A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE
Phase: PHASE2
Conditions: Meningococcal Vaccine
Sponsor: Pfizer

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 1
A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE 
SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY
ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY 
PARTICIPANTS ≥11 TO 15 YEARS OF AGE
Study Intervention Number:
PF-06886992
Study Intervention Name:
Neisseria meningitidis Group A, B, C, W, 
and Y Vaccine (MenABCWY)
US IND Number:
17319
EudraCT Number:
2019-004923-19
Protocol Number:
C3511004
Phase:
2b
Short Title: A Trial to Describe the Safety and Immunogenicity of MenABCWY When 
Administered on 2 Schedules
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.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 2
Protocol Amendment Summary of Changes Table
Document History
Document
Version Date
Summary and Rationale for Changes
Amendment 1
07 January 2021
Updated the study design to decrease intervals between 
MenABCWY doses from 24 and 48 months to 12 and 
36 months in order to shorten the duration of the study.
Removed Visit 11 (36-month post-Dose 2 antibody persistence 
visit for Group 1 and 12-month post-Dose 2 antibody 
persistence visit for Group 2) and the associated 
immunogenicity objectives/estimands from the study design.
Visit 11 is no longer applicable.
Updated the time period for collecting SAEs, MAEs, and 
NDCMCs from 6 months after each vaccination to 6 months 
after Vaccinations 1 and 2, and 1 month after Vaccination 3 as 
Visit 11 was removed from the study design. Removed 
associated estimands relating to descriptive summaries of SAEs, 
MAEs, and NDCMCs reported during the Vaccination 3 
follow-up phase.
Added estimands for the immunogenicity analysis of the blood 
draw after the saline injection in Group 2 per CBER feedback.
Reduced the planned statistical analyses from 3 (after Visit 5, 
after Visit 10, and end of study) to 2 (after Visit 5 and end of 
study). Visit 10 is now the final visit in the study design.
Added instructions to schedule Visit 6 (12-month antibody 
persistence) in Group 1 and Visit 8 (Safety Telephone 
Contact 2) in Group 2 as in-person visits, with Visit 8 to be later 
converted to a telephone contact once study unblinding has 
occurred, in order to maximize scheduling efficiency.
Updated CT SAE Report Form to Vaccine SAE Reporting Form 
throughout, as per PACL dated 08 May 2020.
Corrected the description of the bivalent rLP2086 PFS from a 
0.7 mL PFS to a high-fill volume PFS as the volume contained 
in the PFS is not precisely 0.7 mL.
Made a correction in Section 8.2.1 indicating that pregnancy 
tests will be performed in all female participants rather than 
WOCBP.
Replaced the term SRM with ISF throughout the protocol as the
term SRM is no longer used.
Added Appendix 8: Alternative Measures During Public 
Emergencies as described in CT02-CT45-COVID19-SD-GL01.
Updated to the 15 May 2020 protocol template.
Original protocol
04 February 2020
N/A
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 3
TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................9
1. PROTOCOL SUMMARY...................................................................................................10
1.1. Synopsis ..................................................................................................................10
1.2. Schema ....................................................................................................................16
1.3. Schedule of Activities .............................................................................................17
2. INTRODUCTION ...............................................................................................................21
2.1. Study Rationale .......................................................................................................21
2.2. Background .............................................................................................................22
2.2.1. Background of the Disease and Medical Need...........................................22
2.2.2. Prior Clinical Experience............................................................................23
2.2.2.1. Trumenba (Bivalent rLP2086) ..................................................23
2.2.2.2. Nimenrix (MenACWY-TT) ......................................................24
2.2.2.3. Pentavalent Meningococcal Vaccine (MenABCWY)...............25
2.3. Benefit/Risk Assessment.........................................................................................26
2.3.1. Risk Assessment.........................................................................................28
2.3.2. Benefit Assessment.....................................................................................29
2.3.3. Overall Benefit/Risk Conclusion................................................................29
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS ...........................................................30
4. STUDY DESIGN.................................................................................................................38
4.1. Overall Design.........................................................................................................38
4.1.1. Approximate Duration of Participation for Each Participant .....................38
4.1.2. Approximate Number of Participants.........................................................38
4.2. Scientific Rationale for Study Design.....................................................................38
4.3. Justification for Dose ..............................................................................................39
4.4. End of Study Definition ..........................................................................................40
5. STUDY POPULATION......................................................................................................40
5.1. Inclusion Criteria.....................................................................................................40
5.2. Exclusion Criteria....................................................................................................41
5.3. Lifestyle Considerations..........................................................................................42
5.3.1. Contraception..............................................................................................42

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 4
5.4. Screen Failures ........................................................................................................42
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study 
Intervention Administration ......................................................................................43
5.5.1. Criteria for Temporarily Delaying Vaccine Administration ......................43
5.5.2. Criteria for Temporarily Delaying Immunogenicity Blood Draw..............43
6. STUDY INTERVENTION..................................................................................................43
6.1. Study Intervention(s) Administered........................................................................43
6.1.1. Administration............................................................................................44
6.1.2. Medical Devices .........................................................................................45
6.2. Preparation/Handling/Storage/Accountability ........................................................45
6.2.1. Preparation and Dispensing........................................................................46
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................47
6.3.1. Allocation to Study Intervention ................................................................47
6.3.2. Blinding of Site Personnel..........................................................................47
6.3.3. Blinding of the Sponsor..............................................................................47
6.3.4. Breaking the Blind......................................................................................48
6.3.5. Planned Unblinding ....................................................................................48
6.4. Study Intervention Compliance...............................................................................48
6.5. Concomitant Therapy..............................................................................................48
6.5.1. Prohibited During the Study.......................................................................48
6.5.2. Permitted During the Study ........................................................................49
6.5.3. Prior Treatments .........................................................................................49
6.5.4. Prohibited Prior Treatments........................................................................49
6.6. Dose Modification...................................................................................................49
6.7. Intervention After the End of the Study..................................................................49
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................50
7.1. Discontinuation of Study Intervention ....................................................................50
7.2. Participant Discontinuation/Withdrawal From the Study.......................................50
7.2.1. Withdrawal of Consent...............................................................................51
7.3. Lost to Follow-up....................................................................................................52
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................52

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 5
8.1. Efficacy and/or Immunogenicity Assessments .......................................................53
8.1.1. MenA, MenC, MenW, and MenY Serum Bactericidal Assays..................53
8.1.2. MenB Serum Bactericidal Assays ..............................................................53
8.1.3. Biological Samples.....................................................................................54
8.2. Safety Assessments .................................................................................................54
8.2.1. Pregnancy Testing ......................................................................................55
8.3. Adverse Events and Serious Adverse Events..........................................................56
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......56
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................61
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................61
8.3.2. Method of Detecting AEs and SAEs ..........................................................61
8.3.3. Follow-up of AEs and SAEs.......................................................................61
8.3.4. Regulatory Reporting Requirements for SAEs...........................................61
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ..........................................................................................................62
8.3.5.1. Exposure During Pregnancy......................................................62
8.3.5.2. Exposure During Breastfeeding ................................................64
8.3.5.3. Occupational Exposure .............................................................64
8.3.6. Cardiovascular and Death Events...............................................................64
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................64
8.3.8. Adverse Events of Special Interest.............................................................64
8.3.8.1. Lack of Efficacy........................................................................65
8.3.9. Medical Device Deficiencies......................................................................65
8.3.9.1. Time Period for Detecting Medical Device Deficiencies .........65
8.3.9.2. Follow-up of Medical Device Deficiencies...............................65
8.3.9.3. Prompt Reporting of Device Deficiencies to Sponsor ..............65
8.3.9.4. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................66
8.3.10. Medication Errors.....................................................................................66
8.4. Treatment of Overdose............................................................................................67
8.5. Pharmacokinetics ....................................................................................................67

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 6
8.6. Pharmacodynamics..................................................................................................67
8.7. Genetics...................................................................................................................67
8.8. Biomarkers ..............................................................................................................67
8.9. Immunogenicity Assessments.................................................................................68
8.10. Health Economics .................................................................................................68
8.11. Study Procedures...................................................................................................68
8.11.1. Group 1 (0- and 12-Month Schedule).......................................................68
8.11.1.1. Visit 1 (Day 1), Vaccination 1 ................................................68
8.11.1.2. Visit 2, Month 1 (1 Month [28 to 42 Days] After 
Visit 1), 1-Month Post–Vaccination 1 Blood Draw ..........................69
8.11.1.3. Visit 3, Month 6 (6 Months [168 to 196 Days] After 
Visit 1), Safety Telephone Contact 1 ................................................70
8.11.1.4. Visit 4, Month 12 (12 Months [336 to 394 Days] After 
Visit 1), Vaccination 2.......................................................................71
8.11.1.5. Visit 5, Month 13 (1 Month [28 to 42 Days] After Visit 
4), 1-Month Post–Vaccination 2 Blood Draw...................................73
8.11.1.6. Visit 6, Month 24 (12 Months [336 to 394 Days] After 
Visit 4), 12-Month Antibody Persistence Visit .................................74
8.11.1.7. Visit 7, Month 36, (24 Months [700 to 756 Days] After 
Visit 4), 24-Month Antibody Persistence Visit .................................75
8.11.2. Group 2 (0- and 36-Month Schedule).......................................................76
8.11.2.1. Visit 1 (Day 1), Vaccination 1 ................................................76
8.11.2.2. Visit 2, Month 1 (1 Month [28 to 42 Days] After 
Visit 1), 1-Month Post–Vaccination 1 Blood Draw ..........................77
8.11.2.3. Visit 3, Month 6 (6 Months [168 to 196 Days] After 
Visit 1), Safety Telephone Contact 1 ................................................78
8.11.2.4. Visit 4, Month 12 (12 Months [336 to 394 Days] After 
Visit 1), Vaccination 2.......................................................................79
8.11.2.5. Visit 5, Month 13 (1 Month [28 to 42 Days] After Visit 
4),  1-Month Post–Vaccination 2 Blood Draw..................................80
8.11.2.6. Visit 8, Month 24 (12 Months [336 to 394 Days] After 
Visit 4), Safety Telephone Contact 2 ................................................81
8.11.2.7. Visit 9, Month 36 (24 Months [700 to 756 Days] After 
Visit 4), Vaccination 3.......................................................................82

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 7
8.11.2.8. Visit 10, Month 37 (1 Month [28 to 42 Days] After Visit 
9),  1-Month Post–Vaccination 3 Blood Draw..................................84
8.11.3. Final Telephone Contact for Participants Who Withdraw From the 
Study ................................................................................................................85
8.12. Unscheduled Visits................................................................................................85
9. STATISTICAL CONSIDERATIONS ................................................................................86
9.1. Estimands and Statistical Hypotheses.....................................................................86
9.1.1. Estimands....................................................................................................86
9.2. Sample Size Determination.....................................................................................86
9.3. Analysis Sets ...........................................................................................................87
9.4. Statistical Analyses .................................................................................................88
9.4.1. Immunogenicity Analyses ..........................................................................88
9.4.2. Safety Analyses ..........................................................................................91
9.5. Interim Analyses .....................................................................................................92
9.5.1. Analysis Timing..........................................................................................92
9.6. Data Monitoring Committee or Other Independent Oversight Committee.............92
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................93
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............93
10.1.1. Regulatory and Ethical Considerations ....................................................93
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................93
10.1.2. Financial Disclosure .................................................................................94
10.1.3. Informed Consent Process ........................................................................94
10.1.4. Data Protection .........................................................................................95
10.1.5. Dissemination of Clinical Study Data ......................................................95
10.1.6. Data Quality Assurance ............................................................................97
10.1.7. Source Documents....................................................................................98
10.1.8. Study and Site Start and Closure ..............................................................98
10.1.9. Publication Policy.....................................................................................99
10.1.10. Sponsor’s Qualified Medical Personnel ...............................................100
10.2. Appendix 2: Clinical Laboratory Tests ...............................................................100

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 8
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ....................................................................101
10.3.1. Definition of AE .....................................................................................101
10.3.2. Definition of an NDCMC.......................................................................102
10.3.3. Definition of SAE...................................................................................102
10.3.4. Recording/Reporting and Follow-up of AEs and/or SAEs.....................104
10.3.5. Reporting of SAEs..................................................................................107
10.4. Appendix 4: Contraceptive Guidance .................................................................109
10.4.1. Male Participant Reproductive Inclusion Criteria..................................109
10.4.2. Female Participant Reproductive Inclusion Criteria...............................109
10.4.3. Woman of Childbearing Potential ..........................................................110
10.4.4. Contraception Methods...........................................................................111
10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments ......113
10.6. Appendix 6: Medical Device Adverse Events, Adverse Device Effects, 
Serious Adverse Events, and Device Deficiencies: Definition and Procedures 
for Recording, Evaluating, Follow-up, and Reporting............................................115
10.6.1. Definition of AE and ADE .....................................................................115
10.6.2. Definition of SAE, SADE, and Unanticipated Serious Adverse 
Device Effect .................................................................................................115
10.6.3. Definition of Device Deficiency.............................................................116
10.6.4. Recording/Reporting and Follow-up of AEs and/or SAEs and 
Device Deficiencies .......................................................................................117
10.6.5. Reporting of SAEs..................................................................................119
10.6.6. Reporting of SADEs...............................................................................120
10.7. Appendix 7: Abbreviations .................................................................................121
10.8. Appendix 8: Alternative Measures During Public Emergencies ........................124
10.8.1. Telehealth Visits.....................................................................................124
10.8.2. Home Health Visits.................................................................................124
10.8.3. Adverse Events and Serious Adverse Events.........................................125
11. REFERENCES ................................................................................................................126

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 9
LIST OF TABLES
Table 1.
Study Intervention Administration Schedule............................................45
Table 2.
Summary of Adverse Event Collection for Group 1 (0- and 12-
Month Schedule).......................................................................................59
Table 3.
Summary of Adverse Event Collection for Group 2 (0- and 36-
Month Schedule).......................................................................................60
Table 4.
Expected Half-Width of 95% CIs by Percentage of Participants 
Achieving an hSBA Titer ≥LLOQ for Each Test Strain .........................86
Table 5.
Probability of Observing at Least 1 AE by Assumed True Event 
Rates .........................................................................................................87

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 10
1. PROTOCOL SUMMARY 
1.1. Synopsis
In Study B1971057, an FIH and POC study for MenABCWY, 543 participants received 
MenABCWY on a 0- and 6-month schedule.  Results from B1971057 indicated 
MenABCWY, when given on a 0- and 6-month schedule, is well tolerated with an acceptable 
safety profile, and also provides a high degree of protective immune responses without 
interference among all 5 serogroup components tested. These results are comparable to 
Phase 2 and 3 bivalent rLP2086 (Trumenba®) studies, which demonstrate that by increasing 
the interval between 2 doses, immune responses are enhanced. Study B1971057 also
demonstrated that 1 dose of MenACWY-TT (Nimenrix®) provides protective immune 
responses in a high proportion of those vaccinated, consistent with Phase 3 data supporting 
licensure of Nimenrix.
The aim of this Phase 2b descriptive study is to assess the potential utility of MenABCWY in 
the framework of current US meningococcal vaccination practices, which are based on the 
Centers for Disease Control and Prevention’s ACIP recommendations.  This study will 
describe the immune response following 1 and 2 doses of MenABCWY when administered 
at 12- and 36-month intervals in healthy participants ≥11 to 15 years of age at the time of 
their first dose.  The persistence of the immune response will be described for 24 months 
after 2 doses of MenABCWY administered on a 0- and 12-month schedule.
Data obtained from prior studies supporting the licensure of the 2 vaccines comprising 
MenABCWY, MenACWY-TT (Nimenrix) and bivalent rLP2086 (Trumenba), support a 
favorable benefit-risk assessment for continued study of MenABCWY.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 11
Objectives, Estimands, and Endpoints
Randomization group descriptions are shown in Section 1.2.
Objectives
Estimands
Endpoints
Primary Immunogenicity:
Primary Immunogenicity:
Primary Immunogenicity: 
To describe the immune response for MenB
induced by 2 doses of MenABCWY 
administered on a 0- and 12-month schedule.
In participants receiving 2 doses of MenABCWY and who are 
in compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer 
≥LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, 
and B44) for each of the 4 primary MenB test strains at 
baseline and 1 month after the second dose of 
MenABCWY in Group 1 (0- and 12-month schedule).

hSBA titer for each of the primary 
MenB test strains (A22, A56, B24, 
and B44).
To describe the immune response for MenB
induced by 2 doses of MenABCWY 
administered on a 0- and 36-month schedule.
In participants receiving 2 doses of MenABCWY and who are 
in compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer 
≥LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, 
and B44) for each of the 4 primary MenB test strains at 
baseline and 1 month after the second dose of 
MenABCWY in Group 2 (0- and 36-month schedule).

