A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE
Phase: PHASE4
Conditions: Meningococcal Vaccine
Sponsor: Pfizer

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 1 
 
 
 
 
A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, 
TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA® WHEN 
ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF 
AGE 
 
 
Study Intervention Number: 
PF-05212366 
Study Intervention Name: 
Neisseria meningitidis Serogroup B Bivalent 
Recombinant Lipoprotein 2086 Vaccine 
(Trumenba) 
US IND Number: 
13812 
EudraCT Number: 
2018-002588-24 
Protocol Number: 
B1971060 
Phase: 
4 
Short Title: Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When 
Administered to Immunocompromised Participants ≥10 Years of Age 
 
 
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 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 
Original protocol 
22 January 2021 
N/A 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 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 ..................................................................................................................... 8 
1. PROTOCOL SUMMARY ..................................................................................................... 9 
1.1. Synopsis ..................................................................................................................... 9 
1.2. Schema..................................................................................................................... 12 
1.3. Schedule of Activities .............................................................................................. 13 
2. INTRODUCTION ................................................................................................................ 15 
2.1. Study Rationale ........................................................................................................ 15 
2.2. Background .............................................................................................................. 15 
2.2.1. Neisseria meningitidis Disease Background and Medical Need ................. 15 
2.2.2. Bivalent rLP2086 (Trumenba) .................................................................... 17 
2.2.3. Functional Antibody Assay as a Surrogate of Efficacy .............................. 18 
2.2.4. Clinical Overview ....................................................................................... 18 
2.3. Benefit/Risk Assessment ......................................................................................... 19 
2.3.1. Risk Assessment ......................................................................................... 20 
2.3.2. Benefit Assessment ..................................................................................... 21 
2.3.3. Overall Benefit/Risk Conclusion ................................................................ 21 
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS ............................................................ 22 
4. STUDY DESIGN ................................................................................................................. 24 
4.1. Overall Design ......................................................................................................... 24 
4.1.1. Approximate Duration of Participation for Each Participant ...................... 24 
4.1.2. Approximate Number of Participants .......................................................... 24 
4.2. Scientific Rationale for Study Design ..................................................................... 24 
4.3. Justification for Dose ............................................................................................... 25 
4.4. End of Study Definition ........................................................................................... 25 
5. STUDY POPULATION ...................................................................................................... 25 
5.1. Inclusion Criteria ..................................................................................................... 26 
5.2. Exclusion Criteria .................................................................................................... 26 
5.3. Lifestyle Considerations .......................................................................................... 28 
5.3.1. Contraception .............................................................................................. 28 
5.4. Screen Failures ......................................................................................................... 28 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 4 
 
 
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study 
Intervention Administration ...................................................................................... 28 
5.5.1. Criteria for Temporarily Delaying Vaccine Administration ...................... 28 
5.5.2. Criteria for Temporarily Delaying Immunogenicity Blood Draw .............. 29 
6. STUDY INTERVENTION ................................................................................................. 29 
6.1. Study Intervention(s) Administered ........................................................................ 29 
6.1.1. Administration ............................................................................................ 30 
6.1.2. Medical Devices ......................................................................................... 30 
6.2. Preparation/Handling/Storage/Accountability ......................................................... 30 
6.2.1. Preparation and Dispensing ........................................................................ 32 
6.3. Measures to Minimize Bias: Randomization and Blinding .................................... 32 
6.3.1. Allocation of Study Intervention ................................................................ 32 
6.4. Study Intervention Compliance .............................................................................. 32 
6.5. Concomitant Therapy ............................................................................................. 32 
6.5.1. Prohibited During the Study ...................................................................... 33 
6.5.2. Permitted During the Study ....................................................................... 33 
6.5.3. Prior Treatment .......................................................................................... 33 
6.6. Dose Modification .................................................................................................. 34 
6.7. Intervention After the End of the Study ................................................................. 34 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ........................................................................... 34 
7.1. Discontinuation of Study Intervention .................................................................... 34 
7.2. Participant Discontinuation/Withdrawal From the Study ...................................... 35 
7.2.1. Withdrawal of Consent .............................................................................. 36 
7.3. Lost to Follow-up ................................................................................................... 36 
8. STUDY ASSESSMENTS AND PROCEDURES .............................................................. 37 
8.1. Efficacy and/or Immunogenicity Assessments ....................................................... 37 
8.1.1. Serum Bactericidal Assays ........................................................................ 38 
8.1.2. Biological Samples .................................................................................... 38 
8.2. Safety Assessments ................................................................................................. 39 
8.2.1. Electronic Diary ......................................................................................... 40 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 5 
 
