A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
Phase: PHASE3
Conditions: Meningococcal Vaccine
Sponsor: Pfizer

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED 
TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY
OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
Investigational Product Number:
PF-06886992
Investigational Product Name:
Neisseria meningitidis Group A, B, C, W, 
and Y Vaccine (MenABCWY)
United States (US) Investigational New 
Drug (IND) Number:
European Clinical Trials Database 
(EudraCT) Number:
2019-004313-13
Protocol Number:
C3511001
Phase:
3
Short Title
Phase 3 MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years 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 C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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Protocol Amendment Summary of Changes Table
Document History
Document
Version Date
Summary of Changes and Rationale
Amendment 2
13 June 2022
Protocol Sections 1.1, 3, and 9.4.1: Moved 
MenB secondary strain immunogenicity 
objective from Secondary Immunogenicity 
Objectives to Tertiary/Exploratory 
Objectives.
Protocol Sections 5.2.1.1, 6.5.1, and 6.5.2: 
Made allowance for coronavirus disease 
2019 (COVID-19) vaccinations within 
8 days of study vaccination instead of 
14 days (per the protocol administrative
change letter [PACL] dated 01 July 2021).
Protocol Section 8.1.1.2: Removal of the 
text related to secondary strain testing.
Amendment 1
30 April 2021
Protocol Sections 1.2, 1.3, 4.1, 8, 8.1.1, and 
8.10.1.4: Added an optional increase in the 
volume of the blood draws at Visit 4 for the 
immunogenicity subset from 25 to 50 mL,
to support assay development. The volume 
of blood drawn will depend on the consent
obtained.
Throughout the protocol: The term “CT 
SAE Report Form” has been replaced with 
“Vaccine SAE Reporting Form,” as per the 
PACL dated 08 May 2020.
Protocol Section 10.4.3, Woman of 
Childbearing Potential (WOCBP): The 
definition of postmenopausal state has been 
amended, as per the PACL dated 
08 October 2020.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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Document History
Document
Version Date
Summary of Changes and Rationale
Protocol Section 4.1, Overall Design, and 
protocol summary: Administrative 
clarification:

Estimated that an 80%/20% ratio of 
US/EU participants is a target 
relevant to the immunogenicity 
subset and the overall study, and not 
specific to the safety subset. 

Immunogenicity and safety groups 
contribute to the safety data set.
Protocol Sections 1.2, 4.1 and 9.2.1,: 
Clarification that the sponsor may decide to 
proceed with less than full enrollment if an 
assessment of power shows that it is 
sufficient to meet the primary 
immunogenicity objectives and that this 
assessment will be done in a completely 
blinded fashion before any participants are  
unblinded or the immunogenicity data are
accessed.
Protocol Section 10.4.1: Text updated to 
comply with mandatory protocol template 
text (“Must agree to use a male condom 
when engaging in any activity that allows 
for passage of ejaculate to another 
person.”).
Original protocol
12 December 2019
Not applicable 
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs and any protocol administrative 
clarification letter.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................9
1. PROTOCOL SUMMARY...................................................................................................10
1.1. Synopsis ..................................................................................................................10
1.2. Schema ....................................................................................................................17
1.3. Schedule of Activities (SoA)...................................................................................18
2. INTRODUCTION ...............................................................................................................20
2.1. Study Rationale .......................................................................................................20
2.2. Background .............................................................................................................21
2.2.1. Background of the Disease and Medical Need...........................................21
2.2.2. Prior Clinical Experience............................................................................22
2.2.2.1. Trumenba ..................................................................................22
2.2.2.2. Nimenrix (MenACWY-TT) ......................................................23
2.2.2.3. Pentavalent Meningococcal Vaccine (MenABCWY)...............23
2.3. Benefit/Risk Assessment.........................................................................................25
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS ...........................................................27
4. STUDY DESIGN.................................................................................................................33
4.1. Overall Design.........................................................................................................33
4.1.1. Approximate Duration of Participation for Each Participant .....................34
4.1.2. Approximate Number of Participants.........................................................34
4.2. Scientific Rationale for Study Design.....................................................................34
4.3. Justification for Dose ..............................................................................................35
4.4. End of Study Definition ..........................................................................................35
5. STUDY POPULATION......................................................................................................36
5.1. Inclusion Criteria.....................................................................................................36
5.2. Exclusion Criteria....................................................................................................37
5.2.1. Temporary Delay Criteria...........................................................................38
5.2.1.1. Criteria for Temporarily Delaying Vaccine 
Administration...................................................................................38
5.2.1.2. Criteria for Temporarily Delaying Immunogenicity Blood 
Draw ..................................................................................................39
5.3. Lifestyle Considerations..........................................................................................39
5.3.1. Contraception..............................................................................................39

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
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5.4. Screen Failures ........................................................................................................39
6. STUDY INTERVENTION..................................................................................................40
6.1. Study Intervention(s) Administered........................................................................40
6.1.1. Administration............................................................................................41
6.1.2. Medical Devices .........................................................................................42
6.2. Preparation/Handling/Storage/Accountability ........................................................42
6.2.1. Preparation and Dispensing........................................................................44
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................44
6.3.1. Allocation to Investigational Product .........................................................44
6.3.2. Blinding of Site Personnel..........................................................................44
6.3.3. Blinding of the Sponsor..............................................................................45
6.3.4. Breaking the Blind......................................................................................45
6.4. Study Intervention Compliance...............................................................................45
6.5. Concomitant Therapy..............................................................................................45
6.5.1. Prohibited During the Study.......................................................................45
6.5.2. Permitted During the Study ........................................................................46
6.5.3. Prior Vaccinations and Treatments.............................................................47
6.5.4. Prohibited Prior Treatments........................................................................47
6.6. Dose Modification...................................................................................................47
6.7. Intervention After the End of the Study..................................................................47
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................47
7.1. Discontinuation of Study Intervention ....................................................................47
7.2. Participant Discontinuation/Withdrawal From the Study.......................................47
7.3. Lost to Follow-up....................................................................................................48
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................49
8.1. Efficacy Assessments..............................................................................................50
8.1.1. Immunogenicity Assessments ....................................................................50
8.1.1.1. MenA, MenC, MenW, and MenY Serum Bactericidal 
Assays................................................................................................50
8.1.1.2. MenB Serum Bactericidal Assays.............................................50
8.1.2. Biological Samples.....................................................................................51
8.2. Safety Assessments .................................................................................................51

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Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
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8.2.1. Electronic Diary..........................................................................................53
8.2.1.1. Local Reactions.........................................................................53
8.2.1.2. Systemic Events ........................................................................54
8.2.2. Pregnancy Testing ......................................................................................55
8.3. Adverse Events and Serious Adverse Events..........................................................55
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......56
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................56
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................57
8.3.2. Method of Detecting AEs and SAEs ..........................................................57
8.3.3. Follow-up of AEs and SAEs.......................................................................57
8.3.4. Regulatory Reporting Requirements for SAEs...........................................57
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ..........................................................................................................58
8.3.5.1. Exposure During Pregnancy......................................................58
8.3.5.2. Exposure During Breastfeeding ................................................58
8.3.5.3. Occupational Exposure .............................................................58
8.3.6. Medical Device Incidents (Including Malfunctions)..................................58
8.3.6.1. Time Period for Detecting Medical Device Incidents...............59
8.3.6.2. Follow-up of Medical Device Incidents....................................59
8.3.6.3. Prompt Reporting of Medical Device Incidents to Sponsor .....59
8.3.6.4. Regulatory Reporting Requirements for Medical Device 
Incidents ............................................................................................59
8.3.7. Medication Errors .......................................................................................60
8.4. Treatment of Overdose............................................................................................61
8.5. Pharmacokinetics ....................................................................................................61
8.6. Pharmacodynamics..................................................................................................61
8.7. Genetics...................................................................................................................61
8.8. Biomarkers ..............................................................................................................61
8.9. Health Economics ...................................................................................................61
8.10. Study Procedures...................................................................................................61
8.10.1. Group 1-4 Participants - Immunogenicity Subset ....................................61
8.10.1.1. Visit 1 (Day 1): Vaccination 1 ................................................61

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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8.10.1.2. Visit 2 (28 to 42 Days After Visit 1), Post–Vaccination 1 
Blood Draw .......................................................................................64
8.10.1.3. Visit 3 (173 to 194 Days After Visit 1): Vaccination 2 ..........65
8.10.1.4. Visit 4 (28 to 42 Days After Visit 3), Post–Vaccination 2 
Blood Draw .......................................................................................67
8.10.1.5. Visit 5 (168 to 196 Days After Last Vaccination), 
Telephone Contact.............................................................................68
8.10.2. Group 5-8 Participants - Safety Subset.....................................................69
8.10.2.1. Visit 1 (Day 1): Vaccination 1 ................................................69
8.10.2.2. Visit 2 (28 to 42 Days After Visit 1), Post–Vaccination 1 
Telephone Contact.............................................................................72
8.10.2.3. Visit 3 (173 to 194 Days After Visit 1): Vaccination 2 ..........73
8.10.2.4. Visit 4 (28 to 42 Days After Visit 3), Post–Vaccination 2 
Telephone Contact.............................................................................75
8.10.2.5. Visit 5 (168 to 196 Days After Last Vaccination), 
Telephone Contact.............................................................................76
8.11. Unscheduled Visits................................................................................................77
9. STATISTICAL CONSIDERATIONS ................................................................................77
9.1. Estimands and Statistical Hypotheses.....................................................................77
9.1.1. Estimands....................................................................................................77
9.1.2. Statistical Hypotheses.................................................................................78
9.1.3. Multiplicity Considerations ........................................................................79
9.2. Sample Size Determination.....................................................................................79
9.2.1. Immunogenicity Subset (Groups 1-4) ........................................................79
9.2.2. Additional Participants for Safety Analysis (Groups 5-8)..........................83
9.3. Populations for Analysis .........................................................................................83
9.4. Statistical Analyses .................................................................................................84
9.4.1. Immunogenicity Analyses ..........................................................................85
9.4.2. Safety Analyses ..........................................................................................87
9.5. Interim Analyses .....................................................................................................88
9.5.1. Data Monitoring Committee.......................................................................88
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................89
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............89

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
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10.1.1. Regulatory and Ethical Considerations ....................................................89
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................89
10.1.2. Financial Disclosure .................................................................................90
10.1.3. Informed Consent Process ........................................................................90
10.1.4. Data Protection .........................................................................................91
10.1.5. Dissemination of Clinical Study Data ......................................................91
10.1.6. Data Quality Assurance ............................................................................92
10.1.7. Source Documents....................................................................................94
10.1.8. Study and Site Closure..............................................................................94
10.1.9. Publication Policy.....................................................................................95
10.1.10. Sponsor’s Qualified Medical Personnel .................................................95
10.2. Appendix 2: Clinical Laboratory Tests .................................................................96
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ......................................................................96
10.3.1. Definition of AE .......................................................................................96
10.3.2. Definition of an NDCMC.........................................................................97
10.3.3. Definition of SAE.....................................................................................97
10.3.4. Recording/Reporting and Follow-up of AEs and/or SAEs.......................98
10.3.5. Reporting of SAEs..................................................................................100
10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information..............................................................................................................101
10.4.1. Male Participant Reproductive Inclusion Criteria..................................101
10.4.2. Female Participant Reproductive Inclusion Criteria...............................101
10.4.3. Woman of Childbearing Potential (WOCBP) ........................................101
10.4.4. Contraception Methods...........................................................................102
10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments ......106
10.6. Appendix 6: Medical Device Incidents: Definition and Procedures for 
Recording, Evaluating, Follow-up, and Reporting..................................................108
10.7. Appendix 7: Abbreviations .................................................................................110
11. REFERENCES ................................................................................................................113

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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LIST OF TABLES
Table 1.
Study Design.............................................................................................34
Table 2.
Investigational Product Administration Schedule ....................................42
Table 3.
Grading of Redness and Swelling.............................................................54
Table 4.
Grading of Pain.........................................................................................54
Table 5.
Severity Scale for Fever............................................................................54
Table 6.
Grading of Other Systemic Events ...........................................................55
Table 7.
Power Analysis for First Primary Immunogenicity Objective 
(ACWY-Naïve Participants).....................................................................81
Table 8.
Power Analysis for First Primary Immunogenicity Objective 
(ACWY-Experienced Participants) ..........................................................81
Table 9.
Power Analysis for Second Primary Immunogenicity Objective.............82
Table 10.
Probabilities of Detecting AEs at Specified Incidences ...........................83

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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1. PROTOCOL SUMMARY 
1.1. Synopsis
In Study B1971057, a first-in-human (FIH) and proof-of-concept (POC) study for 
Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY), 543 participants 
received MenABCWY on a 0-month and 6-month schedule.  Results from B1971057 
indicated MenABCWY is well tolerated with an acceptable safety profile, and also provides 
a high degree of protective immune responses among both meningococcal group A, C, W, 
and Y (ACWY)-naïve and ACWY-experienced participants without interference among all 
5 serogroup components.
The aim of this Phase 3 study is to determine the immunologic noninferiority of 
MenABCWY, an investigational pentavalent (serogroups A, B, C, W, Y) meningococcal 
vaccine, to licensed vaccines Trumenba® (serogroup B; bivalent recombinant 
lipoprotein 2086 vaccine [bivalent rLP2086]) and Menveo (meningococcal groups A, C, 
Y, and W-135 oligosaccharide diphtheria conjugate vaccine [MenACWY-CRM]) by 
assessing the safety and immunogenicity of MenABCWY and the comparators in healthy 
participants ≥10 to <26 years of age who have (ACWY-experienced) and have not 
(ACWY-naïve) previously received a conjugated ACWY quadrivalent meningococcal 
vaccine.
Data obtained from prior studies supporting the licensure of the 2 vaccines comprising 
MenABCWY, meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid 
conjugate vaccine (MenACWY-TT; Nimenrix®) and Trumenba, support a favorable 
benefit-risk assessment for continued study of MenABCWY.
Objectives, Estimands, and Endpoints
Randomization group descriptions are shown in Section 1.2.
Objectives
Estimands
Endpoints
Primary Immunogenicity:
Primary Immunogenicity:
Primary Immunogenicity:
To demonstrate that the immune 
response for N meningitidis
group A (MenA), N meningitidis
group C (MenC), N meningitidis
group W (MenW), and 
N meningitidis group Y (MenY)
induced by 2 doses of 
MenABCWY is noninferior to 
the immune response induced by 
1 dose of MenACWY-CRM in 
both ACWY-naïve and 
ACWY-experienced 
participants, separately.
In ACWY-naïve participants receiving at 
least 1 dose (Group 2) of MenACWY-CRM 
or 2 doses (Group 1) of MenABCWY and 
who are in compliance with the key 
protocol criteria (evaluable participants):

Difference in the percentage of 
seroresponders, defined as participants 
achieving at least a 4-fold rise in serum 
bactericidal assay using human 
complement (hSBA) titer from baseline 
for each ACWY test strain, 1 month 
after Vaccination 2 in Group 1 
compared to 1 month after 
Vaccination 1 in Group 2.
hSBA titer for each of the 
ACWY test strains.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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Objectives
Estimands
Endpoints

For participants with a baseline 
hSBA titer below the limit of 
detection (LOD; or an hSBA titer 
of 1:4), a 4-fold response is 
defined as an hSBA titer of ≥1:16.

For participants with a baseline 
hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and lower limit of 
quantitation (LLOQ) (ie, hSBA
titer of 1:8), a 4-fold response is 
defined as an hSBA titer of 
≥4 times LLOQ.  

For participants with a baseline 
hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA 
titer of ≥4 times the baseline titer.
In ACWY-experienced participants 
receiving at least 1 dose (Group 4) of 
MenACWY-CRM or 2 doses (Group 3) of 
MenABCWY and who are in compliance 
with the key protocol criteria (evaluable 
participants):

Difference in the percentage of 
seroresponders, defined as participants 
achieving at least a 4-fold rise in hSBA 
titer from baseline for each ACWY test 
strain, 1 month after Vaccination 2 in 
Group 3 compared to 1 month after 
Vaccination 1 in Group 4.  

For participants with a baseline 
hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold 
response is defined as an hSBA 
titer of ≥1:16.

For participants with a baseline 
hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ 
(ie, hSBA titer of 1:8), a 4-fold 
response is defined as an hSBA 
titer of ≥4 times LLOQ.

For participants with a baseline
hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA 
titer of ≥4 times the baseline titer.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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Objectives
Estimands
Endpoints
To demonstrate that the immune 
response induced by 2 doses of 
MenABCWY is noninferior to 
the immune response induced by 
2 doses of Trumenba.
In participants receiving at least 2 doses of 
investigational product and who are in 
compliance with the key protocol criteria 
(evaluable participants):
Differences in the percentage of
participants achieving an hSBA 
titer ≥LLOQ (1:16 for strain A22 and 
1:8 for strains A56, B24, and B44) for all 
4 primary MenB test strains combined 
(composite response), in Groups 1 and 3 
combined compared to Groups 2 and 4 
combined, at 1 month after 
Vaccination 2. 
Difference in the percentage of 
participants achieving at least a 4-fold 
rise in hSBA titer from baseline for each
of the 4 primary MenB test strains, in 
Groups 1 and 3 combined compared to 
Groups 2 and 4 combined, at 1 month 
after Vaccination 2.

For participants with a baseline 
hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold 
response is defined as an hSBA titer 
of ≥1:16.

For participants with a baseline 
hSBA titer of ≥LOD (ie, hSBA titer 
of ≥1:4) and LLOQ, a 4-fold 
response is defined as an hSBA titer 
of ≥4 times the LLOQ.