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 
when administered on a 0- and 12-month and a 
0- and 36-month schedule.
In participants receiving at least 1 dose of study intervention:
The percentage of participants reporting at least 1 AE, 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 MenABCWY vaccination. 

During the Vaccination 1, 2, and 3 vaccination phases: 
o
From Vaccination 1 (Visit 1) through 1 month after 
Vaccination 1 (Visit 2) in Groups 1 and 2.

AEs, SAEs, MAEs, NDCMCs, and 
immediate AEs.

Days missing from school or work 
because of AEs.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 12
Objectives
Estimands
Endpoints
o
From Vaccination 2 (Visit 4) through 1 month after 
Vaccination 2 (Visit 5) in Groups 1 and 2.
o
From Vaccination 3 (Visit 9) through 1 month after 
Vaccination 3 (Visit 10) in Group 2.

The percentage of participants reporting at least 1 SAE, at 
least 1 MAE, and at least 1 NDCMC during the following 
time periods:

During the follow-up phases:
o
From 1 month after Vaccination 1 (Visit 2) through 
6 months after Vaccination 1 (Visit 3) in Groups 1 
and 2.
o
From 1 month after Vaccination 2 (Visit 5) through 
6 months after Vaccination 2 in Groups 1 and 2.

6 Months after Vaccinations 1 and 2:
o
From Vaccination 1 (Visit 1) through 6 months 
after Vaccination 1 (Visit 3) in Groups 1 and 2.
o
From Vaccination 2 (Visit 4) through 6 months 
after Vaccination 2 in Groups 1 and 2.

The percentage of participants reporting at least 1 
immediate AE after each vaccination.

The percentage of participants who missed days of school or 
work because of AEs occurring within 6 months after 
Vaccinations 1 and 2, and within 1 month after 
Vaccination 3.
Secondary Immunogenicity: 
Secondary Immunogenicity:
Secondary Immunogenicity: 
To describe the immune response for MenA, 
MenC, MenW, and MenY induced by 1 and 
2 doses of MenABCWY administered on a 0-
and 12-month schedule.
In participants receiving 1 dose of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer 
≥LLOQ (ie, hSBA titer of ≥1:8) for each ACWY test 
strain at baseline and 1 month after the first dose of 
MenABCWY in Group 1 (0- and 12-month schedule).

hSBA titer for each of the 
MenACWY test strains.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 13
Objectives
Estimands
Endpoints
In participants receiving 2 doses of MenABCWY and who are 
in compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer 
≥ LLOQ for each ACWY test strain at baseline and 
1 month after the second dose of MenABCWY in 
Group 1 (0- and 12-month schedule).
To describe the immune response for MenA, 
MenC, MenW, and MenY induced by 1 and 
2 doses of MenABCWY administered on a 0-
and 36-month schedule.
In participants receiving 1 dose of MenABCWY and who are 
in compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer 
≥LLOQ (ie, hSBA titer of ≥1:8) for each ACWY test strain 
at baseline and 1 month after the first dose of MenABCWY 
Group 2 (0- and 36-month schedule), 
In participants receiving 2 doses of MenABCWY and who are 
in compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer 
≥LLOQ for each ACWY test strain at baseline and 1 month 
after the second dose of MenABCWY in Group 2 (0- and 
36-month schedule).

hSBA titer for each of the 
MenACWY test strains.
To describe the persistence of the MenB 
response following 2 doses of MenABCWY 
administered on a 0- and 12-month schedule.
In participants receiving 2 doses of MenABCWY and who are 
in compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer ≥ 
LLOQ for each of the 4 primary MenB test strains at 
12 months and 24 months after the second dose of 
MenABCWY in Group 1 (0- and 12-month schedule).

hSBA titer for each of the primary 
MenB test strains (A22, A56, B24, 
and B44).

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
Final Protocol Amendment 1, 07 January 2021
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020)
Page 14
Objectives
Estimands
Endpoints
To describe the persistence of the MenA, 
MenC, MenW, and MenY response following 
2 doses of MenABCWY when administered on 
a 0- and 12-month schedule. 
In participants receiving 2 doses of MenABCWY and who are 
in compliance with the key protocol criteria (evaluable 
participants):

The percentage of participants achieving an hSBA titer 
≥LLOQ for each ACWY test strain at 12 months and
24 months after the second dose of MenABCWY in 
Group 1 (0- and 12-month schedule).

hSBA titer for each of the 
MenACWY test strains.

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Overall Design
This is a Phase 2b, randomized, observer-blinded, multicenter trial in which approximately 
300 US participants ≥11 to 15 years of age will be randomly assigned at a 1:1 ratio to 
receive MenABCWY either on a 0- and 12-month schedule (Group 1) or on a 0- and 
36-month schedule (Group 2) as shown in Section 1.2.  All participants will be naïve to any 
meningococcal vaccine prior to enrollment.
Participants will have blood drawn prior to Vaccination 1 and 1 month after each 
vaccination.  Additionally, to facilitate the description of antibody persistence after 2 doses 
of MenABCWY, participants in Group 1 (0- and 12-month schedule) will have blood drawn 
at 12 and 24 months after the second dose of MenABCWY.  The sponsor will be blinded to 
dosing schedule assignment through Month 13 (1 month after the second dose of 
MenABCWY in Group 1 [0- and 12-month schedule]), after which the dosing schedule 
assignment for all participants will be unblinded.  The second dose of MenABCWY in 
Group 2 (0- and 36-month schedule) will be administered in an open-label manner.
A total of approximately 300 participants will be enrolled, and each participant will 
participate in the study for approximately 37 months.
Statistical Methods
This is not a hypothesis-testing study; an estimation approach will be used to assess the 
descriptive immunogenicity and safety objectives.  All immunogenicity data will be 
summarized descriptively within each vaccination group. All of the binary endpoints 
(including primary endpoints) will be summarized with 2-sided 95% CIs using the 
Clopper-Pearson method.  GMTs for hSBA results will also be summarized with 95% CIs.  
The study team will remain blinded until all participants have completed Visit 5, after which 
select data will be reported, including immunogenicity data for Group 1.  A final analysis 
will be done after all available data have been collected.
The primary safety objectives will be assessed by descriptive summaries of AEs, SAEs, 
NDCMCs, MAEs, and immediate AEs in Groups 1 and 2 as described in Section 9.

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1.2. Schema
Group 1 (0- and 12-Month Schedule)
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety 
Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
12-Month
Antibody 
Persistence 
Visit
24-Month
Antibody 
Persistence 
Visit
Approximate 
Month
0
1
6
12
13
24
36
Visit Number
1
2
3
4
5
6
7a
Group 1 
(n=150)
MenABCWY
MenABCWY
Blood draw
25 mL
25 mL
25 mL
25 mL
25 mL
a.
Visits 8, 9, and 10 will not be conducted for Group 1 participants.
Group 2 (0- and 36-Month Schedule)
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety 
Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
Safety 
Telephone 
Contact 2
Vaccination 3
1 Month Post–
Vaccination 3 
Blood Draw
Approximate 
Month
0
1
6
12
13
24
36
37
Visit Number
1
2
3
4
5a
8b
9
10
Group 2 
(n=150)
MenABCWY
Saline
MenABCWY
Blood draw
25 mL
25 mL
25 mL
25 mL
a.
Visits 6 and 7 will not be conducted for Group 2 participants.
b.
Visit 8 will be scheduled as an in-person visit to maintain the blind and converted to a telephone visit once unblinding has occurred.

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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures.  Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant. 
Group 1 (0- and 12-Month Schedule)
Visit Identifier
Abbreviations used in this table 
may be found in Appendix 7
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7a
Visit Description
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
12-Month 
Antibody 
Persistence Visit
24-Month 
Antibody 
Persistence Visit
Approximate Month
0
1
6
12
13
24
36
Visit Window
Day 1
28 to 42 Days 
After Visit 1
168 to 196 Days 
After Visit 1
336 to 394 Days 
After Visit 1
28 to 42 Days 
After Visit 4
336 to 394 Days 
After Visit 4
700 to 756 Days 
After Visit 4
Informed consent
X
Review eligibility criteria
X
Demography
X
Confirm continued eligibilityb
X
X
X
X
X
X
Medical history 
X
Physical examination
X
X
Record previous PRP-OMP 
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 (~25 mL)
X
X
X
X
X

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Group 1 (0- and 12-Month Schedule)
Visit Identifier
Abbreviations used in this table 
may be found in Appendix 7
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7a
Visit Description
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
12-Month 
Antibody 
Persistence Visit
24-Month 
Antibody 
Persistence Visit
Approximate Month
0
1
6
12
13
24
36
Visit Window
Day 1
28 to 42 Days 
After Visit 1
168 to 196 Days 
After Visit 1
336 to 394 Days 
After Visit 1
28 to 42 Days 
After Visit 4
336 to 394 Days 
After Visit 4
700 to 756 Days 
After Visit 4
Study intervention administration 
and observationc
X
X
Record nonstudy vaccinationsd
X
X
X
X
X
Provide the participant with a 
contact card
X
Provide the participant with a 
memory aid
X
X
Complete Study Visit/Telephone 
Contact AE Checkliste
X
X
X
X
X
X
Record concomitant medications 
used to treat AEs
X
X
X
X
X
X
X
(S)AE collection appropriate for 
the visitf
X
X
X
X
X
X
X
Note: A safety follow-up telephone contact should occur for all participants who withdraw from the study within 6 months after any 
vaccination.  Refer to Section 8.11.3.
a.
Visits 8, 9, and 10 will not be conducted for participants in Group 1.
b.
Ensure that the participant continues to be eligible for the study and continues to comply with contraception requirements, as appropriate.
c.
Observe the participant for at least 30 minutes (or longer as per local practice) after the study intervention administration for any acute reactions.
d.
Record nonstudy vaccinations as described in Section 6.5.
e.
Checklist includes questions regarding NDCMCs, MAEs, and missed days of school or work, as well as neuroinflammatory and autoimmune conditions, 
such as transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
f.
Please refer to Section 8.3.1.

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Group 2 (0- and 36-Month Schedule)
Visit Identifier
Abbreviations used in this table 
may be found in Appendix 7
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5a
Visit 8
Visit 9
Visit 10
Visit Description
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety 
Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
Safety 
Telephone 
Contact 2
Vaccination 3
1 Month Post–
Vaccination 3 
Blood Draw
Approximate Month
0
1
6
12
13
24
36
37
Visit Window
Day 1
28 to 42 Days 
After Visit 1
168 to 196 Days 
After Visit 1
336 to 394 Days 
After Visit 1
28 to 42 Days 
After Visit 4
336 to 394 
Days After 
Visit 4
700 to 756 Days 
After Visit 4
28 to 42 Days 
After Visit 9
Informed consent
X
Review eligibility criteria
X
Demography
X
Confirm continued eligibilityb
X
X
X
X
X
X
X
Medical history 
X
Physical examination
X
X
X
Record previous PRP-OMP 
vaccinations
X
Urine pregnancy test for 
female participants (obtain 
results prior to vaccination)
X
X
X
Oral temperature (prior to 
vaccination)
X
X
X
Randomization
X
Obtain blood sample (~25 mL)
X
X
X
X
Study intervention 
administration and observationc
X
X
X
Record nonstudy vaccinationsd
X
X
X
X
X
X
X
Provide the participant with a 
contact card
X
Provide the participant with a 
memory aid
X
X
Complete Study Visit/ 
Telephone Contact AE 
Checkliste
X
X
X
X
X
X
X

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Group 2 (0- and 36-Month Schedule)
Visit Identifier
Abbreviations used in this table 
may be found in Appendix 7
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5a
Visit 8
Visit 9
Visit 10
Visit Description
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety 
Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
Safety 
Telephone 
Contact 2
Vaccination 3
1 Month Post–
Vaccination 3 
Blood Draw
Approximate Month
0
1
6
12
13
24
36
37
Visit Window
Day 1
28 to 42 Days 
After Visit 1
168 to 196 Days 
After Visit 1
336 to 394 Days 
After Visit 1
28 to 42 Days 
After Visit 4
336 to 394 
Days After 
Visit 4
700 to 756 Days 
After Visit 4
28 to 42 Days 
After Visit 9
Record concomitant 
medications used to treat AEs
X
X
X
X
X
X
X
X
(S)AE collection appropriate 
for the visitf
X
X
X
X
X
X
X
X
Note: A safety follow-up telephone contact should occur for all participants who withdraw from the study within 6 months after any vaccination.  
Refer to Section 8.11.3.
a.
Visits 6 and 7 will not be conducted for participants in Group 2.
b.
Ensure that the participant continues to be eligible for the study and continues to comply with contraception requirements, as appropriate.
c.
Observe the participant for at least 30 minutes (or longer as per local practice) after the study intervention administration for any acute reactions.
d.
Record nonstudy vaccinations as described in Section 6.5.
e.
Checklist includes questions regarding NDCMCs, MAEs, and missed days of school or work, as well as neuroinflammatory and autoimmune conditions, 
such as transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
f.
Please refer to Section 8.3.1.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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2. INTRODUCTION
Bivalent rLP2086 (120 µg) and MenACWY-TT (5 µg of each of the 4 meningococcal 
capsular polysaccharides A, C, W-135, and Y conjugated to 44 µg of tetanus toxoid) are 
available commercially as Trumenba and Nimenrix, respectively.  
Trumenba is composed of 2 recombinant lipidated fHBP variants from MenB, one from 
fHBP subfamily A (A05) and one from subfamily B (B01), 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 Neisseria meningitidis conjugated to tetanus toxoid, is indicated for active immunization 
of individuals 6 weeks of age and older against IMD caused by N meningitidis groups A, C, 
W-135, and Y, and is approved in Europe and other locations. 
Pfizer intends to develop a pentavalent meningococcal vaccine (MenABCWY) by combining 
bivalent rLP2086 (supplied as a high-fill volume PFS) and MenACWY-TT (supplied as a 
single-dose vial containing lyophilized powder to be reconstituted for injection); the resultant 
MenABCWY is administered as a 0.5-mL dose via intramuscular injection.  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.
2.1. Study Rationale 
In Study B1971057, an FIH and POC study for MenABCWY, 543 participants received 
MenABCWY on a 0- and 6-month schedule.  Results from B1971057 indicated 
MenABCWY, when given on a 0- and 6-month schedule, is well tolerated with an acceptable 
safety profile and also provides a high degree of protective immune responses without 
interference among all 5 serogroup components tested.  These results are comparable to 
Phase 2 and 3 bivalent rLP2086 studies, which demonstrate that by increasing the interval 
between 2 doses, immune responses are enhanced.  Study B1971057 also demonstrated that 
1 dose of MenACWY-TT (Nimenrix), as a component of MenABCWY, provides protective 
immune responses in a high proportion of those vaccinated, consistent with Phase 3 data 
supporting licensure of Nimenrix.
The aim of this Phase 2b descriptive study is to assess the potential utility of MenABCWY in 
the framework of current US meningococcal vaccination practices, which are based on ACIP 
recommendations.  The 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 2- or 3-dose 
series MenB vaccine to provide short-term protection against most strains of serogroup B 
meningococcal disease.  A single dose of MenACWY conjugate provides protection in early 
adolescence, but the second dose is required to extend that protection into late adolescence 