 
8.2.1.1. Local Reactions ......................................................................... 41 
8.2.1.2. Redness and Swelling ................................................................ 41 
8.2.1.3. Systemic Events ......................................................................... 42 
8.2.2. Pregnancy Testing ....................................................................................... 43 
8.3. Adverse Events and Serious Adverse Events .......................................................... 43 
8.3.1. Time Period and Frequency for Collecting AE and SAE Information ....... 44 
8.3.1.1. Reporting SAEs to Pfizer Safety ............................................... 45 
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF ................... 45 
8.3.2. Method of Detecting AEs and SAEs ........................................................... 45 
8.3.3. Follow-up of AEs and SAEs ....................................................................... 45 
8.3.4. Regulatory Reporting Requirements for SAEs ........................................... 46 
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational 
Exposure ........................................................................................................... 46 
8.3.5.1. Exposure During Pregnancy ...................................................... 46 
8.3.5.2. Exposure During Breastfeeding ................................................. 48 
8.3.5.3. Occupational Exposure .............................................................. 48 
8.3.6. Cardiovascular and Death Events ................................................................ 48 
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs .............................................................................. 49 
8.3.8. Adverse Events of Special Interest .............................................................. 49 
8.3.8.1. Lack of Efficacy ........................................................................ 49 
8.3.9. Medical Device Deficiencies ...................................................................... 49 
8.3.9.1. Time Period for Detecting Medical Device Deficiencies .......... 49 
8.3.9.2. Follow-up of Medical Device Deficiencies ............................... 49 
8.3.9.3. Prompt Reporting of Device Deficiencies to Sponsor .............. 50 
8.3.9.4. Regulatory Reporting Requirements for Device 
Deficiencies ........................................................................................ 50 
8.3.10. Medication Errors ...................................................................................... 50 
8.4. Treatment of Overdose ............................................................................................ 51 
8.5. Pharmacokinetics ..................................................................................................... 51 
8.6. Pharmacodynamics .................................................................................................. 52 
8.7. Genetics ................................................................................................................... 52 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 6 
 
 
8.8. Biomarkers .............................................................................................................. 52 
8.9. Immunogenicity Assessments ................................................................................ 52 
8.10. Health Economics ................................................................................................. 52 
8.11. Study Procedures .................................................................................................. 52 
8.11.1. Visit 1 (Day 1): Vaccination 1 ................................................................. 52 
8.11.2. Visit 2 (28 to 42 Days After Visit 1): Safety Follow-up Visit ................. 55 
8.11.3. Visit 3 (173 to 194 Days After Visit 1): Vaccination 2 ........................... 56 
8.11.4. Visit 4 (28 to 42 Days After Visit 3): Post–Vaccination 2 Blood 
Draw ................................................................................................................ 58 
8.11.5. Visit 5 (168 to 196 Days After Last Vaccination): Telephone 
Contact ............................................................................................................ 60 
8.12. Unscheduled Visits ............................................................................................... 60 
9. STATISTICAL CONSIDERATIONS ................................................................................ 61 
9.1. Estimands and Statistical Hypotheses .................................................................... 61 
9.1.1. Estimands ................................................................................................... 61 
9.2. Sample Size Determination .................................................................................... 61 
9.3. Analysis Sets ........................................................................................................... 62 
9.4. Statistical Analyses ................................................................................................. 63 
9.4.1. Historical Age-Matched Healthy Controls ................................................. 63 
9.4.2. Immunogenicity Analyses .......................................................................... 64 
9.4.3. Safety Analyses .......................................................................................... 64 
9.4.4. Demographic and Baseline Characteristics ................................................ 65 
9.5. Interim Analyses ..................................................................................................... 65 
9.6. Data Monitoring Committee or Other Independent Oversight Committee .............66 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS.......................................................................................................... 67 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations ............... 67 
10.1.1. Regulatory and Ethical Considerations .................................................... 67 
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP ........................................................................ 67 
10.1.2. Financial Disclosure ................................................................................. 68 
10.1.3. Informed Consent Process ....................................................................... 68 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 7 
 