For participants with a baseline 
hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA titer 
of ≥4 times the baseline titer.
hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and 
B44).
Primary Safety:
Primary Safety:
Primary Safety:
To describe the safety profile of 
MenABCWY, as measured by 
local reactions, systemic events, 
adverse events (AEs), serious 
adverse events (SAEs), newly 
diagnosed chronic medical 
conditions (NDCMCs), 
medically attended AEs (MAEs), 
and immediate AEs.
In participants receiving at least 1 dose of 
investigational product, expressed in 
MenABCWY groups (Groups 1, 3, 5, and 7 
combined) and Trumenba groups 
(Groups 2, 4, 6, and 8 combined):
The percentage of participants reporting 
local reactions, systemic events, and use 
of antipyretic medication within 7 days 
after each vaccination.
Local reactions (pain, 
redness, and 
swelling).
Systemic events 
(fever, vomiting, 
diarrhea, headache, 
fatigue, chills, muscle 
pain other than 
muscle pain at any 
injection site, and 
joint pain). 
Use of antipyretic 
medication.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
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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:
o
30 Days after each vaccination.
o
30 Days after any vaccination.
o
During the vaccination phase 
(from the first study vaccination 
[Visit 1] through 1 month after the 
second study vaccination 
[Visit 4]).
o
During the follow-up phase 
(from 1 month after the second 
study vaccination [Visit 4] 
through 6 months after the second 
study vaccination [Visit 5]).
o
Throughout the study (from the 
first study vaccination [Visit 1] 
through 6 months after the second 
study vaccination [Visit 5]).
The percentage of participants reporting 
at least 1 AE during the following time 
periods:
o
30 Days after each vaccination.
o
30 Days after any vaccination.
o
During the vaccination phase 
(from the first study vaccination 
[Visit 1] through 1 month after the 
second study vaccination 
[Visit 4]).
The percentage of participants reporting 
at least 1 immediate AE.
The percentage of participants who 
missed days of school or work because 
of AEs.
AEs, SAEs, MAEs, 
NDCMCs, and 
immediate AEs.
Days missing from 
school or work 
because of AEs.
Secondary 
Immunogenicity:
Secondary 
Immunogenicity:
Secondary 
Immunogenicity:
To demonstrate that the immune 
response for MenA, MenC, 
MenW, and MenY induced by 
1 dose of MenABCWY is 
noninferior to the immune 
response induced by 1 dose of 
MenACWY-CRM, in both 
ACWY-naïve and 
ACWY-experienced 
participants, separately.
In ACWY-naïve participants receiving at 
least 1 dose of investigational product and 
who are in compliance with the key 
protocol criteria (evaluable participants):
Difference in the percentage of 
seroresponders, defined as participants 
achieving at least a 4-fold rise in hSBA 
titer from baseline for each ACWY test 
strain, 1 month after Vaccination 1 in 
Group 1 compared to Group 2.
hSBA titer for each of the 
ACWY test strains.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511001
Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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Objectives
Estimands
Endpoints

For participants with a baseline 
hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold 
response is defined as an hSBA 
titer of ≥1:16.

For participants with a baseline 
hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ (ie, 
hSBA titer of 1:8), a 4-fold 
response is defined as an hSBA 
titer of ≥4 times LLOQ.

For participants with a baseline 
hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA 
titer of ≥4 times the baseline titer.
In ACWY-experienced participants 
receiving at least 1 dose of investigational 
product and who are in compliance with the 
key protocol criteria (evaluable 
participants):
Difference in the percentage of 
seroresponders, defined as participants 
achieving at least a 4-fold rise in hSBA 
titer from baseline for each ACWY test 
strain, 1 month after Vaccination 1 in 
Group 3 compared to Group 4.  

For participants with a baseline 
hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold 
response is defined as an hSBA 
titer of ≥1:16.

For participants with a baseline 
hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ 
(ie, hSBA titer of 1:8), a 4-fold 
response is defined as an hSBA 
titer of ≥4 times LLOQ.

For participants with a baseline 
hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA 
titer of ≥4 times the baseline titer.

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Overall Design
This is a Phase 3, randomized, active-controlled, observer-blinded multicenter trial in 
which approximately 2413 participants ≥10 to <26 years of age will be randomly assigned 
to receive either MenABCWY and saline, or Trumenba and MenACWY-CRM, as 
shown in Section 1.2.  The study will include evaluation of both ACWY-naïve and 
ACWY-experienced individuals.  All participants will be naïve to any meningococcal group 
B vaccine prior to enrollment.
Participants in Groups 1 through 4 will be considered an immunogenicity subset, and will 
contribute to both the safety and immunogenicity analyses; these participants will have blood 
drawn prior to Vaccination 1 and 1 month after Vaccinations 1 and 2.  Participants in 
Groups 5 through 8 will be considered a safety subset and will contribute to the safety 
analysis only, and will not have blood drawn for immunogenicity evaluations.
Randomization will be stratified by prior vaccination history.  Overall, approximately 
1225 ACWY-naïve and 1188 ACWY-experienced participants (having received 1 dose of 
Menactra or Menveo ≥4 years prior to the date of randomization) will be enrolled.  Of these
total participants, up to 675 ACWY-naïve and 1013 ACWY-experienced participants will 
contribute to the immunogenicity subset.
Participants enrolled in the immunogenicity subset will contribute to both immunogenicity 
and safety evaluations. Additionally, participants will be enrolled in a safety subset that will 
contribute exclusively to the safety evaluation. Numbers enrolled in the safety subset will 
therefore be based on numbers needed to achieve an overall number of enrolled participants,
all of whom will contribute to the safety evaluation. Numbers stated in the protocol to be 
enrolled by group across immunogenicity and safety subsets (Section 1.2 and Table 1) are 
estimates only. 
Additionally, randomization will be stratified by geographic region.  The overall participant 
distribution by region will be approximately 80% from the US and approximately 20% from 
other regions. Among the participants in the immunogenicity subset, approximately 80% 
will be enrolled in US investigative sites, and approximately 20% will be enrolled in other 
regions.  Regional or safety/immunogenicity group enrollment shifts may be necessary based 
on the availability of participants with specific characteristics (age group or ACWY 
experience) in a given location based on local immunization practices. However, these 
minor shifts from the originally targeted numbers will not deviate from original targets to a 
degree that will impact the overall study design or endpoint assessments of the study.
Enrollment targets will also be adjusted to achieve appropriate representation by age group 
(participants 10 to <18 years old and participants 18 to <26 years old) within each subset, and 
ACWY strata within each subset. 
Approximately 2413 participants will be enrolled, and each participant will participate in the 
study for approximately 12 months.

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Statistical Methods
The first primary objective is designed to assess if the immune response induced by 2 doses 
of MenABCWY is noninferior to the immune response induced by 1 dose of 
MenACWY-CRM, for ACWY-naïve and for ACWY-experienced participants separately. 
This will be assessed as the difference in the percentage of seroresponders, defined as 
participants achieving at least a 4-fold rise in hSBA titer from baseline for each ACWY test 
strain, 1 month after Vaccination 2 in Groups 1 and 3 separately (MenABCWY groups) 
compared to 1 month after Vaccination 1 in Groups 2 and 4 separately (MenACWY-CRM 
groups) using a noninferiority criterion of -10%. The first secondary immunogenicity 
objective is also designed to assess the noninferiority in MenA, MenC, MenW, and MenY 
responses in the MenABWCY groups compared to the MenACWY-CRM groups, using the 
same criterion; this comparison will be made 1 month after Vaccination 1 in Groups 1 and 3 
separately (MenABCWY groups) compared to Groups 2 and 4 separately (MenACWY-CRM 
groups).
The second primary objective is designed to assess if the immune response for MenB 
induced by 2 doses of MenABCWY is noninferior to the immune response induced by 
2 doses of Trumenba. This will be assessed using:
1. the differences in the percentage of participants achieving an hSBA titer ≥ LLOQ 
(1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all 4 primary MenB test 
strains combined (composite response), in the MenABCWY groups compared to the 
Trumenba groups, at 1 month after Vaccination 2, and 
2. the difference in the percentage of participants achieving at least a 4-fold rise in hSBA
titer from baseline for each of the 4 primary MenB test strains, in the MenABCWY 
groups compared to the Trumenba groups, 1 month after Vaccination 2, using a 
noninferiority criterion of -10%. The second primary objective will be met if the 
noninferiority criterion is met for all these MenB endpoints.
The primary safety objective will be assessed by descriptive summaries of local reactions, 
systemic events, use of antipyretic medication, AEs, SAEs, NDCMCs, MAEs, and 
immediate AEs in the MenABCWY and Trumenba groups as described in Section 9.

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1.2. Schema
Vaccination 1
Follow-up
Visit 1a
Vaccination 2
Follow-up
Visit 2a
Telephone 
Contact
Approximate 
Month
0
1
6
7
12
Visit Number
1
2
3
4
5
ACWY-naïve 
participants
Group 1 (n=450)
MenABCWY +
saline
MenABCWY
Group 2 (n=225)
Trumenba +
MenACWY-CRM
Trumenba
ACWY-
experienced 
participants
Group 3  (n=675)
MenABCWY +
saline
MenABCWY
Group 4 (n=338)
Trumenba +
MenACWY-CRM
Trumenba
Blood draw
(Groups 1-4 only)
25 mL
25 mL
25 mL or 
50 mL
ACWY-naïve 
participants
Group 5 (n=500)
MenABCWY +
saline
MenABCWY
Group 6
(n=50)
Trumenba +
MenACWY-CRM
Trumenba
ACWY-
experienced 
participants
Group 7 (n=125)
MenABCWY +
saline
MenABCWY
Group 8
(n=50)
Trumenba +
MenACWY-CRM
Trumenba
a. Follow-up Visits 1 and 2 will be telephone contacts for safety-assessment-only participants in 
Groups 5 through 8, for whom blood samples will not be obtained.
A portion of the projected number of participant enrollment slots may be moved from the 
safety subset to the immunogenicity subset to achieve appropriate regional distribution for 
the overall study population and the immunogenicity subset.  This determination will be 
made by the sponsor while still blinded. The sponsor may decide to proceed with less than 
full enrollment if an assessment of power shows that it is sufficient to meet the primary 
objectives.  This assessment will be done in a completely blinded fashion before any 
participants are unblinded or the immunogenicity data are accessed.

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1.3. Schedule of Activities (SoA)
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. 
Visit ID
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit Description
Vaccination 1
Follow-up 
Visit 1a
Vaccination 2
Follow-up 
Visit 2a
Telephone Contact
Approximate Month
0
1
6
7
6 Months After Last 
Study Vaccination
Visit Window
Day 1
28 to 42 Days 
After Visit 1
173 to 194 Days 
After Visit 1
28 to 42 Days 
After Visit 3
168 to 196 Days After 
Last Vaccination
Informed consent
X
Review eligibility criteria
X
Demography
X
Confirm continued eligibilityb
X
X
X
Medical history and physical examination
X
Record previous PRP-OMP vaccinations
X
Record any previous meningococcal vaccinations
X
Urine pregnancy test for female participants 
(obtain results prior to vaccination)
X
X
Oral temperature (prior to vaccination)
X
X
Randomization
X
Obtain blood sample for participants in the 
immunogenicity subset (Groups 1-4 only) prior to 
vaccination
25 mL
25 mL
25 mL
(or 50 mLc)
Investigational product administration and observationd
X
X
Record nonstudy vaccinations
X
X
X

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Visit ID
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit Description
Vaccination 1
Follow-up 
Visit 1a
Vaccination 2
Follow-up 
Visit 2a
Telephone Contact
Approximate Month
0
1
6
7
6 Months After Last 
Study Vaccination
Visit Window
Day 1
28 to 42 Days 
After Visit 1
173 to 194 Days 
After Visit 1
28 to 42 Days 
After Visit 3
168 to 196 Days After 
Last Vaccination
Provide participant with an e-diary, caliper, measuring 
tape/ruler, and digital thermometer, if necessary, and 
provide instructions on use
X
X
Review and collect e-diary
X
X
Assess reactogenicity and record use of antipyretic 
medicationse
Days 1 to 7
Days 1 to 7
Provide the participant with a contact card
X
Provide the participant with a memory aid
X
Complete Study Visit/Telephone Contact AE 
Checklistf
X
X
X
X
Record concomitant medications used to treat AEs
X
X
X
X
X
(S)AE collection appropriate for the visitg
X
X
X
X
X
Abbreviations: e-diary = electronic diary; PRP-OMP = polyribosylribitol phosphate oligosaccharide of Haemophilus influenzae type b conjugated to outer 
membrane protein.
a.
Follow-up Visits 1 and 2 will be telephone contacts for safety-assessment-only participants in Groups 5 through 8, for whom blood samples will not be 
obtained.
b.
Ensure that the participant continues to be eligible for the study, and continues to comply with contraception requirements, as appropriate.
c.
In the subset of participants ≥16 years of age.
d.
Observe the participant for at least 30 minutes (or longer as per local practice) after the investigational product administration for any acute reactions.
e.
Between visits, review the e-diary data online at frequent intervals.  Contact the parent(s)/legal guardian or the participant in order to obtain stop dates for 
any local reactions, systemic events, or use of antipyretic medication that were ongoing on the last day that the e-diary was completed.
f.
Checklist includes questions regarding newly diagnosed chronic medical conditions, medically attended adverse events, and missed days of school or 
work, as well as about neuroinflammatory and autoimmune conditions, such as transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
g.
Please refer to Section 8.3.1 of the protocol.

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2. INTRODUCTION
Bivalent rLP2086 (120 µg) and MenACWY-TT (5 µg of each of the 4 meningococcal 
polysaccharides A, C, W-135, and Y conjugated to 44 µg of tetanus toxoid) are available 
commercially as Trumenba® and Nimenrix®, respectively.  
Pfizer intends to develop a pentavalent meningococcal vaccine (MenABCWY) by combining 
bivalent rLP2086 (supplied as a 0.7-mL prefilled syringe [PFS]) and MenACWY-TT.  The 
target indication for the candidate pentavalent vaccine is active immunization to prevent 
invasive disease caused by N meningitidis groups A, B, C, W, and Y in individuals 
10 through 25 years of age, regardless of prior exposure to a conjugated ACWY quadrivalent 
meningococcal vaccine.
Trumenba is composed of 2 recombinant lipidated factor H binding protein (fHBP) variants 
from MenB, one from fHBP subfamily A and one from subfamily B (A05 and B01, 
respectively), and is indicated for active immunization to prevent invasive disease caused by 
MenB.  Trumenba is approved for use in individuals 10 through 25 years of age in the 
United States and individuals 10 years of age and older in Europe and other locations.
Nimenrix is composed of capsular polysaccharides from each of the A, C, W, and Y groups 
of N meningitidis conjugated to tetanus toxoid, and is indicated for active immunization of 
individuals 6 weeks of age and older against invasive meningococcal diseases caused by 
N meningitidis groups A, C, W-135, and Y and is approved in Europe and other locations. 
2.1. Study Rationale
In Study B1971057, an FIH and POC study for MenABCWY, 543 participants received 
MenABCWY on a 0-month and 6-month schedule.  Results from B1971057 indicated 
MenABCWY is well tolerated with an acceptable safety profile, and also provides a high 
degree of protective immune responses among both ACWY-naïve and ACWY-experienced 
participants without interference among all 5 serogroup components.
The aim of this Phase 3 study is to determine the immunologic noninferiority of 
MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing 
the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve 
and ACWY-experienced healthy participants ≥10 to <26 years of age.
Data obtained from prior studies supporting the licensure of the 2 vaccines comprising 
MenABCWY, Nimenrix and Trumenba, support a favorable benefit-risk assessment for 
continued study of MenABCWY.

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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 invasive meningococcal 
disease (IMD), which clinically presents as septicemia, meningitis, or both.1  N meningitidis
serogroups A, B, C, W, and Y are 5 of the 6 meningococcal serogroups that cause the vast 
majority of meningococcal disease globally,2 and disease incidence is highest in infants and 
children younger than 5 years of age, adolescents and young adults (16 to 21 years), and 
older adults (≥65 years).3  In the United States, meningococcal disease is primarily caused by 
groups B, C, W, and Y, which are responsible for approximately 79% of disease across all 
ages.4
Current preventive vaccination strategies generally require separate immunizations at 
different times for an ACWY conjugate vaccine as well as a separate serogroup B vaccine.  
In the United States, MenACWY vaccination rates among adolescents 13 to 17 years of age 
are estimated to be 86.6% for ≥1 dose and 50.8% for ≥2 doses, and MenB vaccination 
coverage among 17-year-olds approaches only 17.2%.5  In the United States and Europe, 
MenB has become the most common cause of IMD over the past several years. In the 
United States, MenB now exceeds all other serogroups in incidence, accounting for 85% of 
IMD among individuals 11 to 23 years of age, with C, W, and Y accounting for the 
remainder despite high vaccination rates in targeted adolescents.4,6  These data support the 
idea that all 5 serogroups contribute to disease in adolescents and young adults and that a 
multivalent vaccine incorporating serogroup B would have significant public health utility.
Temporal variations in IMD incidence occur naturally.  In industrialized countries, disease 
rates range from 0.1 cases per 100,000 individuals during endemic periods to 5 to 15 or more 
cases per 100,000 individuals during prolonged epidemics.7,8,9,10  During 2017, the incidence 
of IMD in the United States in young adolescents (11 to 15 years) was 0.04 while at the same 
time much higher, 0.2, in 16- to 23-year-olds.4  Although the overall incidence of endemic 
IMD is quite low, it can rise significantly during epidemics, particularly on US college 
campuses, where it has been as high as high as 21.1 to 134 per 100,000 in data reported in 
2014.11,12
In the United States, the Centers for Disease Control and Prevention’s Advisory Committee 
on Immunization Practices (ACIP) recommends that children 11 to 12 years of age should 
receive a MenACWY conjugate vaccination with a booster dose at 16 years of age and that 
adolescents and young adults 16 to 23 years of age may be vaccinated with a MenB vaccine 
to provide short-term protection against most strains of serogroup B meningococcal disease.  
Given that meningococcal serogroups B, C, W, and Y cause disease in the United States 
through early adolescence and young adulthood, with unacceptable mortality and morbidity 
outcomes with an increasing contribution of serogroup 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.13

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2.2.2. Prior Clinical Experience
2.2.2.1. Trumenba
Trumenba was approved on 29 October 2014, under 21 Code of Federal Regulations (CFR) 
601 Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening 
Illnesses, for active immunization of individuals 10 through 25 years of age to prevent 
invasive disease caused by meningococcal group B.
Trumenba was subsequently approved in the European Union (EU) on 24 May 2017 for 
active immunization of individuals 10 years of age and older to prevent IMD caused by
MenB. Trumenba has received marketing authorization in 45 countries and is currently 
marketed in 22 countries.   
Approval of Trumenba was based on the demonstration of safety and a serological correlate 
that showed in Phase 2 studies the induction of serum bactericidal activity against 
4 serogroup B strains that are representative of prevalent US strains.  These were measured 
using hSBAs.  As a requirement of licensure, Phase 3 studies were conducted to confirm the 
safety and immune responses associated with the 3-dose schedule.  As of 28 April 2019, it is 
estimated that 23,586 participants have participated in the Trumenba clinical development 
program: 12,027 participants were exposed to Trumenba alone; a total of 5202 participants 
received Trumenba in combination with: diphtheria, tetanus, and acellular pertussis and
Haemophilus influenzae type b vaccine (DTaP-Hib); hepatitis B virus and inactivated 
poliomyelitis virus vaccine (HBV-IPV)/Prevenar® (32); diphtheria, tetanus, and acellular 
pertussis and inactivated poliomyelitis virus vaccine (DTaP-IPV) (372); human 
papillomavirus vaccine (HPV4) (992); quadrivalent meningococcal polysaccharide conjugate 
and diphtheria, tetanus, and acellular pertussis vaccine (MCV4-Tdap) (884); 
MenACWY-CRM (1057); or saline (1865); 543 participants received bivalent rLP2086 
mixed with MenACWY-TT (Nimenrix) as a single injection in Study B1971057; and 
5847 participants received control. The estimated cumulative worldwide unit distribution 
for Trumenba from launch through 28 April 2019 is approximately 3,367,496 doses.
A licensure persistence-of-immunity and booster study, B1971033, showed that persistence 
of immunity after the 2- and 3-dose primary Trumenba series schedules utilized in 
Studies B1971010 and B1971012 follows similar patterns over 4 years, declining by Year 1
and remaining stable through Year 4, regardless of the primary series schedule.  The immune 
responses following a booster dose with Trumenba 4 years after the primary Trumenba series 
resulted in generally higher hSBA titers compared to 1 month after the primary series, 
irrespective of whether participants received a 2-dose or 3-dose series, demonstrating a 
robust anamnestic response.  Protective hSBA titers (hSBA ≥ LLOQ) also persisted in a high 
proportion of booster recipients (57.5% to 82.8%, depending on the test strain) for up 2 years 
after the booster dose. 