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and early adulthood.1  Therefore, a minimum of 2 doses of an ACWY conjugate vaccine and 
2 doses of a serogroup B vaccine are recommended to provide comprehensive protection 
against IMD in the United States during the specific periods of adolescence and young 
adulthood when there is an increased risk of IMD.  This study is therefore designed to 
describe the short-term immunogenicity and safety of 2 doses of MenABCWY separated by 
either 12 or 36 months during adolescence, and immunopersistence up to 24 months after 
completing 2 doses separated by a 12-month interval, to provide insight as to whether 1 dose 
of MenABCWY in early adolescence could support a recommendation for serogroups A, C, 
W, and Y protection during early adolescence followed by a second dose at least 12 to 36 
months later to provide protection against all 5 serogroups (A, C, W, Y, and B) during later 
adolescence and early adulthood. All study participants will receive 1 dose of MenACWY 
TT (Nimenrix), as a component of MenABCWY at Visit 1 which, as demonstrated in Study 
B1971057, provides protective immune responses in a high proportion of those vaccinated, 
consistent with Phase 3 data supporting licensure of Nimenrix. Demonstration of safety and 
both short-term immunogenicity and longer-term immunopersistence of MenABCWY could 
provide a simplified 2-dose alternative to the current 4-dose regimen recommended for 
comprehensive IMD protection in the United States.
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.
2.2. Background 
2.2.1. Background of the Disease and Medical Need
N meningitidis is an obligate human pathogen that colonizes the upper respiratory tract, 
which, in some individuals, can cause serious, life-threatening IMD, which clinically 
presents as septicemia, meningitis, or both.2  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,3 and disease incidence is highest in infants and children younger than 
5 years of age, adolescents and young adults (16 to 21 years of age), and older adults 
(≥65 years of age).4  In the United States, meningococcal disease is primarily caused by 
groups B, C, W, and Y, which are responsible for approximately 83% of disease across all 
ages.5
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%.6 This suggests that adherence to 
ACIP guidelines for prevention of IMD decreases with increasing age and, for serogroup B, 
suggests the weakness of the recommendation.  This is the trend despite the fact that in the 
United States, MenB now exceeds all other serogroups in incidence, accounting for about 
66% of IMD among individuals 11 to 23 years of age, despite high vaccination rates in 
targeted adolescents.5 These data support the idea that all 5 serogroups contribute to disease 

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in adolescents and young adults and that a multivalent vaccine incorporating serogroup B 
would have significant public health utility. 
A 2-dose MenABCWY vaccination series with at least a 12- to 36-month interval between 
doses that provides protection against serogroups A, C, W, and Y from early adolescence and 
protection against serogroup B after the second dose later in adolescence might also provide 
a simplified approach to comprehensive vaccination against IMD. A 2-dose MenABCWY 
vaccination series may also lead to increased adherence compared to the current 
recommendations for MenACWY vaccination in early adolescence, with a booster in late 
adolescence and a 2-dose MenB vaccination series in later adolescence, requiring a total of 
4 doses (2 each of a MenACWY conjugate and a MenB vaccine) to achieve comprehensive 
protection during adolescence and early adulthood. 
Improving vaccination rates for older adolescents and young adults against all 5 serogroups 
over currently observed rates is particularly important given the recent shifts in disease 
incidence across age groups. Older adolescents and young adults, particularly those 
attending college, are clearly at higher risk than their younger counterparts. During 2017, the 
incidence of IMD in the United States in young adolescents (11 to 15 years of age) was 0.04,
while at the same time was much higher, at 0.2, in 16- to 23-year-olds.5 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 21.1 to 134 per 100,000 in 
data reported in 2014.7,8 These cases of IMD are not inconsequential. Among 7924 cases of 
IMD occurring in the United States from 2006 through 2015, the overall case fatality rate 
was 14.9% and, when stratified by adolescent age group, case fatality rates were 11.5% for 
11- to 15-year-olds, 14.3% for 16- to 20-year-olds, and 16.7% for 21- to 25-year-olds.9
Among survivors, significant long-term sequelae, such as limb loss, neurological disability,
and deafness, can also occur.4 A different approach that could provide broader serogroup 
coverage with 1 vaccine, administered in fewer doses to enhance adherence, could fill some 
of the gaps encountered with operational implementation of the currently recommended IMD 
immunization strategy and reduce overall incidence of IMD as well as morbidity and 
mortality due to IMD among adolescents and young adults in the United States. 
This study is designed to evaluate such an approach with investigational pentavalent vaccine, 
MenABCWY, which could potentially fulfill the unmet need for broader protection with a 
single vaccine against IMD from early adolescence through young adulthood for serogroups 
A, C, W, and Y and from late adolescence through early adulthood for serogroup B, that is 
more durable in the setting of the disease’s changing epidemiology.
2.2.2. Prior Clinical Experience
2.2.2.1. Trumenba (Bivalent rLP2086)
Trumenba was approved in the United States on 29 October 2014, under 21 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 MenB.

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Protocol C3511004
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Trumenba was subsequently approved in the 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 in the United States 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.  
Subsequently, both Phase 2 studies and 1 Phase 3 study have been conducted to confirm 
safety and immunogenicity of a 2-dose schedule.
As of 28 April 2019, it is estimated that 23,586 participants have participated in the 
Trumenba CDP: 12,027 participants were exposed to Trumenba alone; a total of 5202 
participants received Trumenba in combination with DTaP-Hib; HBV-IPV/Prevenar® (32); 
DTaP-IPV (372); HPV4 (992); 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 a similar pattern over 4 years; antibody levels
declined by Year 1 and remained 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 
following 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 test 
strain) for up to 2 years after the booster dose.
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 12 months of age 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 licensed in the United States, though there is an open IND application.  
Licensure outside of the United States was based on safety and demonstration of 
immunologic noninferiority (based mainly on comparing proportions of participants with 
rSBA of at least 1:8) to licensed meningococcal vaccines.

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Cumulatively, it is estimated that 21,520 participants have participated in the Nimenrix CDP. 
Worldwide distribution for Nimenrix from launch through 19 April 2019 is approximately 
16,124,606 doses.
The immunogenicity studies conducted in participants 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 GSK rSBA. Additionally, 
immunopersistence data through 10 years following MenACWY-TT vaccination indicate 
that a high proportion of vacinees remain protected at that time.
2.2.2.3. Pentavalent Meningococcal Vaccine (MenABCWY)
MenABCWY is an investigational pentavalent meningococcal vaccine consisting of 
bivalent rLP2086 (supplied as a high-fill volume 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- and 6-month schedule, or 
Trumenba on a 0- 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 MenB vaccine prior to 
enrollment and approximately half were naïve to 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.  Stage 2, which evaluates 
immunopersistence and safety and immunogenicity of a booster dose 4 years after 
completing the primary series, is ongoing.
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.  Pertinent to the study described herein, 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 C, 10.7% (4.9, 16.1) for W, and 14.1% 
(8.1, 19.7) for Y.  Similarly, noninferiority was also established for the ≥4-fold rise in the 

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percentage of responders after 2 doses of MenABCWY compared to a single dose of 
MenACWY-CRM for ACWY-naïve participants, for whom the 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.  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 for the percentage of
responders who achieved a ≥4-fold rise in hSBA titer over baseline among MenABCWY 
recipients compared with Trumenba recipients for the 4 primary test strains: A22, A56, B24,
and B44.
Reactogenicity data were collected for 7 days following each vaccination by 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.
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
Common AEs noted after vaccination with Trumenba (licensed in the US, EU, and other 
countries) and Nimenrix (licensed in the EU and other non-US countries) 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.

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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 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 based on the 
proportions of participants achieving hSBA titers ≥ LLOQ for each serogroup (≥1:8 for 
serogroups A, C, W, and Y and ≥1:8 or ≥1:16 for serogroup B, depending on the test strain), 
which are higher than the accepted surrogate marker for protective immunity (hSBA 
titer ≥1:4). Additionally, MenABCWY 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. This Phase 2b study is one of several 
studies comprising the MenABCWY development program, which if successful, could 
provide a broadly protective, safe, comprehensive, and first-in-class meningococcal vaccine 
that could contribute significantly to a simplified vaccination program for the prevention of 
IMD.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of MenABCWY may be found in the IB, which is the SRSD for this study.

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2.3.1. Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s) – MenABCWY Vaccination
Potential risks associated with MenABCWY in the 
age group for this study include the following: 
transient injection site pain, injection site redness, 
injection site swelling, headache, 
fatigue/drowsiness, muscle pain, joint pain, nausea, 
vomiting, chills, diarrhea, allergic reactions, 
decreased/lost appetite, dizziness, fainting, 
hypoesthesia, pruritus, rash, pain in extremity, 
injection site hematoma, injection site warmth, 
injection site anesthesia, and extensive limb 
swelling at the injection site.  
The potential risks are based on product labeling 
for bivalent rLP2086 and MenACWY-TT and 
B1971057 FIH study results.
Eligibility criteria have been selected to ensure 
that only appropriate healthy participants are 
included in the study (see Section 5)
Individuals with significant reactions after the first 
vaccination or AEs considered by the investigator 
to present increased risk to the participant if 
rechallenged with the second vaccination or who 
develop exclusionary conditions during the 
conduct of the study will be excluded from further 
vaccinations.
Study Procedures – Venipuncture
Venipuncture will be performed during the study.
There is a risk of bleeding, bruising, hematoma 
formation, and infection at the venipuncture site 
and an overall risk of dizziness and fainting 
associated with the procedure.
Only qualified nurses, physicians, nurse
practitioners, physician’s assistants, phlebotomists, 
or medical assistants certified or otherwise 
authorized to draw blood per the standards and 
procedures of the investigative site as allowed by 
institutional, local, and state guidance will be 
allowed to draw blood to minimize local 
complications. Participants will be placed in the 
supine position prior to and directly after 
phlebotomy to minimize risk of dizziness or 
fainting associated with phlebotomy.

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2.3.2. Benefit Assessment
Based on the known degree of protective immunogenicity afforded by licensed vaccines 
Trumenba and Nimenrix, as well as the data for investigational vaccine MenABCWY from 
Phase 2 Study B1971057, the potential benefits of participation in this study and receipt of all 
vaccination doses include potential protection against IMD caused by N meningitidis
serogroups A, C, W, and Y after a single dose and extended protection for a yet-to-be 
determined period of time after administration of a second dose 12 to 36 months after the 
initial dose.  Participation in the study and receipt of all scheduled vaccinations will also 
potentially provide protection against invasive meningococcal B disease after the second 
dose of MenABCWY.
Other benefits to the individual participant may include physical examination by a medical 
provider at the start of the study and prior to each study vaccination, a thorough review of the 
participant’s vaccination status, and evaluations and management of some illnesses (AEs) 
that occur during participation in the study as part of protocol-specified scheduled and 
unscheduled assessments.
2.3.3. Overall Benefit/Risk Conclusion
Taking into account the measures taken to minimize risk in participants of this study, the 
potential risks identified in association with MenABCWY primarily include well-established 
local and systemic vaccination reactions, which are mostly mild to moderate in severity and 
transient in nature, or minor complications expected from needlesticks (vaccination or 
venipuncture), and are justified by the anticipated benefits (protective immunity against 
IMD) that may be afforded to participants.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS
Objectives
Estimands
Endpoints
Primary Immunogenicity: 
Primary Immunogenicity:
Primary Immunogenicity: 
To describe the immune response for MenB 
induced by 2 doses of MenABCWY 
administered on a 0- and 12-month 
schedule.
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥ LLOQ 
(1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for 
each of the 4 primary MenB test strains at baseline and 1 month 
after the second dose of MenABCWY in Group 1 (0- and 
12-month schedule).

hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and B44).
To describe the immune response for MenB 
induced by 2 doses of MenABCWY
administered on a 0- and 36-month 
schedule.
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥ LLOQ 
(1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for 
each of the 4 primary MenB test strains at baseline and 1 month 
after the second dose of MenABCWY in Group 2 (0- and 
36-month schedule).

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 when administered on a 0-
and 12-month and a 0- and 36-month 
schedule.
In participants receiving at least 1 dose of study intervention:

The percentage of participants reporting at least 1 AE, 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 MenABCWY vaccination. 

During the Vaccination 1, 2, and 3 vaccination phases: 
o From Vaccination 1 (Visit 1) through 1 month after 
Vaccination 1 (Visit 2) in Groups 1 and 2.

AEs, SAEs, MAEs, NDCMCs, 
and immediate AEs.

Days missing from school or 
work because of AEs.

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Objectives
Estimands
Endpoints
o From Vaccination 2 (Visit 4) through 1 month after 
Vaccination 2 (Visit 5) in Groups 1 and 2.
o From Vaccination 3 (Visit 9) through 1 month after 
Vaccination 3 (Visit 10) in Group 2.

The percentage of participants reporting at least 1 SAE, at least 
1 MAE, and at least 1 NDCMC during the following time periods:

During the follow-up phases:
o From 1 month after Vaccination 1 (Visit 2) through 
6 months after Vaccination 1 (Visit 3) in Groups 1 and 2.
o From 1 month after Vaccination 2 (Visit 5) through 
6 months after Vaccination 2 in Groups 1 and 2.

6 Months after Vaccinations 1 and 2:
o From Vaccination 1 (Visit 1) through 6 months after 
Vaccination 1 (Visit 3) in Groups 1 and 2.
o From Vaccination 2 (Visit 4) through 6 months after 
Vaccination 2 in Groups 1 and 2.
The percentage of participants reporting at least 1 immediate AE
after each vaccination.
The percentage of participants with missed days of school or work 
due to AEs occurring within 6 months after Vaccinations 1 and 2
and within 1 month after Vaccination 3.
Secondary Immunogenicity: 
Secondary Immunogenicity:
Secondary Immunogenicity: 
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by 1 and 2 doses of 
MenABCWY administered on a 0- and 
12-month schedule.
In participants receiving 1 dose of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥ LLOQ 
(ie, hSBA titer of ≥1:8) for each ACWY test strain at baseline and 

hSBA titer for each of the 
MenACWY test strains.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Objectives
Estimands
Endpoints
1 month after the first dose of MenABCWY in Group 1 (0- and 
12-month schedule).
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥LLOQ 
for each ACWY test strain at baseline and 1 month after the second 
dose of MenABCWY in Group 1 (0- and 12-month schedule).
To describe the immune response for 
MenA, MenC, MenW, and MenY 
induced by 1 and 2 doses of 
MenABCWY administered on a 0- and 
36-month schedule.
In participants receiving 1 dose of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥ LLOQ 
(ie, hSBA titer of ≥1:8) for each ACWY test strain at baseline and 
1 month after the first dose of MenABCWY Group 2 (0- and 
36-month schedule), 
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥ LLOQ 
for each ACWY test strain at baseline and 1 month after the second 
dose of MenABCWY in Group 2 (0- and 36-month schedule).

hSBA titer for each of the 
MenACWY test strains.
To describe the persistence of the MenB 
response following 2 doses of 
MenABCWY administered on a 0- and 
12-month schedule.
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

The percentage of participants achieving an hSBA titer ≥ LLOQ 
for each of the 4 primary MenB test strains at 12 months and 
24 months after the second dose of MenABCWY in Group 1 
(0- and 12-month schedule).

hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and B44).
To describe the persistence of the MenA, 
MenC, MenW, and MenY response 
following 2 doses of MenABCWY when 
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

hSBA titer for each of the 
MenACWY test strains.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Objectives
Estimands
Endpoints
administered on a 0- and 12-month 
schedule. 

