the study is unblinded.  All laboratory testing personnel performing serology 
assays will remain blinded to vaccine assigned/received and to visit number throughout the 
study.  
All study team members will be unblinded to the use of protocol-assigned paracetamol
regimens, Prevenar 13, and Vaxelis throughout the blinded expanded-enrollment stage.
6.3.3.3. Breaking the Blind
At the initiation of the blinded expanded-enrollment stage, the study site will be instructed on 
the method for breaking the blind.  The method will be either a manual or an electronic 
process.  Blinding codes should only be broken in emergency situations for reasons of 
participant safety.


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In case of an emergency, when knowledge of the study intervention assignment is required 
for the medical management of an individual participant, it may be unblinded.  The 
investigator must notify a member of the study team immediately after determining that it is 
necessary to unblind the assignment.  The investigator must also indicate in source 
documents that the blind was broken and provide the date and reason for breaking the blind.  
Any AE or SAE associated with breaking the blind must be recorded and reported as 
specified in this protocol.
6.4. Study Intervention Compliance
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision.  The date and time of each dose 
administered in the clinic will be recorded in the source documents and recorded in the CRF, 
except protocol-assigned paracetamol administration, which is to be recorded in the source 
documents and in the e-diary.  The dose of study intervention and study participant 
identification will be confirmed at the time of dosing by a member of the study site staff 
other than the person administering the study intervention. 
For protocol-assigned paracetamol administration at the site, the date and time of the dose 
administered will be recorded in the participant’s e-diary. For protocol-assigned paracetamol
administration at home, compliance with the study intervention will be assessed by e-diary 
entry after each primary vaccination (see Section 8.2.1.2.2).
6.5. Concomitant Therapy
The name and date of administration of any nonstudy vaccine (or allergen immunotherapy) 
given from the signing of the ICD up to Visit 6 will be recorded on the CRF.
Sufficient supply of Prevenar 13 and Vaxelis will be provided by Pfizer to sites to ensure 
participants are able to complete the primary series and receive a booster dose of these 
vaccines, in accordance with the national immunization schedule. However, in special 
circumstances and with approval by the sponsor, for doses other than primary vaccinations 
1 and 2, a site may independently obtain pneumococcal vaccine or DTPa-HBV-IPV-Hib or 
its components rather than receive shipment of these vaccines from the sponsor.
The name, start and stop dates, and route of administration for concomitant medications 
(prescription and nonprescription) used to treat an AE (excluding events recorded only in the 
e-diary) from the signing of the ICD to Visit 7 will be recorded on the CRF.


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6.5.1. Prohibited During the Study

Other than determined by protocol assignment/randomization group, antipyretic and other 
pain medications to prevent symptoms that might occur as a result of study vaccination 
are not permitted. Use of antipyretic and other pain medications to alleviate symptoms 
that have occurred following study vaccination is permitted.

On the day of planned vaccination, if the participant has received antipyretic medications 
and/or other pain medications outside protocol assignment, vaccination should be 
temporarily delayed as specified in Section 5.5.1.

Receipt of blood products, including immunoglobulin, and/or immunosuppressive 
therapy (including a ≥14-day course of systemic corticosteroids).

Nonstudy meningococcal vaccines throughout the study.

Nonstudy pneumococcal vaccines and nonstudy DTPa-HBV-IPV-Hib or its components 
through Visit 4.

Nonstudy vaccines, other than nonstudy pneumococcal vaccines or nonstudy
DTPa-HBV-IPV-Hib or its components administered after Visit 4, are not permitted 14 
days (for nonlive vaccines or rotavirus vaccine) or 28 days (for live vaccine other than a 
rotavirus vaccine) before or after any study vaccination.

Intramuscular/sublingual allergen immunotherapy is not permitted within 14 days before 
or after any study vaccination.
6.5.2. Permitted During the Study

Nonstudy vaccines used in the event of a disease outbreak or pandemic are allowed at 
any time.  In such situations, if needed, administration of study intervention may be 
rescheduled to allow it to occur 14 days (for nonlive nonstudy vaccines or rotavirus 
vaccine) or 28 days (for live nonstudy vaccines other than a rotavirus vaccine) after 
administration of nonstudy vaccines used to manage the disease outbreak or pandemic.

Nonstudy pneumococcal vaccines and nonstudy DTPa-HBV-IPV-Hib or its components
are allowed any time after Visit 4, including the administration of such vaccine(s) 
concomitantly with the investigational products administered at Visit 5. Other nonstudy 
vaccines that are part of recommended immunization schedules and not provided through 
the study are allowed anytime during the study but should not be administered within 
14 days (for nonlive vaccines or rotavirus vaccine) or 28 days (for live vaccines other 
than a rotavirus vaccine) of investigational product administration.  

Should nonstudy vaccines be administered concomitantly with the investigational 
products administered at Visit 5, the nonstudy vaccines will be administered in a limb 
other than the left thigh.


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
Antipyretic and other pain medication to treat symptoms following investigational 
product administration is permitted. 

A local anesthetic may be used at the site of the blood draw.

Topical antibiotics are permitted.

Topical and inhaled corticosteroids are permitted.
6.5.3. Prior Vaccinations and Treatments
If the participant is known to have ever received a PRP-OMP vaccine, the name of the 
vaccine and date of administration will be recorded on the CRF. PRP-OMP–containing 
vaccines that are or have been commercially available include Comvax, Procomvax, and 
PedvaxHIB. These are also listed in the ISF.
6.5.4. Prohibited Prior Treatments
Receipt of any blood products, including immunoglobulin, before the first study vaccination.
6.6. Dose Modification
Not applicable.
6.7. Intervention After the End of the Study
No intervention will be provided to study participants at the end of the study.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
In rare instances, it may be necessary for a participant to permanently discontinue study 
intervention (definitive discontinuation). Reasons for definitive discontinuation of study 
intervention include the following: AEs; parent(s)/legal guardian request, and protocol 
violation.
Note that discontinuation of study intervention does not represent withdrawal from the study.
Per the study estimands, if study intervention is definitively discontinued, the participant will 
remain in the study to be evaluated for the collection of safety information. See the SoA for 
data to be collected at the time of discontinuation of study intervention and follow-up for any 
further evaluations that need to be completed.
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, postvaccination study follow-up, 
and/or future collection of additional information.


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Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the IRB/EC, or study intervention safety problems, or at the discretion 
of Pfizer.  In addition, Pfizer retains the right to discontinue development of MenABCWY at 
any time.
If a study is prematurely terminated, Pfizer will promptly notify the investigator. After 
notification, the investigator must contact all participating participants and the hospital 
pharmacy (if applicable) immediately.  As directed by Pfizer, all study materials must be 
collected and all CRFs completed to the greatest extent possible.
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may be withdrawn from the study at any time at the request of his/her
parent(s)/legal guardian. Reasons for discontinuation from the study include the following:

Parent(s)/legal guardian refused further follow-up;

Lost to follow-up;

Death;

Study terminated by sponsor;

AEs;

Parent(s)/legal guardian request;

Protocol violation.
If a participant does not return for a scheduled visit, every effort should be made to contact 
the participant’s parent(s)/legal guardian. All attempts to contact the parent(s)/legal guardian 
and information received during contact attempts must be documented in the participant’s 
source document. In any circumstance, every effort should be made to document participant 
outcome, if possible.
Parent(s)/legal guardian should be questioned regarding the reason for the participant’s 
withdrawal.  The investigator or his or her designee should capture the reason for withdrawal 
in the CRF for all participants.
If a participant is withdrawn from the study, his/her parent(s)/legal guardian may request 
destruction of any remaining samples taken and not tested, and the investigator must 
document any such requests in the site study records and notify the sponsor accordingly.
The parent(s)/legal guardian should be requested that the participant return for the next visit, 
if applicable, and the investigator will perform the procedures indicated for the visit.  Any 
AEs or SAEs that are continuing at the time of withdrawal from the study should be followed 
until resolution or, in case of permanent impairment, until the condition stabilizes.  


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A final telephone contact (Section 8.11.7) for the collection of safety information should be 
completed for all participants who withdraw or have been withdrawn within 6 months after 
administration of study intervention, unless consent for further contact has been withdrawn, 
or the participant is lost to follow-up.  Participant withdrawal should be explained in the 
source documents, and should include whether the withdrawal is only from further receipt of 
study intervention or also from study procedures and/or postvaccination study follow-up.
If the participant is withdrawn from the study and his/her parent(s)/legal guardian also 
withdraws consent (see Section 7.2.1) for disclosure of future information, no further 
evaluations should be performed and no additional data should be collected.  The sponsor 
may retain and continue to use any data collected before such withdrawal of consent.
Lack of completion of all or any of the withdrawal/early termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved.
7.2.1. Withdrawal of Consent 
Participants whose parent(s)/legal guardian request to discontinue receipt of study 
intervention will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures.  The only exception to this is when a participant’s parent(s)/legal 
guardian specifically withdraws consent for any further contact with him or her to provide 
this information.  Participants’ parent(s)/legal guardian should notify the investigator in 
writing of the decision to withdraw consent from future follow-up, whenever possible.  The 
withdrawal of consent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is only from further receipt of study intervention
or also from study procedures and/or postvaccination study follow-up, and entered on the 
appropriate CRF page.  In the event that vital status (whether the participant is alive or dead) 
is being measured, publicly available information should be used to determine vital status 
only as appropriately directed in accordance with local law.
7.3. Lost to Follow-up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and the parent(s)/legal guardian is unable to be contacted by the study site.
The following actions must be taken if a participant’s parent(s)/legal guardian fails to 
respond to a safety telephone call or return to the clinic for a required study visit:

The site must attempt to contact the participant’s parent(s)/legal guardian and reschedule 
the missed visit as soon as possible and counsel the participant’s parent(s)/legal guardian
on the importance of maintaining the assigned visit schedule and ascertain whether or not 
the participant’s parent(s)/legal guardian wishes to and/or should continue in the study;

Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant’s parent(s)/legal guardian (where 
possible, 3 telephone calls and, if necessary, a certified letter to the participant’s 
parent(s)/legal guardian’s last known mailing address or local equivalent methods).
These contact attempts should be documented in the participant’s medical record;


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
Should the participant’s parent(s)/legal guardian continue to be unreachable, the 
participant will be considered to have withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.  
The date of birth will be collected to critically evaluate the immune response and safety 
profile by age.
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described.  However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test.  In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant.  When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible.  The study team must be informed of these incidents in a timely manner.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
The total blood sampling volume for individual participants in this study is approximately 
10 mL. 
8.1. Efficacy Assessments and/or Immunogenicity Assessment
To facilitate immunogenicity analyses, all participants in the study will have approximately 
5 mL of blood collected at Visit 4 (1 month after primary vaccination 2) and Visit 6 (1 month 
after the booster vaccination) during the study, as described in Section 8.11 and the SoA. 


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Sera obtained will be used in immunogenicity assays. LOD and LLOQ titers for these assays 
will be detailed in the SAP.
Sera obtained from participants enrolled in the open-label stages may be used for exploratory 
analysis and meningococcal assay development as a priority over the analysis as shown in the 
estimands below, based on availability of serum volume.  
8.1.1. MenA, MenC, MenW, and MenY Serum Bactericidal Assays
For assessment of the immune response to Nimenrix and the MenACWY components of 
MenABCWY, test strains specific for each of the MenACWY groups (A [PMB277], 
C [PMB3204], W [PMB6270], Y [PMB3385]) will be used in the hSBAs for determination 
of the immunogenicity endpoints in this study.
8.1.2. MenB Serum Bactericidal Assays
For assessment of the immune response to the MenB component of MenABCWY, 
Trumenba, and Bexsero, 2 MenB test strains (1 expressing an LP2086 subfamily A protein 
and 1 expressing an LP2086 subfamily B protein) will be used in the hSBAs for 
determination of the immunogenicity endpoints in this study, which will be identified prior to 
the commencement of testing. MenB test strains will be detailed in the SAP.
8.1.3. Biological Samples 
Serum samples will be used only for scientific research.  Each sample will be labeled with a 
code so that the laboratory personnel testing the samples will not know the participant’s 
identity.  Samples that remain after performing assays outlined in the protocol may be stored 
by Pfizer.  Unless a time limitation is required by local regulations or ethical requirements, 
the samples will be stored for up to 15 years after the end of the study and then destroyed.  
If allowed by the ICD, stored samples may be used for additional testing to better understand 
the immune responses to the vaccine(s) under study in this protocol, to inform the 
development of other products, and/or for vaccine-related assay work supporting vaccine 
programs.  No testing of the participant’s genetic material will be performed. 
The participant may request that his or her samples, if still identifiable, be destroyed at any 
time; however, any data already collected from those samples will still be used for this 
research.  The biological samples may be shared with other researchers as long as 
confidentiality is maintained, and no testing of the participant’s genetic material is 
performed.
A mechanism (eg, appropriate wording within the study ICD) will be established that enables 
testing of serum samples obtained during the study to assess for the preexistence of select 
AEs reported during study participation.
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the SoA.  Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety issues.


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Primary vaccinations for all participants will be conducted in the morning to allow time for 
daytime temperature monitoring.
Any participant who receives at least 1 dose of study intervention will be included in the 
evaluation for safety. The following safety parameters will be assessed as described in 
Section 8.11 and the SoA:

Physical examination.

Reactogenicity: local reactions and systemic events, including fever.

Use of antipyretic medication to treat symptoms following investigational product 
administration.

AEs and SAEs.
A medical history will be obtained and a physical examination will be performed on all 
participants at Visit 1 to establish a baseline. Weight, length, general appearance, skin, head, 
eyes, ears, nose, throat, heart, lungs, abdomen, extremities, neurologic status, 
musculoskeletal, and lymph nodes will be assessed. Significant medical history and 
observations from the physical examination will be documented on the CRF.  
A brief physical examination of general appearance, ears, throat, heart, and lungs will be 
performed prior to vaccinations at Visits 3 and 5 for all participants. 
The safety parameters include reactogenicity, ie, both local reactions and systemic events that 
occur in the 7 days (Days 1 through 7) after investigational product administration.  These 
prompted e-diary events are:

Local reactions at the site of investigational product administration on the left thigh
(redness, swelling, and tenderness).

Systemic events (fever, loss of appetite or decrease appetite, drowsiness [synonym:  
increased sleep], irritability [synonyms: fussiness, restless sleep, and decreased 
sleep]).
Local reactions, systemic events, and use of antipyretic medication associated with vaccine 
administration will be collected using an e-diary.  For events that resolve after Day 7, the end 
date will be collected in the CRF.  If a participant does not complete the e-diary for 7 days, 
end dates of local reactions, systemic events, or antipyretic medication use that was ongoing 
on the last day the e-diary was completed by the participant will be collected on the CRF.
Immediate AEs, defined as AEs occurring within the first 30 minutes after study intervention 
administration, will be assessed and documented on the AE CRF.  The time of onset will be 
recorded for any AEs that occur on the same day as study intervention administration.


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MAEs and NDCMCs will also be assessed throughout the study and documented on the 
appropriate AE CRF.  An MAE is defined as a nonserious AE that results in an evaluation at 
a medical facility.  An NDCMC is defined as a disease or medical condition, not previously 
identified, that is expected to be persistent or otherwise long-lasting in its effects.
AEs (serious and nonserious), NDCMCs, and visits to other medical facilities will be 
assessed at study visits as specified in the SoA and reported as defined in Section 8.3. 
AE-related hospitalizations, visits to other medical facilities, and medication use will be 
collected and recorded in the CRF.  Hospitalizations and visits to medical facilities not 
associated with an AE, such as elective hospitalizations, healthcare visits for preventive care, 
or routine physical examinations, will not be collected.  Non–AE-related concomitant 
medications will not be collected.  A Study Visit/Telephone Contact AE Checklist will be 
used as a guide, will be completed at each scheduled study visit/telephone contact, and will 
be included in the source documentation.  Please refer to the ISF for details.
The participant’s parent(s)/legal guardian will be given a memory aid at Visits 4 and 6.  The 
memory aid will be used to remind parent(s)/legal guardian to review any significant 
illnesses, hospitalizations, NDCMCs, or visits to a medical facility with study site personnel.  
The parent(s)/legal guardian may use the memory aid as needed at Visit 5 and during the 
telephone contact at Visit 7 to prompt recall of events. These may be used to assist in 
reporting and discussion of events with study staff, but these memory aids will not be 
considered source documents and will not be collected at study visits.  Only information 
collected by study staff as part of a study visit or telephone contact will be included in the 
source documents and entered into the CRF.
In addition, AEs and SAEs will be collected as defined in Section 8.3.
8.2.1. Electronic Diary
Participants will be required to use an e-diary, installed on a provisioned device or an 
application on a personal device, and will be asked to monitor and record local reactions, 
systemic events, and antipyretic medication use for 7 days following vaccination.  
The e-diary allows recording of these assessments only within a fixed time window, thus 
providing the accurate representation of the participant’s experience at that time.
For local reactions and systemic events that resolve after Day 7, the end date will be 
collected on the CRF.  If the e-diary is not completed for 7 days, the end dates of local 
reactions, systemic events, or antipyretic medication use that occurred during the 7 days will 
be collected on the CRF.  The investigator or designee must contact the parent(s)/legal 
guardian in order to obtain stop dates for any prompted e-diary events or other AE data 
ongoing on the last day that the e-diary was completed.  The stop dates are to be documented 
in the source documents and the information entered in the CRF.  


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Data reported in the e-diary will be transferred electronically to the e-diary vendor (a trusted 
third party), where they will be available for review by investigators at all times via an 
internet-based portal.  At intervals agreed upon between the vendor and Pfizer, these data 
will be transferred electronically into Pfizer’s database for analysis and reporting.  These data 
do not need to be reported by the investigator on the CRF.
Investigators will be required to review the e-diary data online at frequent intervals as part of 
the ongoing safety review and evaluation of participant compliance.  For sentinel-cohort 
participants, following primary vaccination 1, online review must be performed daily 
(see Section 8.2.4.1).
8.2.1.1. Local Reactions
Local reactions (redness, swelling, and tenderness) at the site of investigational product 
administration will be recorded daily for 7 days (Days 1 through 7) following each 
vaccination. Only local reactions at the site of investigational product administration with 
MenABCWY, Trumenba, or Bexsero on the left thigh will be recorded.
8.2.1.1.1. Injection Site Redness and Swelling
Redness and swelling will be measured and recorded in caliper units (range: 1 to 14) for the 
first 7 days following vaccination (Days 1 through 7), and then categorized using the scale 
shown in Table 2.  The measurements will then be recorded in the e-diary.
A caliper will be given to the participant’s parent(s)/legal guardian with instructions for 
measuring both redness and swelling at the left thigh injection site.  Each caliper unit is 
equivalent to 0.5 cm.  The parent(s)/legal guardian will be asked to measure the largest 
diameters of the local reaction.  Where a caliper measurement is between 2 values, the higher 
value should be reported.  At the time of entry into the e-diary, the parent(s)/legal guardian 
should record the maximum severity of the reaction since the previous entry into the e-diary.  
In the event the reaction exceeds the maximum size the caliper is able to measure 
(>14 caliper units), the participant’s parent(s)/legal guardian will also measure the maximum 
diameter of the redness and/or swelling at the left thigh injection site using the measuring 
tape provided and report this immediately to the investigator.  The participant’s 
parent(s)/legal guardian will report the maximum diameter of the redness and/or swelling at 
the left thigh injection site to the investigator daily until the reaction becomes ≤14 caliper 
units.  These measurements will be recorded in the CRF.
Table 2.
Grading of Redness and Swelling
Mild
0.5 to 2.0 cm (1 to 4 caliper units)
Moderate
>2.0 to 7.0 cm (5 to 14 caliper units)
Severe
>7.0 cm (>14 caliper units)


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8.2.1.1.2. Injection Site Tenderness
Tenderness at the left thigh injection site will be assessed by the participant’s parent(s)/legal 
guardian as mild, moderate, or severe according to the grading scale in Table 3. The 
assessment will then be recorded in the e-diary.
Table 3.
Grading of Tenderness
Mild
Hurts if gently touched (eg, participant whimpers, winces, protests, or withdraws)
Moderate
Hurts if gently touched, with crying
Severe
Causes limitation of limb movement
8.2.1.2. Systemic Events
8.2.1.2.1. Temperature
A digital thermometer will be given to the parent(s)/legal guardian with instructions on how 
to measure the participant’s axillary temperature at home.  Axillary temperature will be 
collected and recorded in the e-diary following each vaccination. Temperature 
measurements will be taken only when the participant is awake at the following intervals:

Approximately 4, 8, 12, and 24 hours after vaccination on Day 1 (day of vaccination). 
The time the measurement is taken is also recorded in the e-diary.

In the evening daily on Days 2 through 7. The time the measurement is taken is also 
recorded in the e-diary.

At any time on Days 1 through 7 when fever is suspected.  The time the measurement
is taken is also recorded in the e-diary.
In addition to the scheduled temperature measurements on Day 1, the highest daily 
temperature and the time the measurement was taken on Days 1 through 7 will be recorded in 
the e-diary.  Fever is defined as a temperature of ≥38.0°C. Temperature will be measured 
and recorded to 1 decimal place and then categorized according to the severity scale in 
Table 4.
Table 4.
Scale for Fever
Temperature 38.0°C to 38.4°C
Temperature 38.5°C to 38.9°C 
Temperature 39.0°C to 40°C 
Temperature >40.0°C 


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8.2.1.2.2. Fever Management

For Participants Assigned to Receive the Prophylactic Liquid Paracetamol Regimen 
(PLP) in Groups 1, 3, 5, 8, and 14 with PLP Stratum
For participants assigned to receive PLP for primary vaccinations, the first dose of PLP will 
be administered orally within 30 minutes before the administration of MenB vaccines. Two 
additional doses of PLP will be provided to parent(s)/legal guardian to administer to the 
participant at 4- to 6-hour intervals on Day 1 following each primary vaccination. 
For 2-month-old participants receiving rLP2086-containing vaccines in Groups 3 and 5, if 
fever persists despite the administration of 3 doses of PLP, additional paracetamol doses 
should be given for up to 48 hours after vaccination.

For Participants Assigned to Receive the Scheduled Liquid Paracetamol Regimen 
(SLP) in Groups 7, 11, and 13
The first dose of paracetamol will be administered orally by parent(s)/legal guardian no later 
than 8 hours after each primary vaccination or earlier if fever or other reactogenicity
symptoms arise and require treatment. Parent(s)/legal guardian will continue administering 
paracetamol for a certain number of doses as described in the protocol-assigned paracetamol 
dosing instructions. The initial regimen will require administration of 4 doses every 4 to 6 
hours with an optional fifth dose if symptoms persist, but this regimen may be adjusted at the 
discretion of the IRC based on ongoing review of the safety data.

For Participants Randomized to Receive the Therapeutic Liquid Paracetamol 
Regimen (TLP) in Groups 11, 13, and 14
The first dose of paracetamol will be administered orally by parent(s)/legal guardian only 
when fever or other reactogenicity symptoms arise and require treatment (if no symptoms are 
experienced, no paracetamol will be given). Parent(s)/legal guardian will continue 
administering paracetamol for a certain number of doses as described in the protocol-
assigned paracetamol dosing instructions. The initial regimen will require administration of 
4 doses every 4 to 6 hours with an optional fifth dose if symptoms persist, but this regimen
may be adjusted at the discretion of the IRC based on ongoing review of the safety data.
See the protocol-assigned paracetamol dosages and schedules in Table 5.


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Table 5.
Protocol-Assigned Paracetamol Dosages and Schedules
Group(s)/Stratum
Protocol-
Assigned 
Paracetamol
Vaccinations
Participant 
Age
at 
Enrollment
Dose
Group 1
PLP
Primary series 
vaccinations 1 
and 2
6 months
120 mg (5 mL)
Groups 3, 5, 8, and 14/PLP 
PLP
Primary series 
vaccinations 1 
and 2
2 months
60 mg (2.5 mL)
Groups 7, and 11-13/SLP
SLP
Primary series 
vaccinations 1 
and 2
2 months
60 mg (2.5 mL)
Groups 11, 13, and 14/TLP
TLP
Primary series 
vaccinations 1 
and 2
2 months
60 mg (2.5 mL)
Abbreviations: PLP = prophylactic liquid paracetamol regimen; SLP = scheduled liquid paracetamol
regimen; TLP = therapeutic liquid paracetamol regimen.
Note: Protocol amendment 2 added 12 additional participants to Group 3 that will receive SLP for primary 
vaccinations. The protocol-assigned paracetamol regimen for Group 11 may be subject to change at the 
discretion of the IRC, and instead of TLP, some participants may receive SLP.
This study will use the above protocol-assigned paracetamol regimens, but these regimens 
may be adjusted based on safety data observed during the study, and the updated regimens 
will be detailed in the paracetamol dosing instructions.
Refer to the participant paracetamol dosing instructions to confirm the current 
protocol-assigned paracetamol dosing schedule to be used per randomization group.
For all participants assigned to receive protocol-assigned paracetamol, if the participant’s 
temperature is ≥38°C after the last dose of protocol-assigned paracetamol and the participant 
is otherwise well, the parent(s)/legal guardian may continue administering paracetamol-
containing antipyretics every 4 to 6 hours and should contact the study site. Parent(s)/legal 
guardian must always leave at least 4 hours between paracetamol doses, but not exceeding 
the maximum daily dosing of 4 doses per 24-hour period per the product instructions.
The timing of all doses of protocol-assigned paracetamol, and the timing of all doses of 
additional antipyretic medication on Day 1, following each vaccination will be recorded in 
the e-dairy as described in Section 8.2.1.3.


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
For Participants Randomized Not to Receive Protocol-Assigned Paracetamol in 
Groups 2, 4, and 10 
The parent(s)/legal guardian will be advised to administer a single dose of paracetamol if a 
participant’s temperature is ≥38°C (conditional on no paracetamol having been received in 
the preceding 4 hours).
If the participant’s temperature remains ≥38°C, further doses of paracetamol may be 
administered every 4 to 6 hours until afebrile, but not exceeding the maximum daily dosing 
of 4 doses per 24-hour period per product instructions.
The timing of all doses of antipyretic medication on Day 1 following each vaccination will 
be recorded in the e-diary as described in Section 8.2.1.3.

Additional Measures for Fever Management
Use of additional therapies (eg, NSAIDs) to treat fever will be at the discretion of the 
parent(s)/legal guardian based on counseling by the participant’s physician.
For persistent fevers or for participants otherwise unwell in the opinion of the parent(s)/legal 
guardian, seeking of medical attention should not be delayed.
8.2.1.2.3. Other Systemic Events
The e-diary will be used to record the presence of other systemic events, including loss of or 
decreased appetite, drowsiness (increased sleep), and irritability (fussiness) after each 
vaccination, using the grading scales in Table 6.
Table 6.
Grading of Other Systemic Events
GRADE 1
(Mild)
GRADE 2
(Moderate)
GRADE 3
(Severe)
Decreased appetite
(loss of appetite)
Decreased interest in 
eating 
Decreased oral intake
Refusal to feed
Drowsiness 
(increased sleep)
Increased or prolonged 
sleeping bouts
Slightly subdued 
interfering with daily 
activity
Disabling, not interested 
in usual daily activity
Irritability 
(fussiness)
(synonymous with restless 
sleep; decreased sleep)
Easily consolable
Requiring increased 
attention
Inconsolable; crying 
cannot be comforted
8.2.1.3. Use of Antipyretic/Pain Medications
The use of antipyretic medication taken to treat fever or pain after vaccination will be 
recorded in the e-diary daily during the active safety observation periods (Day 1 to Day 7) 
after each vaccination.


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Other than determined by protocol assignment/randomization group, prophylactic use of 
antipyretics and other pain medications to prevent fever or pain that might occur as a result of 
study vaccination is not permitted (Section 6.5.1).
On the day prior to vaccination, if the participant has received antipyretics and other pain 
medications outside the protocol-assigned paracetamol use, vaccination should be 
temporarily delayed as specified in Section 5.5.1.
Use of antipyretic and other pain medications following investigational product
administration to treat symptoms is permitted (Section 6.5.2).
Please refer to the ISF for further details.
8.2.2. Open-Label Safety Assessment
8.2.2.1. Sentinel-Cohort Safety Assessment
After primary vaccination 1, 7-day e-diary and AE data will be collected for each sentinel 
cohort.  These safety data from sentinel Cohorts 1 to 4, as well as the safety data from prior 
cohort(s) (if applicable), will be summarized and reviewed by the sponsor’s IRC. Primary 
vaccination 2 in the corresponding cohort and enrollment into the subsequent cohort will not 
be permitted until IRC review of the safety data is complete and these data are found 
acceptable. Stopping rules will apply to participants in sentinel Cohorts 1 to 4 for the 7-day 
safety period following primary vaccination 1 only (Section 4.1.1).
The study will progress to the expanded-enrollment stage following IRC review of post–
primary vaccination 1 safety data from Cohort 4.
Enrollment into the sentinel-control cohort may occur at any time during the sentinel-cohort 
stage without IRC review of data from Cohorts 1 to 4.  Stopping rules will not apply to 
participants in this cohort (Section 8.2.4.1).
In order to provide ongoing oversight of participant safety, 7 days after all sentinel-cohort 
stage participants have completed primary vaccination 2, reactogenicity and AE data from all 
participants available at the time will be summarized for review by the IRC. The IRC does 
maintain discretion to adjust details of the paracetamol regimens and number of participants 
enrolled into each regimen based on review of emerging safety data.
The EDMC will not participate in the decision-making processes for study progression, but 
will be informed of the IRC’s determination. The EDMC will be responsible for ongoing 
monitoring of the safety of participants in the study according to the charter. 
Recommendations made by the EDMC will be forwarded to Pfizer for final decision making. 