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2.2.2.2. Nimenrix (MenACWY-TT)
Nimenrix was first licensed for use in the EU on 20 April 2012 for the active immunization 
of individuals from the age of 12 months and above against IMD caused by N meningitidis
serogroups A, C, W-135, and Y. On 12 December 2016, the indication of Nimenrix was 
extended in Europe to infants 6 weeks of age and older. Nimenrix has received marketing 
authorization in 83 countries and is currently marketed in 59 countries.
Nimenrix is not presently licensed in the United States, though there is an open 
investigational new drug application (IND) (BB-IND 13278).  Licensure outside of the 
United States was based on safety and demonstration of immunologic noninferiority 
(based mainly on comparing proportions of participants with serum bactericidal assay 
using rabbit complement [rSBA] titers of at least 1:8) to licensed meningococcal vaccines. 
Cumulatively, it is estimated that 21,520 participants have participated in the Nimenrix 
clinical development program (CDP). Worldwide distribution for Nimenrix from launch 
through 19 April 2019 is approximately 16,124,606 doses.
The immunogenicity studies conducted in participants from 12 months of age and above 
demonstrate that 1 dose of MenACWY-TT induces a response that is similar to or higher 
than the response induced by licensed meningococcal vaccines used as control, and that the 
vaccine is able to induce immunologic memory against the 4 meningococcal serogroups in 
individuals vaccinated as toddlers 12 to 14 months of age, historically an age group that is 
not responsive to meningococcal polysaccharide vaccines.  Follow-up studies demonstrate 
that persistence of the responses elicited by the vaccine is similar to or higher than 
persistence of those elicited by the licensed meningococcal polysaccharide vaccines 
Meningitec® and Mencevax® when assessed using the GlaxoSmithKline (GSK) rSBA.  
2.2.2.3. Pentavalent Meningococcal Vaccine (MenABCWY)
MenABCWY is an investigational pentavalent meningococcal vaccine consisting of bivalent 
rLP2086 (supplied as a 0.7-mL PFS) and MenACWY-TT, which are administered as a single 
injection after reconstituting the MenACWY-TT components with the bivalent rLP2086
suspension.  MenABCWY has been administered to 543 individuals participating in 
Study B1971057. 
Results from B1971057 demonstrated the immunogenicity and safety of MenABCWY in 
adolescents and young adults. This was a randomized, active-controlled, observer-blinded 
multicenter trial in which approximately 1600 participants ≥10 to <26 years of age were 
randomly assigned to receive either MenABCWY (n=543) on a 0-month and 6-month 
schedule, or Trumenba on a 0-month and 6-month schedule and MenACWY-CRM (n=1057) 
at the same time as the first dose of Trumenba. All participants were naïve to any 
meningococcal group B vaccine prior to enrollment and approximately half were naïve to 
prior MenACWY vaccination, while the other half were considered ACWY-experienced, 
having had no more than 1 previous ACWY component vaccine at least 4 years prior to 
enrollment. Stage 1, which included the vaccination phase of the primary series, is now 
complete. 

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Immunogenicity noninferiority evaluations of hSBA responses to the MenACWY component 
of MenABCWY showed that MenABCWY, both after 1 and 2 doses, was noninferior to a 
single dose of MenACWY-CRM by 3 different statistical methods for individuals who 
were either ACWY-naïve or ACWY-experienced. One and 2 doses of MenABCWY 
were noninferior to 1 dose of MenACWY-CRM at the 10% margin. Specifically, for 
ACWY-naïve participants, the percentage-of-responder (≥4-fold rise) differences between 
a single dose of MenABCWY compared to a single dose of MenACWY-CRM were 1.1% 
(-2.1, 3.7) for serogroup A, 5.5% (-1.3, 11.9) for serogroup C, 10.7% (4.9, 16.1) for 
serogroup W, and 14.1% (8.1, 19.7) for serogroup Y. Among ACWY-experienced 
participants, the percentage differences were -0.8% (-4.5, 2.1) for serogroup A, -2.4% 
(-6.4, 0.9) for C, -0.8% (-4.5, 2.0) for W, and -0.3% (-4.6, 3.3) for Y. Similarly, 
noninferiority was also established for ≥4-fold rise in the percentage of responders after 
2 doses of MenABCWY compared to a single dose of MenACWY-CRM for ACWY-naïve 
and ACWY-experienced participants.
Among the ACWY-naïve participants, percentage-of-responder differences were 1.1% 
(-2.2, 3.8) for serogroup A, 26.5% (21.6, 31.1) for C, 21.5% (17.1, 25.8) for W, and 22.9% 
(17.7, 27.6) for Y. Among the ACWY-experienced participants, differences were -0.8% 
(-4.7, 2.1) for serogroup A, -0.9% (-4.9, 2.2) for C, -1.9% (-6.1, 1.2) for W, and -1.6% 
(-6.5, 2.3) for Y. However, GMTs were markedly higher among ACWY-experienced 
participants than ACWY-naïve participants after MenABCWY administration, indicating the 
pentavalent vaccine’s booster effect for ACWY components. Therefore, MenABCWY, 
whether given as a single dose, or as a 2-dose series separated by 6 months, was noninferior 
to a single dose of MenACWY-CRM, regardless of prior ACWY experience.
For the MenB component of MenABCWY, hSBA responses after the second dose were 
noninferior to those for Trumenba. Noninferiority was established at the 10% margin for 
percentage of responders who achieved ≥4-fold rise in hSBA titer over baseline among 
MenABCWY recipients compared to Trumenba recipients for the 4 primary test strains: A22, 
A56, B24, and B44.
Reactogenicity data were collected for 7 days following each vaccination by electronic 
diaries (e-diaries) applying the same methodology used in the Trumenba development 
program.  Local and systemic reactogenicity was similar between MenABCWY and 
Trumenba/MenACWY-CRM recipients, with injection site pain (93.4% vs 91.1%) being the 
most common local reaction after any vaccination, followed by swelling (26.0% vs 22.4%) 
and redness (24.5% vs 21.1%). No significant differences among MenABCWY recipients 
who were considered either ACWY-naïve or ACWY-experienced were observed. 

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During the vaccination phase (from the first vaccination through 1 month after the second 
vaccination), similar proportions of participants receiving MenABCWY reported any 
AE (39.2%) compared to Trumenba + MenACWY-CRM recipients (40.7%), and the 
2 groups were also similar between ACWY-naïve and ACWY-experienced MenABCWY 
recipients.  During the same period, similar proportions of participants reported SAEs 
(1.1% vs 0.8%, respectively), MAEs (26.2% vs 26.7%, respectively), and NDCMCs 
(0.4% vs 0.8%, respectively).  Based on the immunogenicity and safety results from Study 
B1971057 outlined above, the benefit-risk profile for MenABCWY generated by Phase 2 
Study B1971057 is favorable. 
2.3. Benefit/Risk Assessment
Trumenba and Nimenrix are licensed vaccines, and common AEs noted after vaccination are 
primarily related to reactogenicity, including local reactions (pain, swelling, redness around 
the injection site) and systemic events (headache, fatigue, myalgias, arthralgias, 
nausea/vomiting, diarrhea, chills, fever). As noted above, the MenABCWY profile from the 
Phase 2 portion of Study B1971057 is consistent with these 2 licensed products.
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 feeling faint, dizziness, fainting, pain, 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 external data monitoring 
committee (E-DMC) will serve to monitor and mitigate these risks. 
In Phase 2 Study B1971057, MenABCWY provided a high degree of immunologic 
protection against IMD caused by N meningitidis serogroups A, B, C, W, and Y using the 
accepted surrogate marker for protective immunity, hSBA ≥LLOQ, and was statistically 
noninferior to Trumenba for the B component and MenACWY-CRM for the ACWY 
components in both ACWY-naïve participants and ACWY-experienced participants. Both 
populations will be further evaluated to demonstrate noninferiority in the Phase 3 powered 
study. The proposed Phase 3 clinical trial for MenABCWY is the next step in the pathway 
for licensure, 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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Pfizer therefore considers that the available information regarding licensed products 
Trumenba and Nimenrix, as well safety and immunogenicity results from Study B1971057 
with MenABCWY, support a favorable benefit-risk profile for MenABCWY in this study.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of MenABCWY may be found in the investigator’s brochure (IB), which is the 
single reference safety document (SRSD) for this study. The SRSD is the US package insert 
(USPI) for Trumenba and USPI for MenACWY-CRM. 

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3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS
Objectives
Estimands
Endpoints
Primary Immunogenicity:
Primary Immunogenicity:
Primary Immunogenicity:
To demonstrate that the immune response for 
MenA, MenC, MenW, and MenY induced by 
2 doses of MenABCWY is noninferior to the 
immune response induced by 1 dose of 
MenACWY-CRM in both ACWY-naïve and 
ACWY-experienced participants, separately.
In ACWY-naïve participants receiving at least 1 dose (Group 2) of 
MenACWY-CRM or 2 doses (Group 1) of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):
Difference in the percentage of seroresponders, defined as participants 
achieving at least a 4-fold rise in hSBA titer from baseline for each 
ACWY test strain, 1 month after Vaccination 2 in Group 1 compared to 
1 month after Vaccination 1 in Group 2.

For participants with a baseline hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold response is defined as an hSBA titer 
of ≥1:16.

For participants with a baseline hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ (ie, hSBA titer of 1:8), a 4-fold 
response is defined as an hSBA titer of ≥4 times LLOQ.

For participants with a baseline hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA titer of ≥4 times the baseline titer.
In ACWY-experienced participants receiving at least 1 dose (Group 4) of 
MenACWY-CRM or 2 doses (Group 3) of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):
Difference in the percentage of seroresponders, defined as participants 
achieving at least a 4-fold rise in hSBA titer from baseline for each 
ACWY test strain, 1 month after Vaccination 2 in Group 3 compared to 
1 month after Vaccination 1 in Group 4.  

For participants with a baseline hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold response is defined as an hSBA titer 
of ≥1:16.

For participants with a baseline hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ (ie, hSBA titer of 1:8), a 4-fold 
response is defined as an hSBA titer of ≥4 times LLOQ.
hSBA titer for each of the 
ACWY test strains.

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Objectives
Estimands
Endpoints

For participants with a baseline hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA titer of ≥4 times the baseline titer.
To demonstrate that the immune response for 
MenB induced by 2 doses of MenABCWY is 
noninferior to the immune response induced by 2 
doses of Trumenba.
In participants receiving at least 2 doses of investigational product and who 
are in compliance with the key protocol criteria (evaluable participants):
Differences in the percentage of participants achieving an hSBA titer 
≥LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) 
for all 4 primary MenB test strains combined (composite response), in 
Groups 1 and 3 combined compared to Groups 2 and 4 combined, at 
1 month after Vaccination 2. 
Difference in the percentage of participants achieving at least a 4-fold 
rise in hSBA titer from baseline for each of the 4 primary MenB test 
strains, in Groups 1 and 3 combined compared to Groups 2 and 4 
combined, at 1 month after Vaccination 2.

For participants with a baseline hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold response is defined as an hSBA titer 
of ≥1:16.

For participants with a baseline hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ, a 4-fold response is defined as an 
hSBA titer of ≥4 times the LLOQ.

For participants with a baseline hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA titer of ≥4 times the baseline titer.
hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and 
B44).

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Objectives
Estimands
Endpoints
Primary Safety:
Primary Safety:
Primary Safety:
To describe the safety profile of MenABCWY, as 
measured by local reactions, systemic events, AEs, 
SAEs, NDCMCs, MAEs, and immediate AEs.
In participants receiving at least 1 dose of investigational product, 
expressed in MenABCWY groups (Groups 1, 3, 5, and 7 combined) and 
Trumenba groups (Groups 2, 4, 6, and 8 combined):
The percentage of participants reporting local reactions, systemic 
events, and use of antipyretic medication within 7 days after each 
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 vaccination.

30 Days after any vaccination.

During the vaccination phase (from the first study vaccination 
[Visit 1] through 1 month after the second study vaccination 
[Visit 4]).

During the follow-up phase (from 1 month after the second study 
vaccination [Visit 4] through 6 months after the second study 
vaccination [Visit 5]).

Throughout the study (from the first study vaccination [Visit 1] 
through 6 months after the second study vaccination [Visit 5]).
The percentage of participants reporting at least 1 AE during the 
following time periods:

30 Days after each vaccination.

30 Days after any vaccination.

During the vaccination phase (from the first study vaccination 
[Visit 1] through 1 month after the second study vaccination 
[Visit 4]).
The percentage of participants reporting at least 1 immediate AE.
Local reactions (pain, 
redness, and swelling).
Systemic events (fever, 
vomiting, diarrhea, 
headache, fatigue, 
chills, muscle pain 
other than muscle pain 
at any injection site, 
and joint pain). 
Use of antipyretic 
medication.
AEs, SAEs, MAEs, 
NDCMCs, and 
immediate AEs.
Days missing from 
school or work because 
of AEs.

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Objectives
Estimands
Endpoints
The percentage of participants who missed days of school or work 
because of AEs.
Secondary 
Immunogenicity:
Secondary 
Immunogenicity:
Secondary 
Immunogenicity:
To demonstrate that the immune response for 
MenA, MenC, MenW, and MenY induced by 
1 dose of MenABCWY is noninferior to the 
immune response induced by 1 dose of 
MenACWY-CRM, in both ACWY-naïve and 
ACWY-experienced participants, separately.
In ACWY-naïve participants receiving at least 1 dose of investigational 
product and who are in compliance with the key protocol criteria 
(evaluable participants):
Difference in the percentage of seroresponders, defined as participants 
achieving at least a 4-fold rise in hSBA titer from baseline for each 
ACWY test strain, 1 month after Vaccination 1 in Group 1 compared to
Group 2.

For participants with a baseline hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold response is defined as an hSBA titer 
of ≥1:16.

For participants with a baseline hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ (ie, hSBA titer of 1:8), a 4-fold 
response is defined as an hSBA titer of ≥4 times LLOQ.

For participants with a baseline hSBA titer of ≥LLOQ, a 4-fold 
response is defined as an hSBA titer of ≥4 times the baseline titer.
In ACWY-experienced participants receiving at least 1 dose of 
investigational product and who are in compliance with the key protocol 
criteria (evaluable participants):
Difference in the percentage of seroresponders, defined as participants 
achieving at least a 4-fold rise in hSBA titer from baseline for each 
ACWY test strain, 1 month after Vaccination 1 in Group 3 compared to 
Group 4.  

For participants with a baseline hSBA titer below the LOD (or an 
hSBA titer of 1:4), a 4-fold response is defined as an hSBA titer 
of ≥1:16.
hSBA titer for each of the 
ACWY test strains.

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Objectives
Estimands
Endpoints

For participants with a baseline hSBA titer of ≥LOD (ie, hSBA 
titer of ≥1:4) and LLOQ (ie, hSBA titer of 1:8), a 4-fold 
response is defined as an hSBA titer of ≥4 times LLOQ.

For participants with a baseline hSBA titer of ≥LLOQ, a 4-fold
response is defined as an hSBA titer of ≥4 times the baseline titer.
Tertiary/Exploratory:
Tertiary/Exploratory:
Tertiary/Exploratory:
To describe the immune response for MenA, 
MenC, MenW, and MenY induced by 2 doses of 
MenABCWY compared to the immune response 
induced by 1 dose of MenACWY-CRM, in both 
ACWY-naïve and ACWY-experienced 
participants, separately.
In ACWY-naïve and ACWY-experienced participants separately who have 
received at least 1 dose (Groups 2 and 4) of MenACWY-CRM or 2 doses 
(Groups 1 and 3) of MenABCWY and who are in compliance with the key 
protocol criteria (evaluable participants):
The percentage of participants achieving an hSBA titer ≥1:8 for each 
ACWY test strain, at baseline, 1 month after Vaccination 1 in Groups 2 
and 4, and 1 month after Vaccination 2 in Groups 1 and 3.
The percentage of participants achieving hSBA titers of ≥1:8, ≥1:16, 
≥1:32, ≥1:64, and ≥1:128 for each ACWY test strain, at baseline, 
1 month after Vaccination 1 in Groups 2 and 4, and 1 month after 
Vaccination 2 in Groups 1 and 3.
hSBA GMTs for each of the ACWY test strains, at baseline, 1 month 
after Vaccination 1 in Groups 2 and 4, and 1 month after Vaccination 2 
in Groups 1 and 3.
hSBA titer for each of the 
ACWY test strains.
To describe the immune response for MenA, 
MenC, MenW, and MenY induced by 1 dose of 
MenABCWY compared to the immune response 
induced by 1 dose of MenACWY-CRM, in both 
ACWY-naïve and ACWY-experienced 
participants, separately.
In ACWY-naïve and ACWY-experienced participants separately who have 
received at least 1 dose of investigational product and who are in 
compliance with the key protocol criteria (evaluable participants):
The percentage of participants achieving an hSBA titer ≥1:8 for each 
ACWY test strain, at baseline and 1 month after Vaccination 1 in 
Groups 1 through 4.
The percentage of participants achieving hSBA titers of ≥1:8, ≥1:16, 
≥1:32, ≥1:64, and ≥1:128 for each ACWY test strain, at baseline and 
1 month after Vaccination 1 in Groups 1 through 4.
hSBA GMTs for each of the ACWY test strains, at baseline and 
1 month after Vaccination 1 in Groups 1 through 4.
hSBA titer for each of the 
ACWY test strains.