The percentage of participants achieving an hSBA titer ≥LLOQ 
for each ACWY test strain at 12 and 24 months after the second 
dose of MenABCWY in Group 1 (0- and 12-month schedule).
Exploratory Immunogenicity: 
Exploratory Immunogenicity:
Exploratory Immunogenicity: 
To further describe the immune response 
for MenB induced by 2 doses of 
MenABCWY administered on a 0- and 
12-month schedule.
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

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 at baseline and 1 month after the second dose of 
MenABCWY in Group 1 (0- and 12-month schedule).

hSBA GMTs for each of the 4 primary MenB test strains at 
baseline and 1 month after the second dose of MenABCWY in 
Group 1 (0- and 12-month schedule).

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) at 
baseline and 1 month after the second dose of MenABCWY in 
Group 1 (0- and 12-month schedule).

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 at 1 month after the second dose of MenABCWY in Group 
1 (0- and 12-month schedule).
o
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.
o
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.

hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and B44).

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Objectives
Estimands
Endpoints
o
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 further describe the immune response 
for MenB induced by 2 doses of 
MenABCWY administered on a 0- and 
36-month schedule.
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

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 at baseline and 1 month after the second dose of 
MenABCWY in Group 2 (0- and 36-month schedule).

hSBA GMTs for each of the 4 primary MenB test strains at 
baseline, 13 months after the first dose of MenABCWY, and 
1 month after the second dose of MenABCWY in Group 2 (0- and 
36-month schedule).

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) at 
baseline and 1 month after the second dose of MenABCWY in 
Group 2 (0- and 36-month schedule).

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 at 1 month after the second dose of MenABCWY in 
Group 2 (0- and 36-month schedule).
o
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.
o
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.

hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and B44).

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Objectives
Estimands
Endpoints
o
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.

The percentage of participants achieving an hSBA titer ≥LLOQ 
for each of the 4 primary MenB test strains at 13 months after the 
first dose of MenABCWY in Group 2 (0- and 36-month schedule).
To further describe the immune response 
for MenA, MenC, MenW, and MenY 
induced by 1 and 2 doses of 
MenABCWY administered on a 0- and 
12-month schedule.
In participants receiving 1 dose of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

hSBA GMTs for each ACWY test strain at baseline and 1 month 
after the first dose of MenABCWY in Group 1 (0- and 12-month 
schedule).

The percentage of participants achieving at least a 4-fold rise in 
hSBA titer from baseline for each ACWY test strain at 1 month 
after the first dose of MenABCWY in Group 1 (0- and 12-month 
schedule).
o
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.
o
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.
o
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 participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

hSBA GMTs for each ACWY test strain at baseline and 1 month 
after the second dose of MenABCWY in Group 1 (0- and 
12-month schedule).

hSBA titer for each of the 
MenACWY test strains.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
Protocol C3511004
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Objectives
Estimands
Endpoints

The percentage of participants achieving at least a 4-fold rise in 
hSBA titer from baseline for each ACWY test strain at 1 month 
after the second dose of MenABCWY in Group 1 (0- and 
12-month schedule).
o
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.
o
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.
o
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 further describe the immune response 
for MenA, MenC, MenW, and MenY
induced by 1 and 2 doses of 
MenABCWY administered on a 0- and 
36-month schedule.
In participants receiving 1 dose of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

hSBA GMTs for each ACWY test strain at baseline, 1 month after 
the first dose of MenABCWY, and 13 months after the first dose 
of MenABCWY in Group 2 (0- and 36-month schedule).

The percentage of participants achieving at least a 4-fold rise in 
hSBA titer from baseline for each ACWY test strain at 1 month 
after the first dose of MenABCWY in Group 2 (0- and 36-month 
schedule).
o
For participants with a baseline hSBA titer below LOD (or an 
hSBA titer of 1:4), a 4-fold response is defined as an hSBA 
titer of ≥1:16.
o
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.

hSBA titer for each of the 
MenACWY test strains.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Objectives
Estimands
Endpoints
o
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.

The percentage of participants achieving an hSBA titer ≥LLOQ 
for each ACWY test strain at 13 months after the first dose of 
MenABCWY in Group 2 (0- and 36-month schedule).
In participants receiving 2 doses of MenABCWY and who are in 
compliance with the key protocol criteria (evaluable participants):

hSBA GMTs for each ACWY test strain at baseline and 1 month 
after the second dose of MenABCWY in Group 2 (0- and 
36-month schedule).

The percentage of participants achieving at least a 4-fold rise in 
hSBA titer from baseline for each ACWY test strain at 1 month 
after the second dose of MenABCWY in Group 2 (0- and 
36-month schedule).
o
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.
o
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.
o
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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4. STUDY DESIGN
4.1. Overall Design
This is a Phase 2b, randomized, observer-blinded, multicenter trial in which approximately 
300 US participants ≥11 to 15 years of age will be randomly assigned at a 1:1 ratio to 
receive MenABCWY either on a 0- and 12-month schedule (Group 1) or a 0- and 36-month 
schedule (Group 2) as shown in Section 1.2.  All participants will be naïve to any 
meningococcal vaccine prior to enrollment.
Participants will have blood drawn prior to Vaccination 1 and 1 month after each 
vaccination.  Additionally, to facilitate the description of antibody persistence after 2 doses 
of MenABCWY, participants in Group 1 (0- and 12-month schedule) will have blood drawn 
at 12 and 24 months after the second dose of MenABCWY.  The sponsor will be blinded to 
dosing schedule assignment through Month 13 (1 month after the second dose of 
MenABCWY in Group 1 [0- and 12-month schedule]), after which the dosing schedule 
assignment for all participants will be unblinded.  The second dose of MenABCWY in Group 
2 (0- and 36-month schedule) will be administered in an open-label manner.
4.1.1. Approximate Duration of Participation for Each Participant
Each participant will participate in the study for approximately 37 months.
4.1.2. Approximate Number of Participants
Approximately 300 participants will be enrolled in the study.
4.2. Scientific Rationale for Study Design
In Study B1971057, an FIH and POC study for MenABCWY, 543 participants received 
MenABCWY on a 0- and 6-month schedule.  Results from Study B1971057 indicated 
MenABCWY is well tolerated with an acceptable safety profile and also provides a high 
degree of protective immune responses without interference among all 5 serogroup 
components tested.
The aim of this Phase 2b study is to describe the immunogenicity and safety of 2 doses of 
MenABCWY separated by either 12 or 36 months during adolescence, and the persistence of 
bactericidal responses up to 24 months after completing 2 doses of MenABCWY separated 
by a 12-month interval, to provide insight as to whether 1 dose of MenABCWY in early 
adolescence (≥11 to 15 years of age) could meet safety and immunogenicity requirements 
to support a recommendation for serogroups A, C, W, and Y protection during early 
adolescence, followed by a second dose at least 12 to 36 months later to provide protection 
against all 5 serogroups (A, C, W, Y, and B) during later adolescence (≥15 to 19 years of 
age).  This will allow us to assess the potential utility of MenABCWY in the framework of 
current US meningococcal vaccination practices, which are based on ACIP 
recommendations. Demonstration of safety and both short-term immunogenicity and 
longer-term immunopersistence of MenABCWY could provide a simplified 2-dose 

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alternative to the current 4-dose regimen recommended for comprehensive IMD protection in 
the United States.
Refer to Section 2.1 for further detail about the rationale of the study design.
Data obtained from prior studies evaluating MenABCWY, MenACWY-TT (Nimenrix), and 
bivalent rLP2086 (Trumenba) support a favorable benefit-risk assessment for continued 
study of MenABCWY.
Bivalent rLP2086 and MenACWY-TT are approved for active immunization against IMD
caused by serogroup B and ACWY, respectively, without any contraceptive precautions.  
There is no suspicion of human genotoxicity or teratogenicity based on the intended 
pharmacology and World Health Organization guidance.10 The same is expected for both 
products when administered together as a single dose of MenABCWY.  See Appendix 4 for 
contraceptive requirements.  
4.3. Justification for Dose
Bivalent rLP2086 (120 µg, meningococcal group B vaccine) and MenACWY-TT (5 µg of 
each of the 4 meningococcal capsular 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 US in individuals 10 through 25 years of age.  Nimenrix is indicated for active 
immunization to prevent invasive disease caused by MenA, MenC, MenW, and MenY 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 Nimenrix is supplied as a 
single-dose vial containing lyophilized powder to be reconstituted for injection.
MenABCWY consists of bivalent rLP2086, supplied as a high-fill volume 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 when used 
separately are well established in adolescents and young adults.  Results from Study 
B1971057, which evaluated MenABCWY on a 0- and 6-month schedule in adolescents and 
young adults, showed no clinically significant difference in the tolerability or safety of 
MenABCWY when compared with Trumenba.  Furthermore, no interference was 
demonstrated for either MenB or ACWY responses when compared with 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.

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4.4. End of Study Definition
A participant is considered to have completed the study if he/she has completed all study 
visits.
The end of the study is defined as the date of the last visit for the last participant in the study.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled.  The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate.  All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a particular participant is suitable for this 
protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Male or female participants ≥11 through <15 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 all scheduled visits, treatment plan, laboratory tests, and 
other study procedures.
3. Participants who have never received a prior dose of any meningococcal vaccine.  
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).

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7. Negative urine pregnancy test for all female participants; pregnancy test is not applicable 
to male participants.
Informed Consent:
8. Participants whose parent(s)/legal guardian is capable of giving signed informed consent 
as described in Appendix 1, which includes compliance with the requirements and 
restrictions listed in the ICD and in this protocol.
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 with 
terminal complement deficiency are excluded from participation in this study.  Please 
refer to the ISF 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. Recent (within the past year) hospitalization for psychiatric illness.
8. Other medical or psychiatric condition, including recent (within the past year) or active 
suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study 
participation or, in the investigator’s judgment, make the participant inappropriate for the 
study.
Prior/Concomitant Therapy:
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.

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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. Children or grandchildren who are direct descendants of investigational site staff 
members or Pfizer employees 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.
5.3. Lifestyle Considerations
5.3.1. Contraception
The investigator or his or her designee, in consultation with the participant’s parent(s)/legal 
guardian, will confirm that the participant has selected an appropriate method of 
contraception for the individual participant and his or her partner(s) 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 entered in the study.  Screen failure data are collected and remain as 
source and are not reported to the clinical database.
Individuals who do not meet the criteria for participation in this study (screen failures) may 
not be rescreened.

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5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study Intervention 
Administration
5.5.1. Criteria for Temporarily Delaying Vaccine Administration
The following conditions are temporary or self-limiting and a participant may be vaccinated 
once the conditions have resolved and the participant is eligible for vaccination:
1. Current febrile illness (temperature ≥38.0°C [100.4°F]) or other acute illness within 
48 hours before study intervention administration.
2. Participant has received any nonlive vaccine (or intramuscular/sublingual allergen 
immunotherapy) within 14 days, or any live vaccine within 28 days, before study 
intervention administration.
3. Participant is less than 5 days into a course of systemic antibiotic therapy.
4. Participant has received systemic (oral, intravenous, or intramuscular) corticosteroid 
therapy within the previous 28 days.
If a participant meets any delay criteria for vaccination, all study procedures, including blood 
sample collection relating to that visit, if required, should be delayed until the day of 
vaccination.  When required, blood samples must always be collected prior to vaccination, on 
the day of vaccination.
5.5.2. Criteria for Temporarily Delaying Immunogenicity Blood Draw
The following condition is temporary or self-limiting, and blood may be drawn once the 
condition has resolved and the participant is eligible for blood collection:
1. Participant has received systemic antibiotic therapy within the last 5 days (must have a
full 5-day interval between the date of the last dose and the date of blood collection).
6. STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, medical device(s), or study procedure(s) intended to be administered to a study 
participant according to the study protocol.
For the purposes of this protocol, study intervention refers to MenABCWY, consisting of 
bivalent rLP2086 and MenACWY-TT (Nimenrix), or placebo.
6.1. Study Intervention(s) Administered
MenACWY-TT, supplied as a single-dose vial containing lyophilized powder, will be 
reconstituted with bivalent rLP2086 supplied as a high-fill volume PFS, as detailed in the IP
manual, and 0.5 mL of the resultant MenABCWY will be administered via intramuscular 
injection.  The final MenABCWY composition includes rLP2086 subfamily A and B 
proteins formulated at 120 µg/mL/subfamily, purified capsular polysaccharides of 

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N meningitidis serogroups A, C, W, and Y at a concentration of 10 µg/mL/polysaccharide 
type conjugated to tetanus toxoid 
, in 
 histidine 
 sodium chloride, 
0.5 mg/mL aluminum as AlPO4, 0.035 mg/mL polysorbate 80, and 
 sucrose.
The placebo is sterile normal saline solution for injection and will be administered as a 
0.5-mL intramuscular injection.
Intervention Name
MenABCWY
Placebo
(Normal Saline)
Dose Formulation
MenACWY-TT will be reconstituted 
with bivalent rLP2086, supplied as a 
high-fill volume PFS
Sterile normal saline solution for 
injection 
Dosage Level(s)
0.5-mL dose at Visits 1 and 4 
(Group 1) or at Visits 1 and 9 
(Group 2)
0.5-mL dose at Visit 4 (Group 2)
Route of Administration
Intramuscular
Intramuscular
IMP or NIMP
IMP
IMP
Sourcing
Pfizer
Pfizer
Packaging and Labeling
Each MenABCWY kit will consist of 
a vial of MenACWY-TT, bivalent 
rLP2086 high-fill volume PFS, and 
vial adaptor.  Kits will be packaged 
in a carton and labeled as required 
per country requirement. Kits 
provided for Visits 1 and 4 will 
include a blinded label and a tamper 
evident seal. Kits provided for Visit 9 
will include an open label and a 
tamper evident seal.
Study intervention will be 
provided in a single-dose PFS.  
Each syringe will be packaged in a 
carton and labeled as required per 
country requirement. Kits provided 
for Visit 4 will include a blinded 
label and a tamper evident seal.
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 study interventions should be performed by an appropriately qualified, 
GCP-trained, and vaccine-experienced member of the study staff (eg, physician, nurse, 
physician’s assistant, nurse practitioner, pharmacist, or medical assistant) as allowed by 
local, state, and institutional guidance.
Study intervention administration details will be recorded on the CRF.
Table 1 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.
CCI
CCI
CCI
CCI

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Table 1.
Study Intervention Administration Schedule
Study Intervention
Group(s)
Visit(s)
MenABCWY
1
1 and 4
MenABCWY
2
1 and 9
Placebo
2
4
6.1.2. Medical Devices
1. In this study, medical devices being used will be the vial adaptor and PFS for 
MenABCWY and the PFS only for placebo.
2. Instructions for medical device use are provided in the IP manual.
3. All medical device deficiencies (including malfunction, use error, and inadequate 
labeling) shall be documented and reported by the unblinded personnel throughout the 
clinical investigation (see Section 8.3.6) and appropriately managed by the sponsor.
6.2. Preparation/Handling/Storage/Accountability
1. The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study interventions received and any discrepancies are 
reported and resolved before use of the study intervention.
2. Study intervention will be shipped to the study site after required regulatory and legal 
documents have been received by the sponsor.  These will be shipped at +2°C to +8°C.  
Upon receipt at the study site, the study intervention 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 
temperatures since previously documented for all site storage locations upon return to 
business.
4. Any excursions from the study intervention label storage conditions should be reported to 
Pfizer upon discovery along with any actions taken.  The site should actively pursue 
options for returning the study intervention to the storage conditions described in the 
labeling, as soon as possible.  Once an excursion is identified, the study intervention must 
be quarantined and not used until Pfizer provides permission to use the study 
intervention.  Specific details regarding the definition of an excursion and information the 
site should report for each excursion will be provided to the site in the IP manual.