 
10.1.4. Data Protection ......................................................................................... 69 
10.1.5. Dissemination of Clinical Study Data ...................................................... 69 
10.1.6. Data Quality Assurance ............................................................................ 71 
10.1.7. Source Documents ................................................................................... 72 
10.1.8. Study and Site Start and Closure .............................................................. 72 
10.1.9. Publication Policy .................................................................................... 73 
10.1.10. Sponsor’s Qualified Medical Personnel ................................................. 74 
10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ...................................................................... 75 
10.2.1. Definition of AE ....................................................................................... 75 
10.2.2. Definition of an NDCMC ........................................................................ 76 
10.2.3. Definition of SAE..................................................................................... 76 
10.2.4. Recording/Reporting and Follow-up of AEs and/or SAEs ...................... 78 
10.2.5. Reporting of SAEs ................................................................................... 81 
10.3. Appendix 3: Contraceptive Guidance ................................................................... 83 
10.3.1. Male Participant Reproductive Inclusion Criteria ................................... 83 
10.3.2. Female Participant Reproductive Inclusion Criteria ................................ 83 
10.3.3. Woman of Childbearing Potential (WOCBP) .......................................... 83 
10.3.4. Contraception Methods ............................................................................ 84 
10.4. Appendix 4 : Liver Safety: Suggested Actions and Follow-up Assessments ....... 85 
10.5. Appendix 5: Medical Device Adverse Events, Adverse Device Effects, 
Serious Adverse Events, and Device Deficiencies: Definition and Procedures 
for Recording, Evaluating, Follow-up, and Reporting .............................................. 88 
10.5.1. Definition of AE and ADE ....................................................................... 88 
10.5.2. Definition of SAE, SADE, and Unanticipated Serious Adverse 
Device Effect ................................................................................................... 88 
10.5.3. Definition of Device Deficiency .............................................................. 89 
10.5.4. Recording/Reporting and Follow-up of AEs and/or SAEs and 
Device Deficiencies ......................................................................................... 90 
10.5.5. Reporting of SAEs ................................................................................... 92 
10.5.6. Reporting of SADEs ................................................................................ 93 
10.6. Appendix 6: Alternative Measures During Public Emergencies .......................... 94 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 8 
 
 
10.6.1. Telehealth Visits ........................................................................................ 94 
10.6.2. Home Health Visits ................................................................................... 94 
10.6.3. Adverse Events and Serious Adverse Events............................................ 96 
10.7. Appendix 7: Abbreviations .................................................................................... 97 
11. REFERENCES ................................................................................................................. 100 
 
 
LIST OF TABLES 
Table 1. 
Validated hSBA LODs and LLOQs for the 4 Primary MnB Strains ....... 38 
Table 2. 
Grading of Redness and Swelling ............................................................ 41 
Table 3. 
Grading of Pain ........................................................................................ 42 
Table 4. 
Severity Scale for Fever ........................................................................... 42 
Table 5. 
Grading of Other Systemic Events ............................................................ 43 
Table 6. 
Probability of Observing at Least 1 Event by Assumed True Event 
Rates .......................................................................................................... 62 
Table 7. 
Width of 95% Exact Confidence Interval by Response Rate .................... 62 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 9 
 