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Objectives
Estimands
Endpoints
To describe the immune response for MenB, as 
measured by hSBA performed with primary MenB 
test strains, induced by 2 doses of MenABCWY 
compared to the immune response induced by 2 
doses of Trumenba. 
In participants receiving at least 2 doses of investigational product who are 
in compliance with the key protocol criteria (evaluable participants):
The percentage of participants achieving an hSBA titer ≥LLOQ (1:16 
for A22 and 1:8 for A56, B24, and B44) for each primary MenB test 
strain in Groups 1 and 3 combined, and Groups 2 and 4 combined, at 
baseline and 1 month after Vaccination 2.
The percentage of participants with hSBA titers ≥1:4, ≥1:8, ≥1:16, 
≥1:32, ≥1:64, and ≥1:128 for each of the 4 primary MenB test strains in 
Groups 1 and 3 combined, and Groups 2 and 4 combined, at baseline 
and 1 month after Vaccination 2.
hSBA GMTs for each of the 4 primary MenB test strains in Groups 1 
and 3 combined, and  Groups 2 and 4 combined, at baseline and 
1 month after Vaccination 2.
hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and 
B44).
To describe the immune response for MenB, as 
measured by hSBA performed with secondary 
MenB test strains, induced by 2 doses of 
MenABCWY.
In participants receiving at least 2 doses of investigational product who are 
in compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥LLOQ for 
each secondary MenB test strain in Groups 1 and 3 combined, at 
baseline and 1 month after Vaccination 2.

The percentage of participants with hSBA titers ≥1:4, ≥1:8, ≥1:16, 
≥1:32, ≥1:64, and ≥1:128 for each secondary MenB test strain in 
Groups 1 and 3 combined, at baseline and 1 month after Vaccination 2.

hSBA GMTs for the secondary MenB test strains in Groups 1 and 3 
combined, at baseline and 1 month after Vaccination 2.
hSBA titer for each 
secondary MenB test 
strain.

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4. STUDY DESIGN
4.1. Overall Design
This is a Phase 3, randomized, active-controlled, observer-blinded multicenter trial in which 
approximately 2413 participants ≥10 to <26 years of age will be randomly assigned to 
receive either MenABCWY and saline, or Trumenba and MenACWY-CRM, as shown in 
Table 1.  The study will include evaluation of both ACWY-naïve and ACWY-experienced 
individuals.  All participants will be naïve to any meningococcal group B vaccine prior to 
enrollment.
Participants in Groups 1 through 4 will be considered an immunogenicity subset, and will 
contribute to both the safety and immunogenicity analyses; these participants will have blood 
drawn prior to Vaccination 1 and 1 month after Vaccinations 1 and 2.  Participants in 
Groups 5 through 8 will be considered a safety subset and will contribute to the safety 
analysis only, and will not have blood drawn for immunogenicity evaluations.
Randomization will be stratified by prior vaccination history.  Overall, approximately 
1225 ACWY-naïve and 1188 ACWY-experienced participants (having received 1 dose of 
Menactra or Menveo ≥4 years prior to the date of randomization) will be enrolled.  Of these
total participants, up to 675 ACWY-naïve and 1013 ACWY-experienced participants will 
contribute to the immunogenicity subset.
Participants enrolled in the immunogenicity subset will contribute to both immunogenicity 
and safety evaluations. Additionally, participants will be enrolled in a safety subset that will 
contribute exclusively to the safety evaluation. Numbers enrolled in the safety subset will 
therefore be based on numbers needed to achieve an overall number of enrolled participants,
all of whom will contribute to the safety evaluation. Numbers stated in the protocol to be 
enrolled by group across immunogenicity and safety subsets (Section 1.2 and Table 1) are 
estimates only. 
Additionally, randomization will be stratified by geographic region.  The overall participant 
distribution by region will be approximately 80% from the US and approximately 20% from 
other regions. Among the participants in the immunogenicity subset, approximately 80% 
will be enrolled in US investigative sites, and approximately 20% will be enrolled in other 
regions.  Regional or safety/immunogenicity group enrollment shifts may be necessary based 
on the availability of participants with specific characteristics (age group or ACWY 
experience) in a given location based on local immunization practices. However, these 
minor shifts from the originally targeted numbers will not deviate from original targets to a 
degree that will impact the overall study design or endpoint assessments of the study.
Enrollment targets will also be adjusted to achieve appropriate representation by age group 
(participants 10 to 18 years old and participants 18 to 26 years old) within each subset, and 
ACWY strata within each subset.  

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Table 1.
Study Design
Vaccination 1
Follow-up
Visit 1a
Vaccination 2
Follow-up
Visit 2a
Telephone 
Contact
Approximate 
Month
0
1
6
7
12
Visit Number
1
2
3
4
5
ACWY-naïve 
participants
Group 1 
(n=450)
MenABCWY +
saline
MenABCWY
Group 2 
(n=225)
Trumenba +
MenACWY-CRM
Trumenba
ACWY-
experienced 
participants
Group 3  
(n=675)
MenABCWY +
saline
MenABCWY
Group 4 
(n=338)
Trumenba +
MenACWY-CRM
Trumenba
Blood draw
(Groups 1-4 
only)
25 mL
25 mL
25 mL or 
50 mL
ACWY-naïve 
participants
Group 5 
(n=500)
MenABCWY +
saline
MenABCWY
Group 6 
(n=50)
Trumenba +
MenACWY-CRM
Trumenba
ACWY-
experienced 
participants
Group 7 
(n=125)
MenABCWY +
saline
MenABCWY
Group 8 
(n=50)
Trumenba +
MenACWY-CRM
Trumenba
a.
Follow-up Visits 1 and 2 will be a telephone contacts for safety-assessment-only participants in Groups 5 through 8, 
for whom blood samples will not be obtained.
A portion of the projected number of participant enrollment slots may be moved from the 
safety subset to the immunogenicity subset to achieve appropriate regional distribution for 
the overall study population and the immunogenicity subset.  This determination will be 
made by the sponsor while still blinded. The sponsor may decide to proceed with less than 
full enrollment if an assessment of power shows that it is sufficient to meet the primary 
objectives. This assessment will be done in a completely blinded fashion before any 
participants are unblinded or the immunogenicity data are accessed.
4.1.1. Approximate Duration of Participation for Each Participant
Each participant will participate in the study for approximately 12 months. 
4.1.2. Approximate Number of Participants
Approximately 2413 participants will be enrolled.
4.2. Scientific Rationale for Study Design
In Study B1971057, an FIH and POC study for MenABCWY, 543 participants received 
MenABCWY on a 0-month and 6-month schedule.  Results from B1971057 indicated 
MenABCWY is well tolerated with an acceptable safety profile, and also provides a high 
degree of protective immune responses among both ACWY-naïve and ACWY-experienced 
participants without interference among all 5 serogroup components.

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The aim of this Phase 3 study is to determine the immunologic noninferiority of 
MenABCWY, an investigational pentavalent (serogroups A, B, C, W, and Y) meningococcal 
vaccine, to licensed vaccines Trumenba and Menveo (MenACWY-CRM) by assessing the 
safety and immunogenicity of MenABCWY and the comparators in healthy participants 
≥10 to <26 years of age who are both ACWY-naïve and ACWY-experienced.
Data obtained from prior studies evaluating MenABCWY, MenACWY-TT (Nimenrix), and 
Trumenba support a favorable benefit-risk assessment for continued study of MenABCWY.
4.3. Justification for Dose
Bivalent rLP2086 (120 µg, meningococcal group B vaccine) and MenACWY-TT (5 µg of 
each of the 4 meningococcal polysaccharides A, C, W-135, and Y conjugated to 44 µg of 
tetanus toxoid) are available commercially as Trumenba and Nimenrix, respectively.  
Trumenba is indicated for active immunization to prevent invasive disease caused by MenB, 
and is approved for use in Europe in individuals 10 years of age and older and in the 
United States in individuals 10 through 25 years of age. Nimenrix is indicated for active 
immunization to prevent invasive disease caused by MenA, MenC, MenW, and Men Y, and 
is approved for use in Europe and a number of ex-US countries, in individuals 6 weeks of age 
and older.  Trumenba is supplied as a 0.5-mL dose PFS, while Nimerix is supplied as a 
single-dose vial containing lyophilized powder to be reconstituted for injection.
MenABCWY consists of bivalent rLP2086, supplied as a 0.7-mL PFS, which is used to 
reconstitute MenACWY-TT, and 0.5 mL of the resultant MenABCWY is administered via 
intramuscular injection.
The safety, tolerability, and immunogenicity of Trumenba and Nimenrix are well established 
in adolescents and young adults when used separately.  Results from Study B1971057, which 
evaluated MenABCWY on a 0-month and 6-month schedule in adolescents and young 
adults, showed no clinically significant difference in the tolerability or safety of 
MenABCWY when compared to Trumenba.  Furthermore, no interference was demonstrated 
for either MenB or ACWY responses when compared to licensed vaccines Trumenba and 
Menveo in the United States and the EU.  Therefore, Pfizer is proceeding with adolescent 
and adult Phase 3 development of MenABCWY with the dose used in Study B1971057.
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 Visit 5 (final telephone contact).
The end of the study is defined as the date of the last visit of the last participant in the study.

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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, are 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 10 and <26 years of age at the time of randomization.
Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female 
(Section 10.4.2) participants.
Type of Participant and Disease Characteristics:
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and 
other study procedures.
3. ACWY-naïve participants: Participants who have never received a prior dose of a 
meningococcal vaccine containing ACWY serogroups.  Written confirmation of 
vaccination history must be obtained prior to randomization. 
ACWY-experienced participants: Participants who have received not more than 1 prior 
dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.  
Written confirmation of vaccination history must be obtained prior to randomization.
4. Available for the entire study period and can be reached by telephone.
5. Healthy participant as determined by medical history, physical examination, and
judgment of the investigator.
6. Male and female participants of childbearing potential must agree to use a highly 
effective method of contraception for at least 28 days after the last study vaccination.  A 
participant is of childbearing potential if, in the opinion of the investigator, he/she is 
biologically capable of having children and is sexually active (Appendix 4).
7. Negative urine pregnancy test for all female participants; pregnancy test is not applicable 
to male participants.

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Weight:
Not applicable.
Informed Consent:
8. Capable of giving signed informed consent as described in Appendix 1, which includes 
compliance with the requirements and restrictions listed in the informed consent 
document (ICD) and in this protocol.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. A previous anaphylactic reaction to any vaccine or vaccine-related component.
2. Bleeding diathesis or condition associated with prolonged bleeding time that would 
contraindicate intramuscular injection.
3. 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.  Participants in the 
United States with terminal complement deficiency are excluded from participation in 
this study.  Please refer to the study reference manual (SRM) for additional details.
4. History of microbiologically proven disease caused by N meningitidis or 
Neisseria gonorrhoeae.
5. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
6. Any neuroinflammatory or autoimmune condition, including, but not limited to, 
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
7. Other acute or chronic medical or psychiatric condition including recent (within the past 
year) or active suicidal ideation, recent (within the past year) hospitalization for 
psychiatric illness, or behavior or laboratory abnormality that may increase the risk 
associated with study participation or investigational product administration or may 
interfere with the interpretation of study results and, in the judgment of the investigator, 
would make the participant inappropriate for entry into this study.

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Prior/Concomitant Therapy:
8. Previous vaccination with any meningococcal group B vaccine, any purely 
polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent 
meningococcal vaccine.  Written vaccination history must be obtained prior to 
randomization.
9. Participants receiving any allergen immunotherapy with a nonlicensed product or 
receiving allergen immunotherapy with a licensed product and are not on stable 
maintenance doses.
10. Receipt of any blood products, including immunoglobulin, within 6 months before the 
first study vaccination.
11. Current use of systemic antibiotics with no foreseeable date of discontinuation prior to 
anticipated date of enrollment (first vaccination). 
Prior/Concurrent Clinical Study Experience:
12. 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:
13. Investigator site staff members directly involved in the conduct of the study and their 
family members (including grandchildren), site staff members otherwise supervised by 
the investigator, or Pfizer employees, including their family members, directly involved 
in the conduct of the study. 
14. Pregnant female participants; breastfeeding female participants; fertile male participants 
and female participants of childbearing potential who are unwilling or unable to use a 
highly effective method of contraception.
5.2.1. Temporary Delay Criteria
5.2.1.1. 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.

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2.
Participant has received any nonlive vaccine (or intramuscular/sublingual allergen 
immunotherapy) within 14 days, or any live vaccine within 28 days, before 
investigational product administration (see exception below for any COVID-19 
vaccination).
Guidance provided by the US Centers for Disease Control and Prevention (CDC) states 
that COVID-19 vaccines and other vaccines may now be administered without regard to 
timing. Because of the COVID-19 pandemic and the ongoing COVID-19 vaccinations 
at the time of study recruitment, participants will be allowed to receive any authorized 
(nonexperimental) COVID-19 vaccination within 8 days of investigational product 
administration (ie, not permitted 7 days before or after any study vaccination).
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.
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 vaccination.
5.2.1.2. 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).
5.3. Lifestyle Considerations
5.3.1. Contraception 
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual 
participant from the permitted list of contraception methods (see Appendix 4, Section 10.4.4) 
and will confirm that the participant has been instructed in its consistent and correct use.  At 
time points indicated in the SoA, the investigator or designee will inform the participant of 
the need to use highly effective contraception consistently and correctly and document the 
conversation and the participant’s affirmation in the participant’s chart (participants need to 
affirm their consistent and correct use of at least 1 of the selected methods of contraception).  
In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued or if pregnancy is known or suspected in the 
participant or partner.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently randomly assigned to investigational product/entered in the study.  

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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. 
6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to a study participant according to 
the study protocol.
For the purposes of this protocol, the term investigational product may be used 
synonymously with study intervention.
6.1. Study Intervention(s) Administered
Trumenba is a 0.5-mL dose supplied as a PFS and formulated to contain 60 μg each of a 
purified subfamily A and a purified subfamily B rLP2086 protein, 0.15 M sodium chloride, 
 polysorbate 80, and 0.25 mg of Al3+ as aluminum phosphate (AlPO4) in 
10 mM histidine-buffered saline at pH 6.0.
MenACWY-TT is supplied as a single-dose vial containing lyophilized powder to be 
reconstituted for injection.  The vaccine is formulated on the basis of purified capsular 
polysaccharide content and the amount of protein carrier is dependent on the 
polysaccharide-to-protein ratio.  The vaccine is nonadjuvanted and preservative-free.  
MenACWY-TT will be reconstituted with bivalent rLP2086 supplied as a 0.7-mL PFS, as 
detailed in the investigational product manual (IP manual), and 0.5 mL of the resultant 
MenABCWY will be administered via intramuscular injection.  The final MenABCWY
vaccine composition includes rLP2086 subfamily A and B proteins formulated at 
120 μg/mL/subfamily, purified capsular polysaccharides of N meningitidis serogroups A, C, 
W, and Y at concentration of 10 μg/mL/polysaccharide type conjugated to tetanus toxoid at 
ratios of ~1:3, ~1:3, ~1:1.5, and ~1:1.3, respectively, in 10 mM histidine and 1.2 mM Tris 
buffer containing 150 mM sodium chloride, 0.5 mg/mL aluminum as AlPO4, 0.035 mg/mL 
polysorbate 80, and 56 mg/mL sucrose.
MenACWY-CRM (Menveo) is supplied in 2 vials that must be combined prior to 
administration: the MenA lyophilized conjugate vaccine component is reconstituted with the 
meningococcal group C, Y, and W-135 (MenCYW-135) liquid conjugate vaccine component 
immediately before administration as a 0.5-mL intramuscular injection.
The placebo is sterile normal saline solution for injection and will be administered as a 
0.5-mL intramuscular injection.
CCI

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Intervention Name
Trumenba
MenABCWY
MenACWY-CRM
Placebo
(Normal Saline)
Dose Formulation
Prefilled syringe 0.5 mL
MenACWY-TT will 
be reconstituted with 
bivalent rLP2086, 
supplied as a 
0.7-mL PFS
2 vials
Sterile normal saline 
solution for injection 
Dosage Level(s)
0.5-mL dose at Visits 1 
and 3
0.5_mL dose at Visits
1 and 3
0.5-mL dose at Visit 1
0.5-mL dose at Visit 1 
Route of 
Administration
Intramuscular
Intramuscular
Intramuscular
Intramuscular
Investigational 
Medicinal Product 
(IMP) and 
Noninvestigational 
Medicinal Product 
(NIMP)
IMP
IMP
IMP
IMP
Sourcing
Pfizer
Pfizer
Commercial
Pfizer
Packaging and 
Labeling
Study intervention will be 
provided in a single-dose 
PFS.  Each syringe will 
be packaged in a carton 
with a blinded label and a 
tamper-evident seal, and 
will be labeled as required 
per country requirement.
Each MenABCWY 
kit will consist of a 
vial of 
MenACWY-TT, 
bivalent rLP2086 
0.7-mL PFS, and vial 
adaptor. Kits will be 
packaged in a carton 
with a blinded label 
and a tamper-evident 
seal, and will be 
labeled as required per 
country requirement.
Study intervention will 
be provided in vials.  
The vials will be 
packaged in a carton 
with a blinded label 
and a tamper-evident 
seal, and will be 
labeled as required per 
country requirement.
Study intervention will 
be provided in a 
single-dose PFS.  Each 
syringe will be 
packaged in a carton 
with a blinded label 
and a tamper-evident 
seal, and will be 
labeled as required per 
country requirement.
6.1.1. Administration
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 investigational products should be performed by an appropriately 
qualified, Good Clinical Practice (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. 
Investigational product administration details will be recorded on the case report form (CRF).
Table 2 describes the administration details for each vaccine.  Each vaccine will be 
administered as a 0.5-mL dose in the upper deltoid muscle of the left or right arm.