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8.2.2.2. Expanded-Cohort Safety Assessment
In order to provide ongoing oversight of participant safety, 7 days after the first 25 
participants in Group 11 have received MenABCWY with TLP for primary vaccination 1, 
e-diary and AE data will be summarized, as well as e-diary and AE data from prior cohort(s) 
in the sentinel-cohort stage (if applicable), for review by the sponsor’s IRC. Continuation 
with the enrollment of participants receiving MenABCWY with TLP into Group 11 and 
primary vaccination 2 for the participants already enrolled in the group will not be permitted 
until IRC review of these safety data are complete and found to be acceptable. At any point 
during the study conduct of Group 11, the IRC may determine that the remaining participants 
will be enrolled to receive MenABCWY with SLP, based on the safety data gathered. TLP 
or SLP administration in this group will be associated only with primary series vaccinations. 
In addition, 7 days after all expanded-enrollment stage participants have completed primary 
vaccination 2, reactogenicity and AE data from all participants available at the time will be 
summarized for review by the IRC (Section 4.1.2).
8.2.3. Blinded Phase Safety Assessment
During the blinded phase, an independent statistical center will provide unblinded safety 
reports to the EDMC for review. The exact number of participants to be enrolled into each
group and each stratum for protocol-assigned paracetamol use, the enrollment speed and the 
exact schedules of protocol-assigned paracetamol regimens will be at the discretion of IRC 
and may be subject to change as safety data become available.
Planned safety analysis based on the numbers of participants enrolled per protocol-assigned 
paracetamol regimen following the double-blind and single-blind design will be detailed in 
the SAP.
8.2.4. Study Pause
This study will be paused if stopping rule criteria are met.
8.2.4.1. Stopping Rules
E-diary and AE data will be monitored daily by the investigator (or medically qualified 
designee) and the sponsor during the first 7 days (including nonbusiness days) after primary 
vaccination 1 in order to promptly identify and flag any case that potentially contributes to a 
stopping rule. 
In the event of a stopping rule being met, the following criteria will apply: 

For stopping rules that apply to participants in sentinel Cohorts 1 to 4 only:
o
Individual randomization groups within the sentinel cohort affected by the stopping 
rule will pause enrollment and vaccination.
o
No further study vaccinations will be administered to any participant in the paused
individual randomization groups within the sentinel cohort until the investigator is
directed to do so by the sponsor.


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o
For all sentinel participants affected by a pause, no vaccination visits will be 
conducted until the investigator is directed to proceed. However, all other routine 
study-conduct activities, such as ongoing data entry, reporting of AEs, participant 
e-diary completion, and participant follow-up, will continue during the pause.

For stopping rules that apply to all participants in the open-label stages of the study:
o
Enrollment and vaccination in the whole study will be paused.
o
No further study vaccinations will be administered to any participant in the study until 
directed to do so by the sponsor.
o
For all participants, no vaccination visits will be conducted until the investigator is
directed to proceed. However, all other routine study-conduct activities, such as 
ongoing data entry, reporting of AEs, participant e-diary completion, and participant 
follow-up, will continue during the pause.

Cases that meet stopping rule criteria will be promptly referred to the IRC for rapid 
evaluation. The IRC will review the case safety data and determine whether the study 
may progress. The IRC opinion on study progression will be forwarded to the EDMC.
The following stopping rules are applicable for this study.
1. For participants in sentinel Cohorts 1 to 4 within the 7-day safety period following 
primary vaccination 1:

For individual randomization groups within the sentinel cohort, 2 or more participants 
reporting MAEs that are similar in nature, other than fever, deemed related to 
investigational product or that cannot be attributed to any other cause.

For individual randomization groups within the sentinel cohort, 2 or more participants 
reporting MAEs of fever that lead to invasive investigations performed at a medical 
facility.

For individual randomization groups within the sentinel cohort, 1 or more participants 
reporting febrile convulsions that are deemed related or cannot be attributed to any 
other cause by the investigator.

For individual randomization groups within the sentinel cohort, 1 or more participants 
reporting SAEs of the same type that are deemed related or cannot be attributed to 
any other cause by the investigator.
2. For all participants at any time during the open-label stages of the study:

For the duration of the study, if a death occurs that cannot be attributed to any other 
cause, or if an investigator determines that the death is related to vaccination.


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
For the duration of the study, if any AE occurs that, as judged by the sponsor, 
warrants a study pause to allow IRC evaluation of the event.
For each participant, any given event may not contribute more than once to a stopping rule.
The investigator should immediately notify the sponsor if any participant under the 
investigator’s care appears to fulfill any of the criteria listed above. Reporting details are 
described in the ISF.
8.2.4.2. Resuming Enrollment and Vaccination After a Study Pause
Enrollment and vaccination may proceed at the discretion of the IRC before the IRC receives 
a recommendation from the EDMC. The visit window for primary vaccination 2 may be 
extended for individual participants by up to 14 days from the receipt of the positive IRC 
recommendation, at the discretion of the sponsor.
8.3. Adverse Events and Serious Adverse Events
The definitions of an AE and an SAE can be found in Appendix 3.
The definitions of device-related safety events (ADEs and SADEs) can be found in 
Appendix 6.  Device deficiencies are covered in Section 8.3.9.
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or 
the participant's parent[s]/legal guardian).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study intervention (see Section 7.1). 
Each participant’s parent(s)/legal guardian will be questioned about the occurrence of AEs in 
a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.


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8.3.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant’s parent(s)/legal guardian
provides informed consent, which is obtained before the participant’s participation in the 
study (ie, before undergoing any study-related procedure and/or receiving study 
intervention). This duration of this active collection period is defined below: 

Through and including Visit 4.

From Visit 5 through and including Visit 6. 
The time period for actively eliciting and collecting SAEs, MAEs, and NDCMCs (“active 
collection period”) for each participant begins from the time the parent(s)/legal guardian 
provides informed consent through Visit 7 (final telephone contact) for all groups. 
See Table 7.


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Table 7.
Summary of AE Data Collection
Visit Description
Primary 
Vaccination 1
Safety 
Telephone
Contact 
Primary 
Vaccination 2
Follow-up
After Primary 
Vaccination 2
Booster
Vaccination
Follow-up After 
Booster 
Vaccination
Final Telephone 
Contact
Visit Identifier
1
2
3
4
5
6
7
AEs
SAEs, MAEs, 
NDCMCs
Note: The bars represents safety data collection time periods.


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Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator and Pfizer concurs with that assessment.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant definitively discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the Vaccine SAE Reporting Form.
Investigators are not obligated to actively seek AEs or SAEs after the participant has 
concluded study participation.  However, if the investigator learns of any SAE, including a 
death, at any time after a participant has completed the study, and he/she considers the event 
to be reasonably related to the study intervention, the investigator must promptly report the 
SAE to Pfizer using the Vaccine SAE Reporting Form.
8.3.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the Vaccine SAE Reporting Form immediately 
upon awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3. The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available.
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the CRF. 
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant’s parent(s)/legal guardian.
8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs.  Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.


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8.3.3. Follow-up of AEs and SAEs
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality.  Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided.  In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 3.
8.3.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation.  
The sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
8.3.5. Exposure During Pregnancy or Breastfeeding via Occupational Exposure
Exposure to the study intervention under study during pregnancy or breastfeeding via 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness.
8.3.5.1. Exposure During Pregnancy
An EDP occurs if:

A female is found to be pregnant while being exposed or having been exposed to 
study intervention due to environmental exposure. Below are examples of 
environmental exposure during pregnancy:  

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by needlestick injury or skin contact.


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
A male family member or healthcare provider who has been exposed to the study 
intervention by needlestick injury or skin contact then exposes his female partner 
prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 

If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the Vaccine SAE Reporting Form and EDP 
Supplemental Form. Since the exposure information does not pertain to the 
participant enrolled in the study, the information is not recorded on a CRF; however, 
a copy of the completed Vaccine SAE Reporting Form is maintained in the 
investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs. Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows: 

Spontaneous abortion including miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs. In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention. 


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Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays). In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner.  The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
8.3.5.2. Exposure During Breastfeeding
An exposure during breastfeeding occurs if: 

A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure). An example of environmental 
exposure during breastfeeding is a female family member or healthcare provider who 
reports that she is breastfeeding after having been exposed to the study intervention 
by needlestick injury or skin contact.  
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred. The 
information must be reported using the Vaccine SAE Reporting Form. When exposure 
during breastfeeding occurs in the setting of environmental exposure, the exposure 
information does not pertain to the participant enrolled in the study, so the information is not 
recorded on a CRF. However, a copy of the completed Vaccine SAE Reporting Form is 
maintained in the investigator site file.
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use. However, if the infant experiences an SAE associated with such a drug, the 
SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure
An occupational exposure occurs when a person receives unplanned direct contact with the 
study intervention, which may or may not lead to the occurrence of an AE.  Such persons 
may include healthcare providers, family members, and other roles that are involved in the 
trial participant’s care.
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the 
investigator’s awareness, regardless of whether there is an associated SAE.  The information 
must be reported using the Vaccine SAE Reporting Form.  Since the information does not 
pertain to a participant enrolled in the study, the information is not recorded on a CRF; 
however, a copy of the completed Vaccine SAE Reporting Form is maintained in the 
investigator site file.
8.3.6. Cardiovascular and Death Events
Not applicable.


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8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.3.8. Adverse Events of Special Interest
All AESIs must be reported as an AE or SAE following the procedures described in
Section 8.3.1 through Section 8.3.4. An AESI is to be recorded as an AE or SAE on the 
CRF. In addition, an AESI that is also an SAE must be reported using the Vaccine SAE 
Reporting Form.
8.3.8.1. Lack of Efficacy
Lack of efficacy in an approved indication should be reported as an SAE to Pfizer Safety.
8.3.9. Medical Device Deficiencies
Medical devices are being provided for use in this study for the purposes of administering 
and preparing study intervention. In order to fulfill regulatory reporting obligations 
worldwide, the investigator is responsible for the detection and documentation of events 
meeting the definitions of device deficiency that occur during the study with such devices.
The definition of a medical device deficiency can be found in Appendix 6.
NOTE: Deficiencies fulfilling the definition of an AE/SAE will also follow the processes 
outlined in Section 8.3.1 through Section 8.3.4 and Appendix 3 of the protocol.
8.3.9.1. Time Period for Detecting Medical Device Deficiencies
Medical device deficiencies or malfunctions of the device will be detected, documented, and 
reported during all periods of the study in which the medical device is used.
If the investigator learns of any device deficiency at any time after a participant has been 
discharged from the study, and such incident is considered reasonably related to a medical 
device provided for the study, the investigator will promptly notify the sponsor.
The method of documenting medical device deficiencies is provided in Appendix 6.
8.3.9.2. Follow-up of Medical Device Deficiencies
Follow-up applies to all participants, including those who discontinue study intervention.
The investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency.
New or updated information will be recorded on a follow-up form with all changes signed 
and dated by the investigator.


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8.3.9.3. Prompt Reporting of Device Deficiencies to Sponsor
Device deficiencies will be reported to the sponsor within 1 day after the investigator 
determines that the event meets the protocol definition of a medical device deficiency.  
Information will be provided to the sponsor as described in the IP manual.  
Any device deficiency that is associated with an SAE must be reported to Pfizer Safety 
within 24 hours upon the investigator’s awareness as outlined in Section 8.3.1.1 and
Section 8.3.1.2.
The sponsor will be the contact for the receipt of device deficiency information.
8.3.9.4. Regulatory Reporting Requirements for Device Deficiencies
The investigator will promptly report all device deficiencies occurring with any medical 
device provided for use in the study in order for the sponsor to fulfill the legal responsibility 
to notify appropriate regulatory authorities and other entities about certain safety information 
relating to medical devices being used in clinical studies.
The investigator, or responsible person according to local requirements (eg, the head of the 
medical institution), will comply with the applicable local regulatory requirements relating to 
the reporting of device deficiencies to the IRB/EC.
8.3.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors.
Safety Event
Recorded on the CRF
Reported on the Vaccine SAE 
Reporting Form to Pfizer Safety 
Within 24 Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;

Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.

Other examples include, but are not limited to:


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
The administration of expired study intervention;

The administration of an incorrect study intervention;

The administration of an incorrect dosage;

The administration of study intervention that has undergone temperature excursion 
from the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Reporting Form only when associated with an SAE.
8.4. Treatment of Overdose
For this study, any dose of investigational vaccine greater than 1 dose within a 24-hour time 
period will be considered an overdose. Any dose of paracetamol greater than the maximum 
daily dosing of 4 doses within a 24-hour time period per the product instructions will be 
considered an overdose.
Pfizer does not recommend specific treatment for an overdose.
In the event of an overdose, the investigator should:
1. Contact the medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs.
3. Document the quantity of the excess dose as well as the duration of the overdose in the 
CRF.
4. Overdose is reportable to Safety only when associated with an SAE.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant.
8.5. Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 


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8.6. Pharmacodynamics
Pharmacodynamic parameters are not evaluated in this study.
8.7. Genetics
Genetics (specified analyses) are not evaluated in this study.
8.8. Biomarkers
Biomarkers are not evaluated in this study.
8.9. Immunogenicity Assessments
Immunogenicity assessments are described in Section 8.1.
8.10. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
8.11. Study Procedures
8.11.1. Visit 1 (Day 1): Primary Vaccination 1
In the case of temporary delay of vaccination, the procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination.
Vaccination 1 for all participants should be conducted in the morning to allow time for 
daytime temperature monitoring.

Obtain written informed consent from the participant’s parent(s)/legal guardian 
before performing study-specific procedures.  The date of informed consent will be 
recorded on the CRF.

Record the participant’s demographic information (including date of birth, sex, race, 
and ethnicity). The full date of birth will be collected to critically evaluate the 
immune response and safety profile by age.

Record the presence of chronic conditions and/or medical history of significance,
including relevant surgical procedures and cardiac medical history.

Record previous PRP-OMP vaccinations as describe in Section 6.5.3.

Perform a physical examination including body length and weight, evaluating any 
clinically significant abnormalities within the following body systems: general 
appearance, skin, head, eyes, ears, nose, throat, heart, lungs, abdomen, extremities, 
neurological, musculoskeletal, and lymph nodes, including worsening of medical 
history conditions.  Results must be recorded on source documents and the CRF.  
Findings from a physical examination conducted as part of standard routine care and 
before informed consent may be used for purposes of the study only if the 


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examination was performed no more than 2 days before vaccination.  A brief 
examination must be performed on the day of vaccination to document that no change 
in health has occurred in the interim.

On the day of vaccination, prior to administration of study intervention, measure and 
record the participant’s axillary temperature.

Ensure that all of the inclusion criteria, none of the exclusion criteria, and none of the 
temporary delay criteria are met.

If a participant is eligible for the study, assign a randomization number and 
investigational product container numbers via the IRT, or an equivalent system.

For participants assigned to receive PLP in Groups 1, 3, 5, and 8 or in the PLP 
stratum of Group 14:

Administer a dose of PLP orally within 30 minutes before MenB vaccination.
The dosage to be administered is detailed in Table 5. 

Record the time of PLP administration in the participant’s e-diary. 

For all participants assigned to receive protocol-assigned paracetamol in Groups 1, 3, 
5, 7, 8, 11, 13, and 14:

Issue a bottle of paracetamol to parent(s)/legal guardian for paracetamol to be 
administered orally to the participant after vaccination as detailed in the 
participant paracetamol dosing instructions (Section 8.2.1.2.2). Inform 
parent(s)/legal guardian to return the bottle at the next study site visit.

During the open-label sentinel-cohort and open-label expanded-enrollment stages:

Administer a single intramuscular injection of MenABCWY (0.5 mL) or 
bivalent rLP2086 (0.25 mL for the 60-µg dose or 0.5 mL for the 120-µg dose)
or Bexsero (0.5 mL) into the left thigh. The time of investigational product 
administration will be recorded on the CRF (see Table 1).

Administer a single 0.5-mL intramuscular injection of Nimenrix (if applicable)
into the right thigh.  The time of investigational product administration will be 
recorded on the CRF (see Table 1).

Administer Prevenar 13 and Vaxelis intramuscularly into the right thigh. The 
time of investigational product administration will be recorded on the CRF.


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
During the blinded expanded-enrollment stage, the unblinded administrator will 
administer (Section 6.3.3.1):

A single 0.5-mL intramuscular injection of MenABCWY or Bexsero into the left
thigh.  The time of investigational product administration will be recorded on the 
CRF (see Table 1).

A single 0.5-mL intramuscular injection of placebo or Nimenrix into the right
thigh.  The time of investigational product administration will be recorded on the 
CRF (see Table 1).

Administer Prevenar 13 and Vaxelis intramuscularly into the right thigh.  
The time of investigational product administration will be recorded on the CRF.

Observe the participant for at least 30 minutes (or longer as per local practice) after 
the investigational product administration for any acute reactions.  Record any AEs 
observed during the 30-minute observation period; these AEs are defined as 
immediate AEs (Section 8.2).

Record AEs as described in Section 8.3 and the SoA. Time of onset will be recorded 
for any AEs that occur on the same day as investigational product administration.

Record concomitant medications used to treat AEs as described in Section 6.5.

Assist the participant’s parent(s)/legal guardian in downloading the e-diary app onto 
the participant’s own device or issue a provisioned device if required (Section 8.2.1).

Provide instruction regarding e-diary completion.  Ask the parent(s)/legal guardian to 
complete the e-diary from Day 1 to Day 7 after vaccination.  Day 1 is the day of 
vaccination.  Instructions on daily transfer of data and charging the battery should 
also be provided.

Issue a caliper, a measuring tape/ruler, and a digital thermometer and provide verbal 
and written instructions on their use.

Measuring tape/ruler data must be collected by the parent(s)/legal guardian. All data 
must be recorded in the e-diary by the parent(s)/legal guardian.

Ask the parent(s)/legal guardian to use the caliper to measure the maximum diameter 
of redness and swelling at the left thigh injection site each day for the 7 days after 
study vaccination and record in the e-diary as described in Section 8.2.1.1.1.


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
Ask the parent(s)/legal guardian to contact the investigator immediately if the 
participant experiences severe redness or swelling (>14 caliper units) at the left thigh
injection site or an axillary temperature ≥39°C, within 7 days after vaccination, as an 
unscheduled visit should be arranged (Section 8.12).

If the reaction exceeds the maximum size the caliper is able to measure 
(>14 caliper units, Section 8.2.1.1), the parent(s)/legal guardian should also use 
the measuring tape/ruler to measure the maximum diameter of redness and/or 
swelling at the left thigh injection site, and report this immediately to the 
investigator. 

Ask the parent(s)/legal guardian to report the maximum diameter of the redness 
and/or swelling at the left thigh injection site to the investigator daily until the 
reaction becomes ≤14 caliper units.

Provide the parent(s)/legal guardian with a contact card (Section 10.1.10).

Ask the parent(s)/legal guardian to contact the investigator immediately if any 
significant illness or hospitalization occurs.

For sentinel-cohort participants (Groups 1-10):

Ask the participant’s parent(s)/legal guardian to contact the investigator 
immediately if the child experiences any MAE or SAE during the active safety 
period (Day 1 to Day 7) (see Section 8.2.4.1).

The investigator must contact the Pfizer study physician immediately in the event 
of a participant’s experiencing an MAE or SAE during the active safety period 
(Day 1 to Day 7). See Section 8.2.4.1 for further detail on safety reporting 
requirements for sentinel-cohort participants. All AEs should be promptly 
captured in the CRF and/or SAE reports as applicable (see Section 8.3 for 
reporting requirements). 

Schedule an appointment for the next study visit and confirm that it is scheduled 
within the time window per protocol.

Remind the parent(s)/legal guardian to bring the e-diary to the next study visit.

Complete the source documents.

Complete the CRF and update the investigational product accountability records.


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Between visits, review the e-diary data online at frequent intervals. For sentinel-cohort 
participants, following primary vaccination 1, online review of e-diary data must be 
performed daily (see Section 8.2.4.1). Contact the parent(s)/legal guardian to obtain stop 
dates for any local reactions, systemic events, or use of antipyretic medication that was
ongoing on the last day that the e-diary was completed. The stop dates should be 
documented in the source documents and the information entered into the CRF at the next 
study visit of the participant.
8.11.2. Visit 2 (28 to 42 Days After Visit 1): Safety Telephone Contact

Contact the parent(s)/legal guardian by telephone.

Ensure that the participant continues to be eligible for the study and does not meet 
any withdrawal criteria (Section 7.2).

Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit. Inquire 
whether the participant had any of the following related to an AE since the last 
visit: hospitalizations, visits to other medical facilities, and medication use. 
Please refer to the ISF for additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit and record their end dates 
or confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Schedule an appointment for the next study visit, and confirm that it is scheduled 
within the time window per protocol.

Complete the source documents.

Complete the CRFs.


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8.11.3. Visit 3 (63 to 77 Days After Visit 1): Primary Vaccination 2
The visit window for primary vaccination 2 may be extended for individual participants by 
up to 14 days from the receipt of the positive IRC recommendation, at the discretion of the 
sponsor.
In the case of temporary delay of vaccination, procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination.
Vaccination 2 for all participants should be conducted in the morning to allow time for 
daytime temperature monitoring.

Ensure that the participant continues to be eligible for the study and does not meet 
any withdrawal criteria (Section 7.2) and any of the temporary delay of vaccination 
criteria as described in Section 5.5.1.

Perform a brief physical examination comprising general appearance, ears, throat, 
heart, and lungs.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last 
visit: hospitalizations, visits to other medical facilities, medication use, or missed 
days of school or work.  Please refer to the ISF for additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit and record their end dates 
or confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect the provided bottle of paracetamol from parent(s)/legal guardian of 
participants assigned to receive paracetamol as per protocol for primary 
vaccination 1.

On the day of vaccination, prior to administration of study intervention, measure and 
record the participant’s axillary temperature.

For participants assigned to receive PLP in Groups 1, 3, 5, and 8 or in the PLP 
stratum of Group 14:

Administer a dose of paracetamol orally within 30 minutes before MenB 
vaccination. The dosage to be administered is detailed in Table 5. 


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
Record the time of PLP administration in the participant’s e-diary. 

For all participants assigned to receive protocol-assigned paracetamol in Groups 1, 3, 
5, 7, 8, 11, 13, and 14:

Issue a bottle of paracetamol to parent(s)/legal guardian for additional doses of 
paracetamol to be administered orally to the participant after vaccination as 
detailed in the participant paracetamol dosing instructions (Section 8.2.1.2.2).
Inform parent(s)/legal guardian to return the bottle at the next study site visit.

During the open-label sentinel-cohort and open-label expanded-enrollment stages:

Administer a single intramuscular injection of MenABCWY (0.5 mL) or 
bivalent rLP2086 (0.25 mL for the 60-µg dose or 0.5 mL for the 120-µg dose)
or Bexsero (0.5 mL) into the left thigh. The time of investigational product 
administration will be recorded on the CRF (see Table 1).

Administer a single 0.5-mL intramuscular injection of Nimenrix (if applicable)
into the right thigh. The time of investigational product administration will be 
recorded on the CRF (see Table 1).

For Groups 3 through 12, administer Prevenar 13 and Vaxelis intramuscularly 
into the right thigh. The time of investigational product administration will be 
recorded on the CRF.

During the blinded expanded-enrollment stage, the unblinded administrator will 
administer (Section 6.3.3.1):

A single 0.5-mL intramuscular injection of MenABCWY or Bexsero into the left
thigh.  The time of investigational product administration will be recorded on the 
CRF (see Table 1).

A single 0.5-mL intramuscular injection of placebo or Nimenrix into the right
thigh.  The time of investigational product administration will be recorded on the 
CRF (see Table 1).

Administer Prevenar 13 and Vaxelis intramuscularly into the right thigh.  
The time of investigational product administration will be recorded on the CRF.

Observe the participant for at least 30 minutes (or longer as per local practice) after 
the investigational product administration for any acute reactions.  Record any AEs 
observed during the 30-minute observation period; these AEs are defined as 
immediate AEs (Section 8.2).

Ensure the participant’s parent(s)/legal guardian have access to the e-diary app or a 
provisioned device (see Section 8.2.1) and are comfortable with use of the e-diary.


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
Ask the parent(s)/legal guardian to complete the e-diary from Day 1 to Day 7 after 
vaccination.  Day 1 is the day of vaccination.  Instructions on daily transfer of data 
and charging the battery should also be provided.

Issue a caliper, a measuring tape/ruler, and a digital thermometer and provide verbal 
and written instructions on their use.

Measuring tape/ruler data must be collected by the parent(s)/legal guardian. All data 
must be recorded in the e-diary by the parent(s)/legal guardian.

Ask the parent(s)/legal guardian to use the caliper to measure the maximum diameter 
of redness and swelling at the left thigh injection site each day for the 7 days after 
study vaccination and record in the e-diary as described in Section 8.2.1.1.1.

Ask the parent(s)/legal guardian to contact the investigator immediately if the 
participant experiences severe redness or swelling (>14 caliper units) at the left thigh 
injection site, or an axillary temperature ≥39°C, within 7 days after vaccination, as an 
unscheduled visit should be arranged (Section 8.12).

If the reaction exceeds the maximum size the caliper is able to measure 
(>14 caliper units), the parent(s)/legal guardian should also use the measuring 
tape/ruler to measure the maximum diameter of redness and/or swelling at the left 
thigh injection site, and report this immediately to the investigator. 

Ask the parent(s)/legal guardian to report the maximum diameter of the redness 
and/or swelling at the left thigh injection site to the investigator daily until the 
reaction becomes ≤14 caliper units.

Ask the parent(s)/legal guardian to contact the investigator immediately if any 
significant illness or hospitalization occurs.

Schedule an appointment for the next study visit and confirm that it is scheduled 
within the time window per protocol.

Remind the parent(s)/legal guardian to bring the e-diary to the next study visit.

Complete the source documents.

Complete the CRF and update the investigational product accountability records.
Between visits, review the e-diary data online at frequent intervals. Contact the 
parent(s)/legal guardian to obtain stop dates for any local reactions, systemic events, or use of 
antipyretic medication that was ongoing on the last day that the e-diary was completed. The 
stop dates should be documented in the source documents and the information entered into 
the CRF at the next study visit of the participant.


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8.11.4. Visit 4 (28 to 42 Days After Visit 3): Follow-up After Primary Vaccination 2

Ensure that the participant continues to be eligible for the study and does not meet 
any withdrawal criteria (Section 7.2).

Collect a blood sample (approximately 5 mL) from the participant. Local/topical 
anesthetic may be used to numb the skin prior to the blood draw. 

Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication.

Collect the provisioned e-diary device, if previously provided to the participant’s 
parent(s)/legal guardian.

Collect the provided bottle of paracetamol from parent(s)/legal guardian of 
participants assigned to receive paracetamol as per protocol for primary vaccination 
2.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit. Inquire 
whether the participant had any of the following related to an AE since the last 
visit: hospitalizations, visits to other medical facilities, and medication use.
Please refer to the ISF for additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit and record their end dates 
or confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Provide the parent(s)/legal guardian with a memory aid. Instruct the parent(s)/legal 
guardian to use the memory aid between Visit 4 and Visit 5 to remind him or her to 
review any significant illnesses, hospitalizations, NDCMCs, or visits to a medical 
facility with study site personnel.  The memory aid is not a diary for the collection of 
reactogenicity.  Please refer to the ISF for additional details.

Ask the parent(s)/legal guardian to contact the investigator immediately if any 
significant illness or hospitalization occurs.

Schedule an appointment for the next visit and confirm that it is scheduled within the 
time window per protocol.

Complete the source documents.


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
Complete the CRFs.
8.11.5. Visit 5 (365 to 386 Days of Age): Booster Vaccination
In the case of temporary delay of vaccination, the procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination.
Booster vaccination for all participants can be conducted anytime during the day.

Ensure that the participant continues to be eligible for the study and does not meet 
any withdrawal criteria (Section 7.2) and any of the temporary delay of vaccination 
criteria as described in Section 5.5.1.

Perform a brief physical examination comprising general appearance, ears, throat, 
heart, and lungs.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last 
visit: hospitalizations, visits to other medical facilities, and medication use.  
Please refer to the ISF for additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit and record their end dates 
or confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

On the day of vaccination, prior to administration of study intervention, measure and 
record the participant’s axillary temperature.

During the open-label sentinel-cohort and open-label expanded-enrollment stages:

Administer a single intramuscular injection of MenABCWY (0.5 mL) or 
bivalent rLP2086 (0.25 mL for the 60-µg dose or 0.5 mL for the 120-µg dose)
or Bexsero (0.5 mL) into the left thigh. The time of investigational product 
administration will be recorded on the CRF (see Table 1).

Administer a single 0.5-mL intramuscular injection of Nimenrix (if applicable)
into the right thigh. The time of investigational product administration will be 
recorded on the CRF (see Table 1).


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
During the blinded expanded-enrollment stage, the unblinded administrator will 
administer (Section 6.3.3.1):

A single 0.5-mL intramuscular injection of MenABCWY or Bexsero into the left
thigh.  The time of investigational product administration will be recorded on the 
CRF (see Table 1).

A single 0.5-mL intramuscular injection of Placebo or Nimenrix into the right
thigh.  The time of investigational product administration will be recorded on the 
CRF (see Table 1).

Observe the participant for at least 30 minutes (or longer as per local practice) after 
the investigational product administration for any acute reactions.  Record any AEs 
observed during the 30-minute observation period; these AEs are defined as 
immediate AEs (Section 8.2).