 
1. PROTOCOL SUMMARY 
1.1. Synopsis 
Individuals with anatomic asplenia or some degree of functional asplenia (eg, sickle cell 
anemia) or complement deficiencies (including but not limited to deficiencies in C5-C9, 
properdin, factor D, or factor H) are known to be at increased risk of severe infections caused 
by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and 
Hib. 
This study (designed to functionally assess antibody production in asplenic and 
complement-deficient individuals) is a Phase 4, open-label, single-arm trial evaluating the 
safety, tolerability, and immunogenicity of 2 doses of Trumenba® on a 0- and 6-month 
schedule in immunocompromised participants ≥10 years of age. The 2-dose schedule, which 
is safe and well tolerated and provides protective immunity to a high proportion of healthy 
individuals, will be evaluated in this population. Historical data from age-matched healthy 
participants from the Phase 3 MnB Study B1971057, which confirmed the safety and high 
degree of protective immunity achieved after vaccination with Trumenba on a 2-dose, 0- and 
6-month schedule, will be used as a reference for safety and immunogenicity of Trumenba in 
healthy adolescents and young adults when reporting the results from this study. 
Objectives, Estimands, and Endpoints 
The objective of this study is to describe the immunogenicity and safety of Trumenba in 
individuals with asplenia or complement deficiencies with reference to historical data from 
randomly selected age-matched healthy participants. 
 
Objectives 
Estimands 
Endpoints 
Primary Immunogenicity: 
Primary Immunogenicity: 
Primary 
Immunogenicity: 
To describe the immune response 
induced by 2 doses of Trumenba 
in immunocompromised 
participants and historical age- 
matched healthy participants as 
measured by hSBA performed 
with 4 primary MnB test strains, 
2 expressing an LP2086 
subfamily A protein and 2 
expressing an LP2086 subfamily 
B protein. 
In immunocompromised participants or 
historical age-matched healthy participants 
separately, who are receiving 2 doses of study 
intervention and are in compliance with key 
protocol criteria (evaluable participants): 
• The proportion of participants with hSBA 
titer ≥ LLOQ (1:16 for A22 and 1:8 for A56, 
B24, and B44) for each of the 4 primary MnB 
test strains 1 month after Vaccination 2. 
• 
hSBA titer for 
each of the 
primary MenB 
test strains (A22, 
A56, B24, and 
B44). 
Primary Safety: 
Primary Safety: 
Primary Safety: 
To evaluate the safety profile of 
Trumenba in 
immunocompromised 
participants and historical 
age-matched healthy participants. 
In immunocompromised participants or 
historical age-matched healthy participants 
separately, who are receiving at least 1 dose of 
study intervention: 
• 
Local reactions 
(pain at the 
injection site, 
redness, and 
swelling). 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 10 
 
 
 
Objectives 
Estimands 
Endpoints 
• The percentage of participants reporting local 
reactions, systemic events, and use of 
antipyretic medication within 7 days after 
each vaccination with Trumenba. 
• The percentage of participants with at least 
1 SAE and at least 1 MAE during the 
following time periods: 
• 
30 Days after each vaccination. 
• 
30 Days after any vaccination. 
• 
During the vaccination phase (from 
Vaccination 1 through 1 month after 
Vaccination 2). 
• 
During the follow-up phase (from 
1 month after Vaccination 2 through 6 
months after Vaccination 2). 
• 
From Vaccination 1 through 6 months 
after Vaccination 2). 
• The percentage of participants with at least 
1 AE occurring during the following time 
periods: 
• 
30 Days after each vaccination. 
• 
30 Days after any vaccination. 
• 
During the vaccination phase (from 
Vaccination 1 through 1 month after 
Vaccination 2). 
• The percentage of participants with at least 
1 immediate AE after each vaccination. 
• The percentage of participants with at least 
1 NDCMC occurring during the following 
time periods: 
• 
During the vaccination phase (from 
Vaccination 1 through 1 month after 
Vaccination 2). 
• 
During the follow-up phase (from 
1 month after Vaccination 2 through 6 
months after Vaccination 2). 
• 
Systemic events 
(fever, vomiting, 
diarrhea, 
headache, 
fatigue, chills, 
muscle pain 
other than 
muscle pain at 
the injection site, 
and joint pain). 
• 
Use of 
antipyretic 
medication. 
• 
AEs. 
• 
SAEs. 
• 
MAEs. 
• 
Immediate AEs. 
• 
NDCMCs. 
• 
Days missing 
from school or 
work because of 
AEs. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 11 
 
 
 
Objectives 
Estimands 
Endpoints 
• 
From Vaccination 1 through 6 months 
after Vaccination 2. 
• Number of days participants missed school or 
work because of AEs during the vaccination 
phase (from Vaccination 1 through 1 month 
after Vaccination 2). 
 