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5. Receipt of materials, door opening and closing, and other routine handling operations 
where the products are briefly out of the temperature range described in the labeling are 
not considered excursions.
6. Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the label.
7. Study interventions should be stored in their original containers.
8. See the IP manual for storage conditions of the study intervention once reconstituted.
9. The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records), such as the IPAL or 
sponsor-approved equivalent.  All study interventions will be accounted for using a study 
intervention accountability form/record.  Used needles and syringes should be disposed 
of according to local practice.  Empty outer study intervention containers must be 
retained until reviewed by the sponsor's representative and then may be destroyed after 
the sponsor’s representative has performed accountability.  Study intervention 
return/destruction must be documented on the accountability log.
10. Further guidance and information for the final disposition of unused study interventions 
are provided in the IP manual. All destruction must be adequately documented.  If 
destruction is authorized to take place at the investigator site, the investigator must ensure 
that the materials are destroyed in compliance with applicable environmental regulations, 
institutional policy, and any special instructions provided by Pfizer.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP manual.
Additional details about accountability, storage, destruction, and excursion reporting can be 
found in the IP manual.
6.2.1. Preparation and Dispensing
See the IP manual for instructions on how to prepare the study intervention for 
administration.  Study intervention 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.  All participants will remain blinded to 
whether they received MenABCWY or placebo at Vaccination 2 through and including Visit 
5 (1 month after Vaccination 2).  All participants will be unblinded prior to the time that 
Group 2 participants receive the second dose of MenABCWY at Month 36 in an open-label 
manner.

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6.3. Measures to Minimize Bias: Randomization and Blinding
6.3.1. Allocation to Study Intervention
Allocation (randomization) of participants to vaccine groups will proceed through the use of 
an IRT system 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 ID and password, protocol number, 
participant number, and date of birth of the participant.  The site personnel will then be 
provided with a participant randomization number and 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 
study intervention assignments through and including Visit 5 (Vaccinations 1 and 2).  In 
particular, the individuals who evaluate participant safety will be blinded.  Because the study 
vaccine and placebo are different in physical appearance, the study vaccine syringes will be 
administered in a manner that prevents the study participants from identifying the vaccine 
type based on its appearance.  The second dose of MenABCWY for participants in Group 2 
(Vaccination 3) will be given in an open-label manner.
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 study intervention assignments.
6.3.3. Blinding of the Sponsor
Those study team members who are involved in ensuring that protocol requirements for 
study intervention preparation, handling, allocation, and administration are fulfilled at the site 
will be unblinded for the duration of the study (eg, unblinded study manager, unblinded 
clinical research associate). An unblinded clinician who is not a direct member of the study 
team will review unblinded protocol deviations.  All other study team members will remain 
blinded to the vaccine assigned/received through and including Visit 5 (1 month after 
Vaccination 2).  All laboratory testing personnel performing serology assays will remain 
blinded to vaccine assigned/received and to visit number throughout the study.

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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 study intervention assignment is required 
for the medical management of an individual participant, it may be unblinded.  The 
investigator must notify a member of the study team immediately after determining that it is 
necessary to unblind the assignment.  The investigator must also indicate in source 
documents that the blind was broken and provide the date and reason for breaking the blind.  
Any AE or SAE associated with breaking the blind must be recorded and reported as 
specified in this protocol.
6.3.5. Planned Unblinding
Pfizer will release unblinding information to the investigators after all participants have 
completed the blood draw at Visit 5 (1 month after the second dose of MenABCWY in 
Group 1 [0- and 12-month schedule] or 1 month after placebo in Group 2 [0- and 36-month 
schedule]).  Additional information is included in the ISF.
The second dose of MenABCWY in Group 2 (0- and 36-month schedule) will be 
administered in an open-label manner.
6.4. Study Intervention Compliance
All doses of study intervention 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 approximately 6 months after Vaccinations 1 and 2, 
within approximately 1 month after Vaccination 3 (Group 2 only), and within 28 days before
administration of study intervention at Visit 4 and Visit 9 will be recorded on the CRF.  The 
name and date of administration for any nonstudy meningococcal vaccine received, which is 
exclusionary, will be collected from the signing of the ICD up to the end of study 
participation.
The name, start and stop dates, and route of administration for concomitant medications 
(prescription and nonprescription) used to treat an AE from the signing of the ICD to the 
final visit will be recorded in the CRF.
6.5.1. Prohibited During the Study

Receipt of any blood products, including immunoglobulin, in the period 6 months before 
any blood draw.

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.

Intramuscular/sublingual allergen immunotherapy is not permitted within 14 days before 
or after any study vaccination.

Systemic (oral, intravenous, or intramuscular) corticosteroid therapy within 28 days 
before or after any study vaccination.
6.5.2. Permitted During the Study

Nonstudy vaccines used in the event of a disease outbreak or pandemic are allowed. In 
such situations, effort should be made to appropriately plan the administration of study 
intervention around dosing of the pandemic vaccine.

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) 
before or after administration of study intervention.  

Antipyretic and other pain medication to treat symptoms following administration of 
study intervention 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.

Hormonal contraceptives that meet the requirements of this study are allowed to be used 
in participants who are WOCBP (see Appendix 4).
6.5.3. Prior Treatments
If the participant is known to have ever received a PRP-OMP vaccine, the name of the 
vaccine and date of administration will be recorded on the CRF.
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.

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7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
In rare instances, it may be necessary for a participant to permanently discontinue study 
intervention (definitive discontinuation).  Reasons for definitive discontinuation of study 
intervention include the following: AEs; parent(s)/legal guardian or participant request; 
protocol violation.
Note that discontinuation of study intervention does not represent withdrawal from the study.  
If study intervention is definitively discontinued, the participant will remain in the study to 
be evaluated for the collection of safety information.  See the SoA and Section 8.11.3 for 
data to be collected at the time of discontinuation of study intervention and follow-up for any 
further evaluations that need to be completed.
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, posttreatment study follow-up, 
and/or future collection of additional information.
Premature termination of this study may occur because of a regulatory authority decision, 
change in the opinion of the IRB/EC, or study intervention safety problems, or at the 
discretion of Pfizer.  In addition, Pfizer retains the right to discontinue development of 
MenABCWY at any time.
If a study is prematurely terminated, Pfizer will promptly notify the investigator.  After 
notification, the investigator must contact the parent(s)/guardian of all 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.  Reasons for 
discontinuation from the study include the following:

Refused further follow-up;

Lost to follow-up;

Death;

Study terminated by sponsor;

AEs;

Parent(s)/legal guardian or participant request;

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
Protocol violation.
If a participant does not return for a scheduled visit, every effort should be made to contact 
the participant’s parent(s)/legal guardian.  All attempts to contact the parent(s)/legal guardian 
and information received during contact attempts must be documented in the participant’s 
source document.  In any circumstance, every effort should be made to document participant 
outcome, if possible.
The parent(s)/legal guardian should be questioned regarding the reason for the participant’s 
withdrawal. The investigator or his or her designee should capture the reason for withdrawal 
in the CRF for all participants.
If a participant withdraws from the study, his/her parent(s)/legal guardian may request 
destruction of any remaining samples taken and not tested, and the investigator must 
document any such requests in the site study records and notify the sponsor accordingly.
The parent(s)/legal guardian should be requested to have the participant 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 8.11.3) for the 
collection of safety information should be completed for all participants who withdraw or 
have been withdrawn within 6 months after administration of study intervention, unless 
consent for further contact has been withdrawn or the participant is lost to follow-up.  
Participant withdrawal should be explained in the source documents and should include 
whether the withdrawal is only from further receipt of study intervention or also from study 
procedures and/or postvaccination study follow-up.
If the participant is withdrawn from the study and his/her parent(s)/legal guardian also 
withdraws consent (see Section 7.2.1) for disclosure of future information, no further 
evaluations should be performed and no additional data should be collected.  The sponsor 
may retain and continue to use any data collected before such withdrawal of consent.
Lack of completion of all or any of the withdrawal/early termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved.
7.2.1. Withdrawal of Consent 
Participants whose parent(s)/legal guardian requests to discontinue receipt of study 
intervention will remain in the study and must continue to be followed for protocol-specified 
follow-up procedures.  The only exception to this is when a participant’s parent(s)/legal 
guardian specifically withdraws consent for any further contact with him or her or persons 
previously authorized by the parent(s)/legal guardian to provide this information.  The 
participant’s parent(s)/legal guardian should notify the investigator in writing of the decision 

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to withdraw consent from future follow-up, whenever possible.  The withdrawal of consent 
should be explained in detail in the medical records by the investigator, as to whether the 
withdrawal is only from further receipt of study intervention or also from study procedures 
and/or posttreatment study follow-up, and entered on the appropriate CRF page.  In the event 
that vital status (whether the participant is alive or dead) is being measured, publicly 
available information should be used to determine vital status only as appropriately directed 
in accordance with local law.
7.3. Lost to Follow-up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and the participant’s parent(s)/legal guardian is unable to be contacted by the 
study site.
The following actions must be taken if a participant’s parent(s)/legal guardian fails to 
respond to a safety telephone call or return to the clinic for a required study visit:

The site must attempt to contact the participant’s parent(s)/legal guardian and reschedule 
the missed visit as soon as possible and counsel the participant’s parent(s)/legal guardian 
on the importance of maintaining the assigned visit schedule and ascertain whether or not 
the participant’s parent(s)/legal guardian wishes for the participant to and/or should 
continue in the study;

Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant’s parent(s)/legal guardian  (where 
possible, 3 telephone calls and, if necessary, a certified letter to the participant’s last 
known mailing address or local equivalent methods).  These contact attempts should be 
documented in the participant’s medical record;

Should the participant’s parent(s)/legal guardian continue to be unreachable, the 
participant will be considered to have withdrawn from the study.
8. STUDY ASSESSMENTS AND PROCEDURES
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.
The complete date of birth will be collected to critically evaluate the immune response and 
safety profile by age.
Study procedures and their timing are summarized in the SoA.  Protocol waivers or 
exemptions are not allowed.
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention.

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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. Options 
for alternative measures that may be taken for some study visits in case of a public 
emergency are described in Appendix 8.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
The total blood sampling volume for individual participants in this study is approximately 
125 mL for Group 1 (0- and 12-month schedule) and 100 mL for Group 2 (0- and 36-month 
schedule).  The actual collection times of blood sampling may change.  
8.1. Efficacy and/or Immunogenicity Assessments
To facilitate immunogenicity analyses, participants will have approximately 25 mL of blood 
collected at 4 or 5 visits during the study as described in Section 8.11 and the SoA.  Sera 
obtained at all study visits will be used in immunogenicity assays.  LOD and LLOQ titers for 
these assays will be detailed in the SAP.
8.1.1. MenA, MenC, MenW, and MenY Serum Bactericidal Assays
For assessment of the immune response to 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.  Sera obtained from participants in Groups 1 and 2 at all study visits will be 
used in hSBAs for the ACWY test strains.
8.1.2. MenB Serum Bactericidal Assays
For assessment of the immune response to 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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Sera obtained from participants in Group 1 at Visits 1, 5, 6, and 7, and from participants in 
Group 2 at Visits 1, 5, and 10 will be used in hSBAs for the 4 primary MenB test strains.
8.1.3. 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 or the participant’s parent(s)/legal guardian may request that the participant’s 
samples, if still identifiable, be destroyed at any time; however, any data already collected 
from those samples will still be used for this research.  The biological samples may be shared 
with other researchers as long as confidentiality is maintained and no testing of the 
participant’s genetic material is performed.
A mechanism (eg, appropriate wording within the study ICD) will be established that enables 
testing of serum samples obtained during the study to assess for the preexistence of select 
AEs reported during study participation.
8.2. Safety Assessments
Planned time points for all safety assessments are provided in the SoA.  Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety issues.
Any participant who receives at least 1 dose of study intervention will be included in the 
evaluation for safety.  The following safety parameters will be assessed as described in 
Section 8.11 and in the SoA:

Physical examination;

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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Immediate AEs, defined as AEs occurring within the first 30 minutes after study intervention 
administration, will be assessed and documented on the AE CRF.  The time of onset will be 
recorded for any AEs that occur on the same day as study intervention administration.
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, completed at each scheduled study visit/telephone contact after Visit 1, and 
included in the source documentation.  Please refer to the ISF for details.
The participant’s parent(s)/legal guardian will be given a memory aid at Visits 2 and 5.  The
memory aid will be used to remind parent(s)/legal guardian to review any significant 
illnesses, hospitalizations, NDCMCs, or visits to a medical facility with study site personnel.  
The parent(s)/legal guardian may use the memory aid as needed during the telephone contact 
at Visits 3 and 8 or the follow-up visits at Visits 6, 7, and 10 to prompt recall of events.  
These may be used to assist in reporting and discussion of events with study staff, but these 
memory aids will not be considered source documents and will not be collected at study 
visits.  Only information collected by study staff as part of a study visit or telephone contact 
will be included in the source documents and entered into the CRF.
In addition, AEs and SAEs will be collected as defined in Section 8.3.
8.2.1. Pregnancy Testing
Urine pregnancy tests will have a sensitivity of at least 25 mIU/mL.  Pregnancy tests will be 
performed in all female participants at the times listed in the SoA, immediately before the 
administration of each vaccine dose.  A negative pregnancy test result will be required prior 
to the participant’s receiving the study intervention.  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, the participant will be withdrawn from administration of study 
intervention but may remain in the study for safety follow-up.
In the case of a positive confirmed pregnancy at Visit 1, the participant will not be eligible 
for participation.

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8.3. Adverse Events and Serious Adverse Events
The definitions of an AE and an SAE can be found in Appendix 3.
The definitions of device-related safety events (ADEs and SADEs) can be found in 
Appendix 6.  Device deficiencies are covered in Section 8.3.6.
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or 
the participant’s parent[s]/legal guardian).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study intervention (see Section 7.1).
Each participant/parent/legal guardian will be questioned about the occurrence of AEs in a 
nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
8.3.1. Time Period and Frequency for Collecting AE and SAE Information
For all participants, information about AEs will be collected for events occurring within 
approximately 1 month after each vaccination, and information about SAEs, including 
hospitalizations, MAEs, and NDCMCs, will be collected for events occurring approximately 
6 months after Vaccinations 1 and 2, and within approximately 1 month after Vaccination 3.
Information about AEs and SAEs, including hospitalizations and MAEs will be collected for 
events occurring within 48 hours after each antibody persistence blood draw.
Details for the collection of AE and SAE information for participants in each vaccine group 
are described below.
Group 1 (0- and 12-month schedule)
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant’s parent(s)/legal guardian 
provides informed consent, which is obtained before the participant’s participation in the 
study (ie, before undergoing any study-related procedure and/or receiving study 
intervention), through and including Visit 2 (1 month after the first dose of MenABCWY), 
and from Visit 4 (second dose of MenABCWY) to Visit 5 (1 month after the second dose of 
MenABCWY).
At Visit 3 (safety telephone contact), the participant’s parent(s)/legal guardian will be 
contacted by telephone to inquire about SAEs, MAEs, and NDCMCs since Visit 2.