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Table 2.
Investigational Product Administration Schedule
Investigational Product
Group(s)
Visit(s)
Upper Deltoid Muscle 
Injection Location
Trumenba
2, 4, 6, and 8
1 and 3
Left arm
MenABCWY
1, 3, 5, and 7
1 and 3
Left arm
MenACWY-CRM
2, 4, 6, and 8
1
Right arm
Placebo
1, 3, 5, and 7
1
Right arm
6.1.2. Medical Devices
In this study, medical devices being used will be the vial adaptor for MenABCWY, as well as 
the PFSs for placebo and Trumenba.
Instructions for medical device use are provided in the IP manual.
Medical device incidents, including those resulting from malfunctions of the device, must be 
detected, documented, and reported by the unblinded study personnel throughout the study.  
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, as applicable for 
temperature-monitored shipments.
2.
Investigational product will be shipped to the study site after required regulatory and 
legal documents have been received by the sponsor.  These will be shipped at +2°C to 
+8°C.  Upon receipt at the study site, the investigational product should be immediately 
transferred to a +2°C to +8°C temperature-monitored refrigerator for storage.
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 temperature since previously documented for all site storage locations upon 
return to business.

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4.
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).  All study interventions will be 
accounted for using an investigational product accountability form/record. Used needles 
and syringes should be disposed of according to local practice.  Empty outer 
investigational product containers must be retained until reviewed by the sponsor's 
representative and then may be destroyed after the sponsor’s representative has 
performed accountability.  Investigational product return/destruction must be 
documented on the accountability log.
5.
Further guidance and information for the final disposition of unused study interventions 
are provided in the IP manual.
6.
Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the product label.
7.
Study interventions should be stored in their original containers and in accordance with 
the labels.
8.
See the IP manual for storage conditions of the study intervention once reconstituted.
9.
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.  It will not be considered a protocol deviation if Pfizer approves the use of 
the study intervention after the temperature excursion. Use of the study intervention 
prior to Pfizer approval will be considered a protocol deviation. 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.
10. 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.
11. The sponsor or designee will provide guidance on the destruction of unused study 
intervention (eg, at the site).  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, and all destruction must be adequately documented.
Additional details about accountability, storage, destruction, and excursion reporting can be 
found in the IP manual.

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6.2.1. Preparation and Dispensing
See the IP manual for instructions on how to prepare the investigational product for 
administration.  Investigational product should be prepared and dispensed by an unblinded 
appropriately qualified and experienced member 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. The investigational product will be 
administered to participants who are blinded.
6.3. Measures to Minimize Bias: Randomization and Blinding
6.3.1. Allocation to Investigational Product
Allocation (randomization) of participants to vaccine groups will proceed through the use of 
an interactive response technology (IRT) system that is accessible 24 hours a day, 365 days a 
year.  Having logged in, the site personnel (study coordinator or specified designee) will be 
required to enter or select certain information including but not limited to the user’s 
identification (ID) and password, protocol number, the participant number, if the participant 
should be considered ACWY-naïve or -experienced, and the date of birth of the participant.  
The site personnel will then be provided with a participant randomization number and 
dispensable unit (DU) or container number.  The randomization number and the date on 
which the randomization number was assigned will be recorded on the CRF.  Once 
participant numbers, DU numbers, and randomization numbers have been assigned, they 
cannot be reassigned.  The IRT system will provide a confirmation report containing the 
participant randomization number and DU or container number assigned.  The confirmation 
report must be stored in the site’s files.
The study-specific IRT reference manual will provide the contact information and further 
details on the use of the IRT system.
6.3.2. Blinding of Site Personnel
In this observer-blinded study, the study staff dispensing, preparing, and administering the 
vaccine will be unblinded.  All other study and site personnel, including the investigator, 
investigator staff, participants, and participants’ parent(s)/legal guardian, will be blinded to 
investigational product assignments.  In particular, the individuals who evaluate participant 
safety will be blinded.  Because the investigational products are different in physical 
appearance, the investigational product syringes will be administered in a manner that 
prevents the study participants from identifying the vaccine type based on its appearance.
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.  The remaining site personnel must not 
know investigational product assignments.

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6.3.3. Blinding of the Sponsor
Those study team members who are involved in ensuring that protocol requirements for 
investigational product 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.  All other study team members and 
all laboratory testing personnel performing serology assays will remain blinded to vaccine 
assigned/received throughout the study.  All laboratory testing personnel performing 
serology assays will also remain blinded to visit number throughout the study.
6.3.4. Breaking the Blind
At the initiation of the study, 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.
In case of an emergency, when knowledge of the investigational product 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
All doses of investigational product will be administered by the appropriately designated 
study staff at the investigator site.
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 4 (approximately 1 month after Vaccination 2) 
will be recorded on the CRF.
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 5 will be recorded in the CRF.
Hormonal contraceptives that meet the requirements of this study are allowed to be used in 
participants who are women of childbearing potential (WOCBP) (see Appendix 4).
6.5.1. Prohibited During the Study

Receipt of any blood products, including immunoglobulin.

Nonstudy meningococcal vaccines.

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
Nonlive or live nonstudy vaccines are not permitted 14 and 28 days, respectively, before 
or after any study vaccination (see exception below for any COVID-19 vaccination).
Guidance provided by the US CDC states that COVID-19 vaccines and other vaccines 
may now be administered without regard to timing. Because of the COVID-19 pandemic 
and the ongoing COVID-19 vaccinations at the time of study recruitment, participants 
will be allowed to receive any authorized (nonexperimental) COVID-19 vaccination 
within 8 days of investigational product administration (ie, not permitted 7 days before or 
after any study vaccination).

Intramuscular/sublingual allergen immunotherapy is not permitted within 14 days of any 
study vaccination.

Systemic (oral, intravenous, or intramuscular) corticosteroid therapy within 28 days of 
any study vaccination.
6.5.2. Permitted During the Study

Nonstudy vaccines used in the event of a disease outbreak or pandemic are allowed.  
However, while prioritizing standard clinical care, efforts should be made not to 
administer nonstudy vaccines within 14 days (for nonlive vaccines) or 28 days (for live 
vaccines) as specified below (see exception below for any COVID-19 vaccination).
Guidance provided by the US CDC states that COVID-19 vaccines and other vaccines 
may now be administered without regard to timing. Because of the COVID-19 pandemic 
and the ongoing COVID-19 vaccinations at the time of study recruitment, participants 
will be allowed to receive any authorized (nonexperimental) COVID-19 vaccination 
within 8 days of investigational product administration (ie, not permitted 7 days before or 
after any study vaccination).

Nonstudy vaccines (other than any meningococcal vaccines) that are part of 
recommended immunization schedules are allowed anytime during the study but should 
not be administered within 14 days (for nonlive vaccines) and 28 days (for live vaccines) 
of investigational product administration

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.

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6.5.3. Prior Vaccinations and Treatments
If the participant is known to have ever received a polyribosylribitol phosphate 
oligosaccharide of Haemophilus influenzae type b conjugated to outer membrane protein 
(PRP-OMP) vaccine, the name of the vaccine and date of administration will be recorded on 
the CRF.
Only participants who have never received a prior dose, or who have received not more than 
1 prior dose no sooner than 4 years prior to the date of randomization, of Menveo or 
Menactra may be enrolled (Section 5).  If the participant has received any prior 
meningococcal vaccines or vaccines containing 1 or more ACWY groups, the trade name 
(if known) and date of administration will be recorded on the CRF.  Please refer to the SRM 
for a list of ACWY-containing vaccines that are or have been commercially available.  
Written confirmation of vaccination history should be obtained prior to randomization.  
6.5.4. Prohibited Prior Treatments
Receipt of any blood products, including immunoglobulin, within 6 months 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
Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the institutional review board (IRB)/ethics committee (EC), or 
investigational product 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 withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, 
or administrative reasons.

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If a participant does not return for a scheduled visit, every effort should be made to contact 
the participant.  All attempts to contact the participant 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.  
At the time of discontinuing, please refer to the SRM and SoA for assessments to be 
collected at the time of study discontinuation and follow-up and for any further evaluations 
that need to be completed. 
Participants should be questioned regarding their reason for withdrawal.  The investigator or 
his or her designee should capture the reason for withdrawal in the CRF for all participants.
The participant should be requested to return for a final visit, if applicable, and the 
investigator will perform the procedures indicated for the next 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.  
A final telephone contact 6 months after the last vaccination Section 8.10.1.5 for the 
collection of safety information should be completed for all participants who withdraw or 
have been withdrawn after administration of investigational product, 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 investigational product or also from study 
procedures and/or postvaccination study follow-up.
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples, but data already generated from the samples will continue to be available, and may 
be used to protect the integrity of existing analyses.  The investigator must document any 
such requests in the site study records.
If the participant withdraws from the study and also withdraws consent 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.
When a participant withdraws from the study because of an SAE, the SAE must be recorded 
on the CRF and reported on the Clinical Trial (CT) SAE Report.
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.
7.3. 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 is unable to be contacted by the study site.

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The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:

The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant 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 (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods).  These contact attempts should be documented in the participant’s 
medical record;

Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
Discontinuation of specific sites or of the study as a whole is handled as part of Appendix 1.
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.  
Study procedures and their timing are summarized in the SoA.  Protocol waivers or 
exemptions are not allowed.
Immediate safety concerns should be discussed with the sponsor immediately upon 
occurrence or awareness to determine if 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.

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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 the immunogenicity 
subset of this study is approximately 75 or 100 mL (depending on the amount of blood the 
participant has agreed to colled at Visit 4: 25 or 50 mL).  The actual collection times of blood 
sampling may change. 
8.1. Efficacy Assessments
Not applicable.
8.1.1. Immunogenicity Assessments
To facilitate immunogenicity analyses, participants in the immunogenicity subset will have 
approximately 25 mL of blood collected at Visit 1 (prior to Vaccination 1) and Visit 2 
(1 month after Vaccination 1) and 25 or 50 mL of blood collected at Visit 4 (1 month after 
Vaccination 2). Sera obtained from participants at all time points will be used in these 
assays.  LOD and LLOQ titers for these assays will be detailed in the statistical analysis plan
(SAP). For participants ≥16 years of age who consent to providing an additional 25 mL 
(total 50 mL) of blood at Visit 4, the additional sera will be used for further assay 
development and validation and may be used to support current and ad hoc study endpoint 
immunogenicity analyses.
8.1.1.1. MenA, MenC, MenW, and MenY Serum Bactericidal Assays
For assessment of the immune response to MenACWY-CRM and the ACWY components of 
MenABCWY, test strains specific for each of the ACWY groups (A [PMB277], 
C [PMB3204], W [PMB6270], Y [PMB3385]) will be used in the hSBAs for determination 
of the immunogenicity endpoints in this study.  
8.1.1.2. MenB Serum Bactericidal Assays
For assessment of the immune response to Trumenba and the B component of MenABCWY, 
4 primary MenB test strains, PMB80 (A22), PMB2001 (A56), PMB2948 (B24), and 
PMB2707 (B44), will be used in the hSBAs for determination of the immunogenicity 
endpoints in this study.

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8.1.2. Biological Samples
Blood 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 concerns.
Any participant who received at least 1 dose of investigational product will be included in the 
evaluation for safety.  The following safety parameters will be assessed as described in the 
Study Procedures section (Section 8.10) and Section 1.3:

Physical examination.

Reactogenicity: solicited local reactions and systemic events, including fever.

Use of antipyretic medication.

Unsolicited 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.  When taking the medical history and 
performing the physical examination, particular care must be taken to note any 
neuroinflammatory and autoimmune conditions, such as transverse myelitis, uveitis, optic 
neuritis, and multiple sclerosis.  Significant medical history and observations from the 
physical examination will be documented on the CRF.  In addition, a urine pregnancy test 
will be performed on all female participants.

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The safety parameters include reactogenicity, ie, both local reactions and systemic events that 
occur in the 7 days (Days 1 to 7) after investigational product administration.  These 
prompted e-diary events are:

Local reactions at the site of investigational product administration (redness, swelling, 
and pain).

Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other 
than muscle pain at the injection site, and joint pain).
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 were 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 investigational 
product 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 investigational product 
administration.
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, medication use, and days of 
school or work missed 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 and days of school or work missed not associated 
with an AE 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 SRM for details.
Participants will be given a memory aid at Visit 3.  The memory aid will be used to remind 
participants to review any significant illnesses, hospitalizations, NDCMCs, or visits to a 
medical facility with study site personnel. Participants may use the memory aid as needed 
during the telephone contact at Visit 5 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 (Visit 5) 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.

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8.2.1. Electronic Diary
An e-diary will be issued based on a personal digital assistant or equivalent technology, and 
used to monitor and record the participant’s local reactions, systemic events, and use of 
antipyretic medication for 7 days after each vaccination.  Grading scales for local reactions 
and systemic events are based on US Food and Drug Administration (FDA) Guidance for 
Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in 
Preventive Vaccine Clinical Trials.14  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 should contact the parent(s)/legal 
guardian or participant in order to obtain stop dates for any solicited reactions or other 
solicited data ongoing on the last day that the e-diary was completed.
Data reported on 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 to 
evaluate participant compliance and as part of the ongoing safety review.
8.2.1.1. Local Reactions
Local reactions (redness, swelling, and pain) at the site of investigational product 
administration will be recorded daily for 7 days (Days 1 to 7) after each vaccination.  Only 
local reactions at the site of investigational product administration on the left arm will be 
recorded.
8.2.1.1.1. Redness and Swelling
Redness and swelling will be measured and recorded in caliper units (range: 1 to 21+), and 
then categorized as none, mild, moderate, or severe based on the scale given in Table 3.  
Each caliper unit represents 0.5 cm.  A caliper will be issued with instructions for measuring 
any redness or swelling at the injection site.  The caliper will be used to measure and to 
report the largest diameter of a local reaction.  In the event that a caliper measurement is 
between 2 values, the higher value should be reported.  The measurements will then be 
recorded in the e-diary.

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In the event the reaction exceeds the maximum size the caliper is able to measure 
(21 caliper units), the parent(s)/legal guardian or participant will also measure the 
maximum diameter of the redness and/or swelling at the injection site using the measuring 
tape/ruler provided and report this immediately to the investigator.  The parent(s)/legal 
guardian or participant will report the maximum diameter of the redness and/or swelling at 
the injection site to the investigator daily until the reaction becomes ≤21 caliper units.  These 
measurements will be recorded in the CRF.
Table 3.
Grading of Redness and Swelling
None
0 to 2.0 cm (0 to 4 caliper units)
Mild
2.0 to 5.0 cm (5 to 10 caliper units)
Moderate
5.0 to 10.0 cm (11 to 20 caliper units)
Severe
10.0 cm (20 caliper units)
8.2.1.1.2. Pain
If the participant experiences injection site pain, the pain will be graded using the scale in 
Table 4.  The assessment will then be recorded in the e-diary.
Table 4.
Grading of Pain
Mild
Does not interfere with activity
Moderate
Interferes with activity
Severe
Prevents daily activity
8.2.1.2. Systemic Events
8.2.1.2.1. Temperature
A digital thermometer will be given to the parent(s)/legal guardian or the participant with 
instructions on how to measure the participant’s oral temperature at home.  Oral temperature 
will be collected at in the evening daily for 7 days (Day 1 to Day 7) after each vaccination, 
and at any time during the 7 days when fever is suspected.  The highest temperature for each 
day will be recorded in the e-diary.  Fever is defined as temperature of ≥38.0°C (100.4°F).
Temperature will be measured and recorded to 1 decimal place and then categorized 
according to the severity scale in Table 5.
Table 5.
Severity Scale for Fever
Temperature 38.0°C to 38.4°C (100.4°F to 101.1°F)
Temperature 38.5°C to 38.9°C (101.2°F to 102.0°F)
Temperature 39.0°C to 40.0°C (102.1°F to 104.0°F)
Temperature 40.0°C (104.0°F)

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8.2.1.2.2. Other Systemic Events
The e-diary will be used to record the presence of other systemic events, including vomiting, 
diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, 
and joint pain daily for 7 days (Day 1 to Day 7) after each vaccination, using the scales in 
Table 6.
Table 6.
Grading of Other Systemic Events
Grade 1 (Mild)
Grade 2 (Moderate)
Grade 3 (Severe)
Vomiting
1 to 2 times in 24 hours
>2 times in 24 hours
Requires IV hydration
Diarrhea
2 to 3 loose stools in 
24 hours
4 to 5 loose stools in 
24 hours
6 or more loose stools in 
24 hours
Headache
Does not interfere with 
activity
Some interference with 
activity
Prevents daily routine 
activity
Fatigue
Does not interfere with 
activity
Some interference with 
activity
Prevents daily routine 
activity
Chills
Does not interfere with 
activity
Some interference with 
activity
Prevents daily routine 
activity
Muscle pain (other than 
muscle pain at the injection 
site)
Does not interfere with 
activity
Some interference with 
activity
Prevents daily routine 
activity
Joint pain 
Does not interfere with 
activity
Some interference with 
activity
Prevents daily routine 
activity
Abbreviation: IV = intravenous.
8.2.1.2.3. Use of Antipyretic Medication
The use of antipyretic medication will be recorded in the e-diary daily during the active 
safety observation periods (Day 1 to Day 7) for each vaccination.
8.2.2. Pregnancy Testing 
Urine pregnancy tests will have a sensitivity of at least 25 mIU/mL.  Pregnancy tests will be 
performed in WOCBP at the times listed in the SoA, immediately before the administration 
of the vaccine.  A negative pregnancy test result will be required prior to the participant’s 
receiving the investigational product.  Pregnancy tests may also be repeated if requested by 
IRBs/ECs or if required by local regulations.
In the case of a positive confirmed pregnancy at Visit 1, the participant will not be eligible 
for participation.
8.3. Adverse Events and Serious Adverse Events
The definitions of an AE and an SAE can be found in Appendix 3.
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or 
the participant's legally authorized representative).