Ensure the participant’s parent(s)/legal guardian have access to the e-diary app or a 
provisioned device (see Section 8.2.1) and are comfortable with use of the e-diary.

Ask the parent(s)/legal guardian or participant to complete the e-diary from Day 1 to 
Day 7 after vaccination.  Day 1 is the day of vaccination.  Instructions on daily 
transfer of data and charging the battery should also be provided.

Issue a caliper, a measuring tape/ruler, and a digital thermometer and provide verbal 
and written instructions on their use.

Measuring tape/ruler data must be collected by the parent(s)/legal guardian.  All data 
must be recorded in the e-diary by the parent(s)/legal guardian.

Ask the parent(s)/legal guardian to use the caliper to measure the maximum diameter 
of redness and swelling at the left thigh injection site each day for the 7 days after 
study vaccination and record in the e-diary as described in Section 8.2.1.1.1.

Ask the parent(s)/legal guardian to contact the investigator immediately if the 
participant experiences severe redness or swelling (>14 caliper units) at the left thigh 
injection site, or an axillary temperature ≥39°C, within 7 days after vaccination, as an 
unscheduled visit should be arranged (Section 8.12).

If the reaction exceeds the maximum size the caliper is able to measure 
(>14 caliper units), the parent(s)/legal guardian should also use the measuring 
tape/ruler to measure the maximum diameter of redness and/or swelling at the left 
thigh injection site, and report this immediately to the investigator. 

Ask the parent(s)/legal guardian to report the maximum diameter of the redness 
and/or swelling at the left thigh injection site to the investigator daily until the 
reaction becomes ≤14 caliper units.


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
Ask the parent(s)/legal guardian to contact the investigator immediately if any 
significant illness or hospitalization occurs.

Schedule an appointment for the next study visit and confirm that it is scheduled 
within the time window per protocol.

Remind the parent(s)/legal guardian to bring the e-diary to the next study visit.

Complete the source documents.

Complete the CRF and update the investigational product accountability records.
Between visits, review the e-diary data online at frequent intervals. Contact the 
parent(s)/legal guardian to obtain stop dates for any local reactions, systemic events, or use of 
antipyretic medication that was ongoing on the last day that the e-diary was completed. The 
stop dates should be documented in the source documents and the information entered into 
the CRF at the next study visit of the participant.
8.11.6. Visit 6 (28 to 42 Days After Visit 5): Follow-up After Booster Vaccination

Ensure that the participant continues to be eligible for the study and does not meet 
any withdrawal criteria (Section 7.2).

Collect a blood sample (approximately 5 mL) from the participant. Local/topical 
anesthetic may be used to numb the skin prior to the blood draw. 

Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication.

Collect the provisioned e-diary device, if previously provided to the participant’s 
parent(s)/legal guardian.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit. Inquire 
whether the participant had any of the following related to an AE since the last 
visit: hospitalizations, visits to other medical facilities, medication use, or missed 
days of school or work.  Please refer to the ISF for additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit and record their end dates 
or confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.


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
Provide the parent(s)/legal guardian with a memory aid. Instruct the parent(s)/legal 
guardian to use the memory aid between Visit 6 and Visit 7 (final telephone contact) 
to remind him or her to review any significant illnesses, hospitalizations, NDCMCs, 
or visits to a medical facility with study site personnel.  The memory aid is not a diary 
for the collection of reactogenicity.  Please refer to the ISF for additional details.

Ask the parent(s)/legal guardian to contact the investigator immediately if any 
significant illness or hospitalization occurs.

Schedule an appointment for the final telephone contact and confirm that it is 
scheduled within the time window per protocol.

Complete the source documents.

Complete the CRFs.
8.11.7. Visit 7 (168 to 196 Days After Last Study Vaccination): Final Telephone Contact
This telephone contact should occur approximately 6 months after the last study vaccination; 
this contact should be attempted for all participants who have received at least 1 study 
vaccination, unless they have withdrawn consent or are lost to follow-up.

Contact the parent(s)/legal guardian by telephone.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire about SAEs, NDCMCs, or AEs that resulted in evaluation at a medical 
facility since the last visit.  Please refer to the ISF for additional details.

Report any SAEs to the sponsor as defined in Section 8.3.

Review AEs that were ongoing since the previous visit and record their end dates 
or confirm that they are still continuing.

Record concomitant medications used to treat AEs that were ongoing since the 
previous visit and record their end dates or confirming that they are still continuing as 
described in Section 6.5.

Complete the source documents.

Complete the CRFs.


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8.12. Unscheduled Visits
If the participant experiences a severe redness or swelling at the left thigh injection site 
(>14 caliper units) or a temperature ≥39.0°C in the 7 days after vaccination, a study site visit 
should be arranged as soon as possible to assess the extent of the event. The parent(s)/legal 
guardian contact will be documented in the CRF.
If the reaction exceeds the maximum size the caliper is able to measure (>14 caliper units, 
Section 8.2.1.1.1), ensure the parent(s)/legal guardian has also measured the maximum 
diameter of the redness and/or swelling at the injection site using the measuring tape/ruler 
provided. Ask the parent(s)/legal guardian to report the maximum diameter of the redness 
and/or swelling at the injection site daily until the reaction becomes ≤14 caliper units.
Record these measurements in the CRF.
At an unscheduled visit, the participant’s axillary temperature should be measured and the 
symptom that prompted the visit should be assessed by a medically qualified member of the 
study staff.  Findings will be recorded on the CRF. If the participant experiences any 
unsolicited AEs, these should be recorded on the AE CRF.
If the unscheduled visit does not take place following participant report of fever ≥39.0°C or
severe redness/swelling, the reason must be documented in the CRF (for example, reaction 
no longer present or e-diary entry error).
For the purpose of assessments performed during unscheduled visits, a medically qualified 
member of the study staff is a study physician or a study nurse, as applicable to the 
investigator’s local practice.
9. STATISTICAL CONSIDERATIONS
Methodology for summary and statistical analyses of the data collected in this study is 
described here and further detailed in a SAP, which will be maintained by the sponsor.  The 
SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
In the following statistical sections when groups are written as “Group x and Group y,” this 
indicates that both groups will appear, separately, in the same summary.  When groups are 
written as “group combination x+y,” this indicates that the groups will appear combined in a 
single row or column in the indicated summary.  Table 8 presents the individual group 
numbers along with their descriptions.  


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Table 8.
Vaccine Groups and Descriptions
Group
Description
Sample Size
Open-Label Sentinel-Cohort Stage
6 Months of age
1
MenABCWY + PLP
25
2
MenABCWY
25
2 Months of age
3
60 µg bivalent rLP2086 + Nimenrix + PLP 
37
4
60 µg bivalent rLP2086 + Nimenrix 
25
5
120 µg bivalent rLP2086 + Nimenrix + PLP 
50
7
MenABCWY + SLP
50-100
8
Bexsero + Nimenrix + PLP
55
10
Bexsero + Nimenrix
55
Open-Label Expanded-Enrollment Stage
2 Months of age
11
MenABCWY (with TLP or SLP)
50-100
Blinded Expanded-Enrollment Stage
2 Months of age
Double-blind onlya
13
MenABCWY + placebo (with TLP)
Up to 400
14
Bexsero + Nimenrix (with TLP)
Up to 400
Double-blind and single-blinda
Double-blind
13
MenABCWY + placebo (with TLP)
Up to 200
14
Bexsero + Nimenrix (with TLP)
Up to 200
Single-blind
13
MenABCWY + placebo (with SLP)
Up to 200
14
Bexsero + Nimenrix (with PLP)
Up to 200
Abbreviation: PLP = prophylactic liquid paracetamol; SLP = scheduled liquid paracetamol regimen; 
TLP = therapeutic liquid paracetamol regimen.
a.
Based on the safety data from Groups 7 and 11, the blinded expanded-enrollment stage of the study will 
either be conducted as a completely double-blind stage where both treatment groups use TLP regardless 
of their group assignment or it will be conducted as partially double-blind with some proportion of the 
participants receiving TLP regardless of their group assignment and partially single-blind with the 
remaining participants receiving either SLP or PLP depending on their group assignment. 
9.1. Estimands and Statistical Hypotheses
There are no hypotheses for this study.
9.1.1. Estimands
The estimand(s) corresponding to each primary, secondary, and exploratory objective are 
described in the table in Section 3. These estimands estimate the vaccine effect in the 
hypothetical setting where participants follow the study schedules and protocol requirements 
as directed and are estimating the maximum potential difference between the groups, since 
the impact of noncompliance is likely to diminish the observed difference between the 
groups. The missing serology results will not be imputed.


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In the primary safety objective evaluations, missing e-diary data will not be imputed. 
Missing AE dates will be imputed according to Pfizer safety rules.
9.2. Sample Size Determination
9.2.1. Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
The sample size for this component of the study is not based on any hypothesis-testing 
criteria. The study aims to have a sufficient number of participants in order to describe the 
safety and the immunogenicity. With 150 enrolled participants in Groups 7+11 combined, the 
ratio of the lower bound of the one-sample 95% CI for the GMT to the GMT is 
approximately 0.76 and 0.66, respectively, for an assumed maximum SD of 1.3 for MenB 
test strains and 2.0 for MenA, MenC, MenW, and MenY test strains, assuming that 70% of 
the participants will have test results for all the strains and a 15% exclusion rate from the 
(post–primary vaccination 2) evaluable population. With a similar assumption and
110 enrolled participants in Groups 8+10 combined, the ratio of the lower bound of the one-
sample 95% CI for the GMT to the GMT is approximately 0.73 and 0.62, respectively.
Table 9 shows the expected half-width of the 95% CI for the different scenarios of the 
percentage of participants achieving an hSBA titer ≥LLOQ for each test strain.
Table 9.
Expected Half-Width of One-Sample 95% CIs for Different Scenarios of 
Percentage of Participants Achieving an hSBA Titer ≥LLOQ for Each Test 
Strain
Percentage of Participants
Number of Enrolled Participants 
per Group
Expected Half-Width of 95% CI
(%)
60
110
12.3
70
110
11.6
80
110
9.9
90
110
7.7
60
150
10.5
70
150
9.9
80
150
8.7
90
150
6.7
Abbreviations: hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of 
quantitation.
Note: 70% of participants are expected to have valid test results for all strains. Exclusion rate from the 
(post–primary vaccination 2) evaluable population is assumed to be 15%.
The probability of observing at least 1 occurrence of any AE for true event percentages 
between 0.1% and 5.0%, when MenABCWY is administered to 25, 50, 110, or
150 participants, is displayed in Table 10.


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Table 10.
Probability of Observing at Least 1 Event by Assumed True Event Rates
Assumed True Event 
Percentage
Probability
(N=25)
Probability
(N=50)
Probability
(N=110)
Probability
(N=150)
0.1%
0.02
0.05
0.10
0.14
0.5%
0.12
0.22
0.42
0.53
1.0%
0.22
0.39
0.67
0.78
2.0%
0.40
0.64
0.89
0.95
5.0%
0.72
0.92
>0.99
>0.99
9.2.2. Blinded Expanded-Enrollment Stage
The sample size for this component of the study is not based on any hypothesis-testing 
criteria. The study aims to have a sufficient number of participants in this component in 
order to describe the safety and immunogenicity. At the discretion of the IRC, the split 
between the double-blind (TLP) and single-blind (PLP/SLP) groups can vary from 50/50 
(which corresponds to 200 per group contributing to the double-blind analyses) and 100/0 
(which corresponds to 400 per group contributing to the double-blind analyses).  As the 
number of participants contributing to each of these regimens will influence what are the 
appropriate safety analyses, the final details of these analyses will be specified in the SAP.
With 400 enrolled participants in each of Group 13 and Group 14 the ratio of the lower 
bound of the one-sample 95% CI for the GMT to the GMT is approximately 0.85 and 0.78, 
respectively, for an assumed maximum SD of 1.3 for MenB test strains and 2.0 for MenA, 
MenC, MenW, and MenY test strains, assuming that 70% of the participants will have test 
results for all the strains and a 15% exclusion rate from the (post–primary vaccination 2) 
evaluable population.  With similar assumptions and 200 enrolled participants each in
Groups 13 and 14, the ratio of the lower bound of the one-sample 95% CI for the GMT to the 
GMT is approximately 0.79 and 0.70, respectively.
Table 11 shows the expected half-width of the 95% CI for the different scenarios of the 
percentage of participants achieving an hSBA titer ≥ LLOQ for each test strain.


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Table 11.
Expected Half-Width of One-Sample 95% CIs for Different Scenarios of 
Percentage of Participants Achieving an hSBA Titer ≥LLOQ for Each Test 
Strain
Percentage of Participants
Number of Enrolled Participants 
per Group
Expected Half-Width of 95% CI
(%)
60
200
9.1
70
200
8.5
80
200
7.5
90
200
5.8
60
400
6.4
70
400
6.0
80
400
5.2
90
400
4.0
Abbreviation: LLOQ = lower limit of quantitation.
Note: 70% of participants are expected to have valid test results for all strains. Exclusion rate from the 
(post–primary vaccination 2) evaluable population is assumed to be 15%.
The probability of observing at least 1 occurrence of any AE for true event percentages 
between 0.1% and 5.0%, when MenABCWY is administered to 200 or 400 participants, is 
displayed in Table 12.
Table 12.
Probability of Observing at Least 1 Event by Assumed True Event Rates
Assumed True Event 
Percentage
Probability
(N=200)
Probability
(N=400)
0.1%
0.18
0.33
0.5%
0.56
0.87
1.0%
0.87
0.98
2.0%
0.98
>0.99
5.0%
>0.99
>0.99
9.3. Analysis Sets
For purposes of analysis, the following populations are defined:
Population
Description
Enrolled  
All participants who sign the ICD.
Randomly assigned to investigational 
product
All participants who are assigned a randomization 
number in the IRT system.
Evaluable
Defined according to post–primary vaccination 2 
evaluable and post–booster vaccination evaluable 
criteria.


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Population
Description
Modified intent-to-treat
Defined according to post–primary vaccination 2 
mITT and post–booster vaccination mITT criteria.
Safety
All randomized participants who receive at least 1 
dose of the investigational product and have safety 
data reported after vaccination. Participants will be 
analyzed according to the vaccine they actually 
received.
Defined Population for Analysis
Description
Post–primary vaccination 2 evaluable
All randomized participants who were eligible 
through Visit 4, received the investigational 
products at Visits 1 and 3 as randomized, had blood 
drawn for assay testing within the required time 
frame at Visit 4 (1 month after primary vaccination 
2 [window 28-42 days]), had at least 1 valid and 
determinate MenA, MenC, MenW, MenY, or 
MenB assay result at Visit 4, had received no 
prohibited vaccines or treatment through Visit 4, 
and had no important protocol deviations through 
Visit 4. An important protocol deviation is a 
protocol deviation that, in the opinion of the 
sponsor’s global medical monitor, would materially 
affect assessment of immunogenicity, eg, 
participant receipt of a prohibited vaccine or 
medication that might affect immune response or a 
medication error with suspected decrease in 
potency of the vaccine.
Post–booster vaccination evaluable
All randomized participants who were eligible 
through Visit 6, received the investigational 
products following the vaccination series at 
Visits 1, 3, and 5 as randomized, had blood drawn 
for assay testing within the required time frame at 
Visit 6 (1 month after the booster vaccination 
[window 28-42 days]), had at least 1 valid and 
determinate MenA, MenC, MenW, MenY, or 
MenB assay result at Visit 6, had received no 
prohibited vaccines or treatment through Visit 6, 
and had no important protocol deviations through 
Visit 6. An important protocol deviation is a 
protocol deviation that, in the opinion of the 
sponsor’s global medical monitor, would materially 
affect assessment of immunogenicity, eg, 


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Defined Population for Analysis
Description
participant receipt of a prohibited vaccine or 
medication that might affect immune response or a 
medication error with suspected decrease in 
potency of the vaccine.
Post–primary vaccination 2 modified 
intent-to-treat
All participants who received at least 1 primary 
series study vaccination and have at least 1 valid 
and determinate MenA, MenC, MenW, MenY, or 
MenB assay result available at Visit 4.
Post–booster vaccination modified 
intent-to-treat
All participants who received the booster study 
vaccination and have at least 1 valid and 
determinate MenA, MenC, MenW, MenY, or 
MenB assay result available at Visit 6.
9.4. Statistical Analyses
9.4.1. Immunogenicity Analyses
9.4.1.1. Open-Label Sentinel-Cohort and Open-Label Expanded-Enrollment Stages
Endpoint
Statistical Analysis Methods
Primary
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving an hSBA titer ≥LLOQ for group 
combinations 7+11 and 8+10 at 1 month after primary vaccination 2 will 
be calculated.
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥LLOQ for group combinations 7+11 and 8+10
at 1 month after primary vaccination 2 will be calculated.
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥LLOQ for group combination 3+4 and 
Group 5 at 1 month after primary vaccination 2 will be calculated.
The analysis at 1 month after primary vaccination 2 for the MenA, 
MenC, MenW, and MenY and the MenB test strains is based on the 
post–primary vaccination 2 evaluable population.  
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving an hSBA titer ≥LLOQ for group 
combinations 7+11 and 8+10 at 1 month after the booster vaccination 
will be calculated.


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Endpoint
Statistical Analysis Methods
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥LLOQ for group combinations 7+11 and 8+10
at 1 month after the booster vaccination will be calculated.
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥LLOQ for group combination 3+4 and 
Group 5 at 1 month after the booster vaccination will be calculated.
The analysis at 1 month after the booster vaccination for the MenA, 
MenC, MenW, and MenY and the MenB test strains is based on the 
post–booster vaccination evaluable population.  
Exact 2-sided 95% CIs for the percentages will be provided using the 
Clopper-Pearson method. Supportive analyses will be performed based 
on the post–primary vaccination 2 mITT population for post–primary 
vaccination 2 results, and the post–booster vaccination mITT population 
for postbooster results. Participants will be summarized according to the 
vaccine group to which they were randomized. Missing serology data 
will not be imputed.
Secondary  
The following analyses for the MenB test strains are based on the 
post–primary vaccination 2 evaluable population:
For each of the MenB test strains, the hSBA GMTs for group 
combination 3+4 and Group 5 at 1 month after primary vaccination 2 will 
be calculated.
The following analyses for the MenB test strains are based on the 
post–booster vaccination evaluable population:
For each of the MenB test strains, the hSBA GMTs for group 
combination 3+4 and Group 5 at 1 month after the booster vaccination 
will be calculated.


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Endpoint
Statistical Analysis Methods
Exploratory
The following analyses for the MenA, MenC, MenW, and MenY
and the MenB test strains are based on the post–primary 
vaccination 2 evaluable population:
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
hSBA GMTs for group combinations 7+11 and 8+10 at 1 month after 
primary vaccination 2 will be calculated.
For each of the MenB test strains, the hSBA GMTs for group 
combinations 7+11 and 8+10 at 1 month after primary vaccination 2 
will be calculated.
The following analyses for the MenA, MenC, MenW, and MenY
and the MenB test strains are based on the post–booster 
vaccination evaluable population:
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving hSBA titers of ≥1:8, ≥1:16, ≥1:32, 
≥1:64, and ≥1:128 for group combinations 7+11 and 8+10 at 1 month 
after the booster vaccination will be calculated.
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
hSBA GMTs for group combinations 7+11 and 8+10 at 1 month after 
the booster vaccination will be calculated.
For each of the MenB test strains, the hSBA GMTs for group 
combinations 7+11 and 8+10 at 1 month after the booster vaccination 
will be calculated.
The following analyses for the MenA, MenC, MenW, and MenY
and the MenB test strains by protocol-assigned paracetamol status 
are based on the post–primary vaccination 2 evaluable population:
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving an hSBA titer ≥LLOQ for group 
combinations 7+11 (with SLP), or Groups 8 (with PLP), 11 (with TLP), 
and 10 (without PLP) at 1 month after primary vaccination 2 will be 
calculated. 
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥LLOQ for group combinations 7+11
(with SLP), 8 (with PLP), 11 (with TLP), and 10 (without PLP) at 
1 month after primary vaccination 2 will be calculated.


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Endpoint
Statistical Analysis Methods
Empirical RCDCs will be provided for hSBA titers.
Percentages will be presented with 2-sided 95% CIs using the Clopper-
Pearson method. Geometric means and their 2-sided CIs will be 
derived by calculating means and CIs on the natural log scale based on 
the t-distribution, then exponentiating the results. Titers below LLOQ 
will be set to 0.5 × LLOQ for analysis.
Supportive analyses will be done using the applicable mITT population. 
Participants will be summarized according to the vaccine group to 
which they were randomized. Missing serology data will not be 
imputed.
The following analyses for the MenA, MenC, MenW, and MenY 
and the MenB test strains are based on the post–primary 
vaccination 2 evaluable population:
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving an hSBA titer ≥LLOQ for the 
group combination 1+2 at 1 month after primary vaccination 2 will be 
calculated.
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
hSBA GMTs for the group combination 1+2 at 1 month after primary 
vaccination 2 will be calculated.
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥ LLOQ for the group combination 1+2 at 
1 month after primary vaccination 2 will be calculated.
For each of the MenB test strains, the hSBA GMTs for the group 
combination 1+2 at 1 month after primary vaccination 2 will be 
calculated.
The following analyses for the MenA, MenC, MenW, and MenY 
and the MenB test strains are based on the post–booster 
vaccination evaluable population:
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving an hSBA titer ≥LLOQ for the 
group combination 1+2 at 1 month after the booster vaccination will be 
calculated.


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Endpoint
Statistical Analysis Methods
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
hSBA GMTs for the group combination 1+2 at 1 month after the 
booster vaccination will be calculated.
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥LLOQ for the group combination 1+2 at 
1 month after the booster vaccination will be calculated.
For each of the MenB test strains, the hSBA GMTs for the group 
combination 1+2 at 1 month after the booster vaccination will be 
calculated.
9.4.1.2. Blinded Expanded-Enrollment Stage
Endpoint
Statistical Analysis Methods
Primary
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving an hSBA titer ≥ LLOQ for 
Groups 13 and 14 at 1 month after primary vaccination 2 will be 
calculated.
For each of the 4 MenA, MenC, MenW, and MenY test strains, the hSBA 
GMTs for Groups 13 and 14 at 1 month after primary vaccination 2 will 
be calculated.
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥ LLOQ for Groups 13 and 14 at 1 month after 
primary vaccination 2 will be calculated.
For each of the MenB test strains, the hSBA GMTs for Groups 13 and 
14 at 1 month after primary vaccination 2 will be calculated.
The analysis at 1 month after primary vaccination 2 for the MenA, 
MenC, MenW, and MenY and the MenB test strains is based on the 
post–primary vaccination 2 evaluable population.  
For each of the 4 MenA, MenC, MenW, and MenY test strains, the 
percentages of participants achieving an hSBA titer ≥ LLOQ for Groups
13 and 14 at 1 month after the booster vaccination will be calculated.


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Endpoint
Statistical Analysis Methods
For each of the 4 MenA, MenC, MenW, and MenY test strains, the hSBA 
GMTs for Groups 13 and 14 at 1 month after the booster vaccination will 
be calculated.
For each of the MenB test strains, the percentages of participants 
achieving an hSBA titer ≥ LLOQ for Groups 13 and 14 at 1 month after 
the booster vaccination will be calculated.
For each of the MenB test strains, the hSBA GMTs for Groups 13 and 
14 at 1 month after the booster vaccination will be calculated.
Exact 2-sided 95% CIs for the percentages will be provided using the 
Clopper-Pearson method. Supportive analyses will be performed based 
on the post–primary vaccination 2 mITT population for post–primary 
vaccination 2 results and the post–booster vaccination mITT population 
for postbooster results. Participants will be summarized according to the 
vaccine group to which they were randomized. Missing serology data 
will not be imputed.
9.4.2. Safety Analyses
9.4.2.1. Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
All safety analyses will be performed on the safety population. Separate safety populations 
will be defined for each vaccination visit and follow-up phase (primary vaccination 1, 
primary vaccination 2, primary vaccination 2 follow-up, booster vaccination, and booster 
vaccination follow-up phases) and will be detailed in the SAP.
Endpoint
Statistical Analysis Methods
Primary
The proportion of participants reporting local reactions at the 
investigational product administration site and systemic events within the 
7-day period after each vaccination will be descriptively summarized by 
the following group or combined groups:
Group combination 7+11 (with SLP) (MenABCWY + SLP recipients)
Group 8 (with PLP) (Bexsero + PLP recipients)
Group 11 (with TLP) (MenABCWY recipients)
Group 10 (without PLP) (Bexsero recipients)


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Endpoint
Statistical Analysis Methods
Additionally, summaries without regard to protocol-assigned 
paracetamol administration will be provided for the following combined 
groups:  
Group combination 7+11 (MenABCWY recipients)
Group combination 8+10 (Bexsero recipients)
Two-sided 95% CIs based on the Clopper Pearson method will be 
presented with the proportions. Severities of local reactions and systemic 
events reported after each vaccination will also be descriptively 
summarized by the same group or combined groups. Local reactions will 
be summarized only for the left thigh, which is the MenABCWY, 
Trumenba, Bexsero, or placebo injection site.
The proportion of participants reporting the use of antipyretic medication 
for Days 1 to 7 will be summarized for the group or combined groups 
after each vaccination.
All AEs and SAEs will be categorized according to the latest version of 
MedDRA. An MAE is defined as a nonserious AE that results in an 
evaluation at a medical facility. An NDCMC is defined as a disease or 
medical condition not previously identified that is expected to be 
persistent or otherwise long-lasting in its effects. AEs, SAEs, MAEs, 
and NDCMCs will be summarized by group or combined groups as for 
local reactions and systemic events.
Participants will be analyzed according to the vaccine they actually 
received. Missing e-diary data will not be imputed; missing AE dates 
will be handled according to the Pfizer safety rules.
Detailed analyses for each safety endpoint will be addressed in the SAP.
Secondary
Similar summaries to those proposed for the primary safety endpoint will 
be done for the secondary safety endpoint as well, but using the 
following groups instead:
Group 3 (60 µg bivalent rLP2086 + Nimenrix + PLP recipients)
Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients)
Group 5 (120 µg bivalent rLP2086 + Nimenrix + PLP recipients)


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Endpoint
Statistical Analysis Methods
Exploratory
Similar summaries to those proposed for the primary safety endpoint will 
be done for the exploratory safety endpoint as well, but using the 
following groups instead:
Group 1 (MenABCWY + PLP recipients)
Group 2 (MenABCWY recipients)  
9.4.2.2. Blinded Expanded-Enrollment Stage
Endpoint
Statistical Analysis Methods
Primary
The proportion of participants reporting local reactions at the 
investigational product administration site and systemic events within the 
7-day period after each vaccination will be descriptively summarized by 
the following groups:
Double-blind only:
Group 13 (with TLP) (MenABCWY + TLP recipients)
Group 14 (with TLP) (Bexsero + TLP recipients)
Double-blind and single-blind:
Single-blind groups:
Group 13 (with SLP) (MenABCWY + SLP recipients)
Group 14 (with PLP) (Bexsero + PLP recipients)
Double-blind groups:
Group 13 (with TLP) (MenABCWY + TLP recipients)
Group 14 (with TLP) (Bexsero + TLP recipients)
Two-sided 95% CIs based on the Clopper Pearson method will be 
presented with the proportions. Severities of local reactions and systemic 
events reported after each vaccination will also be descriptively 
summarized by the same group. Local reactions will be summarized only 
for the left thigh, which is the MenABCWY, Trumenba, Bexsero, or 
placebo injection site.
The proportion of participants reporting the use of antipyretic medication 
for Days 1 to 7 will be summarized for the group after each vaccination.
All AEs and SAEs will be categorized according to the latest version of 
MedDRA. An MAE is defined as a nonserious AE that results in an 
evaluation at a medical facility. An NDCMC is defined as a disease or 


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Endpoint
Statistical Analysis Methods
medical condition not previously identified that is expected to be 
persistent or otherwise long-lasting in its effects. AEs, SAEs, MAEs, and 
NDCMCs will be summarized by group as for local reactions and 
systemic events.
Participants will be analyzed according to the vaccine they actually 
received.  Missing e-diary data will not be imputed; missing AE dates 
will be handled according to the Pfizer safety rules.
Detailed analyses for each safety endpoint will be addressed in the SAP.
9.5. Interim Analyses
9.5.1. Analysis Timing
Statistical analyses will be carried out when the final data for the specified analyses are 
available:

Analysis 1: conducted after Group 5, 8, and 10 participants have completed Visit 4, 1 
month after primary vaccination 2.  This analysis will include immunogenicity data 
from Groups 5, 8, and 10 up to 1 month after vaccination 2, and all safety data 
available at that time which, at a minimum, will include safety data from all 
sentinel-cohort groups (Groups 1-5, 7, 8, and 10).  An equivalent analysis may be
conducted after Group 5, 8, and 10 participants have completed Visit 6, 1 month after 
the booster vaccination.

Analysis 2: safety and immunogenicity data through 1 month after primary 
vaccination 2 from participants in the open-label stages;

Analysis 3: safety and immunogenicity data through 1 month after booster 
vaccination from participants in the open-label phase;

Analysis 4: a final analysis will be done after all the available data have been 
collected.
Note that Analysis 1 and Analysis 4 represent the final analyses at the specified time point 
for the specified vaccine group.
As the open-label stage is unblinded, the sponsor may conduct unblinded review of the safety 
and immunogenicity data from this phase at any time during the course of the study.