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At Visit 6 (12-month antibody persistence visit), information about SAEs, MAEs, and 
NDCMCs will be collected for events within 6 months after Visit 4 (second dose of 
MenABCWY).
During the antibody persistence phase (Visits 6 and 7), information about AEs and SAEs, 
including hospitalizations and MAEs, will be collected for events occurring within 48 hours 
after each antibody persistence blood draw.
AE collection for Group 1 (0- and 12-month schedule) is summarized in Table 2.
Group 2 (0- and 36-month schedule)
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant’s parent(s)/legal guardian 
provides informed consent, which is obtained before the participant’s participation in the 
study (ie, before undergoing any study-related procedure and/or receiving study 
intervention), through and including Visit 2 (1 month after the first dose of MenABCWY), 
and from Visit 4 (placebo dose) to Visit 5 (1 month after the placebo dose) and from Visit 9 
(second dose of MenABCWY) to Visit 10 (1 month after the second dose of MenABCWY).
At Visit 3 (safety telephone contact), the participant’s parent(s)/legal guardian will be 
contacted by telephone to inquire about SAEs, MAEs, and NDCMCs since Visit 2.
At Visit 8 (safety telephone contact), the participant’s parent(s)/legal guardian will be 
contacted by telephone to inquire about SAEs, MAEs, and NDCMCs within 6 months after 
Visit 4 (placebo dose).
AE collection for Group 2 (0- and 36-month schedule) is summarized in Table 3.
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator and Pfizer concurs with that assessment.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant definitively discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the Vaccine SAE Reporting Form.
Investigators are not obligated to actively seek AEs or SAEs after the participant has 
concluded study participation.  However, if the investigator learns of any SAE, including a 
death, at any time after a participant has completed or withdrawn early from the study, and 

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he/she considers the event to be reasonably related to the study intervention, the investigator 
must promptly report the SAE to Pfizer using the Vaccine SAE Reporting Form.

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Table 2.
Summary of Adverse Event Collection for Group 1 (0- and 12-Month Schedule)
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7a
Visit 
Description
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety 
Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
12-Month
Antibody 
Persistence 
Visit
24-Month
Antibody 
Persistence 
Visit
Approximate 
Month
0
1
6
12
13
24
36
Nonserious AEs
Within 48 
hours after 
blood draw
Within 48 
hours after 
blood draw
SAEs
                                                                  b,c
Within 48 
hours after 
blood draw
MAEs
                                                                  b,c
Within 48 
hours after 
blood draw
NDCMCs
                                                                   b
Note: The arrows represent the time periods for safety data collection.
a.
Visits 8, 9, and 10 will not be conducted for Group 1 participants.
b.
Events occurring within 6 months after Vaccination 2.
c.
Events occurring within 48 hours after the Visit 6 blood draw.

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Table 3.
Summary of Adverse Event Collection for Group 2 (0- and 36-Month Schedule)
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5a
Visit 8
Visit 9
Visit 10
Visit 
Description
Vaccination 1
1 Month Post–
Vaccination 1 
Blood Draw
Safety 
Telephone 
Contact 1
Vaccination 2
1 Month Post–
Vaccination 2 
Blood Draw
Safety 
Telephone 
Contact 2
Vaccination 3
1 Month Post–
Vaccination 3 
Blood Draw
Approximate 
Month
0
1
6
12
13
24
36
37
Nonserious 
AEs
SAEs
                                                                  b
                                                
MAEs
                                                                   b
                                                         
NDCMCs
                                                                   b
                                                         
Note: The arrows represent the time periods for safety data collection.
a.
Visits 6 and 7 will not be conducted for participants in Group 2.
b.
Events occurring within 6 months after Vaccination 2..

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8.3.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the Vaccine SAE Reporting Form immediately 
upon awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3.  The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available.
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant’s parent(s)/legal guardian.
8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs.  Open-ended and 
nonleading verbal questioning of the participant’s parent(s)/legal guardian 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 toward 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 

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sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate, according to local requirements.
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure
Exposure to the study intervention 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
An EDP occurs if: 

A female participant is found to be pregnant while receiving or after discontinuing study 
intervention.

A male participant who is receiving or has discontinued study intervention exposes a 
female partner prior to or around the time of conception.

A female is found to be pregnant while being exposed or having been exposed to study 
intervention due to environmental exposure.  Below are examples of environmental EDP:  

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by inhalation or skin contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by inhalation or skin contact then exposes his female partner prior to or 
around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred.  The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy).

If EDP occurs in a participant or a participant’s partner, 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.  Details of the 
pregnancy will be collected after the start of study intervention and until the pregnancy is 
completed (or terminated) for pregnancies that initiate within 6 months after 
administration of study intervention.

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
If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the Vaccine SAE Reporting Form and EDP 
Supplemental Form.  Since the exposure information does not pertain to the participant 
enrolled in the study, the information is not recorded on a CRF; however, a copy of the 
completed Vaccine SAE Reporting Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs.  If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs.  Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows:

Spontaneous abortion, including miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard to 
causality, as SAEs.  In addition, infant deaths after 1 month should be reported as SAEs 
when the investigator assesses the infant death as related or possibly related to exposure 
to the study intervention.
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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8.3.5.2. Exposure During Breastfeeding
An exposure during breastfeeding occurs if:

A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure).  An example of environmental exposure 
during breastfeeding is a female family member or healthcare provider who reports that 
she is breastfeeding after having been exposed to the study intervention by inhalation or 
skin contact.
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred.  The 
information must be reported using the Vaccine SAE Reporting Form.  When exposure 
during breastfeeding occurs in the setting of environmental exposure, the exposure 
information does not pertain to the participant enrolled in the study, so the information is not 
recorded on a CRF.  However, a copy of the completed Vaccine SAE Reporting Form is 
maintained in the investigator site file.
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use.  However, if the infant experiences an SAE associated with such a drug, the 
SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure
An occupational exposure occurs when a person receives unplanned direct contact with the 
study intervention, which may or may not lead to the occurrence of an AE.  Such persons 
may include healthcare providers, family members, and other roles that are involved in the 
trial participant’s care.
The investigator must report occupational exposure to Pfizer Safety within 24 hours of the 
investigator’s awareness, regardless of whether there is an associated SAE.  The information 
must be reported using the Vaccine SAE Reporting Form.  Since the information does not 
pertain to a participant enrolled in the study, the information is not recorded on a CRF; 
however, a copy of the completed Vaccine SAE Reporting Form is maintained in the 
investigator site file.
8.3.6. Cardiovascular and Death Events
Not applicable.
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.3.8. Adverse Events of Special Interest
Not applicable.

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8.3.8.1. Lack of Efficacy
Lack of efficacy is reportable to Pfizer Safety only if associated with an SAE.
8.3.9. Medical Device Deficiencies
Medical devices are being provided for use in this study for the purposes of administering 
and preparing study intervention.  In order to fulfill regulatory reporting obligations 
worldwide, the unblinded site staff are responsible for the detection and documentation of 
events meeting the definitions of device deficiency that occur during the study with such 
devices.
The definition of a medical device deficiency can be found in Appendix 6.
NOTE: Deficiencies fulfilling the definition of an AE/SAE will also follow the processes 
outlined in Sections 8.3.1 through 8.3.4 and Appendix 3 of the protocol.
8.3.9.1. Time Period for Detecting Medical Device Deficiencies
Medical device deficiencies or malfunctions of the device will be detected, documented, and 
reported during all periods of the study in which the medical device is used.
If the investigator learns of any device deficiency at any time after a participant has been 
discharged from the study, and such incident is considered reasonably related to a medical 
device provided for the study, the investigator will promptly notify the sponsor.
The method of documenting medical device deficiencies is provided in Appendix 6.
8.3.9.2. Follow-up of Medical Device Deficiencies
Follow-up applies to all participants, including those who discontinue study intervention.
The 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 
deficiency.
New or updated information will be recorded on a follow-up form with all changes signed 
and dated by the unblinded site staff.
8.3.9.3. Prompt Reporting of Device Deficiencies to Sponsor
Device deficiencies will be reported to the sponsor within 1 day after the unblinded site staff 
determine that the event meets the protocol definition of a medical device deficiency.  
Information will be provided to the sponsor as described in the IP manual.  
Any device deficiency that is associated with an SAE must be reported to Pfizer Safety 
within 24 hours upon the investigator’s awareness as outlined in Section 8.3.1.1 and 
Section 8.3.1.2.

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The sponsor will be the contact for the receipt of device deficiency information.
8.3.9.4. Regulatory Reporting Requirements for Device Deficiencies
The investigator will promptly report all device deficiencies occurring with any medical 
device provided for use in the study in order for the sponsor to fulfill the legal responsibility 
to notify appropriate regulatory authorities and other entities about certain safety information 
relating to medical devices being used in clinical studies.
The investigator, or responsible person according to local requirements (eg, the head of the 
medical institution), will comply with the applicable local regulatory requirements relating to 
the reporting of device deficiencies to the IRB/EC.
8.3.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Exposures to the study intervention under study may occur in clinical study settings as 
medication errors.
Safety Event
Recorded on the CRF
Reported on the Vaccine SAE 
Reporting Form to Pfizer Safety 
Within 24 Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;

Potential medication errors or uses outside of what is foreseen in the protocol that do or 
do not involve the study participant.
Other examples include, but are not limited to:

The administration of expired study intervention;

The administration of an incorrect study intervention;

The administration of an incorrect dosage;

The administration of study intervention that has undergone temperature excursion from 
the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use.

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Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Reporting Form only when associated with an SAE.
8.4. Treatment of Overdose
For this study, any dose of investigational 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 within 24 hours.
2. Closely monitor the participant for any AEs/SAEs.
3. Document the quantity of the excess dose as well as the duration of the overdose in the 
CRF.
4. Overdose is reportable to Safety only when associated with an SAE.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant.  
8.5. Pharmacokinetics
Pharmacokinetic parameters are not evaluated in this study. 
8.6. Pharmacodynamics
Pharmacodynamic parameters are not evaluated in this study.
8.7. Genetics
Genetics (specified analyses) are not evaluated in this study.
8.8. Biomarkers
Biomarkers are not evaluated in this study.

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8.9. Immunogenicity Assessments
Immunogenicity assessments are described in Section 8.1.
8.10. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
8.11. Study Procedures
8.11.1. Group 1 (0- and 12-Month Schedule)
8.11.1.1. 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.

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 Section 6.5.3.

Perform a 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 study 
intervention.

On the day of vaccination, prior to administration of study intervention, 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.

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
If a participant is eligible for the study, assign a randomization number and an 
investigational product container number via the IRT, or an equivalent system.

On the day of vaccination, prior to administration of study intervention, 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 
MenABCWY into the upper deltoid muscle of the arm.  The time of study intervention 
administration will be recorded on the CRF.

Observe the participant for at least 30 minutes (or longer as per local practice) after the 
study intervention administration for any acute reactions.  Record any AEs observed 
during the 30-minute observation period; these AEs are defined as immediate AEs 
(Section 8.2).

Record AEs as described in Section 8.3 and the SoA.  Time of onset will be recorded for 
any AEs that occur on the same day as study intervention administration.

Record concomitant medications used to treat AEs as described in Section 6.5.

Provide the parent(s)/legal guardian with a contact card (Section 10.1.10).

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

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 study intervention accountability records.
8.11.1.2. Visit 2, Month 1 (1 Month [28 to 42 Days] After Visit 1), 1-Month 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 as described 
in Section 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

Complete the Study Visit/Telephone Contact AE Checklist to:

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
Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect a blood sample (approximately 25 mL). 

Provide the parent(s)/legal guardian with a memory aid.  Instruct the parent(s)/legal 
guardian to use the memory aid between Visits 2 and 3 to remind him or her to review 
any significant illnesses, hospitalizations, NDCMCs, or visits to a medical facility with 
study site personnel.  The memory aid is not a diary for the collection of reactogenicity.  
Please refer to the ISF for additional details.

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule a telephone contact, and confirm that it is scheduled within the time window 
per protocol.

Complete the source documents.

Complete the CRFs.
8.11.1.3. Visit 3, Month 6 (6 Months [168 to 196 Days] After Visit 1), Safety Telephone 
Contact 1

Contact the parent(s)/legal guardian by telephone.

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 7.

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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 ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

Complete the source documents.

Complete the CRFs.
8.11.1.4. Visit 4, Month 12 (12 Months [336 to 394 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 7 and none of the temporary delay of vaccination criteria as described in
Section 5.5.1.

Perform a brief physical examination of the participant’s general appearance, skin, ears, 
throat, heart, lungs, abdomen, and lymph nodes.  Record any AEs as described in 
Section 8.3.

Complete the Study Visit/Telephone Contact AE Checklist to:

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
Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.  Time of onset will be recorded for 
any AEs that occur on the same day as study intervention administration.

Review AEs that were ongoing since the previous visit, and record their end dates or
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

On the day of vaccination, perform a urine pregnancy test on female participants.  A 
negative pregnancy test result is required before the participant may receive the study 
intervention.

On the day of vaccination, prior to administration of study intervention, measure and 
record the participant’s oral temperature.

The unblinded administrator administers a single 0.5-mL intramuscular injection of 
MenABCWY into the upper deltoid muscle of the arm.  The time of study intervention 
administration will be recorded on the CRF.

Observe the participant for at least 30 minutes (or longer as per local practice) after the 
study intervention 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).

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

Complete the source documents.

Complete the CRFs.

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8.11.1.5. Visit 5, Month 13 (1 Month [28 to 42 Days] After Visit 4), 1-Month 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 as described 
in Section 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect a blood sample (approximately 25 mL).

Provide the parent(s)/legal guardian with a memory aid. Instruct the parent(s)/legal 
guardian to use the memory aid between Visits 5 and 6 to remind him or her to review 
any significant illnesses, hospitalizations, NDCMCs, or visits to a medical facility with 
study site personnel.  The memory aid is not a diary for the collection of reactogenicity.  
Please refer to the ISF for additional details.

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

Complete the source documents.

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
Complete the CRFs.
8.11.1.6. Visit 6, Month 24 (12 Months [336 to 394 Days] After Visit 4), 12-Month 
Antibody Persistence Visit
Visit 6 must not be performed until the investigator is unblinded.  The Visit 6 window may 
be extended for individual participants by up to 60 days, at the discretion of the sponsor, to 
ensure unblinded information is available.

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 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect a blood sample (approximately 25 mL).

Ask the parent(s)/legal guardian to contact the investigator about any AEs occurring 
during the 48-hour period after the blood draw.

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

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
Complete the source documents.

Complete the CRFs.
8.11.1.7. Visit 7, Month 36, (24 Months [700 to 756 Days] After Visit 4), 24-Month 
Antibody Persistence Visit

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 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Collect a blood sample (approximately 25 mL).

Ask the parent(s)/legal guardian to contact the investigator about any AEs occurring 
during the 48-hour period after the blood draw.

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Complete the source documents.