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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 it 
meets the criteria for classification as an SAE or caused the participant to discontinue from 
the study (see Section 7). 
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
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/parent(s)/legal guardian begins from the time the participant 
provides informed consent, which is obtained before the participant’s participation in the 
study (ie, before undergoing any study-related procedure and/or receiving investigational 
product), through and including Visit 4. At Visit 5, the participant will be contacted by 
telephone to inquire about SAEs, MAEs, and NDCMCs, since Visit 4.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
Medical occurrences that begin before the start of study intervention but after obtaining 
informed consent will be recorded on the Medical History/Current Medical Conditions 
section of the CRF, not the AE section.
Follow-up by the investigator continues throughout and after the active collection period and
until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and 
Pfizer concurs with that assessment.
Investigators are not obligated to actively seek AEs or SAEs after conclusion of the study 
participation.  However, if the investigator learns of any SAE, including a death, at any time 
after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study intervention or study participation, the investigator must 
promptly notify the sponsor.
8.3.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period are reported to Pfizer 
Safety on the Vaccine SAE Reporting Form immediately 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.
SAEs occurring in a participant after the active collection period has ended are reported to 
Pfizer Safety if the investigator becomes aware of them; at a minimum, all SAEs that the 
investigator believes have at least a reasonable possibility of being related to investigational 
product must be reported to Pfizer Safety.

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8.3.1.2. Recording Nonserious AEs and SAEs on the CRF
During the active collection period, both nonserious AEs and SAEs are recorded on the CRF.
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.
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 suspected unexpected serious adverse 
reactions (SUSARs) according to local regulatory requirements and sponsor policy and 
forwarded to investigators as necessary.
An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the sponsor will review 
and then file it along with the IB and will notify the IRB/EC, if appropriate according to local 
requirements.

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8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the investigational product under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness.
8.3.5.1. Exposure During Pregnancy
Details of all pregnancies in female participants and, if indicated, female partners of male 
participants will be collected after the start of study intervention and until the end of study 
participation.
If a pregnancy is reported, the investigator should inform the sponsor within 24 hours of 
learning of the pregnancy and should follow the procedures outlined in Appendix 4.
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs.
8.3.5.2. Exposure During Breastfeeding
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated SAE, to Pfizer Safety within 24 hours of the investigator’s awareness, using the
Vaccine SAE Reporting Form.  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’s administration, the SAE is reported together with the exposure 
during breastfeeding.
8.3.5.3. Occupational Exposure
An occupational exposure occurs when, during the performance of job duties, a person 
(whether a healthcare professional or otherwise) gets in unplanned direct contact with the 
product, which may or may not lead to the occurrence of an AE.
An occupational exposure is reported to Pfizer Safety within 24 hours of the investigator’s 
awareness, using the Vaccine SAE Reporting Form, regardless of whether there is an 
associated SAE.  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. Medical Device Incidents (Including Malfunctions)
Medical devices are being provided for use in this study for the purposes of administering 
and preparing investigational product. In order to fulfill regulatory reporting obligations 
worldwide, the unblinded site staff is responsible for the detection and documentation of 
events meeting the definitions of incident or malfunction that occur during the study with 
such devices.
The definition of a medical device incident can be found in Appendix 6.

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NOTE: Incidents fulfilling the definition of an AE/SAE will also follow the processes 
outlined in Section 8.3.3 and Appendix 3 of the protocol.
8.3.6.1. Time Period for Detecting Medical Device Incidents
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 the investigator learns of any incident 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 incidents is provided in Appendix 6.
8.3.6.2. Follow-up of Medical Device Incidents
All medical device incidents involving an AE will be followed and reported in the same 
manner as other AEs (see Section 8.3.3).  This applies to all participants, including those who 
discontinue study intervention.
The unblinded site staff are responsible for ensuring that follow-up includes any 
supplemental investigations as indicated to elucidate the nature and/or causality of the 
incident.
New or updated information will be recorded on the originally completed form with all 
changes signed and dated by the unblinded site staff.
8.3.6.3. Prompt Reporting of Medical Device Incidents to Sponsor
Medical device incidents will be reported to the sponsor within 24 hours after the unblinded 
site staff determines that the event meets the protocol definition of a medical device incident.
Information will be provided to the sponsor as described in the IP manual.
The same individual will be the contact for the receipt of medical device reports and SAEs.
8.3.6.4. Regulatory Reporting Requirements for Medical Device Incidents
The investigator will promptly report all incidents 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 incidents to the IRB/EC.

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8.3.7. Medication Errors
Medication errors may result from the administration or consumption of the investigational 
product by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Exposures to the investigational product 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 investigational product;

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:

The administration of expired investigational product;

The administration of an incorrect investigational product;

The administration of an incorrect dosage;

The administration of investigational product that has undergone temperature excursion 
from the specified storage range, unless it is determined by the sponsor that the 
investigational product 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 immediately.
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 an 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.

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8.4. Treatment of Overdose
For this study, any dose of investigational product greater than 1 dose of investigational 
product within a 24-hour time period 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 immediately.
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 
Not applicable.
8.6. Pharmacodynamics
Not applicable.
8.7. Genetics
Not applicable.
8.8. Biomarkers
Biomarkers are not evaluated in this study.
8.9. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
8.10. Study Procedures
8.10.1. Group 1-4 Participants - Immunogenicity Subset
8.10.1.1. Visit 1 (Day 1): Vaccination 1
In the case of temporary delay of vaccination, procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination.

Obtain written informed consent, and assent if appropriate, before performing 
study-specific procedures.  The date of informed consent will be recorded on the CRF.

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
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 described in the Prior Vaccinations and 
Treatments section (Section 6.5.3).

Record any prior meningococcal vaccines or vaccines containing 1 or more ACWY 
groups as described in the Prior Vaccinations and Treatments section (Section 6.5.3).

Perform physical examination 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 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, perform a urine pregnancy test on female participants.  
A negative pregnancy test result is required before the participant may receive the 
investigational product.

On the day of and before vaccination, measure and record the participant’s oral 
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, randomize the participant using an interactive 
voice response system (IVRS), interactive Web-based response system (IWRS), or an 
equivalent system.

On the day of and before vaccination, collect a blood sample (approximately 25 mL).  
Collect the blood sample only if the participant is eligible for vaccination on the same 
day.

The unblinded administrator administers a single 0.5-mL intramuscular injection of either 
MenABCWY (Groups 1 and 3) or Trumenba (Groups 2 and 4) into the upper deltoid 
muscle of the left arm; and either MenACWY-CRM (Groups 2 and 4) or saline (Groups 1 
and 3) into the upper deltoid muscle of the right arm.  The time of investigational product 
administration will be recorded on the CRF.

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
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 the AE reporting requirements section (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 the Concomitant 
Therapy section (Section 6.5).

Issue a participant e-diary and provide instruction on its completion.  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.

Issue a caliper, a measuring tape/ruler, and a digital thermometer and provide instructions 
on their use.

Measuring tape/ruler data must be collected by the parent(s)/legal guardian for minor 
participants.  All data must be recorded in the e-diary by the parent(s)/legal guardian for 
minor participants.

Ask the parent(s)/legal guardian or the participant to use the caliper to measure the 
maximum diameter of redness and swelling at the left arm 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 or the participant to contact the investigator immediately 
if the participant experiences severe redness or swelling (20 caliper units) at the left arm 
injection site, a fever ≥39.0°C (102.1°F), or a severe headache within 7 days after 
vaccination, as an unscheduled visit should be arranged (Section 8.11).

If the reaction exceeds the maximum size the caliper is able to measure (>21 caliper 
units), the parent(s)/legal guardian or the participant should also use the measuring 
tape/ruler to measure the maximum diameter of redness and/or swelling at the injection 
site, and report this immediately to the investigator. 

Ask the parent(s)/legal guardian or participant to report the maximum diameter of the 
redness and/or swelling at the injection site to the investigator daily until the reaction 
becomes ≤21 caliper units.

Provide the parent(s)/legal guardian or participant with a contact card (Section 10.1.10).

Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs.

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
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 or participant 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 or the participant to obtain stop dates for any local reactions, 
systemic events, or use of antipyretic medication that were 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.
8.10.1.2. Visit 2 (28 to 42 Days After Visit 1), Post–Vaccination 1 Blood Draw

Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements detailed in Section 5.

Ensure that the participant continues to meet none of the withdrawal criteria and none of 
the temporary delay of blood draw criteria as described in Section 5.2.1.

Collect the participant’s e-diary.

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, medication use, or missed days of 
school or work.  Please refer to the SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the SRM for 
additional details.

Record AEs as described in the AE reporting requirements section (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.

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
Record nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5).

Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5).

Collect a blood sample (approximately 25 mL). 

Ask the parent(s)/legal guardian or the participant 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.

Complete the CRFs.
8.10.1.3. Visit 3 (173 to 194 Days After Visit 1): Vaccination 2
In the case of temporary delay of vaccination, procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination.

Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements detailed in Section 5.

Ensure that the participant continues to meet none of the withdrawal criteria as described 
in Section 5.2.1 and none of the temporary delay of vaccination or blood draw criteria as 
described in Section 5.2.1.

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 SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the SRM for 
additional details.

Record AEs as described in the AE reporting requirements section (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.

Review AEs that were ongoing from the previous visit and record their end dates or 
confirm that they are still continuing.

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
Record nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5).

Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5).

On the day of vaccination, perform a urine pregnancy test on female participants.  
A negative pregnancy test result is required before the participant may receive the 
investigational product.

On the day of and before vaccination, measure and record the participant’s oral 
temperature.

The unblinded administrator administers a single 0.5-mL intramuscular injection of either 
MenABCWY (Groups 1 and 3) or Trumenba (Groups 2 and 4) into the upper deltoid 
muscle of the left arm.  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).

Issue a participant e-diary and provide instruction on its completion.  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.

Issue a caliper, a measuring tape/ruler, and a digital thermometer and provide instructions 
on their use.

Measuring tape/ruler data must be collected by the parent(s)/legal guardian for minor 
participants.  All data must be recorded in the e-diary by the parent/legal guardian for 
minor participants.

Ask the parent(s)/legal guardian or the participant to use the caliper to measure the 
maximum diameter of redness and swelling at the left arm 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 or the participant to contact the investigator immediately 
if the participant experiences a severe redness or swelling (20 caliper units) at the left 
arm injection site, a fever ≥39.0°C (102.1°F), or a severe headache within 7 days after 
vaccination, as an unscheduled visit should be arranged (Section 8.11).

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
If the reaction exceeds the maximum size the caliper is able to measure (21 caliper 
units), the parent/legal guardian or the participant should also use the measuring 
tape/ruler to measure the maximum diameter of redness and/or swelling at the injection 
site, and report this immediately to the investigator. 

Ask the parent(s)/legal guardian or participant to report the maximum diameter of the 
redness and/or swelling at the injection site to the investigator daily until the reaction 
becomes ≤21 caliper units.

Provide the parent(s)/legal guardian or the participant with a memory aid. Instruct the 
participant to use the memory aid between Visits 4 and 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 SRM for additional details.

Ask the parent(s)/legal guardian or the participant 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.

Ask the parent(s)/legal guardian or the participant to bring the e-diary to the next 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 or the participant to obtain stop dates for any local reactions,
systemic events, or use of antipyretic medication that were 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.
8.10.1.4. Visit 4 (28 to 42 Days After Visit 3), Post–Vaccination 2 Blood Draw

Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements detailed in Section 5.

Ensure that the participant continues to meet none of the withdrawal criteria and none of 
the temporary delay of blood draw criteria as described in Section 5.2.1.

Collect the participant’s e-diary.

Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication.

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
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 SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis. Please refer to the SRM for 
additional details.

Record AEs as described in the AE reporting requirements section (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 nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5).

Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5).

Collect a blood sample (approximately 25 mL [or 50 mL for the subset of consented 
participants ≥16 years of age]).  

Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs.

Schedule a telephone contact and confirm that it is scheduled within the time window per 
protocol.

Complete the source documents.

Complete the CRFs.
8.10.1.5. Visit 5 (168 to 196 Days After Last Vaccination), 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.

Contact the parent(s)/legal guardian or the participant by telephone.

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
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 SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis. A checklist will be provided 
as a guide. Please refer to the SRM for additional details.

Report any SAEs to the sponsor as defined in Section 8.3.

Record AEs as described in the AE reporting requirements section (Section 8.3) and the
SoA.

Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy Section 6.5.

Review AEs that were ongoing since the previous visit and record their end dates or 
confirm that they are still continuing.

Complete the source documents.

Complete the CRFs.
8.10.2. Group 5-8 Participants - Safety Subset
8.10.2.1. Visit 1 (Day 1): Vaccination 1
In the case of temporary delay of vaccination, procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination.

Obtain written informed consent, and assent if appropriate, 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 described in the Prior Vaccinations and 
Treatments section (Section 6.5.3).

Record any prior meningococcal vaccines or vaccines containing 1 or more ACWY 
groups as described in the Prior Vaccinations and Treatments section (Section 6.5.3).

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
Perform physical examination 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 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, perform a urine pregnancy test on female participants.  A 
negative pregnancy test result is required before the participant may receive the 
investigational product.

On the day of and before vaccination, measure and record the participant’s oral 
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, randomize the participant using an IVRS, IWRS, 
or an equivalent system.

The unblinded administrator administers a single 0.5-mL intramuscular injection of either 
MenABCWY (Groups 5 and 7) or Trumenba (Groups 6 and 8) into the upper deltoid 
muscle of the left arm; and either MenACWY-CRM (Groups 6 and 8) or saline (Groups 5 
and 7) into the upper deltoid muscle of the right arm.  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 the AE reporting requirements section (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 the Concomitant 
Therapy section (Section 6.5).

Issue a participant e-diary and provide instruction on its completion.  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.

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
Issue a caliper, a measuring tape/ruler, and a digital thermometer and provide instructions 
on their use.

Measuring tape/ruler data must be collected by the parent(s)/legal guardian for minor 
participants.  All data must be recorded in the e-diary by the parent(s)/legal guardian for 
minor participants.

Ask the parent(s)/legal guardian or the participant to use the caliper to measure the 
maximum diameter of redness and swelling at the left arm 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 or the participant to contact the investigator immediately 
if the participant experiences severe redness or swelling (20 caliper units) at the left arm 
injection site, a fever ≥39.0°C (102.1°F), or a severe headache within 7 days after 
vaccination, as an unscheduled visit should be arranged (Section 8.11).

If the reaction exceeds the maximum size the caliper is able to measure (21 caliper 
units), the parent(s)/legal guardian or the participant should also use the measuring 
tape/ruler to measure the maximum diameter of redness and/or swelling at the injection 
site, and report this immediately to the investigator. 

Ask the parent(s)/legal guardian or participant to report the maximum diameter of the 
redness and/or swelling at the injection site to the investigator daily until the reaction 
becomes ≤21 caliper units.

Provide the parent(s)/legal guardian or participant with a contact card (Section 10.1.10).

Ask the parent(s)/legal guardian or the participant 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 or participant 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 or the participant to obtain stop dates for any local reactions, 
systemic events, or use of antipyretic medication that were 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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Final Protocol Amendment 2, 13 June 2022
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8.10.2.2. Visit 2 (28 to 42 Days After Visit 1), Post–Vaccination 1 Telephone Contact

Visit 2 will be a telephone contact for participant in the safety subset (Groups 5-8).

Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements detailed in Section 5.

Ensure that the participant continues to meet none of the withdrawal criteria and none of 
the temporary delay of blood draw criteria as described in Section 5.2.1.

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, medication use, or missed days of 
school or work.  Please refer to the SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the SRM for 
additional details.

Record AEs as described in the AE reporting requirements section (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 nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5).

Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5).

Ask the parent(s)/legal guardian or the participant 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.

Complete the CRFs.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Final Protocol Amendment 2, 13 June 2022
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8.10.2.3. Visit 3 (173 to 194 Days After Visit 1): Vaccination 2
In the case of temporary delay of vaccination, procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination.

Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements detailed in Section 5.

Ensure that the participant continues to meet none of the withdrawal criteria as described 
in Section 5.2.1 and none of the temporary delay of vaccination or blood draw criteria as 
described in Section 5.2.1.

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 SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the SRM for 
additional details.

Record AEs as described in the AE reporting requirements section (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.

Review AEs that were ongoing from the previous visit and record their end dates or 
confirm that they are still continuing.

Record nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5).

Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5).

On the day of vaccination, perform a urine pregnancy test on female participants.  
A negative pregnancy test result is required before the participant may receive the 
investigational product.

On the day of and before vaccination, measure and record the participant’s oral 
temperature.

The unblinded administrator administers a single 0.5-mL intramuscular injection of either 
MenABCWY (Groups 5 and 7) or Trumenba (Groups 6 and 8) into the upper deltoid 
muscle of the left arm.  The time of investigational product administration will be 
recorded on the CRF.

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Final Protocol Amendment 2, 13 June 2022
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
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).

Issue a participant e-diary and provide instruction on its completion.  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.

Issue a caliper, a measuring tape/ruler, and a digital thermometer and provide instructions 
on their use.

Measuring tape/ruler data must be collected by the parent(s)/legal guardian for minor 
participants.  All data must be recorded in the e-diary by the parent/legal guardian for 
minor participants.

Ask the parent(s)/legal guardian or the participant to use the caliper to measure the 
maximum diameter of redness and swelling at the left arm 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 or the participant to contact the investigator immediately 
if the participant experiences a severe redness or swelling (20 caliper units) at the left 
arm injection site, a fever ≥39.0°C (102.1°F), or a severe headache within 7 days after 
vaccination, as an unscheduled visit should be arranged (Section 8.11).

If the reaction exceeds the maximum size the caliper is able to measure (21 caliper 
units), the parent/legal guardian or the participant should also use the measuring 
tape/ruler to measure the maximum diameter of redness and/or swelling at the injection 
site, and report this immediately to the investigator. 

Ask the parent(s)/legal guardian or participant to report the maximum diameter of the 
redness and/or swelling at the injection site to the investigator daily until the reaction 
becomes ≤21 caliper units.

As detailed in the SRM, provide the participant with instructions and materials for 
returning the e-diary to the investigational site after completion.

Provide the parent(s)/legal guardian or the participant with a memory aid. Instruct the 
participant to use the memory aid between Visits 4 and 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 SRM for additional details.

Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs.

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
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 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 or the participant to obtain stop dates for any local reactions,
systemic events, or use of antipyretic medication that were 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.
8.10.2.4. Visit 4 (28 to 42 Days After Visit 3), Post–Vaccination 2 Telephone Contact

Visit 4 will be a telephone contact for participants in the safety subset (Groups 5-8).

Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements detailed in Section 5.