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9.6. Data Monitoring Committee or Other Independent Oversight Committee
This study will use an IRC and an EDMC. The IRC is independent of the study team and 
includes only internal members, and the EDMC includes only external members. The 
IRC/EDMC charter describes the role of the IRC/EDMC in more detail.
A Pfizer IRC will review and evaluate post–primary vaccination 1 safety data of each cohort 
in the sentinel-cohort stage and control the study enrollment and progression. The EDMC 
will be informed of the IRC’s determinations. Enrollment and vaccination may proceed at 
the discretion of the IRC. The IRC may also determine the number of participants to be 
enrolled to receive MenABCWY with SLP or TLP in the open-label expanded-enrollment 
stage and decide the enrollment progression and stratification of protocol-assigned 
paracetamol regimens for the blinded expanded-enrollment stage based on the safety data 
gathered during the study. The IRC will also review safety data after all sentinel-cohort 
participants and expanded-enrollment stage participants have completed primary 
vaccination 2.
Safety data will be reviewed by the EDMC throughout the study.  During the blinded phase, 
an independent statistical center will provide unblinded safety reports to the EDMC for 
review.  
The EDMC will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter. The recommendations made by the EDMC to alter the 
conduct of the study will be forwarded to the appropriate Pfizer personnel for final decision.  
Pfizer will forward such decisions, which may include summaries of aggregate analyses of 
safety data, to regulatory authorities, as appropriate. 


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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;

Applicable ICH GCP guidelines;

Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor and submitted to an 
IRB/EC by the investigator and reviewed and approved by the IRB/EC before the study is 
initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
The investigator will be responsible for the following:

Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;

Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;

Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/EC, European regulation 536/2014 
for clinical studies (if applicable), and all other applicable local regulations.
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of ICH GCP that the investigator becomes aware 
of.


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10.1.2. Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or his/her representative will explain the nature of the study to the 
participant’s parent(s)/legal guardian and answer all questions regarding the study.  The 
participant’s parent(s)/legal guardian should be given sufficient time and opportunity to ask 
questions and to decide whether or not to participate in the trial.
The participant’s parent(s)/legal guardian must be informed that participation is voluntary.
The participant’s parent(s)/legal guardian will be required to sign a statement of informed 
consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, HIPAA 
requirements, where applicable, and the IRB/EC or study center.
The investigator must ensure that each study participant’s parent(s)/legal guardian is fully 
informed about the nature and objectives of the study, the sharing of data related to the study,
and possible risks associated with participation, including the risks associated with the 
processing of the participant’s personal data. 
The participant’s parent(s)/legal guardian must be informed that the participant’s personal 
study-related data will be used by the sponsor in accordance with local data protection law. 
The level of disclosure must also be explained to the participant’s parent(s)/legal guardian.
The participant’s parent(s)/legal guardian must be informed that the participant’s medical 
records may be examined by Clinical Quality Assurance auditors or other authorized 
personnel appointed by the sponsor, by appropriate IRB/EC members, and by inspectors 
from regulatory authorities.
The investigator further must ensure that each study participant’s parent(s)/legal guardian is 
fully informed about his or her right to access and correct the participant’s personal data and 
to withdraw consent for the processing of the participant’s personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained.
The authorized person obtaining the informed consent must also sign the ICD.
The participants’ parent(s)/legal guardian must be reconsented to the most current version of 
the ICD(s) during their participation in the study.
A copy of the ICD(s) must be provided to the participant’s parent(s)/legal guardian.


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Unless prohibited by local requirements or IRB/EC decision, the ICD will contain a separate 
section that addresses the use of samples for optional additional research. The optional 
additional research does not require the collection of any further samples.  The investigator 
or authorized designee will explain to each participant the objectives of the additional
research. Participants will be told that they are free to refuse to participate and may 
withdraw their consent at any time and for any reason during the storage period.
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password protected or secured in a locked room to ensure that only 
authorized study staff have access.  The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster.  In the event of a potential personal data breach, the study site will be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law.
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code.
Any participant records or data sets that are transferred to the sponsor will contain the 
numerical code; participant names will not be transferred. All other identifiable data 
transferred to the sponsor will be identified by this single, participant-specific code. The 
study site will maintain a confidential list of participants who participated in the study, 
linking each participant’s numerical code to his or her actual identity and medical record 
identification. In case of data transfer, the sponsor will protect the confidentiality of 
participants’ personal data consistent with the clinical study agreement and applicable 
privacy laws.
10.1.5. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), EudraCT, and/or 
www.pfizer.com, and other public registries in accordance with applicable local 
laws/regulations.  In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.


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www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted.  These results are 
submitted for posting in accordance with the format and timelines set forth by US law.
EudraCT
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are
posted to www.clinicaltrials.gov.
Documents within marketing authorization packages/submissions
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the EMA website.  Clinical data, under Phase 1 of this policy, include clinical 
overviews, clinical summaries, CSRs, and appendices containing the protocol and protocol 
amendments, sample CRFs, and statistical methods.  Clinical data, under Phase 2 of this 
policy, includes the publishing of individual participant data.  Policy 0070 applies to new 
marketing authorization applications submitted via the centralized procedure since 
01 January 2015 and applications for line extensions and for new indications submitted via 
the centralized procedure since 01 July 2015.
Data Sharing
Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes 
of “bona-fide scientific research” that contributes to the scientific understanding of the 
disease, target, or compound class. Pfizer will make available data from these trials 
24 months after study completion.  Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations.  CSRs will have personally identifiable information 
redacted.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.


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10.1.6. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents.  This 
verification may also occur after study completion.  It is important that the investigator(s) 
and their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process.
Monitoring details describing strategy (eg, risk-based initiatives in operations and quality 
such as risk management and mitigation strategies and analytical risk-based monitoring), 
methods, responsibilities, and requirements, including handling of noncompliance issues and 
monitoring techniques (central, remote, or on-site monitoring), are provided in the 
monitoring plan.
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.


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The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study.  Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection.  The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant's medical records.  The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent.  Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
10.1.7. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site.
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
Definition of what constitutes source data can be found in the ISF.
Description of the use of computerized system is documented in the data management plan.
10.1.8. Study and Site Start and Closure
The study start date is the date on which the clinical study will be open for recruitment of 
participants.
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date.
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon 
study completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time upon notification to the sponsor 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:

Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor's procedures, or GCP guidelines;

Inadequate recruitment of participants by the investigator;


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
Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement.  If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
10.1.9. Publication Policy
The results of this study may be published or presented at scientific meetings by the 
investigator after publication of the overall study results or 1 year after the end of the study 
(or study termination), whichever comes first. 
The investigator agrees to refer to the primary publication in any subsequent publications 
such as secondary manuscripts, and submits all manuscripts or abstracts to the sponsor 
30 days before submission. This allows the sponsor to protect proprietary information and to 
provide comments and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study- or Pfizer 
intervention-related information necessary for the appropriate scientific presentation or 
understanding of the study results.
For all publications relating to the study, the investigator will comply with recognized ethical 
standards concerning publications and authorship, including those established by the 
International Committee of Medical Journal Editors.
The sponsor will comply with the requirements for publication of the overall study results 
covering all investigator sites.  In accordance with standard editorial and ethical practice, the 
sponsor will support publication of multicenter studies only in their entirety and not as 
individual site data.  In this case, a coordinating investigator will be designated by mutual 
agreement.
Authorship of publications for the overall study results will be determined by mutual 
agreement and in line with International Committee of Medical Journal Editors authorship 
requirements. 
If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply.


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10.1.10. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the investigator site file.
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, participants are provided with a contact card at the time of informed 
consent.  The contact card contains, at a minimum, protocol and study intervention
identifiers, participant numbers, contact information for the investigator site, and contact 
details for a contact center in the event that the investigator site staff cannot be reached to 
provide advice on a medical question or problem originating from another healthcare 
professional not involved in the participant’s participation in the study.  The contact number 
can also be used by investigator staff if they are seeking advice on medical questions or 
problems; however, it should be used only in the event that the established communication 
pathways between the investigator site and the study team are not available.  It is therefore 
intended to augment, but not replace, the established communication pathways between the 
investigator site and the study team for advice on medical questions or problems that may 
arise during the study.  The contact number is not intended for use by the participant directly, 
and if a participant calls that number, he or she will be directed back to the investigator site.
10.2. Appendix 2: Clinical Laboratory Tests
Not applicable.


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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
10.3.1. Definition of AE
AE Definition
An AE is any untoward medical occurrence in a patient or clinical study participant, 
temporally associated with the use of study intervention, whether or not considered related 
to the study intervention.
NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator.  Any abnormal laboratory test 
results that meet any of the conditions below must be recorded as an AE:

Is associated with accompanying symptoms.

Requires additional diagnostic testing or medical/surgical intervention.

Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy.

Exacerbation of a chronic or intermittent preexisting condition including either an 
increase in frequency and/or intensity of the condition.

New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE/SAE unless it is an intentional overdose taken with possible 
suicidal/self-harming intent. Such overdoses should be reported regardless of 
sequelae.

The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will 
be reported as an AE or SAE if they fulfill the definition of an AE or SAE and meet 
the requirements as per Section 8.3.8.1. Also, “lack of efficacy” or “failure of 
expected pharmacological action” does not constitute an AE or SAE.


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Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.

The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.

Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.

Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).

Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present 
or detected at the start of the study that do not worsen.
10.3.2. Definition of an NDCMC
An NDCMC is defined as a disease or medical condition, not previously identified, that is 
expected to be persistent or is otherwise long-lasting in its effects.
10.3.3. Definition of SAE
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death 
due to progression of disease).
An SAE is defined as any untoward medical occurrence that, at any dose:
a.
Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.


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An SAE is defined as any untoward medical occurrence that, at any dose:
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been detained (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting.  Complications that occur during hospitalization are AEs.  If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE 
should be considered serious.
Hospitalization for elective treatment of a preexisting condition that did not worsen from 
baseline is not considered an AE.
d. Results in persistent disability/incapacity

The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.

This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Other situations:

Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that 
may not be immediately life-threatening or result in death or hospitalization but 
may jeopardize the participant or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events 
should usually be considered serious.

Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.

Suspected transmission via a Pfizer product of an infectious agent, pathogenic or 
nonpathogenic, is considered serious.  The event may be suspected from clinical 
symptoms or laboratory findings indicating an infection in a patient exposed to a 
Pfizer product.  The terms “suspected transmission” and “transmission” are 
considered synonymous.  These cases are considered unexpected and handled as 
serious expedited cases by pharmacovigilance personnel.  Such cases are also 
considered for reporting as product defects, if appropriate.


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10.3.4. Recording/Reporting and Follow-up of AEs and/or SAEs
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording AEs on the CRF and for 
reporting SAEs on the Vaccine SAE Reporting Form to Pfizer Safety.  These requirements 
are delineated for 3 types of events: (1) SAEs; (2) nonserious AEs; and (3) exposure to the 
study intervention under study during pregnancy or breastfeeding, and occupational 
exposure. 
It should be noted that the Vaccine SAE Reporting Form for reporting of SAE information 
is not the same as the AE page of the CRF.  When the same data are collected, the forms 
must be completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the Vaccine SAE 
Reporting Form for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported on the Vaccine 
SAE Reporting Form to 
Pfizer Safety Within 24 
Hours of Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under 
study during 
pregnancy or 
breastfeeding, and 
occupational exposure
All AEs/SAEs associated with 
exposure during pregnancy or 
breastfeeding
Occupational exposure is not 
recorded.
All (and EDP supplemental 
form for EDP)  
Note:  Include all SAEs 
associated with exposure 
during pregnancy or 
breastfeeding. Include all 
AEs/SAEs associated with 
occupational exposure.

When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic 
reports) related to the event.

The investigator will then record all relevant AE/SAE information in the CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the Vaccine SAE 
Reporting Form/AE/SAE CRF page.

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the participant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety.


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AE and SAE Recording/Reporting

The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE/SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories: 
GRADE If required on the AE page of the CRF, the investigator will use the 
adjectives MILD, MODERATE, or SEVERE to describe the maximum 
intensity of the AE. For purposes of consistency, these intensity grades are 
defined as follows:
1
MILD
Does not interfere with participant's usual function.
2
MODERATE
Interferes to some extent with participant's usual 
function.
3
SEVERE
Interferes significantly with participant's usual 
function.
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated.

The investigator will also consult the IB and/or product information, for marketed 
products, in his/her assessment.


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Assessment of Causality

For each AE/SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE/SAE and has provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is 
very important that the investigator always make an assessment of causality 
for every event before the initial transmission of the SAE data to the sponsor.

The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.

If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by the sponsor.  In addition, if the investigator determines that 
an SAE is associated with study procedures, the investigator must record this 
causal relationship in the source documents and CRF, and report such an 
assessment in the dedicated section of the Vaccine SAE Reporting Form and in 
accordance with the SAE reporting requirements.
Follow-up of AEs and SAEs

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE or SAE as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings, including histopathology.

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.


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10.3.5. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool

The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic data collection tool.

If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours.

The site will enter the SAE data into the electronic system as soon as the data
become available.

After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (see 
next section) or to Pfizer Safety by telephone.
SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form

Facsimile transmission of the Vaccine SAE Reporting Form is the preferred 
method to transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Reporting Form sent by overnight mail 
or courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Reporting Form pages within the designated 
reporting time frames.
10.4. Appendix 4: Contraceptive Guidance 
Not applicable.


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10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments 
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury, but adapt 
are termed “adaptors.”  In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome.  These participants fail to adapt and therefore are 
"susceptible" to progressive and serious liver injury, commonly referred to as DILI.  
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are an “adaptor” or are “susceptible.”
LFTs are not required as a routine safety monitoring procedure in this study.  However, 
should an investigator deem it necessary to assess LFTs because a participant presents with 
clinical signs/symptoms, such LFT results should be managed and followed as described 
below.
In the majority of DILI cases, elevations in AST and/or ALT precede TBili elevations 
(>2 × ULN) by several days or weeks.  The increase in TBili typically occurs while 
AST/ALT is/are still elevated above 3 × ULN (ie, AST/ALT and TBili values will be 
elevated within the same laboratory sample).  In rare instances, by the time TBili elevations 
are detected, AST/ALT values might have decreased.  This occurrence is still regarded as a 
potential DILI.  Therefore, abnormal elevations in either AST OR ALT in addition to TBili 
that meet the criteria outlined below are considered potential DILI (assessed per Hy’s law 
criteria) cases and should always be considered important medical events, even before all 
other possible causes of liver injury have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions.  Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:

Participants with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available.

For participants with baseline AST OR ALT OR TBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:

Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values >2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is 
smaller).


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
Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches 
>3 × ULN (whichever is smaller).
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor.  
The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results.  This evaluation should 
include laboratory tests, detailed history, and physical assessment.
In addition to repeating measurements of AST and ALT and TBili for suspected cases of 
Hy’s law, additional laboratory tests should include albumin, CK, direct and indirect 
bilirubin, GGT, PT/INR, total bile acids, and alkaline phosphatase.  Consideration should 
also be given to drawing a separate tube of clotted blood and an anticoagulated tube of blood 
for further testing, as needed, for further contemporaneous analyses at the time of the 
recognized initial abnormalities to determine etiology.  A detailed history, including relevant 
information, such as review of ethanol, acetaminophen/paracetamol (either by itself or as a 
coformulated product in prescription or over-the-counter medications), recreational drug, 
supplement (herbal) use and consumption, family history, sexual history, travel history, 
history of contact with a jaundiced person, surgery, blood transfusion, history of liver or 
allergic disease, and potential occupational exposure to chemicals, should be collected.  
Further testing for acute hepatitis A, B, C, D, and E infection and liver imaging (eg, biliary 
tract) and collection of serum samples for acetaminophen/paracetamol drug and/or protein 
adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found.  Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.


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10.6. Appendix 6: Medical Device Adverse Events, Adverse Device Effects, Serious 
Adverse Events, and Device Deficiencies: Definition and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
Definitions of a Medical Device Incident
The definitions and procedures detailed in this appendix are in accordance with ISO 14155. 
Both the investigator and the sponsor will comply with all local medical device reporting 
requirements.
The detection and documentation procedures described in this protocol apply to all sponsor 
medical devices provided for use in the study (see Section 6.1.2) for the list of sponsor 
medical devices).
10.6.1. Definition of AE and ADE
AE and ADE Definition

An AE is defined as any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory finding) in study 
participants, users, or other persons, whether or not related to the investigational 
medical device. This definition includes events related to the investigational 
medical device or comparator for study participants, users, and other persons. This 
definition also includes events considered related to procedures for study 
participants only.

An ADE is defined as an AE related to the use of an investigational medical device. 
This definition includes any AEs resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device as well as any event resulting 
from use error or from intentional misuse of the investigational medical device.


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10.6.2. Definition of SAE, SADE, and Unanticipated Serious Adverse Device Effect
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death 
due to progression of disease).
An SAE is an AE that:
a.
Led to death.
b. Led to serious deterioration in the health of the participant, that either resulted in:

A life-threatening illness or injury. The term “life-threatening” in the definition of 
serious refers to an event in which the participant was at risk of death at the time of 
the event. It does not refer to an event that hypothetically might have caused death, 
if it were more severe.

A permanent impairment of a body structure or a body function.

Inpatient or prolonged hospitalization. Planned hospitalization for a preexisting 
condition, or a procedure required by the protocol, without serious deterioration in 
health, is not considered an SAE.

Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
c.
Led to fetal distress, fetal death, or a congenital abnormality or birth defect.
SADE Definition

An SADE is defined as an adverse device effect that has resulted in any of the 
consequences characteristic of an SAE.
USADE Definition

A USADE is a serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the current version of the risk 
analysis management file.
10.6.3. Definition of Device Deficiency
Device Deficiency Definition

A device deficiency is an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety, or performance. Device deficiencies 
include malfunctions, use errors, and inadequate labeling.


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10.6.4. Recording/Reporting and Follow-up of AEs and/or SAEs and Device 
Deficiencies
AE, SAE, and Device Deficiency Recording

When an AE/SAE/device deficiency occurs, it is the responsibility of the 
investigator to review all documentation (eg, hospital progress notes, laboratory 
reports, and diagnostic reports) related to the event.

The investigator will then record all relevant AE/SAE/device deficiency 
information in the participant’s medical records, in accordance with the 
investigator’s normal clinical practice and on the appropriate form of the CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of following the reporting process described 
in the IP manual.

There may be instances when copies of medical records for certain cases are 
requested by Pfizer Safety. In this case, all participant identifiers, with the 
exception of the participant number, will be redacted on the copies of the medical 
records before submission to Pfizer Safety.

The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE/SAE.

For device deficiencies, it is very important that the investigator describes any 
corrective or remedial actions taken to prevent recurrence of the incident.

A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessary to prevent recurrence of a device 
deficiency. This includes any amendment to the device design to prevent 
recurrence.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE/SAE/device deficiency 
reported during the study and assign it to 1 of the following categories: 

Mild: An event that is easily tolerated by the participant, causing minimal 
discomfort and not interfering with everyday activities.

Moderate: An event that causes sufficient discomfort and interferes with normal 
everyday activities.

Severe: An event that prevents normal everyday activities. An AE that is assessed 
as severe should not be confused with an SAE. Severe is a category utilized for 
rating the intensity of an event; and both AEs and SAEs can be assessed as severe.

An event is defined as “serious” when it meets at least 1 of the predefined 
outcomes as described in the definition of an SAE, NOT when it is rated as severe.


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Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE/device deficiency.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.

The investigator will also consult the IB and/or product information, for marketed 
products, in his/her assessment.

For each AE/SAE/device deficiency, the investigator must document in the 
medical notes that he/she has reviewed the AE/SAE/device deficiency and has 
provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is 
very important that the investigator always make an assessment of causality for 
every event before the initial transmission of the SAE data to the sponsor.

The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
Follow-up of AE/SAE/Device Deficiency

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE/SAE/device deficiency as 
fully as possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings including histopathology.

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.


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10.6.5. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool

The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic data collection tool.

If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours.

The site will enter the SAE data into the electronic system as soon as the data
become available.

After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form 
(see next section) or to Pfizer Safety by telephone.
SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form

Facsimile transmission of the Vaccine SAE Reporting Form is the preferred 
method to transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Reporting Form sent by overnight mail 
or courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Reporting Form pages within the designated 
reporting time frames.


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10.6.6. Reporting of SADEs
SADE Reporting to Pfizer Safety
NOTE: There are additional reporting obligations for medical device incidents that are 
potentially related to SAEs that must fulfill the legal responsibility to notify appropriate 
regulatory authorities and other entities about certain safety information relating to medical 
devices being used in clinical studies.

Any device deficiency that is associated with an SAE must be reported to the 
sponsor within 24 hours after the investigator determines that the event meets the 
definition of a device deficiency.

The sponsor shall review all device deficiencies and determine and document in 
writing whether they could have led to an SAE. These shall be reported to the 
regulatory authorities and IRBs/ECs as required by national regulations.


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10.7. Appendix 7: Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic in participating countries in Europe and will become effective for 
other public emergencies only upon written notification from Pfizer. 
Use of these alternative study measures are expected to cease upon the return of business as 
usual (including the lifting of any quarantines and travel bans/advisories). 
10.7.1. Telehealth Visits
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow up on the safety of study participants at scheduled visits per the SoA or unscheduled 
visits. Telehealth visits may be used to continue to assess participant safety and collect data 
points. Telehealth includes the exchange of healthcare information and services via 
telecommunication technologies (eg, audio, video, video-conferencing software) remotely, 
allowing the participant and the investigator to communicate on aspects of clinical care, 
including medical advice, reminders, education, and safety monitoring. The following 
assessments must be performed during a telehealth visit:

Assess the severe reactogenicity symptoms that meet the requirement for an unplanned 
visit. The parent(s)/legal guardian contact outcome will be documented in the CRF.
Refer to Section 8.12.

Review the participant’s e-diary data since the last contact and follow up on any ongoing 
reactogenicity or use of antipyretic medication on the last day that the e-diary was 
completed. Obtain the stop dates and document in the CRFs. Refer to Section 8.2.1.

Review and record any AEs and SAEs since the last contact. Refer to Section 8.3.

Review and record any new concomitant medications used to treat an AE since the last 
contact. Refer to Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.
In addition to the above, procedures outlined for a typical safety telephone contact 
(see Section 8.11.2) may be performed during a telehealth visit. 
Study participants must be reminded to promptly notify site staff about any change in their 
health status.


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10.7.2. Home Health Visits
A home health care service may be utilized to facilitate scheduled visits per the SoA. Home 
health visits include a healthcare provider conducting an in-person study visit at the 
participant’s location, rather than an in-person study visit at the site. The following may be 
performed during a home health visit:

Ensure that the participant continues to be eligible for the study and does not meet 
any withdrawal criteria (Section 7.2).

Collect a blood sample (approximately 5 mL) from the participant. Local/topical 
anesthetic may be used to numb the skin prior to the blood draw. 

Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication.

Collect the provisioned e-diary device, if previously provided to the participant’s 
parent(s)/legal guardian.

Collect the provided bottle of paracetamol from parent(s)/legal guardian of 
participants assigned to receive paracetamol as per protocol for primary vaccinations.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit. Inquire 
whether the participant had any of the following related to an AE since the last 
visit: hospitalizations, visits to other medical facilities, and medication use. 
Please refer to the ISF for additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit and record their end dates 
or confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Provide the parent(s)/legal guardian with a memory aid. Instruct the parent(s)/legal 
guardian to use the memory aid between Visit 4 and Visit 5 or Visit 6 and Visit 7 to 
remind him or her to review any significant illnesses, hospitalizations, NDCMCs, or 
visits to a medical facility with study site personnel.  The memory aid is not a diary 
for the collection of reactogenicity.  Please refer to the ISF for additional details.

Ask the parent(s)/legal guardian to contact the investigator immediately if any 
significant illness or hospitalization occurs.


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
Schedule an appointment for the next visit and confirm that it is scheduled within the 
time window per protocol.

Complete the source documents.

Complete the CRFs.
10.7.3. Adverse Events and Serious Adverse Events
If a participant has COVID-19 during the study, this should be reported as an AE or SAE and 
appropriate medical intervention provided. Study treatment should continue unless the 
investigator/treating physician is concerned about the safety of the participant, in which case 
temporary or permanent discontinuation may be required.
It is recommended that the investigator discuss temporary or permanent discontinuation of 
study intervention with the study medical monitor.


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10.8. Appendix 8: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
ADE
adverse device effect
AE
adverse event
AESI
adverse event of special interest
ALT
alanine aminotransferase
app
application
AST
aspartate aminotransferase
bivalent rLP2086
bivalent recombinant lipoprotein 2086 vaccine
CDS
core data sheet
CFR
Code of Federal Regulations
CI
confidence interval
CK
creatine kinase
CRF
case report form
CRO
contract research organization
CSR
clinical study report
CT
clinical trial
DILI
drug-induced liver injury
DTPa-HBV-IPV-
Hib
diphtheria, tetanus, and pertussis acellular; hepatitis B virus; 
inactivated poliomyelitis; and Haemophilus influenzae type b 
vaccine
DU
dispensable unit
EC
ethics committee
ECG
electrocardiogram
e-diary
electronic diary
EDMC
external data monitoring committee
EDP
exposure during pregnancy
EEA
European Economic Area
EMA
European Medicines Agency
EU
European Union
EudraCT
European Clinical Trials Database
fHBP
factor H binding protein
FIH
first in human
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMT
geometric mean titer
HIPAA
Health Insurance Portability and Accountability Act
hSBA
serum bactericidal assay using human complement 
IB
investigator’s brochure
ICD
informed consent document
ICH
International Council for Harmonisation
ID
identification


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Abbreviation
Term
IMD
invasive meningococcal disease
IMP
investigational medicinal product
IND
investigational new drug
INR
international normalized ratio
IP manual
investigational product manual
IPAL
Investigational Product Accountability Log
IRB
institutional review board
IRC
internal review committee
IRT
interactive response technology
ISF
investigator site file
ISO
International Organization for Standardization
IWR
interactive Web-based response
LFT
liver function test
LLOQ
lower limit of quantitation
LOD
limit of detection
LP2086
lipoprotein 2086
MAE
medically attended adverse event
MedDRA
Medical Dictionary for Regulatory Activities
MenA
Neisseria meningitidis group A
MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
MenACWY
Neisseria meningitidis group A, C, W, and Y
MenACWY-CRM
meningococcal groups A, C, Y, and W-135 oligosaccharide 
diphtheria conjugate vaccine
MenACWY-TT
meningococcal polysaccharide groups A, C, W, and Y tetanus 
toxoid conjugate vaccine
MenB
Neisseria meningitidis group B
MenC
Neisseria meningitidis group C
MenW
Neisseria meningitidis group W
MenY
Neisseria meningitidis group Y
mITT
modified intent-to-treat
N/A
not applicable
NDCMC
newly diagnosed chronic medical condition
NIMP
noninvestigational medicinal product
NSAID
nonsteroidal anti-inflammatory drug
PFS
prefilled syringe
PLP
prophylactic liquid paracetamol regimen
POC
proof of concept
PRP-OMP
polyribosylribitol phosphate oligosaccharide of Haemophilus 
influenzae type b conjugated to outer membrane protein
PT
prothrombin time
RCDC
reverse cumulative distribution curve
rDNA
recombinant deoxyribonucleic acid
SADE
serious adverse device effect


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Abbreviation
Term
SAE
serious adverse event
SAP
statistical analysis plan
SD
standard deviation
SLP
scheduled liquid paracetamol regimen
SmPC
summary of product characteristics
SoA
schedule of activities
SOP
standard operating procedure
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
TBD
to be determined
TBili
total bilirubin
TLP
therapeutic liquid paracetamol regimen
ULN
upper limit of normal
US
United States
USADE
unanticipated serious adverse device effect


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11. REFERENCES
1.
Prymula R, Esposito S, Zuccotti GV, et al. A phase 2 randomized controlled trial of a 
multicomponent meningococcal serogroup B vaccine (I). Hum Vaccin Immunother 
2014;10(7):1993-2004.
2.
Wang B, Clarke M, Thomas N, et al. The clinical burden and predictors of sequelae 
following invasive meningococcal disease in Australian children. Pediatr Infect Dis J 
2014;33(3):316-8.
3.
European Centre for Disease Prevention and Control. Invasive meningococcal disease. 
In: ECDC. Annual epidemiological report for 2017. Stockholm: ECDC; 2019.
Available from: 
https://www.ecdc.europa.eu/sites/default/files/documents/AER_for_2017-invasive-
meningococcal-disease.pdf. Accessed: 22 Apr 2020.
4.
Harrison LH, Pelton SI, Wilder-Smith A, et al. The Global Meningococcal Initiative: 
recommendations for reducing the global burden of meningococcal disease. Vaccine 
2011;29(18):3363-71.
5.
Rivero-Calle I, Vilanova-Trillo L, Pardo-Seco J, et al. The burden of pediatric invasive 
meningococcal disease in Spain (2008-2013). Pediatr Infect Dis J. 2016;35(4):407-13.
6.
Ladhani SN, Flood JS, Ramsay ME, et al. Invasive meningococcal disease in England 
and Wales: implications for the introduction of new vaccines. Vaccine 
2012;30(24):3710-16.