Complete the CRFs.

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8.11.2. Group 2 (0- and 36-Month Schedule)
8.11.2.1. 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 Section 6.5.

Perform a 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 study 
intervention.

On the day of vaccination, prior to administration of study intervention, 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, assign a randomization number and an 
investigational product container number via the IRT, or an equivalent system.

On the day of vaccination, prior to administration of study intervention, collect a blood 
sample (approximately 25 mL).  Collect the blood sample only if the participant is 
eligible for vaccination on the same day. 

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
The unblinded administrator administers a single 0.5-mL intramuscular injection of 
MenABCWY into the upper deltoid muscle of the arm.  The time of study intervention 
administration will be recorded on the CRF.

Observe the participant for at least 30 minutes (or longer as per local practice) after the 
study intervention administration for any acute reactions.  Record any AEs observed 
during the 30-minute observation period; these AEs are defined as immediate AEs 
(Section 8.2).

Record AEs as described in Section 8.3 and the SoA.  Time of onset will be recorded for 
any AEs that occur on the same day as study intervention administration.

Record concomitant medications used to treat AEs as described in Section 6.5.

Provide the parent(s)/legal guardian with a contact card (Section 10.1.10).

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

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 study intervention accountability records.
8.11.2.2. Visit 2, Month 1 (1 Month [28 to 42 Days] After Visit 1), 1-Month 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 as described 
in Section 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

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
Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect a blood sample (approximately 25 mL).

Provide the parent(s)/legal guardian with a memory aid.  Instruct the parent(s)/legal 
guardian to use the memory aid between Visits 2 and 3 to remind him or her to review 
any significant illnesses, hospitalizations, NDCMCs, or visits to a medical facility with 
study site personnel.  The memory aid is not a diary for the collection of reactogenicity.  
Please refer to the ISF for additional details.

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule a telephone contact, and confirm that it is scheduled within the time window 
per protocol.

Complete the source documents.

Complete the CRFs.
8.11.2.3. Visit 3, Month 6 (6 Months [168 to 196 Days] After Visit 1), Safety Telephone 
Contact 1

Contact the parent(s)/legal guardian by telephone.

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 7.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

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Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

Complete the source documents.

Complete the CRFs.
8.11.2.4. Visit 4, Month 12 (12 Months [336 to 394 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 7 and none of the temporary delay of vaccination criteria as described in
Section 5.5.1.

Perform a brief physical examination of the participant’s general appearance, skin, ears, 
throat, heart, lungs, abdomen, and lymph nodes.  

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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
Record AEs as described in Section 8.3 and the SoA.  Time of onset will be recorded for 
any AEs that occur on the same day as study intervention administration.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

On the day of vaccination, perform a urine pregnancy test on female participants.  A 
negative pregnancy test result is required before the participant may receive the study 
intervention.

On the day of vaccination, prior to administration of study intervention, measure and 
record the participant’s oral temperature.

The unblinded administrator administers a single 0.5-mL intramuscular injection of saline 
placebo into the upper deltoid muscle of the arm.  The time of study intervention 
administration will be recorded on the CRF.

Observe the participant for at least 30 minutes (or longer as per local practice) after the 
study intervention 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).

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

Complete the source documents.

Complete the CRFs.
8.11.2.5. Visit 5, Month 13 (1 Month [28 to 42 Days] After Visit 4),  1-Month 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 as described 
in Section 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

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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 ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect a blood sample (approximately 25 mL). 

Provide the parent(s)/legal guardian with a memory aid.  Instruct the parent(s)/legal 
guardian to use the memory aid between Visits 5 and 10 to remind him or her to review 
any significant illnesses, hospitalizations, NDCMCs, or visits to a medical facility with 
study site personnel.  The memory aid is not a diary for the collection of reactogenicity.  
Please refer to the ISF for additional details.

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule an appointment for the next study visit as an in-person visit to maintain 
blinding, and confirm that it is scheduled within the time window per the protocol.  
Convert the scheduled next study visit to a telephone contact after the study-planned 
unblinding occurs.

Complete the source documents.

Complete the CRFs.
8.11.2.6. Visit 8, Month 24 (12 Months [336 to 394 Days] After Visit 4), Safety 
Telephone Contact 2
Visit 8 must not be performed until the investigator is unblinded.  The Visit 8 window may 
be extended for individual participants by up to 60 days, at the discretion of the sponsor, to 
ensure unblinded information is available.

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
Contact the parent(s)/legal guardian by telephone.

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 7.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

Complete the source documents.

Complete the CRFs.
8.11.2.7. Visit 9, Month 36 (24 Months [700 to 756 Days] After Visit 4), Vaccination 3
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 7 and none of the temporary delay of vaccination criteria as described in
Section 5.5.1.

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
Perform a brief physical examination of the participant’s general appearance, skin, ears, 
throat, heart, lungs, abdomen, and lymph nodes.  Record any AEs as described in 
Section 8.3.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.  Time of onset will be recorded for 
any AEs that occur on the same day as study intervention administration.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

On the day of vaccination, perform a urine pregnancy test on female participants.  A 
negative pregnancy test result is required before the participant may receive the study 
intervention.

On the day of vaccination, prior to administration of study intervention, measure and 
record the participant’s oral temperature.

Administer a single 0.5-mL intramuscular injection of MenABCWY into the upper 
deltoid muscle of the arm.  The time of study intervention administration will be recorded 
on the CRF.

Observe the participant for at least 30 minutes (or longer as per local practice) after the 
study intervention 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).

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window per protocol.

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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
Complete the source documents.

Complete the CRFs.
8.11.2.8. Visit 10, Month 37 (1 Month [28 to 42 Days] After Visit 9),  1-Month Post–
Vaccination 3 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 as described 
in Section 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

Complete the Study Visit/Telephone Contact AE Checklist to:

Inquire whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect a blood sample (approximately 25 mL).

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Complete the source documents.

Complete the CRFs.

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8.11.3. Final Telephone Contact for Participants Who Withdraw From the Study

This telephone contact should occur if a participant withdraws or is withdrawn from the 
study within 6 months after Vaccinations 1 and 2, or within 1 month after Vaccination 3; 
this contact should be attempted for all participants who have withdrawn from the study 
within the specified timeframe after receiving any 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 whether the participant had any NDCMCs since the last visit.  Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work.  Please refer to the ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Report any SAEs to the sponsor as defined in Section 8.3.

Record AEs as described in Section 8.3 and the SoA.

Record concomitant medications used to treat AEs as described in Section 6.5.

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 Section 6.5.

Complete the source documents.

Complete the CRFs.
8.12. Unscheduled Visits
An unscheduled telephone contact or visit may be scheduled for further assessment of any 
AE.  The symptom that prompted the visit should be assessed by a medically qualified 
member of the study staff.  Findings should be recorded on the CRF.
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.

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9. STATISTICAL CONSIDERATIONS
Methodology for summary and statistical analyses of the data collected in this study is 
described here and further detailed in a SAP, which will be maintained by the sponsor.  The 
SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Estimands and Statistical Hypotheses
No specific hypotheses will be tested in this study.
9.1.1. Estimands
The estimand(s) corresponding to each primary, secondary, and exploratory objective are 
described in the table in Section 3.  The estimands to evaluate the immunogenicity objectives 
are based on evaluable populations (see Section 9.3 for definition). These estimands estimate 
the vaccine effect in the hypothetical setting where participants follow the study schedules 
and protocol requirements as directed.  Missing serology results will not be imputed. 
In the primary safety objective evaluations, missing AE dates will be imputed according to 
Pfizer safety rules.
9.2. Sample Size Determination
The study sample size is not based on any hypothesis testing criteria.  All statistical analyses 
of immunogenicity and safety will be descriptive. The study will enroll approximately 150 
participants in each vaccine group. Assuming up to 20% exclusion rate from the applicable 
evaluable population, there will be approximately 120 evaluable participants in each vaccine 
group.
Table 4 shows the expected half-width of the 95% CI by percentage of participants achieving 
an hSBA titer ≥LLOQ for each test strain.
Table 4.
Expected Half-Width of 95% CIs by Percentage of Participants Achieving 
an hSBA Titer ≥LLOQ for Each Test Strain
Percentage of Participants
Number of Participants per 
Group
Expected Half-Width of 95% CI
(%)
60
120
9.1
70
120
8.5
80
120
7.5
90
120
5.8

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The probability of observing at least 1 occurrence of any AE for true event percentages 
between 0.1% and 2.0%, when MenABCWY is administered to 150 participants, is displayed 
in Table 5.
Table 5.
Probability of Observing at Least 1 AE by Assumed True Event Rates
Assumed True Event Percentage
Probability (N=150)
0.1%
0.14
0.5%
0.53
1.0%
0.78
2.0%
0.95
9.3. Analysis Sets
For purposes of analysis, the following populations are defined:
Population
Description
Enrolled 
All participants who sign the ICD.
Randomly assigned to 
investigational product
All participants who are assigned a randomization number in the IRT system.
Evaluable
Defined according to post–Vaccination 1 evaluable and post–Vaccination 2 
evaluable criteria.
Modified intent-to-treat 
(mITT)
Defined according to post–Vaccination 1 and post–Vaccination 2 criteria.
Safety
All randomized participants who receive at least 1 dose of the study 
intervention and have safety data reported after vaccination.  Participants will 
be analyzed according to the vaccine they actually received.
Defined Population for 
Analysis
Description
Post–Vaccination 1 
evaluable
All randomized participants who were:
•
eligible throughout Visit 2, 
•
received the investigational product at Visit 1 as randomized, 
•
had blood drawn for assay testing within the required time frames at 
Month 0 (Visit 1; before Vaccination 1) and Month 1 (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’s receipt of a prohibited vaccine or 

PF-06886992 (Neisseria meningitidis Group A, B, C, W, and Y Vaccine [MenABCWY])
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Defined Population for 
Analysis
Description
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 1 month after the second dose of MenABCWY, 
•
received the investigational product at Visit 1 (for Groups 1 and 2) and 
Visit 4 (for Group 1) and Visit 9 (for Group 2) as randomized, 
•
had blood drawn for assay testing within the required time frames at 
Month 0 (Visit 1; before Vaccination 1) and at 1 month after the second 
MenABCWY vaccination (Visit 5 for Group 1 and Visit 10 for Group 2: 
window 28-42 days), 
•
had at least 1 valid and determinate MenA/C/W/Y or MenB assay result 
at 1 month after the second MenABCWY vaccination (Visit 5 for 
Group 1 and Visit 10 for Group 2), 
•
had received no prohibited vaccines or treatment through Visit 5 
(Group 1) or Visit 10 (Group 2), and 
•
had no important protocol deviations through Visit 5 (Group 1) or 
Visit 10 (Group 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’s 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 1 mITT
All participants who received at least 1 study vaccination and had at least 
1 valid and determinate MenB or MenA/C/W/Y assay result available at any 
time point from Visit 1 to Visit 2.
Post–Vaccination 2 mITT
All participants who received at least 1 study vaccination and had at least 
1 valid and determinate MenB or MenA/C/W/Y assay result available at any 
time point from Visit 1 to Visit 5 for Group 1 and from Visit 1 to Visit 10 for 
Group 2.
9.4. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe 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 
exploratory endpoints.
9.4.1. Immunogenicity Analyses
Primary
For each of the 4 primary MenB test strains, the percentage of participants with an 
hSBA titer ≥ LLOQ at baseline and at 1 month after the second dose of MenABCWY 
will be calculated for each vaccine group.  Exact 2-sided 95% CIs for the percentages 
will be provided using the Clopper-Pearson method.

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The primary analysis for the primary MenB strains is based on the post–Vaccination 2 
evaluable population.
A supportive analysis will be performed based on the applicable mITT population.  
Participants will be summarized according to the vaccine group to which they were 
randomized.  Missing serology data will not be imputed.
Secondary 
The percentage of participants in Group 1 (0- and 12-month schedule) with hSBA titers 
≥ LLOQ for each of the primary MenB test strains at 12 and 24 months after the 
second dose of MenABCWY will be summarized using the post–Vaccination 2 
evaluable population.  
The percentage of participants in Group 1 with hSBA titers ≥ LLOQ for each of the 
ACWY test strains at 12 and 24 months after the second dose of MenABCWY will be 
summarized using the post–Vaccination 2 evaluable population.  
The percentage of participants in Group 1 (0- and 12-month schedule) and Group 2 
(0- and 36-month schedule) separately with hSBA titers ≥ LLOQ for each of the 
ACWY test strains at baseline and at 1 month after the first dose of MenABCWY will 
be summarized using the post–Vaccination 1 evaluable population.  The percentage of 
participants in Groups 1 and 2 separately with hSBA titers ≥ LLOQ for each of the 
ACWY test strains at baseline and at 1 month after the second dose of MenABCWY 
will be summarized using the post–Vaccination 2 evaluable population. 
Reverse cumulative distribution functions will be provided for both MenA/C/W/Y 
strains (1 month after the first and second dose of MenABCWY) and MenB strains 
(1 month after the second dose of MenABCWY) for each vaccine group.
Supportive analyses will be done using the applicable 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.
Exploratory
The following analyses for the primary MenB test strains are based on the post–
Vaccination 2 evaluable population for Groups 1 and 2 (separately):

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 at baseline and 
1 month after the second dose of MenABCWY.

MenB hSBA GMTs for each of the 4 primary MenB test strains at baseline, 
13 months after the first dose of MenABCWY (Group 2 only), and 1 month 
after the second dose of MenABCWY.

The percentage of participants achieving an hSBA titer ≥ LLOQ (1:16 for 
A22 and 1:8 for A56, B24, and B44) for all primary MenB test strains 
combined (composite response) at baseline and 1 month after the second dose 
of MenABCWY.

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 at 1 month after the 
second dose of MenABCWY.

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o
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.
o
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.
o
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.

The percentage of participants with hSBA titers ≥ LLOQ for each of the 
4 primary MenB test strains at 13 months after the first dose of MenABCWY 
(Group 2 only).
The following analyses for the ACWY test strains are based on the post–Vaccination 2 
evaluable population for Groups 1 and 2 (separately):

hSBA GMTs for each ACWY test strain at baseline and 1 month after the 
second dose of MenABCWY.

The percentage of participants achieving at least a 4-fold rise in hSBA titers
from baseline for each ACWY test strain at 1 month after the second dose of 
MenABCWY.
o
For participants with a baseline hSBA titer below the LOD (or an 
hSBA titer of <1:4), a 4-fold response is defined as a participant with 
an hSBA titer of 1:16.
o
For participants with a baseline hSBA titer of LOD (ie, hSBA titer 
of 1:4) and < LLOQ (ie, an hSBA titer of 1:8), a 4-fold response is 
defined as a participant with an hSBA titer of 4 times LLOQ.
o
For participants with a baseline hSBA titer of LLOQ, a 4-fold 
response is defined as a participant with an hSBA titer of 4 times 
the baseline titer.
The following analyses for the ACWY test strains are based on the post–Vaccination 1 
evaluable population for Groups 1 and 2 (separately):

hSBA GMTs for each ACWY test strain at baseline, 1 month after the first 
dose of MenABCWY, and 13 months after the first dose of MenABCWY 
(Group 2 only).

The percentage of participants achieving at least a 4-fold rise in hSBA titer 
from baseline for each ACWY test strain at 1 month after the first dose of 
MenABCWY.
o
For participants with a baseline hSBA titer below the LOD (or an 
hSBA titer of <1:4), a 4-fold response is defined as a participant with 
an hSBA titer of 1:16.