Ensure that the participant continues to meet none of the withdrawal criteria and none of 
the temporary delay of blood draw criteria as described in Section 5.2.1.

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, medication use, or missed days of 
school or work.  Please refer to the SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the SRM for 
additional details.

Record AEs as described in the AE reporting requirements section (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 nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5).

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
Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5).

Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs.

Schedule a telephone contact and confirm that it is scheduled within the time window per 
protocol.

Complete the source documents.

Complete the CRFs.
8.10.2.5. Visit 5 (168 to 196 Days After Last Vaccination), 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.

Contact the parent(s)/legal guardian or the participant 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 SRM for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis. A checklist will be provided 
as a guide. Please refer to the SRM for additional details.

Report any SAEs to the sponsor as defined in Section 8.3.

Record AEs as described in the AE reporting requirements section (Section 8.3) and the
SoA.

Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy Section 6.5.

Review AEs that were ongoing since the previous visit and record their end dates or 
confirm that they are still continuing.

Complete the source documents.

Complete the CRFs.

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8.11. Unscheduled Visits
If the participant experiences a severe redness or swelling at the left arm injection site 
(20 caliper units), a temperature ≥39.0°C (102.1°F), or a severe headache 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 or participant contact will be documented in the CRF.
If the reaction exceeds the maximum size the caliper is able to measure (21 caliper units,
Section 8.2.1.1.1), ensure the parent(s)/legal guardian or participant 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 or participant to report the maximum 
diameter of the redness and/or swelling at the injection site daily until the reaction becomes 
≤21 caliper units.  Record these measurements in the CRF.
At an unscheduled visit, the participant’s oral 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, 
severe redness/swelling, or severe headache, 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 
outlined 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.
9.1. Estimands and Statistical Hypotheses
9.1.1. Estimands
The estimands corresponding to each primary, secondary, and tertiary/exploratory objective 
are described in the table in Section 3. For estimands to evaluate the immunogenicity 
objectives for noninferiority, these estimands estimate the vaccine effect in the hypothetical 
setting where participants follow the study schedules and protocol requirements as directed. 
This addresses the objective of estimating the maximum potential difference between 2 
groups, since the impact of noncompliance is likely to diminish the observed difference 
between the 2 groups. The mechanism for missing data is assumed to be missing completely 
at random (MCAR), and 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.
9.1.2. Statistical Hypotheses
This study has 2 primary objectives and 1 secondary objective where hypothesis testing is 
applicable.  The primary objectives are 1) to demonstrate that the immune response induced 
by 2 doses of MenABCWY is noninferior to the immune response induced by 1 dose of 
MenACWY-CRM, for ACWY-naïve and ACWY-experienced participants separately and 
2) to demonstrate that the immune response for MenB induced by 2 doses of MenABCWY is 
noninferior to the immune response induced by 2 doses of Trumenba. The hypothesis testing 
for the secondary objective is to demonstrate that the immune response induced by 1 dose of 
MenABCWY is noninferior to the immune response induced by 1 dose of 
MenACWY-CRM, for ACWY-naïve and ACWY-experienced participants separately. 
Hypothesis testing for the secondary objective will be performed only if the primary 
objectives are successful.
For all objectives evaluating noninferiority of the immune response for MenA, MenC, 
MenW, and MenY, the definition of a seroresponder is a participant achieving at least a 
4-fold rise in hSBA titer from baseline for each ACWY test strain, at the relevant analysis 
time point.
For the ACWY noninferiority evaluation in ACWY-naïve participants, the immune response 
will be evaluated at 1 month following Vaccination 2 for Group 1 and at 1 month following 
Vaccination 1 for Group 2. The null hypothesis (H0) for each ACWY serogroup for 
noninferiority is as follows:
H0:  πG1- πG2 ≤ -10%
where πG1 and πG2 are the percentages of participants who achieve a 4-fold rise in hSBA 
titers for MenA, MenC, MenW, and MenY for Group 1 and Group 2, respectively.  
If the lower limit of the 2-sided 95% confidence interval (CI) for the difference in 
seroresponders (Group 1 – Group 2) is > -10% for all of the ACWY test strains (at 1 month 
after the second vaccination for Group 1 and at 1 month after the first vaccination for 
Group 2), the noninferiority of the MenABCWY regimen to the MenACWY-CRM regimen 
is declared for the ACWY-naïve participants.
For the ACWY noninferiority evaluation in ACWY-experienced participants, the approach 
will be identical to in ACWY-naïve participants, but Group 3 will be compared to Group 4, 
instead of Group 1 compared to Group 2. The noninferiority evaluations for both the 
ACWY-naïve and the ACWY-experienced participants are required to be successful to meet 
the first primary objective.

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The second primary objective will be evaluated at 1 month following Vaccination 2 and the 
post–Vaccination 2 evaluable population will be used. The null hypothesis (H0) for 
noninferiority for each primary MenB test strain is as follows:
H0:  πG1+G3- πG2+G4 ≤ -10%
where πG1+G3 and πG2+G4 are the percentages of 4-fold rises and composite responses for 
Groups 1 and 3 combined and for Groups 2 and 4 combined, respectively, at 1 month after 
the second vaccination. 
If the lower limit of the 2-sided 95% CI for the differences in 4-fold rises and composite 
responses (Group 1+3 – Group 2+4) is > -10% for all of the primary MenB test strains at 
1 month after the second vaccination, the noninferiority of the MenABCWY regimen to the 
Trumenba regimen is declared.
If noninferiority for both the primary objectives is demonstrated, then an additional 
noninferiority evaluation of the ACWY response will be performed. This evaluation will be 
a secondary objective and will be conducted as for the primary ACWY noninferiority 
assessment; however, the secondary objective will be an evaluation of noninferiority of 
seroresponders who achieve a 4-fold rise at 1 month following Vaccination 1 for both groups 
evaluated (Group 1 versus Group 2 for ACWY-naïve and Group 3 versus Group 4 for 
ACWY-experienced).
9.1.3. Multiplicity Considerations
All the primary immunogenicity endpoints/estimands are considered coprimary in the study. 
For the primary immunogenicity objectives comparing immune responses induced by 
vaccine antigens from the MenABCWY group(s) to that from the comparator group(s), 
noninferiority is assessed by hypothesis tests as stated in Section 9.1.2, at a 2-sided level of 
0.05 for each of the endpoints. The primary immunogenicity objectives will be met if  
noninferiority is achieved for each endpoint. Therefore, the type I error rate for the 
immunogenicity assessment is well controlled at the 0.05 level. If the primary objectives are 
met, then testing of noninferiority for all the secondary endpoints related to seroresponders 
who achieve a 4-fold rise at 1 month after Vaccination 1 will be done at the 0.05 level.
9.2. Sample Size Determination
9.2.1. Immunogenicity Subset (Groups 1-4)
Table 7 and Table 8 present the power to demonstrate that the immune response induced by 
2 doses of MenABCWY is noninferior to the immune response induced by 1 dose of 
MenACWY-CRM for ACWY-naïve and ACWY-experienced participants, respectively, and 
Table 9 presents the power to demonstrate that the immune response induced by 2 doses of 
MenABCWY is noninferior to the immune response induced by 2 doses of Trumenba. The 
study is powered based on a combined (product) power across both the primary objectives.

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Noninferiority comparisons will be based on the 4-fold rises and also composite response for 
the MenB endpoints (at 1 month following Vaccination 2) and seroresponders who achieve a 
4-fold response for the ACWY endpoints (at 1 month after Vaccination 2 for Groups 1 and 3 
and at 1 month after Vaccination 1 for Groups 2 and 4). The lower bounds of the 
corresponding 95% CIs of the group differences will be compared to the noninferiority 
criterion (-10%). 
With 360, 180, 540, and 270 evaluable participants in Groups 1, 2, 3, and 4, respectively, and 
the assumptions in the tables below, the power is:

above 99.9% to demonstrate noninferiority for the first primary objective relating to the 
ACWY response in ACWY-naïve participants, 

above 99.4% to demonstrate noninferiority for the first primary objective relating to the 
ACWY response in ACWY-experienced participants, and

above 91.6% for the second primary objective relating to the MenB response. 
The combined power, across both primary objectives, is above 91.0%.  Therefore, assuming 
a nonevaluable rate of 20%, 450, 225, 675, and 338 participants in Groups 1, 2, 3, and 4, 
respectively, will be enrolled to have sufficient evaluable participants.
Some participants may be moved from the safety subset to the immunogenicity subset as 
described in Section 4.1. The sponsor may decide to proceed with less than full enrollment if 
an assessment of power shows that it is sufficient (<91% with full enrollment but still >85%)
to meet the primary objectives. This assessment will be done in a completely blinded fashion 
before any participants are unblinded or the immunogenicity data are accessed.

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Table 7.
Power Analysis for First Primary Immunogenicity Objective (ACWY-Naïve Participants)
Criteria
ACWY Test 
Strains
Reference Rate 
(Group 2)a
Assumed 
Difference 
(G1 – G2)a
Number of 
Evaluable 
Participants 
(Group 1)
Number of 
Evaluable 
Participants
(Group 2)
Powerb
Power to Meet 
NI for All 
Serogroups
Lower limit of 95% 
CI for the difference 
in seroresponders 
(Group 1 – Group 2) 
> -10%
MenA
95.8%
0
360
180
99.96%
MenC
70%
15%
360
180
>99.99%
MenW
75.9%
15%
360
180
>99.99%
MenY
71.9%
15%
360
180
>99.99%
Power (to meet NI for all ACWY test strains) >99.93%
Abbreviations: ACWY = meningococcal groups A, C, W, and Y; G1 and G2 = Groups 1 and 2; MenA, MenC, MenW, and MenY = Neisseria meningitidis
groups A, C, W, and Y; NI = noninferiority.
a.
Reference Study B1971057, ACWY-naïve participants.
b.
At 0.05 alpha level (2-sided).
Table 8.
Power Analysis for First Primary Immunogenicity Objective (ACWY-Experienced Participants) 
Criteria
ACWY Test 
Strains
Reference Rate 
(Group 3)a
Assumed
Difference 
(G3 – G4)a
Number of 
Evaluable 
Participants 
(Group 3)
Number of 
Evaluable 
Participants 
(Group 4)
Powerb
Power to Meet NI 
for All Serogroups
Lower limit of 95% CI 
for the difference in 
seroresponders 
(Group 3 – Group 4) 
> -10%
MenA
97%
-1%
540
270
>99.99%
MenC
95.8%
-1%
540
270
>99.99%
MenW
97%
-2%
540
270
99.98%
MenY
94.6
-2%
540
270
99.49%
Power (to meet NI for all ACWY test strains) >99.45%
Abbreviations: ACWY = meningococcal groups A, C, W, and Y; G3 and G4 = Groups 3 and 4; MenA, MenC, MenW, and MenY = Neisseria meningitidis
groups A, C, W, and Y; NI = noninferiority.
a.
Reference Study B1971057, ACWY-experienced participants.
b.
At 0.05 alpha level (2-sided).

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Table 9.
Power Analysis for Second Primary Immunogenicity Objective 
Criteria
Endpoint
MenB 
Strain
Reference Rate 
(Groups 2 + 4)a
Assumed
Difference 
(G1 and G3 
Combined – G2 
and G4 
Combined) 
Number of 
Evaluable 
Participants 
(Groups 1 + 3 
Combined)
Number of 
Evaluable 
Participants 
(Groups 2 + 4 
Combined)
Powerb
Power to Meet 
NI for All 
Endpoints
Lower limit of 
95% CI for the 
difference in 
4-fold rises and 
composite 
responses 
(Groups 1 + 3 
combined –
Groups 2 + 4 
combined) 
> -10%
hSBA titer 
fold rise
≥4 from 
baseline
A22
73.8%
0
900
450
98.03%
A56
95%
0
900
450
>99.99%
B24
64.5%
0
900
450
95.64%
B44
86.4%
0
900
450
99.94%
Composite 
response
72.9%
0
900
450
97.80%
Power (to meet NI for all MenB endpoints) >91.63%
Abbreviations: G1, G2, G3, and G4 = Groups 1, 2, 3, and 4; hSBA = serum bactericidal assay using human complement; Men B = Neisseria meningitidis group 
B; NI = noninferiority.
a.
Reference Studies B1971057 and B1971012 (0-, 6-month schedule) for B24 and the composite response.
b.
At 0.05 alpha level (2-sided).

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There is over 90% power to demonstrate noninferiority for the secondary objective for 
ACWY-naïve and -experienced participants separately, evaluating the seroresponse for 
ACWY endpoints at 1 month following vaccination for each group.
9.2.2. Additional Participants for Safety Analysis (Groups 5-8)
The sample sizes in Groups 5, 6, 7, and 8 are not based on any hypothesis testing but rather 
are based on having a sufficient number of participants enrolled to sufficiently characterize
the safety profile of MenABCWY.  Overall, 1750 participants will be randomized to receive 
MenABCWY and 663 will be randomized to receive Trumenba + MenACWY-CRM.  
Table 10 shows the probability to detect at least 1 AE for different true incidence rates given 
that 1750 participants will receive MenABCWY.
Table 10.
Probabilities of Detecting AEs at Specified Incidences
Sample Size
True Incidence of AE
Probability of Detecting at Least 1 AE
1750
0.001%
1.7%
1750
0.01%
16.1%
1750
0.1%
82.6%
9.3. Populations for Analysis
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–Vaccination 1 evaluable 
and post–Vaccination 2 evaluable criteria.
Modified intent-to-treat
All participants who received at least 1 study 
vaccination and have at least 1 valid and determinate 
MenB or MenA/C/W/Y assay result available at any 
time point from Visit 1 to Visit 4. 
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.

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Defined Population for Analysis
Description
Post–Vaccination 1 evaluable
All randomized participants who were eligible 
throughout Visit 2, received the investigational 
products at Visit 1 as randomized, had blood drawn 
for assay testing within the required time frames at 
Months 0 (Visit 1: before Vaccination 1) and 2 
(Visit 2: 1 month after the first vaccination: window 
28-42 days), had at least 1 valid and determinate 
MenA/C/W/Y assay result at Visit 2, had received no 
prohibited vaccines or treatment through Visit 2, and 
had no important protocol deviations through Visit 2. 
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–Vaccination 2 evaluable
All randomized participants who were eligible 
throughout Visit 4, received the investigational 
products at Visit 1 and Visit 3 as randomized, had 
blood drawn for assay testing within the required time 
frames at Months 0 (Visit 1: before Vaccination 1) 
and 7 (Visit 4: 1 month after the second vaccination: 
window 28-42 days), had at least 1 valid and 
determinate MenA/C/W/Y 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.
9.4. Statistical Analyses
The SAP will be developed and finalized before database lock and will describe the 
participant populations to be included in the analyses, and procedures for accounting for 
missing, unused, and spurious data.  This section is a summary of the planned statistical 
analyses of the primary, secondary, and tertiary/exploratory endpoints.

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9.4.1. Immunogenicity Analyses
Primary
For each of the 4 ACWY test strains, the difference in the percentages of 
seroresponders, defined as participants achieving a 4-fold rise from baseline, in 
Group 1 at 1 month after Vaccination 2 compared to Group 2 at 1 month after 
Vaccination 1, and also the difference in seroresponders in Group 3 at 1 month after 
Vaccination 2 compared to Group 4 at 1 month after Vaccination 1, will be 
calculated.  
For each of the 4 primary MenB test strains, the differences of the 4-fold rises and 
composite responses of Groups 1 and 3 combined compared to Groups 2 and 4 
combined at 1 month after Vaccination 2 will be calculated.  
The Miettinen and Nurminen method will be used to derive the CI for the difference 
in percentages between vaccine groups.  The lower limit of the CI will be used in the 
hypothesis test for noninferiority as detailed in Section 9.1.
The analysis for the ACWY test strains is based on the post–Vaccination 1 evaluable 
population for Groups 2 and 4 and on the post–Vaccination 2 evaluable population 
for Groups 1 and 3 and the analysis for the primary MenB strains is based on the 
post–Vaccination 2 evaluable population in order to provide a comparison that has the 
greatest chance of identifying a difference between the groups with respect to 
immunogenicity, if a meaningful difference in vaccine effect actually exists. 
Exact 2-sided 95% CIs for the percentages (seroresponders, 4-fold-rises and 
composite responses) will be provided using the Clopper-Pearson method. 
A supportive analysis will be performed based on the modified intent-to-treat (mITT) 
population. Participants will be summarized according to the vaccine group to which 
they were randomized. Missing serology data will not be imputed.
Secondary 
For each of the 4 ACWY test strains, the difference in the percentage of 
seroresponders, defined as participants achieving a 4-fold rise from baseline, in 
Group 1 at 1 month after Vaccination 1 compared to Group 2 at 1 month after 
Vaccination 1, and also the differences in seroresponders between Group 3 at 1 month 
after Vaccination 1 and Group 4 at 1 month after Vaccination 1, will be calculated.  
The Miettinen and Nurminen method will be used to derive the CIs for the difference 
in percentages between vaccine groups. The lower limit of the CI will be used in the 
hypothesis test for noninferiority as detailed in Section 9.1 (conditional on the success 
of analysis of the primary objectives).
The analysis for the ACWY test strains is based on the post–Vaccination 1 evaluable 
population for Groups 1, 2, 3, and 4.
Percentages will be presented with 2-sided 95% CIs using the Clopper-Pearson 
method. 
Reverse cumulative distribution functions will be provided for both MenA/C/W/Y 
strains (1 month following Vaccination 1 for Groups 2 and 4 and 1 month following 
Vaccination 1 and Vaccination 2 for Groups 1 and 3) and MenB strains (1 month 
following Vaccination 2).
Supportive analyses will be done using the mITT population. Exact 2-sided 95% CIs 
for the percentages will be provided using the Clopper-Pearson method. Participants 
will be summarized according to the vaccine group to which they were randomized. 
Missing serology data will not be imputed.

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Tertiary/Exploratory
The following analyses for the ACWY test strains are based on the post–Vaccination 
1 evaluable population for Groups 2 and 4, and on the post–Vaccination 2 evaluable 
population for Groups 1 and 3:
The percentage of participants achieving an hSBA titer ≥1:8 for each ACWY test 
strain, at baseline and 1 month after Vaccination 1 in Groups 2 and 4, and 1 month 
after Vaccination 2 in Groups 1 and 3. 
The percentage of participants achieving hSBA titers of ≥1:8, ≥1:16, ≥1:32, ≥1:64, 
and ≥1:128 for each ACWY test strain, at baseline, 1 month after Vaccination 1 in 
Groups 2 and 4, and 1 month after Vaccination 2 in Groups 1 and 3.
hSBA GMTs for each of the ACWY test strains, at baseline, 1 month after 
Vaccination 1 in Groups 2 and 4, and 1 month after Vaccination 2 in Groups 1 and 3. 
The following analyses for the ACWY test strains are based on the post–Vaccination 
1 evaluable population for all groups:

The percentage of participants achieving an hSBA titer ≥1:8 for each ACWY test 
strain, at baseline and 1 month after Vaccination 1 in Groups 1 through 4.