SAP_001.pdf: 
        Protocol C3511002 (PF-06886992) Statistical Analysis Plan
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Protocol C3511002
A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND 
IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS 
OF AGE
Statistical Analysis Plan 
(SAP)
Version:
1
Date:
30 Nov 2021


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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................6
APPENDICES ...........................................................................................................................7
1. VERSION HISTORY............................................................................................................8
2. INTRODUCTION .................................................................................................................8
2.1. Study Objectives, Endpoints, and Estimands..........................................................12
2.2. Study Design ...........................................................................................................25
3. ENDPOINTS AND BASELINE VARIABLES:  DEFINITIONS AND 
CONVENTIONS ................................................................................................................26
3.1. Primary Endpoint(s) ................................................................................................26
3.1.1. Primary Endpoints for Open-Label Stage...................................................26
3.1.1.1. Primary Immunogenicity Endpoints .........................................26
3.1.1.2. Primary Safety Endpoints..........................................................27
3.1.2. Primary Endpoints for Blinded Expanded-Enrollment Stage.....................27
3.1.2.1. Primary Immunogenicity Endpoints .........................................27
3.1.2.2. Primary Safety Endpoints..........................................................28
3.2. Secondary Endpoint(s) ............................................................................................28
3.2.1. Secondary Endpoints for Open-Label Stage...............................................28
3.2.1.1. Secondary Immunogenicity Endpoints .....................................28
3.2.1.2. Secondary Safety Endpoints......................................................28
3.3. Tertiary/Exploratory Endpoint(s)............................................................................28
3.3.1. Tertiary/Exploratory Endpoints for Open-Label Stage ..............................28
3.3.1.1. Tertiary/Exploratory Immunogenicity Endpoints .....................28
3.3.1.2. Tertiary/Exploratory Safety Endpoints .....................................29
3.4. Baseline Variables...................................................................................................29
3.4.1. Demographic, Medical History, and Baseline Characteristic 
Variables ..........................................................................................................29
3.4.2. Previous Vaccinations ................................................................................29
3.4.3. E-Diary Completion....................................................................................30
3.5. Safety Endpoints .....................................................................................................30
3.5.1. Adverse Events ...........................................................................................30


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3.5.1.1. Analysis Intervals......................................................................31
3.5.2. Laboratory Data..........................................................................................33
3.5.3. Reactogenicity Data....................................................................................33
3.5.3.1. Local Reactions Endpoints........................................................33
3.5.3.2. Systemic Events Endpoints .......................................................36
3.5.3.3. Use of Antipyretic Medication..................................................37
3.5.4. Medical Device Errors................................................................................37
4. ANALYSIS SETS (POPULATIONS FOR ANALYSIS)...................................................37
5. GENERAL METHODOLOGY AND CONVENTIONS....................................................39
5.1. Hypotheses and Decision Rules ..............................................................................39
5.2. General Methods .....................................................................................................40
5.2.1. Analyses for Binary Endpoints...................................................................40
5.2.1.1. Immunogenicity Data................................................................40
5.2.1.2. Safety Data ................................................................................41
5.2.2. Analyses for Continuous Endpoints ...........................................................41
5.2.2.1. Geometric Mean Titers..............................................................41
5.2.2.2. Reverse Cumulative Distribution Curves..................................41
5.3. Methods to Manage Missing Data ..........................................................................41
5.3.1. Safety Data..................................................................................................41
5.3.1.1. Reactogenicity Data ..................................................................41
5.3.2. Immunogenicity Data .................................................................................42
6. ANALYSES AND SUMMARIES ......................................................................................42
6.1. Primary Endpoint(s) ................................................................................................42
6.1.1. Primary Endpoints for Open-Label Stage...................................................42
6.1.1.1. hSBA Titer for Each of the MenA, MenC, MenW, and 
MenY Test Strains.............................................................................42
6.1.1.2. hSBA Titer for Each of the MenB Test Strains ........................43
6.1.1.3. Local Reactions Within 7 Days.................................................45
6.1.1.4. Systemic Events Within 7 Days................................................48
6.1.1.5. Use of Antipyretic Medications Within 7 Days........................51


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6.1.1.6. Serious Adverse Events, Medically Attended Events, and 
Newly Diagnosed Chronic Medical Conditions................................53
6.1.1.7. Adverse Events..........................................................................54
6.1.1.8. Immediate Adverse Events........................................................55
6.1.2. Primary Endpoints for Blinded Expanded-Enrollment Stage.....................55
6.1.2.1. hSBA Titer for Each of the MenA, MenC, MenW, and 
MenY Test Strains.............................................................................55
6.1.2.2. hSBA Titer for Each of the MenB Test Strains ........................57
6.1.2.3. Local Reactions Within 7 Days.................................................58
6.1.2.4. Systemic Events Within 7 Days................................................61
6.1.2.5. Use of Antipyretic Medications Within 7 Days........................63
6.1.2.6. Serious Adverse Events, Medically Attended Events, and 
Newly Diagnosed Chronic Medical Conditions................................65
6.1.2.7. Adverse Events..........................................................................66
6.1.2.8. Immediate Adverse Events........................................................67
6.2. Secondary Endpoint(s) ............................................................................................68
6.2.1. Secondary Endpoints for Open-Label Stage...............................................68
6.2.1.1. hSBA Titer for Each of the MenB Test Strains ........................68
6.2.1.2. Main Analysis ...........................................................................68
6.2.1.3. Sensitivity/Supplementary Analysis .........................................69
6.2.2. Local Reactions Within 7 Days ..................................................................69
6.2.2.1. Main Analysis ...........................................................................69
6.2.2.2. Supplementary Analysis............................................................70
6.2.3. Systemic Events Within 7 Days .................................................................72
6.2.3.1. Main Analysis ...........................................................................72
6.2.3.2. Supplementary Analysis............................................................73
6.2.4. Use of Antipyretic Medications Within 7 Days .........................................74
6.2.4.1. Main Analysis ...........................................................................74
6.2.4.2. Supplementary Analysis............................................................75
6.2.5. Serious Adverse Events, Medically Attended Events, and Newly 
Diagnosed Chronic Medical Conditions..........................................................75


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6.2.6. Adverse Events ...........................................................................................76
6.2.7. Immediate Adverse Events.........................................................................77
6.3. Tertiary/Exploratory Endpoints...............................................................................78
6.3.1. hSBA Titer for Each of the MenA, MenC, MenW, and MenY Test 
Strains ..............................................................................................................78
6.3.1.1. Main Analysis ...........................................................................78
6.3.1.2. Sensitivity/Supplementary Analyses.........................................79
6.3.2. hSBA Titer for Each of the MenB Test Strains..........................................79
6.3.2.1. Main Analysis ...........................................................................79
6.3.2.2. Sensitivity/Supplementary Analyses.........................................81
6.3.3. Local Reactions Within 7 Days ..................................................................81
6.3.3.1. Main Analysis ...........................................................................81
6.3.3.2. Supplementary Analysis............................................................82
6.3.4. Systemic Events Within 7 Days .................................................................83
6.3.4.1. Main Analysis ...........................................................................83
6.3.4.2. Supplementary Analysis............................................................84
6.3.5. Use of Antipyretic Medications Within 7 Days .........................................84
6.3.5.1. Main Analysis ...........................................................................84
6.3.5.2. Supplementary Analysis............................................................85
6.3.6. Serious Adverse Events, Medically Attended Events, and Newly 
Diagnosed Chronic Medical Conditions..........................................................85
6.3.7. Adverse Events ...........................................................................................86
6.3.8. Immediate Adverse Events.........................................................................87
6.4. Subset Analyses.......................................................................................................88
6.5. Baseline and Other Summaries and Analyses.........................................................88
6.5.1. Study Conduct and Participant Disposition................................................88
6.5.2. Study Intervention Exposure ......................................................................89
6.5.3. Demographic, Medical History, and Baseline Characteristics ...................89
6.5.4. E-Diary Completion....................................................................................89
6.5.5. Concomitant Medications and Nondrug Treatments..................................89
6.6. Safety Summaries and Analyses .............................................................................90


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6.6.1. Adverse Events ...........................................................................................90
6.6.1.1. Related Events...........................................................................90
6.6.1.2. Severe Events ............................................................................90
6.6.1.3. Neuroinflammatory and Autoimmune Conditions....................90
6.6.1.4. AEs Leading to Study Withdrawal............................................90
6.6.1.5. Death .........................................................................................90
6.6.2. Reactogenicity Data....................................................................................90
6.6.3. Physical Examination .................................................................................91
7. INTERIM ANALYSES.......................................................................................................91
7.1. Introduction .............................................................................................................91
7.2. Interim Analyses and Summaries............................................................................91
8. REFERENCES ....................................................................................................................92
9. APPENDICES .....................................................................................................................93
LIST OF TABLES
Table 1.
Summary of Changes..................................................................................8
Table 2.
Open-Label Sentinel-Cohort Stage.............................................................9
Table 3.
Open-Label Expanded-Enrollment Stage.................................................10
Table 4.
Blinded Expanded-Enrollment Stage .......................................................11
Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages ..............12
Table 6.
Blinded Expanded-Enrollment Stage .......................................................22
Table 7.
Study Progression Flowchart....................................................................26
Table 8.
Summary of Adverse Event Collection....................................................30
Table 9.
Analysis Intervals for AEs, SAEs, MAEs, and NDCMCs .......................31
Table 10.
Analysis Intervals for Immediate AEs......................................................32
Table 11.
Analysis Intervals for Reactogenicity Date ..............................................33
Table 12.
Derived Variables for Local Reactions.....................................................34
Table 13.
Grading of Redness and Swelling.............................................................34
Table 14.
Grading of Tenderness..............................................................................34
Table 15.
Grading of Other Systemic Events ...........................................................36


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Table 16.
Severity Scale for Fever............................................................................36
Table 17.
Qualified hSBA LLOQ for MenB Test Strains ........................................40
Table 18.
Qualified hSBA LLOQ for MenACWY Serogroups ...............................40
APPENDICES
Appendix 1. List of Abbreviations...........................................................................................93


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1. VERSION HISTORY
Table 1.
Summary of Changes
Version/
Date
Associated 
Protocol 
Amendment
Rationale
Specific Changes
1/
30 Nov 2021
Amendment 2
13 Sep 2021
N/A
N/A
2. INTRODUCTION
This SAP provides the detailed methodology for summary and statistical analyses of the data 
collected in Study C3511002. A brief description of the study design and the study 
objectives are given.  Subsequent sections include analysis populations and the definitions of 
the immunogenicity and safety endpoints, followed by details around statistical analysis and 
reporting.  A list of tables, listings, and figures, mock-up tables, and programming rules are 
prepared separately based on the methods described in this document. This document may 
modify the plans outlined in the protocol; however, any major modifications of the primary 
endpoint definition or its analysis will also be reflected in a protocol amendment. Table 2,
Table 3, and Table 4 show the study design.  The impacts of COVID-19 will be assessed 
prior to the first planned analysis, and the SAP will be amended accordingly to account for 
these impacts, if needed.


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Table 2.
Open-Label Sentinel-Cohort Stage
Visit Description
Primary 
Vaccination 1
Safety 
Telephone
Contact
Primary 
Vaccination 2
Follow-up After 
Primary 
Vaccination 2
Booster
Vaccination
Follow-up After 
Booster 
Vaccination
Final
Telephone
Contact
Visit Identifier
1
2
3
4
5
6
7
Approximate Month of Agea
6
7
8
9
12
13
18
Cohort 1
Group 1 (n ~ 25)
MenABCWY + 
PLP
MenABCWY + 
PLP
MenABCWY
Cohort 2
Group 2 (n ~ 25)
MenABCWY
MenABCWY
MenABCWY
Approximate 
Months of Age
2
3
4
5
12
13
18
Group 3
(n ~ 37)
60 µg rLP2086 
+ Nimenrix + PLPb
60 µg rLP2086
+ Nimenrix + PLP
60 µg rLP2086 
+ Nimenrix
Cohort 3
Group 4
(n ~ 25)
60 µg rLP2086 
+ Nimenrix
60 µg rLP2086 
+ Nimenrix
60 µg rLP2086 
+ Nimenrix
Group 5
(n ~ 50)
120 µg rLP2086 
+ Nimenrix + PLP
120 µg rLP2086 + 
Nimenrix + PLP
120 µg rLP2086
+ Nimenrix
Cohort 4
Group 7
(n ~ 50-100)
MenABCWY + 
SLPc
MenABCWY + 
SLP
MenABCWY
Sentinel-
Control 
Cohortd
Group 8
(n ~ 55)
Bexsero +
Nimenrix + PLP
Bexsero +
Nimenrix + PLP
Bexsero + 
Nimenrix
Group 10
(n ~ 55)
Bexsero +
Nimenrix
Bexsero +
Nimenrix
Bexsero +
Nimenrix
Blood Draw
5 mL
5 mL
Abbreviations: bivalent rLP2086 = bivalent recombinant lipoprotein 2086 vaccine; EDMC = external data monitoring committee; IRC = institutional review board; 
PLP = prophylactic liquid paracetamol regimen; SLP = scheduled liquid paracetamol regimen.
Note: “rLP2086” refers to bivalent rLP2086.
Note: Groups 6 and 9 were removed in protocol amendment 2 based on the EDMC’s recommendation.
a.
Participants 6 months of age (Groups 1 and 2) will receive Prevenar 13 and Vaxelis at 6 months of age (Visit 1). Participants 2 months of age (Groups 3-5, 7, 8, and 10) 
will receive Prevenar 13 and Vaxelis at 2 and 4 months of age (Visits 1 and 3).
b.
Protocol amendment 2 added 12 additional participants to Group 3 that will receive SLP for primary vaccinations.
c.
Group 7 will receive SLP.
d.
Enrollment into the sentinel-control cohort may occur at any time during the sentinel-cohort stage without IRC review of data from Cohorts 14.


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Table 3.
Open-Label Expanded-Enrollment Stage
Visit Description
Primary 
Vaccination 1
Safety 
Telephone 
Contact
Primary 
Vaccination 2
Follow-up After 
Primary 
Vaccination 2
Booster
Vaccination
Follow-up After 
Booster 
Vaccination
Final 
Telephone 
Contact
Visit Identifier
1
2
3
4
5
6
7
Approximate
Months of Agea
2
3
4
5
12
13
18
Group 11
(n ~ 50 to 100)
MenABCWY
+ TLPb
MenABCWY
+ TLP 
MenABCWY
Blood Draw
5 mL
5 mL
Abbreviations: IRC = institutional review board; SLP = scheduled liquid paracetamol regimen; TLP = therapeutic liquid paracetamol regimen.
a.
Participants will receive Prevenar 13 and Vaxelis at 2 and 4 months of age (Visits 1 and 3).
b.
The protocol-assigned paracetamol regimen for Group 11 may be subject to change at the discretion of the IRC, and instead of TLP, some participants may 
receive SLP.


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Table 4.
Blinded Expanded-Enrollment Stage
Visit Description
Primary 
Vaccination 1
Safety 
Telephone 
Contact
Primary 
Vaccination 2
Follow-up After 
Primary 
Vaccination 2
Booster
Vaccination
Follow-up After 
Booster 
Vaccination
Final
Telephone 
Contact
Visit Identifier
1
2
3
4
5
6
7
Approximate
Month of Agea
2
3
4
5
12
13
18
Group 13
(n = up to 400)b
MenABCWY
+ placebo + SLP or 
TLP
MenABCWY
+ placebo + SLP 
or TLP
MenABCWY
+ placebo
Group 14
(n = up to 400)b
Bexsero
+ Nimenrix
+ PLP or TLP
Bexsero
+ Nimenrix
+ PLP or TLP
Bexsero
+ Nimenrix
Blood Draw
5 mL
5 mL
Abbreviations: SLP = scheduled liquid paracetamol regimen; TLP = therapeutic liquid paracetamol regimen.
a.
Participants will receive Prevenar 13 and Vaxelis at 2 and 4 months of age (Visits 1 and 3).
b.
Up to 400 participants will be enrolled in Groups 13 and 14.


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2.1. Study Objectives, Endpoints, and Estimands
The estimands corresponding to each primary, secondary, and exploratory objective are described in Table 5 and Table 6 for
open-label and blinded stages, respectively.
Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints
Primary Immunogenicity:
Primary Immunogenicity:
Primary Immunogenicity:
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by MenABCWY compared to 
the immune response induced by 
Nimenrix after 2 primary vaccinations 
and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed in the following group 
combinations:
Groups 7+11 (MenABCWY recipients)
Groups 8+10 (Nimenrix recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each 
MenA, MenC, MenW, and MenY test strain 1 month after primary 
vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:

The percentage of participants achieving an hSBA titer ≥LLOQ for each 
MenA, MenC, MenW, and MenY test strain 1 month after the booster 
vaccination.
hSBA titer for each of the MenA, 
MenC, MenW, and MenY test 
strains.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints
To describe the immune response for 
MenB induced by MenABCWY 
compared to the immune response 
induced by Bexsero after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed in the following group 
combinations:
Groups 7+11 (MenABCWY recipients)
Groups 8+10 (Bexsero recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.
hSBA titer for each of the MenB 
test strains.
To describe the immune response for 
MenB induced by 60 µg and 120 µg of 
bivalent rLP2086 after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance with
the key protocol criteria (evaluable participants), expressed in the following group 
or combination:
Groups 3+4 (60 µg bivalent rLP2086 recipients)
Group 5 (120 µg bivalent rLP2086 recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.
hSBA titer for each of the MenB 
test strains.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints
Primary Safety:
Primary Safety:
Primary Safety:
To describe the safety profile of 
MenABCWY after primary 
vaccinations, by protocol-assigned 
paracetamol regimen, and after a 
booster dose.
In participants receiving at least 1 dose of investigational product, expressed by 
protocol-assigned paracetamol regimen and irrespective of protocol-assigned 
paracetamol regimen receipt, in the following group combinations:
Groups 7+11 (MenABCWY recipients with SLP or TLP) 
Groups 8+10 (Bexsero + Nimenrix recipients with or without PLP)

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after each primary vaccination.

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

During the primary series follow-up phase (from Visits 4-5).

Throughout the primary series stage (from Visits 1-5).

The percentage of participants reporting at least 1 AE during the following 
time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

The percentage of participants reporting at least 1 immediate AE after each 
primary vaccination.
In participants who completed primary vaccinations and received a booster dose, 
expressed in the same group combinations as above, regardless of 
protocol-assigned paracetamol regimen receipt during the primary vaccination 
series:

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after the booster vaccination.

Local reactions (tenderness, 
redness, and swelling).

Systemic events (fever, 
increased sleep, decreased 
appetite, and irritability).

Use of antipyretic 
medication. 

AEs, SAEs, MAEs, 
NDCMCs, and immediate 
AEs.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

During the booster vaccination phase (from Visits 5-6).

During the booster follow-up phase (from Visits 6-7).

Throughout the booster stage (from Visits 5-7).

The percentage of participants reporting at least 1 AE during the following 
time period:

During the booster vaccination phase (from Visits 5-6).

The percentage of participants reporting at least 1 immediate AE after the 
booster vaccination.
Secondary Immunogenicity:
Secondary Immunogenicity:
Secondary Immunogenicity:
To further describe the immune 
response for MenB induced by 60 µg 
and 120 µg of bivalent rLP2086 after 
2 primary vaccinations and after a 
booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed in the following group 
or combination:
Groups 3+4 (60 µg bivalent rLP2086 recipients)
Group 5 (120 µg bivalent rLP2086 recipients)

hSBA GMTs for each of the MenB test strains 1 month after primary 
vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:

hSBA GMTs for each of the MenB test strains 1 month after the booster 
vaccination.
hSBA titer for each of the MenB 
test strains.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints
Secondary Safety:
Secondary Safety:
Secondary Safety:
To describe the safety profile of 60 µg 
and 120 µg of bivalent rLP2086 after 
primary vaccinations, by 
protocol-assigned paracetamol 
regimen, and after a booster dose.
In participants receiving at least 1 dose of investigational product, expressed by 
protocol-assigned paracetamol regimen and irrespective of protocol-assigned 
paracetamol regimen receipt, in the following groups:
Group 3 (60 µg bivalent rLP2086 + Nimenrix + PLP recipients)
Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients)
Group 5 (120 µg bivalent rLP2086 + Nimenrix + PLP recipients)

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after each primary vaccination.

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

During the primary series follow-up phase (from Visits 4-5).

Throughout the primary series stage (from Visits 1-5).

The percentage of participants reporting at least 1 AE during the following 
time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

The percentage of participants reporting at least 1 immediate AE after each 
primary vaccination.
In participants who completed primary vaccinations and received a booster dose, 
expressed in the same groups as above, regardless of protocol-assigned paracetamol 
regimen receipt during primary vaccinations:

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after the booster vaccination.

Local reactions (tenderness, 
redness, and swelling). 

Systemic events (fever, 
increased sleep, decreased 
appetite, and irritability).

Use of antipyretic 
medication.

AEs, SAEs, MAEs, 
NDCMCs, and immediate 
AEs.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

During the booster vaccination phase (from Visits 5-6).

During the booster follow-up phase (from Visits 6-7).

Throughout the booster stage (from Visits 5-7).

The percentage of participants reporting at least 1 AE during the following 
time period:

During the booster vaccination phase (from Visits 5-6).

The percentage of participants reporting at least 1 immediate AE after the 
booster vaccination.
Tertiary/Exploratory 
Immunogenicity:
Tertiary/Exploratory Immunogenicity:
Tertiary/Exploratory 
Immunogenicity:
To further describe the immune 
response for MenA, MenC, MenW, 
and MenY induced by MenABCWY 
compared to the immune response 
induced by Nimenrix after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed in the following group 
combinations:
Groups 7+11 (MenABCWY recipients)
Groups 8+10 (Nimenrix recipients)

hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combinations as above:

hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after the booster vaccination.

hSBA titer for each of the 
MenA, MenC, MenW, and 
MenY test strains.
To further describe the immune 
response for MenB induced by 
MenABCWY compared to the 
immune response induced by Bexsero 
after 2 primary vaccinations and after 
a booster dose.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed in the following group 
combinations:
Groups 7+11 (MenABCWY recipients)
Groups 8+10 (Bexsero recipients)

hSBA titer for each of the 
MenB test strains.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints

hSBA GMTs for each of the MenB test strains 1 month after primary 
vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the following group combinations as above:

hSBA GMTs for each of the MenB test strains 1 month after the booster 
vaccination.
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by 2 doses of MenABCWY 
compared to the immune response 
induced by 2 doses of Nimenrix, by 
protocol-assigned paracetamol 
regimen.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed by protocol-assigned 
paracetamol regimen and irrespective of protocol-assigned paracetamol regimen 
receipt, in the following group combinations:
Groups 7+11 (MenABCWY recipients with SLP or TLP)
Groups 8+10 (Nimenrix recipients with or without PLP)

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenA, MenC, MenW, and MenY test strains 1 month after primary 
vaccination 2.

hSBA titer for each of the 
MenA, MenC, MenW, and 
MenY test strains.
To describe the immune response for 
MenB induced by 2 doses of 
MenABCWY compared to the 
immune response induced by 2 doses 
of Bexsero, by protocol-assigned 
paracetamol regimen.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed by protocol-assigned 
paracetamol regimen and irrespective of protocol-assigned paracetamol regimen 
receipt, in the following group combinations:
Groups 7+11 (MenABCWY recipients with SLP or TLP)
Groups 8+10 (Bexsero recipients with or without PLP)

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.

hSBA titer for each of the 
MenB test strains.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by MenABCWY after 
2 primary vaccinations and after a 
booster dose in healthy infants 
6 months of age at study entry.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed in the following group 
combination:
Groups 1+2 (MenABCWY recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each 
MenA, MenC, MenW, and MenY test strain 1 month after primary 
vaccination 2.

hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combination as above:

The percentage of participants achieving an hSBA titer ≥LLOQ for each 
MenA, MenC, MenW, and MenY test strain 1 month after the booster 
vaccination.

hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after the booster vaccination.

hSBA titer for each of the 
MenA, MenC, MenW, and 
MenY test strains.
To describe the immune response for 
MenB induced by MenABCWY after 
2 primary vaccinations and after a 
booster dose in healthy infants 
6 months of age at study entry.
In participants receiving primary vaccinations 1 and 2, who are in compliance with 
the key protocol criteria (evaluable participants), expressed in the following group 
combination:
Groups 1+2 (MenABCWY recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each of 
the MenB test strains 1 month after primary vaccination 2.

hSBA GMTs for each of the MenB test strains 1 month after primary 
vaccination 2.

hSBA titer for each of the 
MenB test strains (TBD).


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same group combination as above:

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.

hSBA GMTs for each of the MenB test strains 1 month after the booster 
vaccination.
Tertiary/Exploratory Safety:
Tertiary/Exploratory Safety:
Tertiary/Exploratory Safety:
To describe the safety profile of 
MenABCWY after primary 
vaccinations with and without PLP, 
and after a booster dose in participants 
6 months of age.
In participants receiving at least 1 dose of investigational product, expressed with, 
without, and irrespective of PLP receipt during primary vaccinations, in Groups 1 
and 2:
Group 1 (MenABCWY + PLP recipients)
Group 2 (MenABCWY recipients)

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after each primary vaccination.

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

Throughout the primary series stage (from Visits 1-5).

The percentage of participants reporting at least 1 AE during the following 
time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

The percentage of participants reporting at least 1 immediate AE after each 
primary vaccination.

Local reactions (tenderness, 
redness, and swelling).

Systemic events (fever, 
increased sleep, decreased 
appetite, and irritability).

Use of antipyretic 
medication.

AEs, SAEs, MAEs, 
NDCMCs, and immediate 
AEs.


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Table 5.
Open-Label Sentinel-Cohort and Expanded-Enrollment Stages
Objectives
Estimands
Endpoints
In participants who completed primary vaccinations and received a booster dose, 
expressed in Groups 1 and 2 as above, regardless of PLP receipt during primary 
vaccinations:

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after the booster vaccination.

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

During the booster vaccination phase (from Visits 5-6).

During the booster follow-up phase (from Visits 6-7).

Throughout the booster stage (from Visits 5-7).

The percentage of participants reporting at least 1 AE during the following 
time period:

During the booster vaccination phase (from Visits 5-6).

The percentage of participants reporting at least 1 immediate AE after the 
booster vaccination.


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Table 6.
Blinded Expanded-Enrollment Stage
Objectives
Estimands
Endpoints
Primary Immunogenicity:
Primary Immunogenicity:
Primary Immunogenicity:
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by MenABCWY compared to 
the immune response induced by 
Nimenrix after 2 primary vaccinations 
and after a booster dose.
In participants receiving primary vaccinations 1 and 2 who are in compliance with 
the key protocol criteria (evaluable participants) expressed in the following groups:
Group 13 (MenABCWY recipients)
Group 14 (Nimenrix recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each 
MenA, MenC, MenW, and MenY test strain 1 month after primary 
vaccination 2.

hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains 
1 month after primary vaccination 2.
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same groups as above:

The percentage of participants achieving an hSBA titer ≥LLOQ for each 
MenA, MenC, MenW, and MenY test strain 1 month after the booster 
vaccination.

hSBA GMTs for each of the MenA, MenC, MenW, and MenY test strains after 
the booster vaccination.
hSBA titer for each of the MenA, 
MenC, MenW, and MenY test 
strains.
To describe the immune response for 
MenB induced by MenABCWY
compared to the immune response 
induced by Bexsero after 2 primary 
vaccinations and after a booster dose.
In participants receiving primary vaccinations 1 and 2 who are in compliance with 
the key protocol criteria (evaluable participants) expressed in the following groups:
Group 13 (MenABCWY recipients)
Group 14 (Bexsero recipients)

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after primary vaccination 2.

hSBA GMTs for each of the MenB test strains 1 month after primary 
vaccination 2.
hSBA titer for each of the MenB 
test strains (TBD).


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Table 6.
Blinded Expanded-Enrollment Stage
Objectives
Estimands
Endpoints
In participants who completed primary vaccinations and received a booster dose, 
and who are in compliance with the key protocol criteria (evaluable participants), 
expressed in the same groups as above:

The percentage of participants achieving an hSBA titer ≥LLOQ for each of the 
MenB test strains 1 month after the booster vaccination.

hSBA GMTs for each of the MenB test strains after the booster vaccination.
Primary Safety:
Primary Safety:
Primary Safety:
To describe the safety profile of 
MenABCWY after primary 
vaccinations, by protocol-assigned 
paracetamol regimen, and after a 
booster dose.
In participants receiving at least 1 dose of investigational product, expressed by 
protocol-assigned paracetamol regimen receipt in the following groups:
Group 13 (MenABCWY recipients with SLP or TLP) 
Group 14 (Bexsero + Nimenrix recipients with PLP or TLP)

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after each primary vaccination.

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

During the primary series follow-up phase (from Visits 4-5).

Throughout the primary series stage (from Visits 1-5).

The percentage of participants reporting at least 1 AE during the following 
time periods:

30 Days after each primary vaccination.

30 Days after any primary vaccination.

During the primary series vaccination phase (from Visits 1-4).

The percentage of participants reporting at least 1 immediate AE after each 
primary vaccination.

Local reactions (tenderness, 
redness, and swelling). 

Systemic events (fever, 
increased sleep, decreased 
appetite, and irritability).

Use of antipyretic 
medication. 

AEs, SAEs, MAEs, 
NDCMCs, and immediate 
AEs.


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Table 6.
Blinded Expanded-Enrollment Stage
Objectives
Estimands
Endpoints
In participants who completed primary vaccinations and received a booster dose, 
expressed by protocol-assigned paracetamol regimen receipt in the same groups as 
above, during the primary vaccination series:

The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after the booster vaccination.

The percentage of participants reporting at least 1 SAE, at least 1 MAE, and at 
least 1 NDCMC during the following time periods:

During the booster vaccination phase (from Visits 5-6).

During the booster follow-up phase (from Visits 6-7).

Throughout the booster stage (from Visits 5-7).

The percentage of participants reporting at least 1 AE during the following 
time period:

During the booster vaccination phase (from Visits 5-6).

The percentage of participants reporting at least 1 immediate AE after the 
booster vaccination.