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o
For participants with a baseline hSBA titer of LOD (ie, hSBA titer 
of 1:4) and < LLOQ (ie, an hSBA titer of 1:8), a 4-fold response is 
defined as a participant with an hSBA titer of 4 times the LLOQ. 
o
For participants with a baseline hSBA titer of LLOQ, a 4-fold 
response is defined as a participant with an hSBA titer of 4 times 
the baseline titer.

The percentage of participants with hSBA titers ≥ LLOQ for each ACWY test 
strain at 13 months after the first dose of MenABCWY (Group 2 only).
Percentages will be presented with 2-sided 95% CIs using the Clopper-Pearson 
method.  Geometric means and their 2-sided CIs will be derived by calculating means 
and CIs on the natural log scale based on the t-distribution, then exponentiating the 
results.  Titers below LLOQ will be set to 0.5 × LLOQ for analysis.
Supportive analyses will be done using the applicable mITT population.  Participants 
will be summarized according to the vaccine group to which they were randomized.  
Missing serology data will not be imputed.
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, and will be detailed in the 
SAP.
Endpoint
Statistical Analysis Methods
Primary
The percentage of participants reporting at least 1 SAE, the percentage of participants 
reporting at least 1 MAE, and the percentage of participants reporting at least 1 
NDCMC will be descriptively summarized (percentages and associated 
Clopper-Pearson 95% CIs) by vaccination group for each time period defined in 
Section 3.
All AEs and SAEs will be categorized according to the latest version of MedDRA.  An 
MAE is defined as a nonserious AE that results in an evaluation at a medical facility.  
An NDCMC is defined as a disease or medical condition not previously identified that
is expected to be persistent or otherwise long-lasting in its effects.  AEs, SAEs, MAEs, 
and NDCMCs will be summarized by vaccine group.
Participants will be analyzed according to the vaccine they actually received.  Missing 
AE dates will be handled according to the Pfizer safety rules.
Detailed analyses for each safety endpoint will be addressed in the SAP.

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9.5. Interim Analyses
No interim analysis is planned in this study.
9.5.1. Analysis Timing
The study team will remain blinded until all participants have completed Visit 5, after which 
time select data will be reported, including immunogenicity data for Group 1.  A final 
analysis will be done after all available data have been collected.
9.6. Data Monitoring Committee or Other Independent Oversight Committee
This study will use a DMC.  The DMC is independent of the study team and includes only 
external members.  The DMC charter describes the role of the DMC in more detail.
An independent statistical center will provide unblinded safety reports to the DMC for 
review.  Safety data will be reviewed by the DMC throughout the study.  No alpha 
adjustments will be made to the immunogenicity summaries (CIs) for these periodic safety 
assessments.
The DMC will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter.  The recommendations made by the DMC to alter the conduct 
of the study will be forwarded to the appropriate Pfizer personnel for final decision.  Pfizer 
will forward such decisions, which may include summaries of aggregate analyses, to 
regulatory authorities, as appropriate.

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

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

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

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

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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.
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 onsite 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.

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

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

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

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

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
The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will be 
reported as an AE or SAE if they fulfill the definition of an AE or SAE and meet the 
requirements as per Section 8.3.8.1.  Also, “lack of efficacy” or “failure of expected 
pharmacological action” constitutes an AE or SAE.
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).

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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.
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 

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convulsions that do not result in hospitalization, or development of drug dependency or 
drug abuse.

Suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-
pathogenic, is considered serious.  The event may be suspected from clinical symptoms 
or laboratory findings indicating an infection in a patient exposed to a Pfizer product.  
The terms “suspected transmission” and “transmission” are considered synonymous.  
These cases are considered unexpected and handled as serious expedited cases by 
pharmacovigilance personnel.  Such cases are also considered for reporting as product 
defects, if appropriate.
10.3.4. Recording/Reporting and Follow-up of AEs and/or SAEs
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording AEs on the CRF and for 
reporting SAEs on the Vaccine SAE Reporting Form to Pfizer Safety.  These requirements 
are delineated for 3 types of events: (1) SAEs; (2) nonserious AEs; and (3) exposure to the 
study intervention under study during pregnancy or breastfeeding, and occupational 
exposure. 
It should be noted that the Vaccine SAE Reporting Form for reporting of SAE information 
is not the same as the AE page of the CRF.  When the same data are collected, the forms 
must be completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the Vaccine SAE 
Reporting Form for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported on the Vaccine 
SAE Reporting Form to 
Pfizer Safety Within 24 
Hours of Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding and 
occupational exposure
All AEs/SAEs associated 
with exposure during 
pregnancy or breastfeeding.
Occupational exposure is 
not recorded.
All (and EDP Supplemental 
Form for EDP)
Note: Include all SAEs 
associated with exposure 
during pregnancy or 
breastfeeding. Include all 
AEs/SAEs associated with 
occupational exposure.  

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
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.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories: 
GRADE If required on the AE page of the CRF, the investigator will use the 
adjectives MILD, MODERATE, or SEVERE to describe the maximum 
intensity of the AE. For purposes of consistency, these intensity grades are 
defined as follows:
1
MILD
Does not interfere with participant’s usual 
function.
2
MODERATE
Interferes to some extent with participant’s usual 
function.
3
SEVERE
Interferes significantly with participant’s usual 
function.
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.

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Assessment of Causality

The investigator is obligated to assess the relationship between study intervention and 
each occurrence of each AE/SAE.

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 study intervention caused the 
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by the sponsor.  In addition, if the investigator determines that an 
SAE is associated with study procedures, the investigator must record this causal 
relationship in the source documents and CRF, and report such an assessment in the 
dedicated section of the Vaccine SAE Reporting Form and in accordance with the SAE 
reporting requirements.

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Follow-up of AEs and SAEs

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor, to elucidate the nature and/or causality of the AE or SAE as fully as possible.  
This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized follow-up 
period, the investigator will provide Pfizer Safety with a copy of any postmortem 
findings including histopathology.

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours of 
receipt of the information.
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.

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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 
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 may be 
considered 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.

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10.4.3. Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
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.  In addition, a

high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using hormonal 
contraception or HRT. 

Female 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.

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10.4.4. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
3. Intrauterine hormone-releasing system.
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.

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

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

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

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

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

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Severe: An event that prevents normal everyday activities.  An AE that is assessed 
as severe should not be confused with an SAE.  Severe is a category utilized for 
rating the intensity of an event; and both AEs and SAEs can be assessed as severe.

An event is defined as “serious” when it meets at least 1 of the predefined 
outcomes as described in the definition of an SAE, NOT when it is rated as severe.
Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE/SAE/device deficiency.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.

The investigator will use clinical judgment to determine the relationship.

Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.

The investigator will also consult the IB and/or product information, for marketed 
products, in his/her assessment.

For each AE/SAE/device deficiency, the investigator must document in the 
medical notes that he/she has reviewed the AE/SAE/device deficiency and has 
provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is 
very important that the investigator always make an assessment of causality for 
every event before the initial transmission of the SAE data to the sponsor.

The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.

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Follow-up of AE/SAE/Device Deficiency

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the AE/SAE/device deficiency as 
fully as possible.  This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings, including histopathology.  

New or updated information will be recorded in the originally completed CRF.

The investigator will submit any updated SAE data to the sponsor within 24 hours 
of receipt of the information.
10.6.5. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool

The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic data collection tool.

If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) in order to report the event within 24 hours.

The site will enter the SAE data into the electronic system as soon as the data 
become available.

After the study is completed at a given site, the electronic data collection tool will 
be taken off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form (see 
next section) or to Pfizer Safety by telephone.

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SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form

Facsimile transmission of the Vaccine SAE Reporting Form is the preferred 
method to transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Reporting Form sent by overnight mail 
or courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Reporting Form pages within the designated 
reporting time frames.
10.6.6. Reporting of SADEs
SADE Reporting to Pfizer Safety 
NOTE: There are additional reporting obligations for medical device incidents that are 
potentially related to SAEs that must fulfill the legal responsibility to notify appropriate 
regulatory authorities and other entities about certain safety information relating to medical 
devices being used in clinical studies. 

Any device deficiency that is associated with an SAE must be reported to the 
sponsor within 24 hours after the investigator determines that the event meets the 
definition of a device deficiency.

The sponsor shall review all device deficiencies and determine and document in 
writing whether they could have led to an SAE.  These shall be reported to the 
regulatory authorities and IRBs/ECs as required by national regulations.

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10.7. Appendix 7: 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 
ADE
adverse device effect
AE
adverse event
AlPO4
aluminum phosphate
ALT
alanine aminotransferase
AST
aspartate aminotransferase
bivalent rLP2086
bivalent recombinant lipoprotein 2086 vaccine (Trumenba)
CDP
clinical development program
CFR
Code of Federal Regulations
CI
confidence interval
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
DILI
drug-induced liver injury
DMC
data monitoring committee
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
fHBP
factor H binding protein
FIH
first-in-human
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMT
geometric mean titer

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Abbreviation
Term
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
IP manual
investigational product manual
IPAL
Investigational Product Accountability Log
IRB
institutional review board
IRT
interactive response technology
ISF
investigator site file
ISO
International Organization for Standardization
LFT
liver function test
LLOQ
lower limit of quantitation
LOD
limit of detection
MAE
medically attended adverse event
MCV4-Tdap
quadrivalent meningococcal polysaccharide conjugate and tetanus, 
diphtheria, and acellular pertussis vaccine
MedDRA
Medical Dictionary for Regulatory Activities
MenA
Neisseria meningitidis group A 
MenA/C/W/Y
Neisseria meningitidis group A, C, W, and/or Y
MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
MenACWY
meningococcal groups A, C, W, and Y conjugate vaccine
MenACWY-CRM
meningococcal group A, C, W-135, and Y 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 
MenW
Neisseria meningitidis group W 
MenY
Neisseria meningitidis group Y 
mITT
modified intent-to-treat
N/A
not applicable
NDCMC
newly diagnosed chronic medical condition
NIMP
noninvestigational medicinal product

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Abbreviation
Term
PACL
protocol administrative change letter
PFS
prefilled syringe
POC
proof of concept
PRP-OMP
polyribosylribitol phosphate oligosaccharide of 
Haemophilus influenzae type b conjugated to outer membrane 
protein
PT/INR
prothrombin time/international normalized ratio
rLP2086
recombinant lipoprotein 2086
rSBA
serum bactericidal assay using rabbit complement
SADE
serious adverse device effect
SAE
serious adverse event
SAP
statistical analysis plan
SoA
schedule of activities
SOP
standard operating procedure
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
TBili
total bilirubin
ULN
upper limit of normal
US
United States
USADE
unanticipated serious adverse device effect
WOCBP
woman/women of childbearing potential
CCI

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10.8. Appendix 8: Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic in the US and will become effective for other public emergencies 
only upon written notification from Pfizer.
Use of these alternative study measures are expected to cease upon the return of business as 
usual circumstances (including the lifting of any quarantines and travel bans/advisories).
10.8.1. Telehealth Visits
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow up on the safety of study participants at scheduled visits per the SoA or unscheduled 
visits. Telehealth visits may be used to continue to assess participant safety and collect data 
points. Telehealth includes the exchange of healthcare information and services via 
telecommunication technologies (eg, audio, video, and video-conferencing software) 
remotely, allowing the participant and the investigator to communicate on aspects of clinical 
care, including medical advice, reminders, education, and safety monitoring. The following 
assessments must be performed during a telehealth visit:

Review and record any AEs and SAEs since the last contact. Refer to Section 8.3.

Review and record any new concomitant medications used to treat an AE since the last 
contact. Refer to Section 6.5.

Confirm that the participant is adhering to the contraception method(s) required in the 
protocol. Refer to Appendix 4.
In addition to the above, procedures outlined for a typical safety telephone contact 
(see Section 8.11.1.3) may be performed during a telehealth visit.  Study participants must be 
reminded to promptly notify site staff about any change in their health status.
10.8.2. Home Health Visits
A home healthcare service may be utilized to facilitate scheduled visits per the Schedule of 
Activities. Home health visits include a healthcare provider conducting an in-person study 
visit at the participant’s location, rather than an in-person study visit at the site. The 
following may be performed during a home health visit:

Ensure that the participant continues to be eligible for the study and 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 7 and none of the temporary delay of blood draw criteria as described in
Section 5.5.2.

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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 ISF for additional details.

Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis.  Please refer to the ISF for 
additional details.

Record AEs as described in Section 8.3 and the SoA.

Review AEs that were ongoing since the previous visit, and record their end dates or 
confirm that they are still continuing.

Record concomitant medications used to treat AEs as described in Section 6.5.

Record nonstudy vaccinations as described in Section 6.5.

Collect a blood sample (approximately 25 mL). 

Ask the parent(s)/legal guardian to contact the investigator immediately if any significant 
illness or hospitalization occurs.

Schedule an appointment for the next study visit, and confirm that it is scheduled within 
the time window indicated in the protocol.

Complete the source documents.

Complete the CRFs.
10.8.3. Adverse Events and Serious Adverse Events
If a participant has COVID-19 during the study, this should be reported as an AE or SAE and 
appropriate medical intervention provided. Study treatment should continue unless the 
investigator/treating physician is concerned about the safety of the participant, in which case 
temporary or permanent discontinuation may be required.
It is recommended that the investigator discuss temporary or permanent discontinuation of 
study intervention with the study medical monitor. 

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11. REFERENCES
1.
Centers for Disease Control and Prevention. Meningococcal vaccination for 
adolescents: information for healthcare professionals. Available from: 
https://www.cdc.gov/vaccines/vpd/mening/hcp/adolescent-vaccine.html. Last reviewed: 
26 Jul 2019. Accessed: 22 Jan 2020.
2.
Wang B, Clarke M, Thomas N, et al. The clinical burden and predictors of sequelae 
following invasive meningococcal disease in Australian children. Pediatr Infect Dis J 
2014;33(3):316-8.
3.
Purmohamad A, Abasi E, Azimi T, et al. Global estimate of Neisseria meningitidis 
serogroups proportion in invasive meningococcal disease: a systematic review and 
meta-analysis. Microb Pathog 2019;134:103571.
4.
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(RR-2):1-28.
5.
Centers for Disease Control and Prevention. Enhanced meningococcal disease 
surveillance report, 2018. Available from: 
https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report-2018.pdf. 
Accessed: 13 Jan 2020.
6.
Walker TY, Elam-Evans LD, Yankey D, et al. National, regional, state, and selected 
local area vaccination coverage among adolescents aged 13-17 years - United States, 
2018. MMWR Morb Mortal Wkly Rep 2019;68(33):718-23.
7.
National Foundation for Infectious Diseases. Addressing the challenges of serogroup B 
meningococcal disease outbreaks on campuses: a report by the National Foundation for 
Infectious Diseases. May 2014. Available from: 
http://www.nfid.org/publications/reports/meningococcal-b-outbreaks.pdf. Accessed: 
14 Dec 2014.
8.
Wendling P. Campus meningitis outbreaks tamed but can our approach last? 28 Feb 
2014. Available from: 
http://www.clinicalneurologynews.com/index.php?id=9843&cHash=071010&tx_ttnews
[tt_news]=239545.  Accessed: 14 Dec 2014.
9.
MacNeil JR, Blain AE, Wang X, et al.  Current epidemiology and trends in 
meningococcal disease–United States, 1996-2015. Clin Infect Dis 2018;66(8):1276-81.
10.
World Health Organization. WHO Technical Report Series, No. 927, 2005.  Available 
from: 
https://www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/
ANNEX%201Nonclinical.P31-63.pdf?ua=1.  Accessed: 21 Nov 2019.

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