The percentage of participants achieving hSBA titers of ≥1:8, ≥1:16, ≥1:32, 
≥1:64, and ≥1:128 for each ACWY test strain, at baseline and 1 month after 
Vaccination 1 in Groups 1 through 4.

hSBA GMTs for each of the ACWY test strains, at baseline and 1 month after 
Vaccination 1 in Groups 1 through 4.
The following analyses are for the primary MenB test strains:
The percentage of participants achieving an hSBA titer ≥LLOQ (1:16 for A22 and 
1:8 for A56, B24, and B44) for each primary MenB test strain in Groups 1 + 3 
combined and Groups 2 + 4 combined, at baseline and 1 month after Vaccination 2,
will be summarized using the post–Vaccination 2 evaluable population.
The percentage of participants with hSBA titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and 
≥1:128 for each of the 4 primary MenB test strains in Groups 1 + 3 combined and 
Groups 2 + 4 combined, at baseline and 1 month after Vaccination 2, will be 
summarized using the post–Vaccination 2 evaluable population. MenB hSBA GMTs 
for each of the 4 primary MenB test strains in Groups 1 + 3 combined and Groups 2 +
4 combined, at baseline and 1 month after Vaccination 2, will be summarized using 
the post–Vaccination 2 evaluable population.
The percentage of participants achieving an hSBA titer ≥LLOQ for each secondary 
MenB test strain in Groups 1 + 3 combined, at baseline and 1 month after 
Vaccination 2, will be summarized using the post–Vaccination 2 evaluable 
population.
The percentage of participants with hSBA titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and 
≥1:128 for each of the secondary MenB test strains in Groups 1 + 3 combined, at 
baseline and 1 month after Vaccination 2, will be summarized using the 
post–Vaccination 2 evaluable population. 
hSBA GMTs for each of the secondary MenB test strains in Groups 1 + 3 combined, 
at baseline and 1 month after Vaccination 2, will be summarized using the 
post–Vaccination 2 evaluable population.
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, and then exponentiating 
the results. Titers below LLOQ will be set to 0.5 × LLOQ for analysis.

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Supportive analyses will be done using the mITT population. 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
All safety analyses will be performed on the safety population. Separate safety populations 
will be defined for each vaccination visit and follow-up phase, Vaccination 1, Vaccination 2, 
and follow-up phase, 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 MenABCWY and Trumenba combined groups 
(ie, Groups 1, 3, 5, and 7 combined compared to Groups 2, 4, 6, and 8 combined).  
Two (2)-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 MenABCWY and 
Trumenba combined groups.  Local reactions will be summarized only for the left 
arm, which is the MenABCWY or Trumenba injection site.
The proportion of participants reporting the use of antipyretic medication for Days 1 
to 7 will be compiled for MenABCWY and Trumenba combined groups after each 
vaccination.
All AEs and SAEs will be categorized according to the latest version of the Medical 
Dictionary for Regulatory Activities (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 vaccine group.
A 3-tier approach will be used to summarize AEs. Under this approach AEs are 
classified into 1 of 3 tiers: (1) Tier 1 events are prespecified events of clinical
importance; (2) Tier 2 events are those that are not Tier 1 but are considered 
“relatively common”; a MedDRA preferred term is defined as a Tier 2 event if there 
are at least 4 participants in at least 1 (combined) vaccine group reporting the event; 
and (3) Tier 3 events are those that are neither Tier 1 nor Tier 2 events. For both 
Tier 1 and Tier 2 events, the 95% CIs for the difference in percentage of participants 
reporting the events between MenABCWY and Trumenba combined groups will be 
calculated using the Miettinen and Nurminen method. There is no Tier 1 event 
identified for MenABCWY at this stage. Descriptive summary statistics (counts and 
percentages and associated Clopper-Pearson 95% CIs) will be provided for Tier 3 
events for MenABCWY and Trumenba combined groups.
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
Not applicable.
Tertiary/Exploratory
Not applicable.

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9.5. Interim Analyses
No interim analysis is planned for the study. Only 1 analysis will be performed at the 
completion of the study. 
9.5.1. Data Monitoring Committee 
This study will use an E-DMC.
An independent statistician will provide unblinded safety reports to the E-DMC for review.  
Safety data will be reviewed by the E-DMC throughout the study, and no adjustments to the 
type I error for the noninferiority assessments will be made for these periodic safety reviews.
The E-DMC will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter.  The recommendations made by the E-DMC to alter the 
conduct of the study will be forwarded to Pfizer for final decision.  Pfizer will forward such 
decisions, which may include summaries of aggregate analyses of endpoint events and of 
safety data that are not endpoints, 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 Council for International Organizations of Medical Sciences 
(CIOMS) International Ethical Guidelines;

Applicable International Council for Harmonisation (ICH) GCP guidelines;

Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, IB, 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 investigational 
product, 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 or his/her parent(s)/legal guardian and answer all questions regarding the study.
Participants must be informed that their participation is voluntary.  Participants or their 
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, Health Insurance 
Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB/EC 
or study center.
The investigator must ensure that each study participant or his or her 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 or his or her parent(s)/legal guardian must be informed that his/her 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.
The participant or his or her parent(s)/legal guardian must be informed that his/her 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 or his or her parent(s)/legal 
guardian is fully informed about his or her right to access and correct his or her personal data 
and to withdraw consent for the processing of his or her 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.
Participants 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 or the parent(s)/legal guardian.

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A study-specific assent form will be provided to pediatric participants as required by local 
regulations.  It is to be understood as the adolescent's will to participate in a trial after 
having received age-appropriate information and is sometimes also referred to as 
"knowing agreement."  If the study includes minor participants who reach the age of majority 
during the study, as recognized under local law, they must reconsent as adults to remain in 
the study.  If the enrollment of emancipated minors is permitted by the study age criteria, the 
IRB/EC, and local law, they must provide documentation of legal status to give consent 
without the permission of a parent or legal guardian.
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 shall 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 natural persons 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.  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), the European Clinical Trials 
Database (EudraCT)/Clinical Trial Information System (CTIS), 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 standard operating procedures (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/CTIS
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer sponsored interventional studies 
in accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts CSR synopses and plain language study results summaries on www.pfizer.com
for Pfizer-sponsored interventional studies at the same time the corresponding study results 
are posted to www.clinicaltrials.gov. CSR synopses will have personally identifiable 
information anonymized.
Documents within marketing applications
Pfizer complies with applicable local laws/regulations to publish clinical documents included 
in marketing applications. Clinical documents include summary documents and CSRs 
including the protocol and protocol amendments, sample CRFs and SAPs. Clinical 
documents will have personally identifiable information anonymized.
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 data from these trials available
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.
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.

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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 electronic CRF (eCRF) that are transcribed 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 SRM.
10.1.8. Study and Site Closure
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 contract 
research organization (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;

Discontinuation of further study intervention development.
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.

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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 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.
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.  The contact card 
contains, at a minimum, protocol and investigational product 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.  

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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.
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, electrocardiogram [ECG], radiological scans, vital sign measurements), including those 
that worsen from baseline, considered clinically significant in the medical and scientific judgment of the 
investigator (ie, not related to progression of underlying disease).

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.  Also, “lack of efficacy” or “failure of expected 
pharmacological action” constitutes 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.
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.

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An SAE is defined as any untoward medical occurrence that, at any dose:
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.
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 adverse events on the CRF and for reporting 
serious adverse events 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 investigational product 
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 investigational 
product under study during 
pregnancy or breastfeeding, 
and occupational exposure
None
All (and exposure during 
pregnancy [EDP] supplemental 
form for EDP)  

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.

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.

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Assessment of Intensity
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.
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.
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.

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 investigational product caused the event, then the 
event will be handled as “related to investigational product” 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 professionals.

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Follow-up of AEs and SAEs

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.
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.

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10.4. Appendix 4: Contraceptive Guidance and Collection of Pregnancy Information
10.4.1. Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 28 days after the last dose of study intervention:

Refrain from donating sperm.
PLUS either:

Be abstinent from heterosexual intercourse with a female of childbearing potential as 
their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and 
agree to remain abstinent. 
OR

Must agree to use a male condom when engaging in any activity that allows for passage 
of ejaculate to another person.

In addition to male condom use, a highly effective method of contraception is 
recommended in WOCBP partners of male participants (refer to the list of highly 
effective methods below in Section 10.4.4).
10.4.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies:

Is not a WOCBP (see definitions below in Section 10.4.3).
OR

Is a WOCBP and using an acceptable contraceptive method as described below during 
the intervention period (for a minimum of 28 days after the last dose of study 
intervention).  The investigator should evaluate the effectiveness of the contraceptive 
method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
10.4.3. Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).

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If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1. Premenarchal.  
2. Premenopausal female with 1 of the following:

Documented hysterectomy;

Documented bilateral salpingectomy;

Documented bilateral oophorectomy.
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview.  The method of documentation should be recorded in the participant’s medical 
record for the study.
3. Postmenopausal female:

A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 

A high follicle-stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormone replacement therapy (HRT). 

Females on HRT and whose menopausal status is in doubt will be required to use 
one of the nonestrogen hormonal highly effective contraception methods if they 
wish to continue their HRT during the study.  Otherwise, they must discontinue 
HRT to allow confirmation of postmenopausal status before study enrollment.
10.4.4. Contraception Methods
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device (IUD).
3. Intrauterine hormone-releasing system (IUS).

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4. Bilateral tubal occlusion.
5. Vasectomized partner:

Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the woman of childbearing potential and the 
absence of sperm has been confirmed.  If not, an additional highly effective method 
of contraception should be used.  The spermatogenesis cycle is approximately 
90 days.
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

oral;

intravaginal;

transdermal;

injectable.
7. Progestogen-only hormone contraception associated with inhibition of ovulation:

oral;

injectable.
8. Sexual abstinence:

Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention.  The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.
9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action.
10. Male or female condom with or without spermicide.
11. Cervical cap, diaphragm, or sponge with spermicide.
12. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).

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Collection of Pregnancy Information
For both unapproved/unlicensed products and for marketed products, an exposure during 
pregnancy (EDP) occurs if:

A female becomes, or is found to be, pregnant either while receiving or having been 
exposed (eg, because of treatment or environmental exposure) to the investigational 
product; or the female becomes or is found to be pregnant after discontinuing and/or 
being exposed to the investigational product;

An example of environmental exposure would be a case involving direct contact with 
a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant and has 
been exposed to chemotherapeutic products).

A male has been exposed (eg, because of treatment or environmental exposure) to the 
investigational product prior to or around the time of conception and/or is exposed during 
his partner’s pregnancy.
If a participant or participant’s partner becomes or is found to be pregnant during the 
participant’s treatment with the investigational product, the investigator must report this 
information to Pfizer Safety on the Vaccine SAE Reporting Form and an EDP supplemental 
form, regardless of whether an SAE has occurred.  In addition, the investigator must submit 
information regarding environmental exposure to a Pfizer product in a pregnant woman 
(eg, a participant reports that she is pregnant and has been exposed to a cytotoxic product by 
inhalation or spillage) to Pfizer Safety using the EDP supplemental form.  This must be done 
irrespective of whether an AE has occurred and within 24 hours of awareness of the 
exposure.  The information submitted should include the anticipated date of delivery 
(see below for information related to termination of pregnancy).
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).
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.

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Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs 
follows: 

Spontaneous abortion includes 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 investigational product. 
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.

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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 drug-induced 
liver injury (DILI).  Participants who experience a transaminase elevation above 3 times the 
upper limit of normal (× ULN) should be monitored more frequently to determine if they are 
an “adaptor” or are “susceptible.”
Liver function tests (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 aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) precede total bilirubin (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, creatine kinase (CK), direct and 
indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time (PT)/international 
normalized ratio (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 (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 sample for acetaminophen 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 Incidents: Definition and Procedures for Recording,
Evaluating, Follow-up, and Reporting
Definitions of a Medical Device Incident
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).
Medical Device Incident Definition

A medical device incident is any malfunction or deterioration in the characteristics and/or performance of 
a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, 
might lead to or might have led to the death of a participant/user/other person or to a serious deterioration 
in his/her state of health.

Not all incidents lead to death or serious deterioration in health.  The nonoccurrence of such a result might 
have been due to other fortunate circumstances or to the intervention of healthcare personnel.
It is sufficient that:

An incident associated with a device happened.
AND

The incident was such that, if it occurred again, might lead to death or a serious 
deterioration in health.
A serious deterioration in state of health can include any of the following:

Life-threatening illness;

Permanent impairment of body function or permanent damage to body structure;

Condition necessitating medical or surgical intervention to prevent one of the above;

Fetal distress, fetal death, or any congenital abnormality or birth defects.
Examples of Incidents

A participant, user, caregiver, or healthcare professional is injured as a result of a medical device failure 
or its misuse.

A participant’s study intervention is interrupted or compromised by a medical device failure.

A misdiagnosis due to medical device failure leads to inappropriate treatment.

A participant’s health deteriorates due to medical device failure.

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Documenting Medical Device Incidents
Medical Device Incident Documentation

Any medical device incident occurring during the study will be documented in the participant’s medical 
records, in accordance with the investigator’s normal clinical practice, and on the appropriate form of the 
CRF.

For incidents fulfilling the definition of an AE or an SAE, the appropriate AE/SAE CRF page will be 
completed as described in Appendix 3.

The CRF will be completed as thoroughly as possible and signed by the investigator before transmittal to 
the sponsor or designee.

It is very important that the unblinded site staff provides his/her assessment of causality (relationship to 
the medical device provided by the sponsor) at the time of the initial AE or SAE report and 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 an incident.  This includes any amendment to the device 
design to prevent recurrence.

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10.7. Appendix 7: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
ACIP
Advisory Committee on Immunization Practices
ACWY
meningococcal group A, C, W, and Y 
AE
adverse event
AlPO4
aluminum phosphate
ALT
alanine aminotransferase
AST
aspartate aminotransferase
bivalent rLP2086
bivalent recombinant lipoprotein 2086 vaccine (Trumenba)
CBER
Center for Biologics Evaluation and Research
CDC
Centers for Disease Control and Prevention
CDP
clinical development program
CFR
Code of Federal Regulations
CI
confidence interval
COVID-19
coronavirus disease 2019
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CRF
case report form
CRM
cross-reactive material
CRO
contract research organization
CSR
clinical study report
CT
clinical trial
DILI
drug-induced liver injury
DTaP-Hib
diphtheria, tetanus, and acellular pertussis and 
Haemophilus influenzae type b vaccine
dTaP-IPV
diphtheria, tetanus, and acellular pertussis and inactivated 
poliomyelitis virus vaccine
DU
dispensable unit
EC
ethics committee
ECG
electrocardiogram
eCRF
electronic case report form
e-diary
electronic diary
E-DMC
external data monitoring committee 
EDP
exposure during pregnancy
EMA
European Medicines Agency
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration (United States)
fHBP
factor H binding protein
FIH
first-in-human
FSH
follicle-stimulating hormone

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Abbreviation
Term
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMT
geometric mean titer
GSK
GlaxoSmithKline
HBV-IPV
hepatitis B virus and inactivated poliomyelitis virus vaccine
HIPAA
Health Insurance Portability and Accountability Act
HPV4
human papillomavirus vaccine
HRT
hormone replacement therapy
hSBA
serum bactericidal assay using human complement
IB
investigator’s brochure
ICD
informed consent document
ICH
International Council for Harmonisation
ID
identification
IMD
invasive meningococcal disease
IMP
investigational medicinal product
IND
investigational new drug application
INR
international normalized ratio
IP manual
investigational product manual
IRB
institutional review board
IRT
interactive response technology
IUD
intrauterine device
IUS
intrauterine hormone-releasing system
IVRS
interactive voice response system
IWRS
interactive Web-based response system 
LFT
liver function test
LLOQ
lower limit of quantitation
LOD
limit of detection
MAE
medically attended adverse event
MCAR
missing completely at random
MCV4-Tdap
quadrivalent meningococcal polysaccharide conjugate and 
diphtheria, tetanus, and acellular pertussis vaccine
MedDRA
Medical Dictionary for Regulatory Activities
MenA
Neisseria meningitidis group A
MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
MenACWY-CRM
meningococcal groups A, C, Y, and W-135 oligosaccharide 
diphtheria conjugate vaccine (Menveo)
MenACWY-TT
meningococcal polysaccharide groups A, C, W-135, and Y tetanus 
toxoid conjugate vaccine (Nimenrix)
MenB
Neisseria meningitidis group B
MenC
Neisseria meningitidis group C
MenCYW-135
meningococcal group C, Y, and W-135
MenW
Neisseria meningitidis group W

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Abbreviation
Term
MenY
Neisseria meningitidis group Y
mITT
modified intent-to-treat
NDCMC
newly diagnosed chronic medical condition
NIMP
noninvestigational medicinal product
PACL
protocol administrative change letter
PCD
primary completion date
PFS
prefilled syringe
POC
proof of concept
PRP-OMP
polyribosylribitol phosphate oligosaccharide of 
Haemophilus influenzae type b conjugated to outer membrane 
protein
PT
prothrombin time
rSBA
serum bactericidal assay using rabbit complement
SAE
serious adverse event
SAP
statistical analysis plan
SoA
schedule of activities
SOP
standard operating procedure
SRM
study reference manual
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
TBili
total bilirubin
ULN
upper limit of normal
US
United States
USPI
US package insert
WOCBP
woman/women of childbearing potential

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11. REFERENCES
1.
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.
2.
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(8):3363-71.
3.
Cohn AC, MacNeil JR, Clark TA, et al. Prevention and control of meningococcal 
disease: recommendations of the Advisory Committee on Immunization Practices 
(ACIP). MMWR Recomm Rep 2013;62(2):1-28.
4.
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Accessed: 10 March 2015.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Final Protocol Amendment 2, 13 June 2022
PFIZER CONFIDENTIAL
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