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2.2. Study Design
This is a Phase 2b multicenter trial that will enroll at least 1272 healthy infants, beginning 
with infants 6 months of age and progressing to infants 2 months of age.  All participants will 
be naive to any meningococcal vaccines prior to enrollment.  The study will be conducted 
in 3 stages: an open-label sentinel-cohort stage, an open-label expanded-enrollment stage, 
and a blinded expanded-enrollment stage.  Approximately 472 participants will be enrolled in 
the open-label stages and up to 800 will be enrolled in the blinded expanded-enrollment stage
of this study.  An overview of study progression through these stages is shown in Table 7.
During each stage, participants will receive coadminstered Prevenar 13® and Vaxelis per the 
national immunization schedule for a primary series.  Local reactions, systemic events, and 
use of antipyretic/pain medications will be collected by e-diary for 7 days following primary 
vaccinations 1 and 2 and the booster vaccination.
The protocol-assigned paracetamol regimen for Group 11 (open-label expanded-enrollment 
stage) may be subject to change at the discretion of the IRC, and instead of TLP, some 
participants may receive SLP.
At the discretion of the IRC, for Groups 13 and 14 (blinded expanded-enrollment stage), 
the split between the double-blind (TLP) and single-blind (PLP/SLP) groups can vary 
from 50/50 (which corresponds to 200 per group contributing to the double-blind analyses) 
and 100/0 (which corresponds to 400 per group contributing to the double-blind analyses).  
After the IRC decision, and prior to the analysis of the blinded expanded-enrollment stage 
data, the SAP will be updated to reflect the appropriate analyses of the data from this stage of 
the study.


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Table 7.
Study Progression Flowchart
Open-Label Sentinel-Cohort Stage (Groups 1-5, 7, 8, and 10)
Cohorts 1-4
Sentinel-Control Cohort
Progression through Cohorts 1-4 based on IRC 
review of 7-day post–Vaccination 1 safety data
Enrollment into the sentinel-control cohort may occur at any 
time during the sentinel-cohort stage without IRC review of 
data from Cohorts 1-4.
Progression to the open-label expanded-enrollment stage based on
IRC review of 7-day post–Vaccination 1 safety data from Cohort 4
Open-Label Expanded-Enrollment Stage (Group 11)
IRC review of 7-day post–Vaccination 1 safety data for the first 25 participants and other ad hoc data reviews to 
determine the enrollment progression into Group 11
Progression to the blinded expanded-enrollment stage based on IRC review of
post–Vaccination 2 or 3 immunogenicity data from Groups 5, 8, and 10
and all safety data available at the time of this analysis.  At a minimum, 
this will include safety data from all sentinel-cohort groups (Groups 1-5, 7, 8, and 10) and 7-day post–Vaccination 1 
safety data from Group 11
The enrollment progression and the stratification of protocol-assigned paracetamol regimen use in the blinded 
expanded-enrollment stage will be at the discretion of the IRC based on safety data review
Blinded Expanded-Enrollment Stage (Groups 13 and 14)
3. ENDPOINTS AND BASELINE VARIABLES:  DEFINITIONS AND 
CONVENTIONS
3.1. Primary Endpoint(s)
3.1.1. Primary Endpoints for Open-Label Stage
3.1.1.1. Primary Immunogenicity Endpoints

hSBA titer for each of the MenA, MenC, MenW, and MenY test strains 1 month after 
primary vaccination 2 and 1 month after the booster vaccination in Groups 7, 8, 10,
and 11.

Classification of titer as ≥LLOQ


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
hSBA titer for each of the MenB test strains (A22 and B44 [PMB2707], which are tested 
together, and A12, A29, B16, B24, and B44 [PMB3042]) at 1 month after primary 
vaccination 2 and 1 month after the booster vaccination in Groups 3, 4, 5, 7, 8, 10,
and 11.

Classification of titer as ≥LLOQ
Where assay titers are available, participants with hSBA titers ≥LLOQ will be derived as 
follows:
= ., if the assay result is missing, indeterminate, or otherwise unavailable;
= 1, if the assay result meets the specific LLOQ value;
= 0, if the assay result does not meet the specific LLOQ value.
3.1.1.2. Primary Safety Endpoints

Local reactions (tenderness, redness, and swelling) within 7 days after each primary 
vaccination and the booster vaccination in Groups 7, 8, 10, and 11.

Systemic events (fever, increased sleep, decreased appetite, and irritability) within 7 days 
after each primary vaccination and the booster vaccination in Groups 7, 8, 10, and 11.

Use of antipyretic medications within 7 days after each primary vaccination and the 
booster vaccination in Groups 7, 8, 10, and 11.

AEs, SAEs, MAEs, NDCMCs, and immediate AEs in Groups 7, 8, 10, and 11.
3.1.2. Primary Endpoints for Blinded Expanded-Enrollment Stage
3.1.2.1. Primary Immunogenicity Endpoints

hSBA titer for each of the MenA, MenC, MenW, and MenY test strains 1 month after 
primary vaccination 2 and 1 month after the booster vaccination in Groups 13 and 14.

Classification of titer as ≥LLOQ

hSBA titer for each of the MenB test strains 1 month after primary vaccination 2 and 
1 month after the booster vaccination in Groups 13 and 14.

Classification of titer as ≥LLOQ
Where assay titers are available, participants with hSBA titers ≥LLOQ will be derived
similarly to Section 3.1.1.1.


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3.1.2.2. Primary Safety Endpoints

Local reactions (tenderness, redness, and swelling) within 7 days after each primary 
vaccination and the booster vaccination in Groups 13 and 14.

Systemic events (fever, increased sleep, decreased appetite, and irritability) within 7 days 
after each primary vaccination and the booster vaccination in Groups 13 and 14.

Use of antipyretic medications within 7 days after each primary vaccination and the 
booster vaccination in Groups 13 and 14.

AEs, SAEs, MAEs, NDCMCs, and immediate AEs in Groups 13 and 14.
3.2. Secondary Endpoint(s)
3.2.1. Secondary Endpoints for Open-Label Stage
3.2.1.1. Secondary Immunogenicity Endpoints

hSBA titer for each of the MenB test strains 1 month after primary vaccination 2 and 
1 month after the booster vaccination in Groups 3, 4, and 5.
3.2.1.2. Secondary Safety Endpoints
For local reactions (tenderness, redness, and swelling), systemic events (fever, increased 
sleep, decreased appetite, and irritability), and use of antipyretic medications within 7 days; 
and AEs, SAEs, MAEs, NDCMCs, and immediate AEs in Groups 3, 4, and 5.
3.3. Tertiary/Exploratory Endpoint(s)
3.3.1. Tertiary/Exploratory Endpoints for Open-Label Stage
3.3.1.1. Tertiary/Exploratory Immunogenicity Endpoints

hSBA titer for each of the MenA, MenC, MenW, and MenY test strains 1 month after 
primary vaccination 2 and 1 month after the booster vaccination in Groups 1, 2, 7, 8, 10,
and 11.

hSBA titer for each of the MenB test strains 1 month after primary vaccination 2 and 
1 month after the booster vaccination in Groups 1, 2, 7, 8, 10, and 11.
Where assay titers are available, participants with hSBA titers ≥LLOQ will be derived
similarly to Section 3.1.1.1.


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3.3.1.2. Tertiary/Exploratory Safety Endpoints
For local reactions (tenderness, redness, and swelling), systemic events (fever, increased 
sleep, decreased appetite, and irritability), and use of antipyretic medications within 7 days; 
and AEs, SAEs, MAEs, NDCMCs, and immediate AEs in Groups 1 and 2 will be handled 
similarly to Section 3.1.1.2.
3.4. Baseline Variables
3.4.1. Demographic, Medical History, and Baseline Characteristic Variables
Demographic variables collected at Visit 1 include sex, race, ethnicity, and date of birth.  
Race collected includes:

Black or African American

Asian

White

Multiracial

Not reported
Ethnicity collected includes:

Hispanic or Latino

Not Hispanic or not Latino

Not reported
For countries where full date of birth is collected, age at time of first vaccination will be 
derived based on birthday.
Medical history will be assessed at Visit 1 and categorized according to the current version 
(at the time of reporting) of MedDRA.
Physical examination will be assessed prior to vaccination at Visit 1 and each body system 
examined will be recorded in the CRF as normal, abnormal, or not done.
3.4.2. Previous Vaccinations
For participants who have ever received a PRP-OMP vaccine, the name of the vaccine and 
date of administration will be recorded on the CRF. PRP-OMP–containing vaccines that are 
or have been commercially available include Comvax, Procomvax, and PedvaxHIB.


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3.4.3. E-Diary Completion
For any given day, an e-diary will be transmitted and considered complete if all expected 
data (the 3 local reactions and the 4 systemic events, including fever, and use of antipyretic
medications) are available.  If all data are missing for all items on the e-diary, for all days 
following vaccination, the e-diary will be considered not transmitted.  An e-diary will be 
considered completed if all expected data for all days are available (ie, not missing) and data 
are valid.  Otherwise, the e-diary will be considered incomplete.  For any given day, an 
e-diary will be considered complete if all expected data are available.
The following e-diary compliance variables will be provided for each vaccination:
1. Compliance in the first 24 hours and per day: completed (transmitted) the e-diary on a 
given day (Day 1 through Day 7).
2. At least X day(s): completed (transmitted) the e-diary on any X number of days
(X = 1 through 7; compliance will be computed for each value of X).
3. All 7 days: completed (transmitted) the e-diary on all 7 days.
3.5. Safety Endpoints
3.5.1. Adverse Events
The relationship between SAEs/AEs and the investigational products will be characterized as 
related or not related as determined by investigators and as described in the protocol.  The 
severity of AEs will be characterized as mild, moderate, or severe.
The time period for actively eliciting and collecting SAEs, AEs, MAEs, and NDCMCs for 
each participant is outlined in Table 8.
Table 8.
Summary of Adverse Event Collection
Visit 
Description
Primary 
Vaccination 1
Safety 
Telephone
Contact 
Primary 
Vaccination 2
Follow-up
After Primary 
Vaccination 2
Booster
Vaccination
Follow-up 
After 
Booster 
Vaccination
Final 
Telephone 
Contact
Visit 
Identifier
1
2
3
4
5
6
7
AEs
SAEs, 
MAEs, 
NDCMCs
Abbreviations: MAE = medically attended adverse event; NDCMC = newly diagnosed chronic medical condition.


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An MAE is defined as a nonserious AE that results in an evaluation at a medical facility.
Participants’ missed days of school or work due to an AE will be captured via the 
AE checklist.  Neuroinflammatory and autoimmune conditions will also be captured via the 
AE checklist.  An NDCMC is defined as a disease or medical condition not previously 
identified that is expected to be persistent or otherwise long-lasting in its effects.
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant’s parent(s)/legal guardian 
provides informed consent, which is obtained before the participant’s participation in the 
study (ie, before undergoing any study-related procedure and/or receiving study 
intervention).  This duration of this active collection period is defined below:

Through and including Visit 4.

From Visit 5 through and including Visit 6.
The time period for actively eliciting and collecting SAEs, MAEs, and NDCMCs 
(“active collection period”) for each participant begins from the time the parent(s)/legal 
guardian provides informed consent through Visit 7 (final telephone contact) for all groups.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
All events collected on the CRF will be categorized according to the current version 
(at the time of reporting) of MedDRA.
3.5.1.1. Analysis Intervals
There will be 9 analysis intervals for the AE data collected via the CRF (Table 9). The 
analysis populations used for these intervals are described in detail in Section 4.
Table 9.
Analysis Intervals for AEs, SAEs, MAEs, and NDCMCs
#
Analysis 
Interval
Analysis 
Population
Interval Start Date 
(Inclusive)
Interval Stop Date 
(Inclusive)
Safety 
Data
1 Within 30 days 
after primary 
vaccination 1
Vaccination 1 
safety
Vaccination 1 date
Vaccination 1 date + 30 days AEs, SAEs, 
MAEs, 
NDCMCs
2 Within 30 days 
after primary 
vaccination 2
Vaccination 2 
safety
Vaccination 2 date
Vaccination 2 date + 30 days AEs, SAEs, 
MAEs, 
NDCMCs


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Table 9.
Analysis Intervals for AEs, SAEs, MAEs, and NDCMCs
#
Analysis 
Interval
Analysis 
Population
Interval Start Date 
(Inclusive)
Interval Stop Date 
(Inclusive)
Safety 
Data
3 Within 30 days 
after any 
primary 
vaccination
Safety
Vaccination 1 date or 
Vaccination 2 date
Vaccination 1 date + 30 days 
or Vaccination 2 date +
30 days
AEs, SAEs, 
MAEs, 
NDCMCs
4 During 
primary 
vaccination 
phase
Safety
Visit 1 date
Visit 4 date - 1 (or end of 
primary vaccination day)
AEs, SAEs, 
MAEs, 
NDCMCs
5 During 
primary 
follow-up 
phase
Follow-up
Visit 4 date, or
end of primary vaccination
date + 1 for early-withdrawal 
participants
Visit 5 date - 1
SAEs, 
MAEs, 
NDCMCs
6 Throughout 
primary stage
Safety
Visit 1 date
Visit 5 date - 1
SAEs, 
MAEs, 
NDCMCs
7 During booster 
vaccination 
phase
Booster safety Visit 5 date
Visit 6 date (or end of 
booster vaccination day)
AEs, SAEs, 
MAEs, 
NDCMCs
8 During booster 
follow-up 
phase
Booster 
Follow-up
Visit 6 date + 1, or
end of booster vaccination
date + 1 for early-withdrawal 
participants
Visit 7 date
SAEs, 
MAEs, 
NDCMCs
9 Throughout 
booster stage
Booster safety Visit 5 date
Visit 7 date
SAEs, 
MAEs, 
NDCMCs
Abbreviations: MAE = medically attended adverse event; NDCMC = newly diagnosed chronic medical 
condition.
Note: Visit 1 is the date of primary vaccination 1; Visit 4 is the date of follow-up after primary vaccination 2; 
Visit 5 is the date of booster vaccination; Visit 6 is the date of follow-up after booster vaccination; and 
Visit 7 is the date of final telephone contact.
Three analysis intervals will be applied to immediate AEs (Table 10).
Table 10.
Analysis Intervals for Immediate AEs
#
Analysis Interval
Analysis Population
Interval Start 
Date/Time (Inclusive)
Interval Stop Date/Time 
(Inclusive)
1
Primary vaccination 1
Vaccination 1 safety
Vaccination 1 time
Vaccination 1 time + 
30 minutes
2
Primary vaccination 2
Vaccination 2 safety
Vaccination 2 time
Vaccination 2 time + 
30 minutes
3
Booster vaccination
Booster safety
Booster vaccination time
Booster vaccination + 
30 minutes


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3.5.2. Laboratory Data
Laboratory assessments will not be collected for this study.
3.5.3. Reactogenicity Data
Reactogenicity data are solicited AEs.  The reactogenicity data collected from the study 
e-diary will include local reactions (tenderness, redness, and swelling), systemic events 
(fever, increased sleep, decreased appetite, and irritability), and use of antipyretic medication.
The e-diary will record reactogenicity data from Day 1 through Day 7 starting on the day of 
each vaccination (Day 1), following investigational product administration.  Only local 
reactions at the site of investigational product administration on the left thigh will be 
recorded.
Four analysis intervals will be applied to reactogenicity data (Table 11).
Table 11.
Analysis Intervals for Reactogenicity Date
#
Analysis Interval
Analysis 
Population
Interval Start Date 
(Inclusive)
Interval Stop Date (Inclusive)
1
Primary 
vaccination 1
Vaccination 1 
safety
Vaccination 1 date
Vaccination 1 date + 6 days (or until 
resolved day)
2
Primary 
vaccination 2
Vaccination 2 
safety
Vaccination 2 date
Vaccination 2 date + 6 days (or until 
resolved day)
3
Any primary 
vaccination
Safety
Vaccination 1 or 
Vaccination 2 date
Vaccination 1 or Vaccination 2 + 6 days 
(or until resolved day)
4
Booster vaccination Booster safety
Booster vaccination
date
Booster vaccination 1 date + 6 days 
(or until resolved day)
3.5.3.1. Local Reactions Endpoints
For each local reaction, the derivation of whether or not the specific reaction occurred on 
each day and “any day (Days 1-7)” will be made.  The variable will be calculated for each 
vaccination as well as overall reactions for any vaccination.  The derivation of this variable is 
given in Table 12.


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Table 12.
Derived Variables for Local Reactions
Variable
Yes (1)a
No (0)b
Missing (.)
Each day 
(Days 1-7)
Parent/legal guardian reports 
the reaction as “mild,”
“moderate,” or “severe” on 
each individual day
Participant/parent/legal 
guardian reports the reaction 
as “none” on the individual 
day 
Parent/legal guardian did not 
report on the reaction on the 
individual day
Any day 
(Days 1-7)
Parent/legal guardian reports 
the reaction as “mild,”
“moderate,” or “severe” on 
any day (Days 1-7)
Parent/legal guardian reports 
the reaction as “none” on all 
7 days or as a combination of 
“none” and missing on all 
7 days
Parent/legal guardian did not 
report on the reaction on any 
of the 7 days
a.
For redness and swelling, mild, moderate, and severe categories were based on the caliper size reported 
from the e-diary and defined in Table 13.
b.
For redness and swelling, “none” means 0 caliper units reported in the e-diary.
A caliper (measuring device) is used to measure the redness or swelling of the injection site 
area. Caliper units are converted to centimeters according to 1 caliper unit = 0.5 centimeters 
and then categorized as none, mild, moderate, or severe based on the grading scale of local 
reactions in Table 13.  Tenderness will be assessed by the participant/parent/legal guardian 
according to the grading scale in Table 14.
Table 13.
Grading of Redness and Swelling
Mild
0.5 to 2.0 cm (1 to 4 caliper units)
Moderate
2.0 to 7.0 cm (5 to 14 caliper units)
Severe
7.0 cm (14 caliper units)
Table 14.
Grading of Tenderness
Mild
Hurts if gently touched (eg, participant whimpers, winces, protests, or withdraws)
Moderate
Hurts if gently touched, with crying
Severe
Causes limitation of limb movement


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The maximum severity (highest grading) of each local reaction within 7 days after
vaccination will be derived for each primary series vaccination, any primary series 
vaccination, and booster vaccination.  The maximum severity will be derived as follows:

= ., if values are missing for all days (Days 1-7);

= 0, if the parent/legal guardian reports all reactions as “none” or a combination of 
missing and “none” for all days (Days 1-7);

= highest grade (maximum severity) within 7 days after vaccination, if the answer is not 
“none” for at least 1 day.
For participants experiencing any local reactions (or those with derived reaction presence 
in Table 12), the maximum duration (last day of reaction - first day of reaction + 1) will be 
derived for the study vaccination.  Resolution of the event is the last day on which the event 
is recorded in the e-diary or the date the event ends if it is unresolved during the participant 
diary-recording period (end date collected on the CRF), unless chronicity is established.  
If there is no known end date, the duration will be considered unknown and set to missing.
For reactions that continue into the next vaccination visit, the duration will be calculated in a 
segmented fashion.  The reaction end date will be set to the day prior to the next vaccination 
and will have a new start date as the day of next vaccination and duration will be calculated 
separately from this start date to the date of resolution.  Participants with reactions spanning 
multiple vaccination visits will be included in a footnote.
Participants with no reported reaction have no duration.
For local reactions, the following variables will be derived for local reactions:
1. Each local reaction on each day (Days 1-7) after each primary series vaccination and 
booster vaccination.
2. Each local reaction on any day (Days 1-7) after each primary series vaccination, any 
primary series vaccination, and booster vaccination.
3. Any local reaction on any day (Days 1-7) after each primary series vaccination, any 
primary series vaccination, and booster vaccination.
4. Maximum severity of each local reaction on any day (Days 1-7) after each primary series 
vaccination, any primary series vaccination, and booster vaccination.
5. Duration of each local reaction after each primary series vaccination and booster 
vaccination.


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3.5.3.2. Systemic Events Endpoints
Participants will be asked to assess severity of each event according to Table 15.
Table 15.
Grading of Other Systemic Events
Grade 1 (Mild)
Grade 2 (Moderate)
Grade 3 (Severe)
Decreased appetite
(loss of appetite)
Decreased interest in 
eating 
Decreased oral intake
Refusal to feed
Drowsiness 
(increased sleep)
Increased or prolonged 
sleeping bouts
Slightly subdued 
interfering with daily 
activity
Disabling; not interested 
in usual daily activity
Irritability 
(fussiness)
(synonymous with restless 
sleep; decreased sleep)
Easily consolable
Requiring increased 
attention
Inconsolable; crying 
cannot be comforted
Axillary temperature will be collected in the e-diary for Day 1 at 4, 8, 12, and 24 hours, and 
daily for Days 2 through 7 after each primary series vaccination and booster vaccination at 
any time during the 7 days when fever is suspected.  The highest temperature for each day 
will be recorded in the e-diary.  The protocol defines fever as an oral temperature ≥38.0°C.  
Fever will be scaled as shown in Table 16.
Table 16.
Severity Scale for Fever
Temperature 38.0°C to 38.4°C
Temperature 38.4°C to 38.9°C
Temperature 38.9°C to 40°C
Temperature 40.0°C
For each systemic event, the following variables will be available:
1. Each systemic event on each day (Days 1-7) after each primary series vaccination and 
booster vaccination.
2. Each systemic event on any day (Days 1-7) after each primary series vaccination, any 
primary series vaccination, and booster vaccination.
3. Any systemic event on any day (Days 1-7) after each primary series vaccination, any 
primary series vaccination, and booster vaccination.


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4. Maximum severity of each systemic event on any day (Days 1-7) after each primary 
series vaccination, any primary series vaccination, and booster vaccination.
5. Duration of each systemic event after each primary series vaccination and booster 
vaccination.
The derivation of these variables is similar to the derivation of the variables for local 
reactions (Section 3.5.3.1).
3.5.3.3. Use of Antipyretic Medication
The use of antipyretic medication will be recorded in the e-diary for 7 days (Day 1 through
Day 7) after each primary series vaccination and booster vaccination.
The following variables will be derived:
1. Use of antipyretic medication on each day (Days 1-7) after each primary series 
vaccination and booster vaccination.
2. Use of antipyretic medication on any day (Days 1-7) after each primary series 
vaccination, any primary series vaccination, and booster vaccination.
3. Use of antipyretic medication during the first 24 hours after each primary series 
vaccination and booster vaccination.
4. Number of antipyretic medication doses during the first 24 hours after each primary 
series vaccination and booster vaccination.
Duration of use of antipyretic medication after each primary series vaccination and booster 
vaccination.
3.5.4. Medical Device Errors
Medical device incidents or malfunctions of the device that result in an incident will be 
detected, documented, and reported during all periods of the study in which the medical 
device is used. If a medical device error involves an AE, it will be summarized according to 
AE reporting conventions.
4. ANALYSIS SETS (POPULATIONS FOR ANALYSIS)
Data for all participants will be assessed to determine if participants meet the criteria for 
inclusion in each analysis population prior to unblinding and releasing the database and 
classifications will be documented per SOPs. In the population and defined population for 
analysis tables below, investigational product is referring to MenABCWY, bivalent rLP2086, 
Nimenrix, or Bexsero, not the paracetamol regimen.


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Population
Description
Enrolled
All participants who sign the ICD.
Randomly assigned to investigational product 
(as-randomized)
All participants who are assigned a randomization 
number in the IRT system.
Evaluable
Defined according to post–primary vaccination 2 
evaluable and post–booster vaccination evaluable 
criteria.
mITT
Defined according to post–primary vaccination 2 
mITT and post–booster vaccination mITT criteria.
Safety
All randomized participants who receive at least 
1 dose of the investigational product and have safety 
data reported after vaccination.  Participants will be 
analyzed according to the vaccine they actually 
received.
Defined Population for 
Analysis
Description
Post–primary vaccination 2 
evaluable immunogenicity 
population
1.
Were randomized to the study group of interest.
2.
Were eligible through Visit 4, ie, fulfilling all of the inclusion criteria 
and none of the exclusion criteria at each visit where eligibility criteria 
are collected and confirmed.
3.
Received the investigational products at Visits 1 and 3 as randomized.
4.
Had blood drawn for assay testing within the required time frames at 
Visit 4 (1 month after primary vaccination 2 [window 28-42 days]).
5.
Had at least 1 valid and determinate MenA, MenC, MenW, MenY, or 
MenB assay result at Visit 4.
6.
Had received no prohibited vaccines or treatment through Visit 4.
7.
Had no important protocol deviations through Visit 4.
Post–booster vaccination 
evaluable immunogenicity 
population
1.
Were randomized to the study group of interest.
2.
Were eligible through Visit 6, ie, fulfilling all of the inclusion criteria 
and none of the exclusion criteria at each visit where eligibility criteria 
are collected and confirmed.
3.
Received the investigational products at Visits 1, 3, and 5 as 
randomized.
4.
Had blood drawn for assay testing within the required time frames at 
Visit 6 (1 month after the booster vaccination [window 28-42 days]).
5.
Had at least 1 valid and determinate MenA, MenC, MenW, MenY, or 
MenB assay result at Visit 6.
6.
Had received no prohibited vaccines or treatment through Visit 6.
7.
Had no important protocol deviations through Visit 6.
Post–primary vaccination 2 
mITT
All participants who received at least 1 primary series study vaccination 
and had at least 1 valid and determinate MenA, MenC, MenW, MenY, or 
MenB assay result available at Visit 4.
Post–booster vaccination mITT
All participants who received the booster study vaccination and had at 
least 1 valid and determinate MenA, MenC, MenW, MenY, or MenB assay 
result available at Visit 6.
Primary vaccination 1 safety 
population
This population will include participants who received the first dose of 
investigational product at Visit 1 and who had safety follow-up between 
Visit 1 and prior to Visit 3.


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Defined Population for 
Analysis
Description
Primary vaccination 2 safety 
population
This population will include participants who received the second dose of 
investigational product at Visit 3 and who had safety follow-up between 
Visit 3 and prior to Visit 4.
Primary vaccination 2 follow-up 
safety population
This population will include participants who received at least 1 dose of 
investigational product and who had safety follow-up between Visit 4 and 
prior to Visit 5.
Booster vaccination safety 
population
This population will include participants who received the booster dose of 
investigational product and who had safety follow-up between Visit 5 and 
prior to Visit 6.
Booster vaccination follow-up 
safety population
This population will include participants who received the booster dose of 
investigational product and who had safety follow-up between Visit 6 and 
up to and including Visit 7.
For determination of the evaluable immunogenicity population(s), items 1 through 5 will 
be computerized checks of the data, while items 6 and 7 will be determined by clinical 
review. An important protocol deviation is a protocol violation that, in the opinion of the 
sponsor’s global medical monitor, would materially affect assessment of immunogenicity, 
eg, participant receipt of a prohibited vaccine or medication that might affect immune 
response or a medication error with suspected decrease in potency of the vaccine. The global 
medical monitor from the sponsor will identify those participants with a protocol violation
for the open-label stage prior to each immunogenicity analysis involving those populations 
being done and for the blinded expanded-enrollment stage prior to unblinding of the study.
Vaccinated but not randomized: these participants will be included in the safety population 
for safety analysis and will be reported under the vaccine group based on the vaccine 
received, but will be excluded from immunogenicity analyses.
Randomized but not vaccinated: these participants will be included in the randomly assigned
population and excluded from any safety analyses.
Randomized but received incorrect vaccine: these participants will be included in the mITT 
population for immunogenicity analyses if data are available and will be reported under the 
vaccine group based on the randomized vaccine.  These participants will also be included in 
the safety population for safety analysis and will be reported under the vaccine group based 
on the vaccine received.
5. GENERAL METHODOLOGY AND CONVENTIONS
5.1. Hypotheses and Decision Rules
There are no hypotheses for this study.


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5.2. General Methods
Descriptive summary statistics will be provided for all endpoints.  Unless otherwise 
explicitly stated, descriptive statistics for continuous variables are n, mean, median, standard 
deviation, minimum, and maximum.  Descriptive statistics for categorical variables are the 
percentage (%) and the n (the numerator) and N (the denominator) used in the calculation of 
the proportion.
5.2.1. Analyses for Binary Endpoints
The number and percentage of participants in each category will be summarized.  
The 95% CI for percentages, and for difference in percentages, will also be presented, where 
appropriate. The 95% CI for the proportion will be constructed by the Clopper-Pearson 
method described by Agresti (2002).1 The 95% CI will be presented in terms of percentages.
5.2.1.1. Immunogenicity Data
Each MenB test strain has a qualified LLOQ value defined in Table 17.
Table 17.
Qualified hSBA LLOQ for MenB Test Strains
Strain Variant
LLOQ
PMB80 (A22)
1:16
PMB2707 (B44)
1:8
PMB824 (A12)
1:16
PMB3175 (A29)
1:8
PMB451 (B16)
1:8
PMB2948 (B24)
1:8
PMB3042 (B44)
1:8
Abbreviations: hSBA = serum bactericidal assay using human complement; LLOQ = lower level of 
quantitation; MenB = Neisseria meningitidis group B.
Each MenACWY serogroup has a qualified LLOQ value defined in Table 18.
Table 18.
Qualified hSBA LLOQ for MenACWY Serogroups
Serogroup
LLOQ
A
1:8
C
1:8
W
1:8
Y
1:8
Abbreviations: hSBA = serum bactericidal assay using human complement; LLOQ = lower level of 
quantitation; MenACWY = Neisseria meningitidis group A, C, W, and Y.


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5.2.1.2. Safety Data
All safety endpoints (including reactogenicity data recorded from the e-diary and AE data 
recorded from the CRF) will be summarized with percentages and 95% exact CIs 
(Clopper-Pearson method) for each group.
5.2.2. Analyses for Continuous Endpoints
5.2.2.1. Geometric Mean Titers
GMTs will be computed for each hSBA titer for MenB and MenACWY strains.  If the hSBA 
result is below LLOQ, it will be set to 0.5 × LLOQ for the GMT calculation.  The assay 
results at each blood sampling time point will be (natural-log) logarithmically transformed 
for analysis.  GMTs are obtained by log transformations of indicated values, averaging the 
log values, then exponentiating the result. The associated 2-sided 95% CIs are obtained by 
exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the 
Student t distribution).
5.2.2.2. Reverse Cumulative Distribution Curves
RCDCs will plot proportions of participants with values equal to or exceeding a specified 
assay value versus the indicated assay value, for all observed assay values. Data points will 
be joined by a step function with data points on the right side of the step.
5.3. Methods to Manage Missing Data
5.3.1. Safety Data
Standard algorithms on handling missing AE dates will be applied according to the 
following: A partial AE start date (missing day or missing both month and day) will be 
imputed by assigning the earliest possible start date using all available information, such as 
the stop date of the AE and the vaccination date(s) from the same participant, following the 
Pfizer standard of handling incomplete AE start date. A completely missing start date for an 
AE is not allowed in the data collection.
5.3.1.1. Reactogenicity Data
For derived variables based on reactogenicity data, if any day of the 7-day e-diary is 
available, the “any day (Days 1-7)” data will be considered nonmissing.  Participants are 
excluded from the analysis if they do not receive the particular dose or the safety data are
missing on all days within the interval.
The reactogenicity data are collected through the e-diary, which does not allow participants
to skip the question.  Therefore, for a specific day, as long as the e-diary data are transferred 
for that day, all of the reactogenicity data for the participant on that day are nonmissing.  
The e-diary transmission and completion status will be summarized per Section 6.5.4.  


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The e-diary completion summary will provide the missing data information on the 
reactogenicity data.
Based on data from available studies, the missing data on reactogenicity are minimal, which 
is consistent with Li et al (2011).2  No sensitivity analysis is planned for reactogenicity data.
5.3.2. Immunogenicity Data
As assay data are expected to be missing completely at random, the primary analysis for the 
primary objectives will be based upon the observed, determinate observations.  No 
imputation will be performed.  The proportion of participants with missing immunogenicity 
data may be summarized at each blood sampling visit for each MenB and MenACWY strain.  
The denominator will be the as-randomized population.  The category of missing reasons 
(QNS, indeterminate, not done, dropout) may also be summarized.
For the hSBA assay results, the following values will be set to missing: QNS 
(insufficient sera), indeterminate results, and not done.  Participants without blood draw 
(ie, dropout) will also have missing data for immunogenicity.
6. ANALYSES AND SUMMARIES
Section 2.1 describes the estimands for each of the study objectives. Below are the planned 
analyses by endpoints.
6.1. Primary Endpoint(s)
6.1.1. Primary Endpoints for Open-Label Stage
6.1.1.1. hSBA Titer for Each of the MenA, MenC, MenW, and MenY Test Strains
6.1.1.1.1. Main Analysis
For the primary vaccinations:

Planned analysis: Percentage of participants achieving an hSBA titer ≥LLOQ for 
each MenA, MenC, MenW, and MenY test strain 1 month after primary vaccination 2 
for the following group combinations: Groups 7+11 (MenABCWY recipients) and 
Groups 8+10 (Nimenrix recipients).

Analysis set: Post–primary vaccination 2 evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results: For each strain, the numerator (n) and denominator (N) used in the 
percentage calculation, the percentage (%), and the corresponding 2-sided 95% CIs for 
the percentages will be provided.


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For the booster vaccination:

Planned analysis: Percentage of participants achieving an hSBA titer ≥LLOQ for 
each MenA, MenC, MenW, and MenY test strain 1 month after the booster vaccination 
for the following group combinations: Groups 7+11 (MenABCWY recipients) and 
Groups 8+10 (Nimenrix recipients).

Analysis set: Post–booster vaccination evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results: For each strain, the numerator (n) and denominator (N) used in the 
percentage calculation, the percentage (%), and the corresponding 2-sided 95% CIs for 
the percentages will be provided.
6.1.1.1.2. Sensitivity/Supplementary Analyses
For the primary vaccination, the main analysis will also be performed on the post–primary 
vaccination 2 mITT population if there is a difference of more than 10% between the
post–primary vaccination 2 evaluable immunogenicity and post–primary vaccination 2 mITT 
populations. Similarly, for the booster vaccination, the main analysis will also be performed 
on the post–booster vaccination mITT population if there is a difference of more than 10% 
between the post–booster vaccination evaluable immunogenicity and post–booster 
vaccination mITT populations.
6.1.1.2. hSBA Titer for Each of the MenB Test Strains
6.1.1.2.1. Main Analysis
For the primary vaccinations:

Planned analysis:
1. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenB test strain 
1 month after primary vaccination 2 for the following group combinations: 
Groups 7+11 (MenABCWY recipients) and Groups 8+10 (Bexsero recipients).
2. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenB test strain 
1 month after primary vaccination 2 for the following group combinations: 
Groups 3+4 (60 µg bivalent rLP2086 recipients) and Group 5 (120 µg bivalent 
rLP2086 recipients).

Analysis set: Post–primary vaccination 2 evaluable immunogenicity population.


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
Analysis methodology: Descriptive statistics.

Reporting results: For each MenB test strain, the numerator (n) and denominator (N) used 
in the percentage calculation, the percentage (%), and the corresponding 2-sided 95% CIs 
for the percentages will be provided.
For the booster vaccination:

Planned analysis:
1. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenB
test strain 1 month after the booster vaccination for the following group and 
group combinations: Groups 7+11 (MenABCWY recipients) and 
Groups 8+10 (Bexsero recipients).
2. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenB test 
strain 1 month after the booster vaccination for the following group combination: 
Groups 3+4 (60 µg bivalent rLP2086 recipients) and Group 5 (120 µg bivalent 
rLP2086 recipients).

Analysis set: Post–booster vaccination evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results: For each MenB test strain, the numerator (n) and denominator (N) used 
in the percentage calculation, the percentage (%), and the corresponding 2-sided 95% CIs 
for the percentages will be provided.
6.1.1.2.2. Sensitivity/Supplementary Analyses
For the primary vaccination, the main analysis will also be performed on the post–primary 
vaccination 2 mITT population if there is a difference of more than 10% between the
post–primary vaccination 2 evaluable immunogenicity and post–primary vaccination 2 mITT 
populations. Similarly, for the booster vaccination, the main analysis will also be performed 
on the post–booster vaccination mITT population if there is a difference of more than 10% 
between the post–booster vaccination evaluable immunogenicity and post–booster 
vaccination mITT populations.


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6.1.1.3. Local Reactions Within 7 Days
6.1.1.3.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after each primary vaccination for the 
following groups or group combinations: Groups 7+11 (MenABCWY recipients with 
SLP), Group 8 (Bexsero recipients with PLP), Group 11 (MenABCWY recipients with 
TLP), Group 10 (Bexsero recipients without PLP), Groups 7+11 (MenABCWY 
recipients [without regard to protocol-assigned paracetamol]), and Groups 8+10 (Bexsero 
recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Presence or absence of any local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Maximum severity of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after the booster vaccination for 
the following group combinations: Groups 7+11 (MenABCWY recipients) and 
Groups 8+10 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.


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
Presence or absence of any local reaction on “any day (Day 1-7)” after the booster 
vaccination.

Maximum severity of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.
6.1.1.3.2. Supplementary Analysis
As supplementary analyses to support the assessment of local reactions, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each local reaction after each primary vaccination for the following 
groups or group combinations:

Groups 7+11 (MenABCWY recipients with SLP),

Group 8 (Bexsero recipients with PLP),

Group 11 (MenABCWY recipients with TLP),

Group 10 (Bexsero recipients without PLP),

Groups 7+11 (MenABCWY recipients [without regard to protocol-assigned 
paracetamol]), and

Groups 8+10 (Bexsero recipients)
and booster vaccination for the following group combinations:

Groups 7+11 (MenABCWY recipients) and

Groups 8+10 (Bexsero recipients).

Onset day of each local reaction after each primary vaccination for the following groups 
or group combinations:

Groups 7+11 (MenABCWY recipients with SLP),

Group 8 (Bexsero recipients with PLP),

Group 11 (MenABCWY recipients with TLP),

Group 10 (Bexsero recipients without PLP),


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
Groups 7+11 (MenABCWY recipients [without regard to protocol-assigned 
paracetamol]), and

Groups 8+10 (Bexsero recipients)
and booster vaccination for the following group combinations:

Groups 7+11 (MenABCWY recipients) and

Groups 8+10 (Bexsero recipients).
These continuous endpoints will be summarized by displaying n, mean, median, 
standard deviation, minimum, and maximum.
Figures:
Bar charts with the proportions of participants for any day (Day 1 through Day 7) will be 
plotted for each primary vaccination for the following groups or group combinations:

Groups 7+11 (MenABCWY recipients with SLP),

Group 8 (Bexsero recipients with PLP),

Group 11 (MenABCWY recipients with TLP),

Group 10 (Bexsero recipients without PLP),

Groups 7+11 (MenABCWY recipients [without regard to protocol-assigned 
paracetamol]), and

Groups 8+10 (Bexsero recipients)
and booster vaccination for the following group combinations:

Groups 7+11 (MenABCWY recipients) and

Groups 8+10 (Bexsero recipients),
with different patterns displayed in the bar charts for different maximum severity levels for 
any day.


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6.1.1.4. Systemic Events Within 7 Days
6.1.1.4.1. Main Analysis
For primary vaccination:

Planned analysis: The percentage of participants reporting prompted systemic events
(fever, increased sleep, decreased appetite, and irritability) within 7 days after each 
primary vaccination for the following groups or group combinations: 
Groups 7+11 (MenABCWY recipients with SLP), Group 8 (Bexsero recipients with 
PLP), Group 11 (MenABCWY recipients with TLP), Group 10 (Bexsero recipients 
without PLP), Groups 7+11 (MenABCWY recipients [without regard to 
protocol-assigned paracetamol]), and Groups 8+10 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after each 
primary vaccination and any primary vaccination.

Presence or absence of any systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Maximum severity of each systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted systemic 
events (fever, increased sleep, decreased appetite, and irritability) within 7 days 
after the booster vaccination for the following group combinations: 
Groups 7+11 (MenABCWY recipients) and Groups 8+10 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.


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
Presence or absence of any systemic event on “any day (Day 1-7)” after the booster 
vaccination.

Maximum severity of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.
6.1.1.4.2. Supplementary Analysis
As supplementary analyses to support the assessment of systemic events, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each systemic event after each primary vaccination for the following 
groups or group combinations:

Groups 7+11 (MenABCWY recipients with SLP),

Group 8 (Bexsero recipients with PLP),

Group 11 (MenABCWY recipients with TLP),

Group 10 (Bexsero recipients without PLP),

Groups 7+11 (MenABCWY recipients [without regard to protocol-assigned 
paracetamol]), and

Groups 8+10 (Bexsero recipients)
and booster vaccination for the following group combinations:

Groups 7+11 (MenABCWY recipients) and

Groups 8+10 (Bexsero recipients).

Onset day of each systemic event after each primary vaccination for the following groups 
or group combinations:

Groups 7+11 (MenABCWY recipients with SLP),

Group 8 (Bexsero recipients with PLP),

Group 11 (MenABCWY recipients with TLP),

Group 10 (Bexsero recipients without PLP),


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
Groups 7+11 (MenABCWY recipients [without regard to protocol-assigned 
paracetamol]), and

Groups 8+10 (Bexsero recipients)
and booster vaccination for the following group combinations:

Groups 7+11 (MenABCWY recipients) and

Groups 8+10 (Bexsero recipients).
These continuous endpoints will be summarized by displaying n, mean, median, 
standard deviation, minimum, and maximum.
Figures:
Bar charts with the proportions of participants for any day (Day 1 through Day 7) will be 
plotted for each primary vaccination for the following groups or group combinations:

Groups 7+11 (MenABCWY recipients with SLP),

Group 8 (Bexsero recipients with PLP),

Group 11 (MenABCWY recipients with TLP),

Group 10 (Bexsero recipients without PLP),

Groups 7+11 (MenABCWY recipients [without regard to protocol-assigned 
paracetamol]), and

Groups 8+10 (Bexsero recipients)
and booster vaccination for the following group combinations:

Groups 7+11 (MenABCWY recipients) and

Groups 8+10 (Bexsero recipients),
with different patterns displayed in the bar charts for different maximum severity levels for 
any day.


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6.1.1.5. Use of Antipyretic Medications Within 7 Days
6.1.1.5.1. Main Analysis
For primary vaccination:

Planned analysis: The percentage of participants reporting prompted use of 
antipyretic medication within 7 days after each primary vaccination for the following 
groups or group combinations: Groups 7+11 (MenABCWY recipients with SLP), 
Group 8 (Bexsero recipients with PLP), Group 11 (MenABCWY recipients with TLP), 
Group 10 (Bexsero recipients without PLP), Groups 7+11 (MenABCWY recipients
[without regard to protocol-assigned paracetamol]), and Groups 8+10 (Bexsero 
recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after each primary vaccination
and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted use of antipyretic
medication within 7 days after the booster vaccination for the following group
combinations: Groups 7+11 (MenABCWY recipients) and Groups 8+10 (Bexsero 
recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after the booster vaccination.
6.1.1.5.2. Supplementary Analysis
As supplementary analyses to support the assessment of protocol-assigned paracetamol use, 
the following endpoints will be summarized with the same analysis time point and analysis 
population:

The percentage of participants reporting prompted use of protocol-assigned paracetamol 
dosing compliance after each primary vaccination, which is calculated for the following:


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
(number of actual SLP doses / number of planned SLP doses) × 100 for the following 
groups: Groups 7 and 11 (MenABCWY recipients with SLP). If the optional fifth 
dose of SLP is given, this will be used in the calculation of number of planned SLP 
doses; else if it is not given, then the number of planned SLP doses will be 4.

(number of actual PLP doses / number of planned PLP doses) × 100 for the following 
group: Group 8 (Bexsero recipients with PLP).

If the first dose of TLP (if required) is given, then the following calculation applies: 
(number of actual TLP doses / number of planned TLP doses) × 100 for the following 
group: Group 11 (MenABCWY recipients with TLP). If the optional fifth dose of 
SLP is given, this will be used in the calculation of number of planned SLP doses;
else if it is not given, then the number of planned SLP doses will be 4.

The percentage of participants reporting prompted use PLP dosing compliance based on 
protocol-specified timing after each primary vaccination, which is calculated for the 
following:

(number of SLP doses within per-protocol timing window / number of planned SLP 
doses within per-protocol timing window) × 100 for the following groups: Groups 7 
and 11 (MenABCWY recipients with SLP).  The first dose of SLP should be given no 
later than 8 hours from vaccination time.  The rest of the SLP doses should be given 
every 4 to 6 hours. The fifth SLP dose is optional.

(number of actual PLP doses within per-protocol timing window / number of 
planned PLP doses within per-protocol timing window) × 100 for the following 
group: Group 8 (Bexsero recipients with PLP).

(number of actual TLP doses within per-protocol timing window / number of 
planned TLP doses within per-protocol timing window) × 100 for the following 
group: Group 11 (MenABCWY recipients with TLP).  The first dose of TLP 
(if required) should be given no later than 48 hours from vaccination time.  The rest 
of the TLP doses should be given every 4 to 6 hours. The fifth TLP dose is optional.


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6.1.1.6. Serious Adverse Events, Medically Attended Events, and Newly Diagnosed 
Chronic Medical Conditions
For primary vaccination:

Planned analysis: The numbers and percentages of participants with SAEs, MAEs, and 
NDCMCs for each of the analysis intervals defined in Table 9 and will be summarized by 
the following groups or group combinations: Groups 7+11 (MenABCWY recipients 
with SLP), Group 8 (Bexsero recipients with PLP), Group 11 (MenABCWY recipients 
with TLP), Group 10 (Bexsero recipients without PLP), Groups 7+11 (MenABCWY 
recipients [without regard to protocol-assigned paracetamol]), and Groups 8+10 (Bexsero 
recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For the events during the vaccination and follow-up phases, the n, %, 
and 95% CI may be presented for any event, for each SOC, and for each preferred term 
within each SOC.
For booster vaccination:

Planned analysis: The numbers and percentages of participants with MAEs, SAEs, 
and NDCMCs for each of the analysis intervals defined in Table 9 will be summarized
by the following group combinations: Groups 7+11 (MenABCWY recipients) and 
Groups 8+10 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the events during the booster phase, the n, %, 
and 95% CI may be presented for any event, for each SOC, and for each preferred term 
within each SOC.


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6.1.1.7. Adverse Events
For primary vaccination:

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4 
and 7 defined in Table 9 will be summarized by the following groups or group 
combinations: Groups 7+11 (MenABCWY recipients with SLP), Group 8 (Bexsero 
recipients with PLP), Group 11 (MenABCWY recipients with TLP), Group 10 (Bexsero 
recipients without PLP), Groups 7+11 (MenABCWY recipients [without regard to 
protocol-assigned paracetamol]), and Groups 8+10 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.
For booster vaccination:

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4 
and 7 defined in Table 9 will be summarized by the following group combinations: 
Groups 7+11 (MenABCWY recipients) and Groups 8+10 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.


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6.1.1.8. Immediate Adverse Events
For primary vaccination:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the first 2 analysis intervals defined in Table 10 by the 
following groups or group combinations: Groups 7+11 (MenABCWY recipients with 
SLP), Group 8 (Bexsero recipients with PLP), Group 11 (MenABCWY recipients with 
TLP), Group 10 (Bexsero recipients without PLP), Groups 7+11 (MenABCWY 
recipients [without regard to protocol-assigned paracetamol]), and Groups 8+10 (Bexsero 
recipients) after each primary vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.
For booster vaccination:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the last analysis interval defined in Table 10 by the following 
group combinations: Groups 7+11 (MenABCWY recipients) and Groups 8+10 (Bexsero 
recipients) after the booster vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.
Reporting results: For each group, the n, %, and 95% CI may be presented for any event, for 
each SOC, and for each preferred term within each SOC.
6.1.2. Primary Endpoints for Blinded Expanded-Enrollment Stage
6.1.2.1. hSBA Titer for Each of the MenA, MenC, MenW, and MenY Test Strains
6.1.2.1.1. Main Analysis
For the primary vaccinations:


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
Planned analysis:
1. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenA, MenC, 
MenW, and MenY test strain 1 month after primary vaccination 2 for the following 
groups: Group 13 (MenABCWY recipients) and Group 14 (Nimenrix recipients).
2. hSBA GMTs for each MenA, MenC, MenW, and MenY test strain 1 month after 
primary vaccination 2 for the following groups: Group 13 (MenABCWY recipients) 
and Group 14 (Nimenrix recipients).

Analysis set: Post–primary vaccination 2 evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results:
1. For each strain, the numerator (n) and denominator (N) used in the percentage 
calculation, the percentage (%), and the corresponding 2-sided 95% CIs for the 
percentages will be provided.
2. For each strain, the GMT and corresponding 2-sided 95% CI for the GMT will be 
provided.
For the booster vaccination:

Planned analysis:
1. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenA, MenC, 
MenW, and MenY test strain 1 month after the booster vaccination for the following 
groups: Group 13 (MenABCWY recipients) and Group 14 (Nimenrix recipients).
2. hSBA GMTs for each MenA, MenC, MenW, and MenY test strain 1 month after the 
booster vaccination for the following groups: Group 13 (MenABCWY recipients) and 
Group 14 (Nimenrix recipients).

Analysis set: Post–booster vaccination evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results:
1. For each strain, the numerator (n) and denominator (N) used in the percentage 
calculation, the percentage (%), and the corresponding 2-sided 95% CIs for the 
percentages will be provided.


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2. For each strain, the GMT and corresponding 2-sided 95% CI for the GMT will be 
provided.
6.1.2.1.2. Sensitivity/Supplementary Analyses
For the primary vaccination, the main analysis will also be performed on the post–primary 
vaccination 2 mITT population if there is a difference of more than 10% between the 
post–primary vaccination 2 evaluable immunogenicity and post–primary vaccination 2 mITT 
populations. Similarly, for the booster vaccination, the main analysis will also be performed 
on the post–booster vaccination mITT population if there is a difference of more than 10% 
between the post–booster vaccination evaluable immunogenicity and post–booster 
vaccination mITT populations.
6.1.2.2. hSBA Titer for Each of the MenB Test Strains
6.1.2.2.1. Main Analysis
For the primary vaccinations:

Planned analysis:
1. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenB test 
strain 1 month after primary vaccination 2 for the following groups: 
Group 13 (MenABCWY recipients) and Group 14 (Bexsero recipients).
2. hSBA GMTs for each of the MenB test strains 1 month after primary 
vaccination 2 for the following groups: Group 13 (MenABCWY recipients) 
and Group 14 (Bexsero recipients).

Analysis set: Post–primary vaccination 2 evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results:
1. For each MenB test strain, the numerator (n) and denominator (N) used in the 
percentage calculation, the percentage (%), and the corresponding 2-sided 95% CIs 
for the percentages will be provided.
2. For each MenB test strain, the GMT and corresponding 2-sided 95% CI for the GMT 
will be provided.


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For the booster vaccination:

Planned analysis:
1. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenB test 
strain 1 month after the booster vaccination for the following groups: 
Group 13 (MenABCWY recipients) and Group 14 (Bexsero recipients).
2. hSBA GMTs for each of the MenB test strains 1 month after the booster 
vaccination for the following groups: Group 13 (MenABCWY recipients) and 
Group 14 (Bexsero recipients).

Analysis set: Post–booster vaccination evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results:
1. For each MenB test strain, the numerator (n) and denominator (N) used in the 
percentage calculation, the percentage (%), and the corresponding 2-sided 95% CIs 
for the percentages will be provided.
2. For each MenB test strain, the GMT and corresponding 2-sided 95% CI for the GMT 
will be provided.
6.1.2.2.2. Sensitivity/Supplementary Analyses
For the primary vaccination, the main analysis will also be performed on the post–primary 
vaccination 2 mITT population if there is a difference of more than 10% between the 
post–primary vaccination 2 evaluable immunogenicity and post–primary vaccination 2 mITT
populations. Similarly, for the booster vaccination, the main analysis will also be performed 
on the post–booster vaccination mITT population if there is a difference of more than 10% 
between the post–booster vaccination evaluable immunogenicity and post–booster 
vaccination mITT populations.
6.1.2.3. Local Reactions Within 7 Days
6.1.2.3.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after each primary vaccination for the 
following groups:


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
Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Presence or absence of any local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Maximum severity of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after the booster vaccination 
for the following groups: Group 13 (MenABCWY recipients) and Group 14 
(Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.

Presence or absence of any local reaction on “any day (Day 1-7)” after the booster 
vaccination.


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
Maximum severity of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.
6.1.2.3.2. Supplementary Analysis
As supplementary analyses to support the assessment of local reactions, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each local reaction after each primary vaccination for the following 
groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups and 
booster vaccination for the following groups: Group 13 (MenABCWY recipients) and 
Group 14 (Bexsero recipients).

Onset day of each local reaction after each primary vaccination for the following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups and 
booster vaccination for the following groups: Group 13 (MenABCWY recipients) and
Group 14 (Bexsero recipients).
These continuous endpoints will be summarized by displaying n, mean, median, 
standard deviation, minimum, and maximum.
Figures:
Bar charts with the proportions of participants for any day (Day 1 through Day 7) will be 
plotted for each primary vaccination for the following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or


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
Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients with PLP), 
Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero recipients 
with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups and 
booster vaccination for the following groups: Group 13 (MenABCWY recipients with TLP) 
and Group 14 (Bexsero recipients with TLP), with different patterns displayed in the bar 
charts for different maximum severity levels for any day.
6.1.2.4. Systemic Events Within 7 Days
6.1.2.4.1. Main Analysis
For primary vaccination:

Planned analysis: The percentage of participants reporting prompted systemic events 
(fever, increased sleep, decreased appetite, and irritability) within 7 days after each 
primary vaccination for the following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after each 
primary vaccination and any primary vaccination.

Presence or absence of any systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Maximum severity of each systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.


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For booster vaccination:

Planned analysis: The percentage of participants reporting prompted systemic events 
(fever, increased sleep, decreased appetite, and irritability) within 7 days after the 
booster vaccination for the following groups: Group 13 (MenABCWY recipients) and 
Group 14 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.

Presence or absence of any systemic event on “any day (Day 1-7)” after the booster 
vaccination.

Maximum severity of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.
6.1.2.4.2. Supplementary Analysis
As supplementary analyses to support the assessment of systemic events, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each systemic event after each primary vaccination for the following 
groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups and 
booster vaccination for the following groups: Group 13 (MenABCWY recipients) and
Group 14 (Bexsero recipients).

Onset day of each systemic event after each primary vaccination for the following 
groups:


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
Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups and 
booster vaccination for the following groups: Group 13 (MenABCWY recipients) and
Group 14 (Bexsero recipients).
These continuous endpoints will be summarized by displaying n, mean, median, 
standard deviation, minimum, and maximum.
Figures:
Bar charts with the proportions of participants for any day (Day 1 through Day 7) will be 
plotted for each primary vaccination for the following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients with PLP), 
Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero recipients 
with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups and 
booster vaccination for the following groups: Group 13 (MenABCWY recipients with TLP)
and Group 14 (Bexsero recipients with TLP), with different patterns displayed in the bar 
charts for different maximum severity levels for any day, respectively.
6.1.2.5. Use of Antipyretic Medications Within 7 Days
6.1.2.5.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted use of antipyretic
medication within 7 days after each primary vaccination for the following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or


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
Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after each primary vaccination 
and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted use of antipyretic
medication within 7 days after the booster vaccination for the following groups: 
Group 13 (MenABCWY recipients) and Group 14 (Bexsero recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after the booster vaccination.
6.1.2.5.2. Supplementary Analysis
As supplementary analyses to support the assessment of protocol-assigned paracetamol use, 
the following endpoints will be summarized with the same analysis time point and analysis 
population:

The percentage of participants reporting prompted use protocol-assigned paracetamol 
dosing compliance after each primary vaccination, which is calculated as (number of 
actual protocol-assigned paracetamol doses / number of planned protocol-assigned 
paracetamol doses) × 100 for the following groups:

Group 13 (MenABCWY recipients with TLP) and

Group 14 (Bexsero recipients with TLP)
or


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
Group 13 (MenABCWY recipients with SLP),

Group 14 (Bexsero recipients with PLP),

Group 13 (MenABCWY recipients with TLP), and

Group 14 (Bexsero recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups.

The percentage of participants reporting prompted use protocol-assigned paracetamol
dosing compliance per-protocol timing after each primary vaccination, which is 
calculated as (number of protocol-assigned paracetamol doses within per-protocol timing 
window / number of planned protocol-assigned paracetamol doses within per-protocol 
timing window) × 100 for the following groups:

Group 13 (MenABCWY recipients with TLP) and

Group 14 (Bexsero recipients with TLP)
or

Group 13 (MenABCWY recipients with SLP),

Group 14 (Bexsero recipients with PLP),

Group 13 (MenABCWY recipients with TLP), and

Group 14 (Bexsero recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups.
6.1.2.6. Serious Adverse Events, Medically Attended Events, and Newly Diagnosed 
Chronic Medical Conditions
For primary vaccinations:

Planned analysis: The numbers and percentages of participants with SAEs, MAEs, and 
NDCMCs for each of the analysis intervals defined in Table 9 will be summarized by the 
following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or


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
Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups after 
each primary vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the events during the vaccination and follow-up 
phases, the n, %, and 95% CI may be presented for any event, for each SOC, and for each 
preferred term within each SOC.
For booster vaccination:

Planned analysis: The numbers and percentages of participants with MAEs, SAEs, 
and NDCMCs for each of the analysis intervals defined in Table 9 will be summarized 
by the following groups: Group 13 (MenABCWY recipients) and Group 14 (Bexsero 
recipients) after the booster vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the events during the booster phase, the n, %, and 
95% CI may be presented for any event, for each SOC, and for each preferred term 
within each SOC.
6.1.2.7. Adverse Events
For primary vaccinations:

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4 
and 7 defined in Table 9 will be summarized by the following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or

Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);


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this will depend on the proportion of participants to be enrolled in SLP/PLP groups after 
each primary vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.
For booster vaccination: 

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4 
and 7 defined in Table 9 will be summarized by the following groups: 
Group 13 (MenABCWY recipients) and Group 14 (Bexsero recipients) after the booster 
vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.
6.1.2.8. Immediate Adverse Events
For primary vaccinations:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the first 2 analysis intervals defined in Table 10 by the 
following groups:

Group 13 (MenABCWY recipients with TLP) and Group 14 (Bexsero recipients 
with TLP) or


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
Group 13 (MenABCWY recipients with SLP), Group 14 (Bexsero recipients 
with PLP), Group 13 (MenABCWY recipients with TLP), and Group 14 (Bexsero 
recipients with TLP);
this will depend on the proportion of participants to be enrolled in SLP/PLP groups after 
each primary vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.
For booster vaccination:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the last analysis interval defined in Table 10 by the following 
groups: Group 13 (MenABCWY recipients) and Group 14 (Bexsero recipients) after the 
booster vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.
Reporting results: For each group, the n, %, and 95% CI may be presented for any event, for 
each SOC, and for each preferred term within each SOC.
6.2. Secondary Endpoint(s)
6.2.1. Secondary Endpoints for Open-Label Stage
6.2.1.1. hSBA Titer for Each of the MenB Test Strains
6.2.1.2. Main Analysis
For the primary vaccinations:

Planned analysis: hSBA GMTs for each of the MenB test strains 1 month after primary 
vaccination 2 for the group combination 3+4 (60 µg bivalent rLP2086 recipients) and 
Group 5 (120 µg bivalent rLP2086 recipients).

Analysis set: Post–primary vaccination 2 evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.


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
Reporting results: For each MenB test strain, the GMT and corresponding 2-sided 
95% CI for the GMT will be provided.
For the booster vaccination:

Planned analysis: hSBA GMTs for each of the MenB test strains 1 month after the 
booster vaccination for the group combination 3+4 (60 µg bivalent rLP2086 recipients) 
and Group 5 (120 µg bivalent rLP2086 recipients).

Analysis set: Post–booster vaccination evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results: For each MenB test strain, the GMT and corresponding 2-sided 
95% CI for the GMT will be provided.
6.2.1.3. Sensitivity/Supplementary Analysis
If the mITT analysis is done for the primary analysis, then the same approach may need to be 
performed for the secondary analysis.
6.2.2. Local Reactions Within 7 Days
6.2.2.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after each primary vaccination for the 
following groups: Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP 
or SLP), Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and 
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Presence or absence of any local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.


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
Maximum severity of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after the booster vaccination for 
the group combination 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.

Presence or absence of any local reaction on “any day (Day 1-7)” after the booster 
vaccination.

Maximum severity of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.
6.2.2.2. Supplementary Analysis
As supplementary analyses to support the assessment of local reactions, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each local reaction after each primary vaccination for the following 
groups:

Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP or SLP),

Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP)
and booster vaccination for the group or group combination

Groups 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients).


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
Onset day of each local reaction after each primary and booster vaccination for the 
following groups:

Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP or SLP),

Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP)
and booster vaccination for the group or group combination

Groups 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients).
These continuous endpoints will be summarized by displaying n, mean, median, 
standard deviation, minimum, and maximum.
Figures:
Bar charts with the proportions of participants for any day (Day 1 through Day 7) will be 
plotted for each primary vaccination for the following groups:

Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP or SLP),

Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP)
and booster vaccination for the group or group combination

Group 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients),
with different patterns displayed in the bar charts for different maximum severity levels for 
any day.


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6.2.3. Systemic Events Within 7 Days
6.2.3.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted systemic events 
(fever, increased sleep, decreased appetite, and irritability) within 7 days after each 
primary vaccination for the following groups: Group 3 (60 µg bivalent rLP2086 + 
Nimenrix recipients with PLP or SLP), Group 4 (60 µg bivalent rLP2086 + Nimenrix 
recipients without PLP), and Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients 
with PLP).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after each 
primary vaccination and any primary vaccination.

Presence or absence of any systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Maximum severity of each systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted systemic events 
(fever, increased sleep, decreased appetite, and irritability) within 7 days after the booster 
vaccination for the group combination 3+4 (60 µg bivalent rLP2086 + Nimenrix 
recipients) and Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.


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
Presence or absence of any systemic event on “any day (Day 1-7)” after the booster 
vaccination.

Maximum severity of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.
6.2.3.2. Supplementary Analysis
As supplementary analyses to support the assessment of systemic events, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each systemic event after each primary vaccination for the following 
groups:

Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP or SLP),

Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP)
and booster vaccination for the group or group combination

Groups 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients).

Onset day of each systemic event after each primary vaccination for the following 
groups:

Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP),

Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP)
and booster vaccination for the group or group combination

Groups 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients).
These continuous endpoints will be summarized by displaying n, mean, median, 
standard deviation, minimum, and maximum.


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Figures:
Bar charts with the proportions of participants for each systemic event on each day (Day 1 
through Day 7) and any day (Day 1 through Day 7) will be plotted for each primary 
vaccination for the following groups:

Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP),

Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP)
and booster vaccination for the group or group combination

Groups 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and

Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients),
with different patterns displayed in the bar charts for different severity levels (each day) and 
different maximum severity levels for any day.
6.2.4. Use of Antipyretic Medications Within 7 Days
6.2.4.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted use of antipyretic
medication within 7 days after each primary vaccination for the following groups: 
Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP or SLP), 
Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and 
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after each primary vaccination
and any primary vaccination.


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For booster vaccination:

Planned analysis: The percentage of participants reporting prompted use of antipyretic
medication within 7 days after the booster vaccination for the group combination 3+4
(60 µg bivalent rLP2086 + Nimenrix recipients) and Group 5 (120 µg bivalent rLP2086 + 
Nimenrix recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after the booster vaccination.
6.2.4.2. Supplementary Analysis
As supplementary analyses to support the assessment of protocol-assigned paracetamol use, 
the following endpoints will be summarized with the same analysis time point and analysis 
population:

The percentage of participants reporting prompted use protocol-assigned 
paracetamol dosing compliance after each primary vaccination, which is calculated as 
(number of actual PLP doses / number of planned PLP doses) × 100 for the following 
groups: Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP) and 
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP).

The percentage of participants reporting prompted use protocol-assigned 
paracetamol dosing compliance per-protocol timing after each primary vaccination, 
which is calculated as (number of PLP doses within per-protocol timing window / 
number of planned PLP doses within per-protocol timing window) × 100 for the 
following groups: Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP) 
and Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP).
6.2.5. Serious Adverse Events, Medically Attended Events, and Newly Diagnosed 
Chronic Medical Conditions
For primary vaccinations:

Planned analysis: The numbers and percentages of participants with MAEs, SAEs, 
and NDCMCs for each of the analysis intervals defined in Table 9 will be summarized by 
the following groups: Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP 
or SLP), Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and 
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP) after each primary 
vaccination.


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
Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the events during the vaccination and follow-up 
phases, the n, %, and 95% CI may be presented for any event, for each SOC, and for each 
preferred term within each SOC.
For booster vaccination:

Planned analysis: The numbers and percentages of participants with MAEs, SAEs, and 
NDCMCs for each of the analysis intervals defined in Table 9 will be summarized by 
the group combination 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients) after the booster vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the events during the vaccination and follow-up 
phases, the n, %, and 95% CI may be presented for any event, for each SOC, and for each 
preferred term within each SOC.
6.2.6. Adverse Events
For primary vaccinations:

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4
and 7 defined in Table 9 will be summarized by the following groups: 
Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP or SLP), 
Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and 
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP) after each primary 
vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.


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For booster vaccination:

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4 
and 7 defined in Table 9 will be summarized by the group combination 3+4 (60 µg 
bivalent rLP2086 + Nimenrix recipients) and Group 5 (120 µg bivalent rLP2086 + 
Nimenrix recipients) after the booster vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.
6.2.7. Immediate Adverse Events
For primary vaccinations:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the first 2 analysis intervals defined in Table 10 by the 
following groups: Group 3 (60 µg bivalent rLP2086 + Nimenrix recipients with PLP 
or SLP), Group 4 (60 µg bivalent rLP2086 + Nimenrix recipients without PLP), and 
Group 5 (120 µg bivalent rLP2086 + Nimenrix recipients with PLP) after each primary 
vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.
For booster vaccination:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the first 2 analysis intervals defined in Table 10 by the group 
combination 3+4 (60 µg bivalent rLP2086 + Nimenrix recipients) and Group 5 (120 µg 
bivalent rLP2086 + Nimenrix recipients) after the booster vaccination.


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
Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.
Reporting results: For each group, the n, %, and 95% CI may be presented for any event, for 
each SOC, and for each preferred term within each SOC.
6.3. Tertiary/Exploratory Endpoints
6.3.1. hSBA Titer for Each of the MenA, MenC, MenW, and MenY Test Strains
6.3.1.1. Main Analysis
For the primary vaccinations:

Planned analysis:
1. hSBA GMTs for each MenA, MenC, MenW, and MenY test strain 1 month after
primary vaccination 2 for the following group combinations: Groups 7+11
(MenABCWY recipients) and Groups 8+10 (Nimenrix recipients).
2. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenA, MenC, 
MenW, and MenY test strain 1 month after primary vaccination 2 for the following 
group combination and groups: Groups 7+11 (MenABCWY recipients with SLP),
Group 8 (Nimenrix with PLP recipients), Group 11 (MenABCWY recipients with 
PLP), and Group 10 (Nimenrix recipients without PLP).
3. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenA, MenC, 
MenW, and MenY test strain 1 month after primary vaccination 2 for the following 
group combination: Groups 1+2 (MenABCWY recipients).
4. hSBA GMTs for each MenA, MenC, MenW, and MenY test strain 1 month after 
primary vaccination 2 for the following group combination: Groups 1+2 
(MenABCWY recipients).

Analysis set: Post–primary vaccination 2 evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results: For each strain, the GMT and corresponding 2-sided 95% CI for the 
GMT will be provided for 1 and 4 in the planned analysis (above) and the numerator (n) 
and denominator (N) used in the percentage calculation, the percentage (%), and the
corresponding 2-sided 95% CIs for the percentages will be provided for 2 and 3 in the 
planned analysis.


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For the booster vaccination:

Planned analysis:
1. hSBA GMTs for each MenA, MenC, MenW, and MenY test strain 1 month after the 
booster vaccination for the following group combinations: Groups 7+11 
(MenABCWY recipients) and Groups 8+10 (Nimenrix recipients).
2. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenA, MenC, 
MenW, and MenY test strain 1 month after the booster vaccination for the following 
group combination: Groups 1+2 (MenABCWY recipients).
3. hSBA GMTs for each MenA, MenC, MenW, and MenY test strain 1 month after the 
booster vaccination for the following group combination: Groups 1+2 (MenABCWY 
recipients).

Analysis set: Post–booster vaccination evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results: For each strain, the GMT and corresponding 2-sided 95% CI for the 
GMT will be provided for 1 and 3 in the planned analysis (above) and the numerator (n) 
and denominator (N) used in the percentage calculation, the percentage (%), and the 
corresponding 2-sided 95% CIs for the percentages will be provided for 2 in the planned 
analysis.
6.3.1.2. Sensitivity/Supplementary Analyses
If the mITT analysis is done for the primary analysis, then the same approach may need to be 
performed for the tertiary analysis.
6.3.2. hSBA Titer for Each of the MenB Test Strains
6.3.2.1. Main Analysis
For the primary vaccinations:

Planned analysis:
1. hSBA GMTs for each of the MenB test strains 1 month after primary vaccination 2 
for the following group combinations: Groups 7+11 (MenABCWY recipients) and 
Groups 8+10 (Bexsero recipients).


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2. Percentage of participants achieving an hSBA titer ≥LLOQ for each MenB test strain 
1 month after primary vaccination 2 for the following group combination and groups: 
Groups 7+11 (MenABCWY recipients with SLP), Group 8 (Nimenrix recipients 
with PLP), Group 11 (MenABCWY recipients with PLP), and Group 10 (Nimenrix 
recipients without PLP).
3. Percentage of participants achieving an hSBA titer ≥LLOQ for each of the MenB test 
strains 1 month after primary vaccination 2 for the following group combination: 
Groups 1+2 (MenABCWY recipients).
4. hSBA GMTs for each of the MenB test strains 1 month after primary vaccination 2 
for the following group combination: Groups 1+2 (MenABCWY recipients).

Analysis set: Post–primary vaccination 2 evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.

Reporting results: For each MenB test strain, the GMT and corresponding 2-sided 
95% CI for the GMT will be provided for 1 and 4 in the planned analysis (above) and the 
numerator (n) and denominator (N) used in the percentage calculation, the percentage 
(%), and the corresponding 2-sided 95% CIs for the percentages will be provided for 2
and 3 in the planned analysis.
For the booster vaccination:

Planned analysis:
1. hSBA GMTs for each of the MenB test strains 1 month after the booster vaccination 
for the following group combinations: Groups 7+11 (MenABCWY recipients) and 
Groups 8+10 (Bexsero recipients).
2. Percentage of participants achieving an hSBA titer ≥LLOQ for each of the MenB test 
strains 1 month after the booster vaccination for the following group combination: 
Groups 1+2 (MenABCWY recipients).
3. hSBA GMTs for each of the MenB test strains 1 month after the booster vaccination 
for the following group combination: Groups 1+2 (MenABCWY recipients).

Analysis set: Post–booster vaccination evaluable immunogenicity population.

Analysis methodology: Descriptive statistics.


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
Reporting results: For each MenB test strain, the GMT and corresponding 2-sided 
95% CI for the GMT will be provided for 1 and 3 in the planned analysis (above) and the 
numerator (n) and denominator (N) used in the percentage calculation, the percentage 
(%), and the corresponding 2-sided 95% CIs for the percentages will be provided for 2 in 
the planned analysis.
6.3.2.2. Sensitivity/Supplementary Analyses
If the mITT analysis is done for the primary analysis, then the same approach may need to be 
performed for the secondary analysis.
6.3.3. Local Reactions Within 7 Days
6.3.3.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after each primary vaccination for the 
following groups: Group 1 (MenABCWY recipients with PLP) and Group 2
(MenABCWY recipients without PLP).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Presence or absence of any local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Maximum severity of each local reaction on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted local reactions 
(redness, swelling, and tenderness) within 7 days after the booster vaccination for the 
following group combination: Groups 1+2 (MenABCWY recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.


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
Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.

Presence or absence of any local reaction on “any day (Day 1-7)” after the booster 
vaccination.

Maximum severity of each local reaction on “any day (Day 1-7)” after the booster 
vaccination.
6.3.3.2. Supplementary Analysis
As supplementary analyses to support the assessment of local reactions, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each local reaction after each primary vaccination for the following 
groups: Group 1 (MenABCWY recipients with PLP) and Group 2 (MenABCWY 
recipients without PLP); and booster vaccination for the following group combination: 
Groups 1+2 (MenABCWY recipients).

Onset day of each local reaction after each primary vaccination for the following groups: 
Group 1 (MenABCWY recipients with PLP) and Group 2 (MenABCWY recipients 
without PLP); and booster vaccination for the following group combination: 
Groups 1+2 (MenABCWY recipients).
These continuous endpoints will be summarized by displaying n, mean, median, 
standard deviation, minimum, and maximum.
Figures:
Bar charts with the proportions of participants for each local reaction on each day (Day 1 
through Day 7) and any day (Day 1 through Day 7) will be plotted for each primary 
vaccination for the following groups: Group 1 (MenABCWY recipients with PLP) and 
Group 2 (MenABCWY recipients without PLP); and booster vaccination for the following 
group combination: Groups 1+2 (MenABCWY recipients), with different patterns displayed 
in the bar charts for different severity levels (each day) and different maximum severity 
levels for any day.


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6.3.4. Systemic Events Within 7 Days
6.3.4.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted systemic events
(fever, increased sleep, decreased appetite, and irritability) within 7 days after each 
primary vaccination for the following groups: Group 1 (MenABCWY recipients
with PLP) and Group 2 (MenABCWY recipients without PLP).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after each 
primary vaccination and any primary vaccination.

Presence or absence of any systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.

Maximum severity of each systemic event on “any day (Day 1-7)” after each primary 
vaccination and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted systemic events
(fever, increased sleep, decreased appetite, and irritability) within 7 days after the booster 
vaccination for the following group combination: Groups 1+2 (MenABCWY recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variables:

Presence or absence of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.

Presence or absence of any systemic event on “any day (Day 1-7)” after the booster 
vaccination.


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
Maximum severity of each systemic event on “any day (Day 1-7)” after the booster 
vaccination.
6.3.4.2. Supplementary Analysis
As supplementary analyses to support the assessment of systemic events, the following 
endpoints will be summarized with the same analysis time point and analysis population:

Duration (days) of each systemic event after each primary vaccination for the following 
groups: Group 1 (MenABCWY recipients with PLP) and Group 2 (MenABCWY
recipients without PLP); and booster vaccination for the following group combination: 
Groups 1+2 (MenABCWY recipients).

Onset day of each systemic event after each primary vaccination for the following 
groups: Group 1 (MenABCWY recipients with PLP) and Group 2 (MenABCWY 
recipients without PLP); and booster vaccination for the following group combination: 
Groups 1+2 (MenABCWY recipients).
These continuous endpoints will be summarized by displaying n, mean, median, standard 
deviation, minimum, and maximum.
Figures:
Bar charts with the proportions of participants for each systemic event on each day (Day 1 
through Day 7) and any day (Day 1 through Day 7) will be plotted for each primary 
vaccination for the following groups: Group 1 (MenABCWY recipients with PLP) and 
Group 2 (MenABCWY recipients without PLP); and booster vaccination for the following 
group combination: Groups 1+2 (MenABCWY recipients), with different patterns displayed 
in the bar charts for different severity levels (each day) and different maximum severity 
levels for any day.
6.3.5. Use of Antipyretic Medications Within 7 Days
6.3.5.1. Main Analysis
For primary vaccinations:

Planned analysis: The percentage of participants reporting prompted use of antipyretic
medication within 7 days after each primary vaccination for the following groups: 
Group 1 (MenABCWY recipients with PLP) and Group 2 (MenABCWY recipients 
without PLP).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.


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
Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after each primary vaccination 
and any primary vaccination.
For booster vaccination:

Planned analysis: The percentage of participants reporting prompted use of antipyretic
medication within 7 days after the booster vaccination for the following group
combination: Groups 1+2 (MenABCWY recipients).

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, n, %, and 95% CI will be for the following variable:

Use of antipyretic medication on “any day (Day 1-7)” after the booster vaccination.
6.3.5.2. Supplementary Analysis
As supplementary analyses to support the assessment of protocol-assigned paracetamol use, 
the following endpoints will be summarized with the same analysis time point and analysis 
population:

The percentage of participants reporting prompted use protocol-assigned paracetamol
dosing compliance after each primary vaccination, which is calculated as (number of 
actual PLP doses / number of planned PLP doses) × 100 for the following group: 
Group 1 (MenABCWY recipients with PLP).

The percentage of participants reporting prompted use protocol-assigned paracetamol
dosing compliance per-protocol timing after each primary vaccination, which is 
calculated as (number of PLP doses within per-protocol timing window / number of 
planned PLP doses within per-protocol timing window) × 100 for the following group: 
Group 1 (MenABCWY recipients with PLP).
6.3.6. Serious Adverse Events, Medically Attended Events, and Newly Diagnosed 
Chronic Medical Conditions
For primary vaccinations:

Planned analysis: The numbers and percentages of participants with MAEs, SAEs, 
and NDCMCs for each of the analysis intervals defined in Table 9 will be 
summarized by the following groups: Group 1 (MenABCWY recipients with PLP) and 
Group 2 (MenABCWY recipients without PLP) after each primary vaccination.


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
Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the events during the vaccination and follow-up 
phases, the n, %, and 95% CI may be presented for any event, for each SOC, and for each 
preferred term within each SOC.
For booster vaccination:

Planned analysis: The numbers and percentages of participants with MAEs, SAEs, and 
NDCMCs for each of the analysis intervals defined in Table 9 will be summarized by the 
following group combination: Groups 1+2 (MenABCWY recipients) after the booster 
vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the events during the vaccination and follow-up 
phases, the n, %, and 95% CI may be presented for any event, for each SOC, and for each 
preferred term within each SOC.
6.3.7. Adverse Events
For primary vaccinations:

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4 
and 7 defined in Table 9 will be summarized by the following groups: Group 1 
(MenABCWY recipients with PLP) and Group 2 (MenABCWY recipients without PLP) 
after each primary vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.


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For booster vaccination:

Planned analysis: The numbers of participants with AEs for analysis intervals 1 through 4 
and 7 defined in Table 9 will be summarized by the following group combination: 
Groups 1+2 (MenABCWY recipients) after the booster vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.

Nonserious AEs are not required to be reported during the follow-up phase; however,
if nonserious AEs during the follow-up phase were recorded in the database 
(excluding MAEs and nonserious NDCMCs), these data may be listed separately.
6.3.8. Immediate Adverse Events
For primary vaccinations:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the first 2 analysis intervals defined in Table 10 by the 
following groups: Group 1 (MenABCWY recipients with PLP) and Group 2 
(MenABCWY recipients without PLP) after each primary vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.

Reporting results: For each group, the n, %, and 95% CI may be presented for any event, 
for each SOC, and for each preferred term within each SOC.
For booster vaccination:

Planned analysis: The number and percentage of participants reporting AEs occurring 
within the 30-minute observation period immediately after vaccination will be 
summarized according to the last analysis interval defined in Table 10 by the following 
group combination: Groups 1+2 (MenABCWY recipients) after the booster vaccination.

Analysis set: Safety. Refer to Section 4 for visit-specific populations.

Analysis methodology: Descriptive statistics.


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Reporting results: For each group, the n, %, and 95% CI may be presented for any event, for 
each SOC, and for each preferred term within each SOC.
6.4. Subset Analyses
Subgroup analyses may be performed on the primary and secondary immunogenicity 
and safety endpoints described in Section 6.1 and Section 6.2.  No subgroup analyses 
is planned for rare events (endpoints with less than 1% of participants in any group). 
Subgroups include sex, race, and geographic location. If a subgroup variable (eg, race) 
does not have more than 1 group with greater than 5% of participants in the group, the 
corresponding subset analyses may not be reported.
6.5. Baseline and Other Summaries and Analyses
6.5.1. Study Conduct and Participant Disposition
All participants in the mITT population will be included in the disposition summaries.  
Summaries will be displayed by vaccine group separately.
Disposition summaries include:

N and % of participants included in each study population (post–primary vaccination 2 
mITT, post–booster vaccination mITT, post–primary vaccination 2 evaluable 
immunogenicity, and post–booster vaccination evaluable immunogenicity)

N and % of participants receiving each primary vaccination and booster vaccination

N and % of participants completing the primary vaccination phase, primary follow-up 
phase, booster vaccination phase, and booster follow-up phase

N and % of participants who withdrew during the primary vaccination phase (Visit 1 to 
before Visit 4) and reason for withdrawal

N and % of participants who withdrew during the primary follow-up phase (Visit 4 to 
before Visit 5) and reason for withdrawal

N and % of participants who withdrew during the booster vaccination phase (Visit 5 to 
before Visit 6) and reason for withdrawal

N and % of participants who withdrew during the booster follow-up phase (Visit 6 to 
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For each blood draw, the number and percentage of participants randomized, primary 
vaccinated at each visit (Visits 1, 3), booster vaccinated at Visit 5, and providing blood 
samples within the protocol-specified time frame, as well as before and after the specified 
time frame, will be tabulated by randomized vaccine group and total population.
Participant data listings for participants who are included and excluded from each of the 
analysis populations and reason for exclusion may be provided by randomized vaccination 
group.  A listing of protocol deviations may also be provided.
6.5.2. Study Intervention Exposure
Study vaccination data, temporary delays and reasons for vaccination delays, and 
noncompliant vaccine administration and reasons may be listed by vaccine group according 
to vaccine as administered.  Participants not receiving vaccination as randomized, or 
randomized to the wrong group, may be listed by vaccine group as randomized.
6.5.3. Demographic, Medical History, and Baseline Characteristics
The safety population will be used to generate these tables.  All summaries will be presented 
for each vaccine group separately and for the total population.
Variables defined in Section 3.4.1 will be reported according to Pfizer’s standard summary 
reporting.
Medical history and baseline physical examination will descriptively summarized.
6.5.4. E-Diary Completion
E-diary compliance as defined in Section 3.4.3 will be summarized for each dose (primary 
vaccination 1, primary vaccination 2, and booster vaccination) by vaccine group and total 
compliance using descriptive statistics.  The safety population will be used to generate the 
summary reports.  The denominator for the e-diary compliance rates will be the total number 
of participants who received the specific vaccination.
6.5.5. Concomitant Medications and Nondrug Treatments
Nonstudy vaccines and concomitant medications captured throughout the study will be 
categorized according to the WHODD and will be descriptively summarized for participants
in the safety population.
Antipyretic and other pain medication reported the day prior to vaccine administration will 
be summarized separately from the concomitant medications and for each vaccination 
separately.


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6.6. Safety Summaries and Analyses
All safety data will be summarized according to the vaccine received.  The safety population 
will be used for the analysis.
6.6.1. Adverse Events
It should be recognized that most studies are not designed to reliably demonstrate a causal 
relationship between the use of a pharmaceutical product and an AE or a group of AEs.  
Except for select events in unique situations, studies do not employ formal adjudication 
procedures for the purpose of event classification.
6.6.1.1. Related Events
AEs and SAEs deemed by the investigator to be related to study intervention will be 
summarized separately.  The denominator for the percentages will be the safety population.
The number and percentage of participants reporting at least 1 related AE or SAE and the 
total number of related events may be summarized by SOC and preferred term.  Associated 
95% exact CIs will also be displayed.
6.6.1.2. Severe Events
AEs deemed severe by the investigator may be summarized separately.  The denominator for 
the percentages will be the safety population. The number and percentage of participants
reporting at least 1 severe AE and the total number of severe events will be reported and will 
be summarized by SOC and preferred term.  Associated 95% exact CIs will also be 
displayed.
6.6.1.3. Neuroinflammatory and Autoimmune Conditions
A list of preferred terms to include all of the neuroinflammatory and autoimmune conditions 
will be provided by the medical monitor prior to database lock. These events can be SAEs or 
AEs.
6.6.1.4. AEs Leading to Study Withdrawal
Any AEs leading to withdrawal from the study may be included in a participant data listing.
6.6.1.5. Death
Any death data will be included in a participant data listing.
6.6.2. Reactogenicity Data
Local reactions and systemic events will be summarized according to Section 6.1.1.3 and
Section 6.1.1.4.


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6.6.3. Physical Examination
Descriptive summaries (counts and percentages) and listings based on the safety population 
may be provided.
7. INTERIM ANALYSES
7.1. Introduction
No interim analysis is planned in this study. The following statistical analyses will be carried 
out when the data for the specified analyses are available:

Analysis 1: conducted after Group 5, 8, and 10 participants have completed Visit 4, 
1 month after primary vaccination 2.  This analysis will include immunogenicity data 
from Groups 5, 8, and 10 up to 1 month after Vaccination 2, and all safety data available 
at that time, which, at a minimum, will include safety data from all sentinel-cohort groups 
(Groups 1-5, 7, 8, and 10).  An equivalent analysis may be conducted after Group 5, 8, 
and 10 participants have completed Visit 6, 1 month after the booster vaccination.

Analysis 2: safety and immunogenicity data through 1 month after primary vaccination 2 
from participants in the open-label stages;

Analysis 3: safety and immunogenicity data through 1 month after booster vaccination 
from participants in the open-label phase;

Analysis 4: a final analysis will be done after all the available data have been collected.
As the open-label stage is unblinded, the sponsor may conduct unblinded review of the safety 
and immunogenicity data from this phase at any time during the course of the study.
7.2. Interim Analyses and Summaries
This study will use an IRC and an EDMC.  The IRC is independent of the study team and 
includes only internal members, and the EDMC includes only external members.  The 
IRC/EDMC charter describes the role of the IRC/EDMC in more detail.
A Pfizer IRC will review and evaluate post–primary vaccination 1 safety data of each cohort 
in the sentinel-cohort stage and control the study enrollment and progression. The EDMC 
will be informed of the IRC’s determinations.  Enrollment and vaccination may proceed at 
the discretion of the IRC.  The IRC will also review safety data after all expanded-enrollment 
stage participants have completed primary vaccination 2.


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The EDMC will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter. The recommendations made by the EDMC to alter the 
conduct of the study will be forwarded to the appropriate Pfizer personnel for final decision.  
Pfizer will forward such decisions, which may include summaries of aggregate analyses of 
safety data, to regulatory authorities, as appropriate.
8. REFERENCES
1.
Agresti A. Exact small-sample inference. Chapter 1. In: Categorical data analysis. 
2nd ed. Hoboken, NJ: John Wiley & Sons; 2002:18-20.
2.
Li X, Wang WWB, Liu GF, et al. Handling missing data in vaccine clinical trials for 
immunogenicity and safety evaluation. J Biopharm Stat. 2011; 21(2): 294-310.


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9. APPENDICES
Appendix 1. List of Abbreviations
Abbreviation
Term
AE
adverse event
bivalent rLP2086
bivalent recombinant lipoprotein 2086 vaccine
CI
confidence interval
COVID-19
coronavirus disease 2019
CRF
case report form
DMC
data monitoring committee
e-diary
electronic diary
EDMC
external data monitoring committee 
GMT
geometric mean titer
hSBA
serum bactericidal assay using human complement 
ICD
informed consent document
IRC
internal review committee
IRT
interactive response technology
ITT
intent-to-treat
LLOQ
lower limit of quantitation
MAE
medically attended adverse event
MedDRA
Medical Dictionary for Regulatory Activities
MenA
Neisseria meningitidis group A
MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
MenACWY
Neisseria meningitidis group A, C, W, and Y
MenB
Neisseria meningitidis group B
MenC
Neisseria meningitidis group C
MenW
Neisseria meningitidis group W
MenY
Neisseria meningitidis group Y
mITT
modified intent-to-treat
N/A
not applicable
NDCMC
newly diagnosed chronic medical condition
PLP
prophylactic liquid paracetamol
PRP-OMP
polyribosylribitol phosphate oligosaccharide of Haemophilus influenzae
type b conjugated to outer membrane protein
QNS
quantity not sufficient
RCDC
reverse cumulative distribution curve
rLP2086
recombinant lipoprotein 2086
SAE
serious adverse event
SAP
statistical analysis plan
SLP
scheduled liquid paracetamol
SOC
system organ class


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Abbreviation
Term
SOP
standard operating procedure
TBD
to be determined
TLP
therapeutic liquid paracetamol
WHODD
World Health Organization Drug Dictionary