Overall Design 
This is a Phase 4, open-label, single-arm, multicenter trial in which up to 50 
immunocompromised participants ≥10 years of age with asplenia (anatomic or functional) or 
complement deficiency will be enrolled and receive Trumenba on a 2-dose, 0- and 6-month 
schedule. All participants will be naive to any meningococcal serogroup B vaccine prior to 
enrollment. 
Historical data from age-matched healthy participants from a pivotal Phase 3 MnB study 
(that has previously completed the primary analysis) will be used as a reference for the safety 
and immunogenicity of Trumenba. Healthy adolescents and young adults (10 to <26 years of 
age) from Study B1971057 will be randomly selected and details on how these participants 
will serve as controls are in Section 9.4.1. 
For this study, immunocompromised participants are individuals at increased risk for 
meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell 
anemia) or complement deficiencies (including but not limited to deficiencies in C5-C9, 
properdin, factor H, or factor D). 
Enrolled participants will be vaccinated with 2 doses of Trumenba at Months 0 and 6 
(Visits 1 and 3). Blood samples (approximately 20 mL per visit) for immunogenicity 
analysis by hSBA (performed with 4 primary MenB test strains as detailed in Section 3) will 
be collected prior to Vaccination 1 and 1 month after Vaccination 2 (Visits 1 and 4). Given 
the immunocompromised population enrolled in this study, participants will receive an 
on-site follow-up visit 1 month after Vaccination 1 (Visit 2). Participants will attend 4 study 
visits and a telephone contact will be made at Visit 5 (6 months after the last vaccination). 
Statistical Methods 
This is a descriptive study; therefore, an estimation approach will be utilized to address the 
immunogenicity objectives. All binary immunogenicity endpoints will be presented with 
2-sided exact 95% CIs. Safety endpoints will be descriptively summarized via proportions of 
participants with any local reactions, systemic events, AEs, MAEs, SAEs, NDCMCs, and 
immediate AEs and the associated 2-sided exact 95% CIs. Immunogenicity and safety will 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 12 
 
 
be reported descriptively for the immunocompromised participants and historical 
age-matched healthy control participants. 
1.2. Schema 
 
Vaccination 1 
Safety Follow-up 
Visit 
Vaccination 2 
Post– 
Vaccination 2 
Blood Draw 
Telephone 
Contact 
Visit ID 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Approximate 
month 
0 
1 
6 
7 
12 
Vaccination 
Trumenba 
Trumenba 
Blood draw 
20 mL 
20 mL 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
 Final Protocol, 22 January 2021 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 13 
 
 
 
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 info1mation 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 paiiicipant. 
 
Visit ID 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit Description 
Vaccination 
1 
Safety Follow-up 
Visit 
Vaccination 2 
Post-Vaccination 2 
Blood Draw 
Telephone Contact 
Approximate Month 
0 
1 
6 
7 
6 Months After Last 
Study Vaccination 
Visit Window 
Dayl 
28 to 42 Days 
After Visit 1 
173 to 194 Days 
After Visit 1 
28 to 42 Days Afte1· 
Visit 3 
168 to 196 Days Afte1· 
Visit 3 
Infonued consent 
X 
Review eligibility criteria 
X 
Demography 
X 
Confinu continued eligibility3 
X 
X 
X 
Medical history and physical examination 
X 
Record previous pneumococcal and meningococcal 
sero1Zrouo ACWY vaccinations 
X 
Record blood transfusions within prior 3 months 
X 
Urine pregnancy test for all female participants 
X 
X 
Obtain prevaccination oral temperature 
X 
X 
IVRS/IWRS kit assignment 
X 
X 
Obtain blood sample 
20mL 
20mL 
Study intervention administration and observationb 
X 
X 
Record nonstudy vaccinations and any blood transfusions 
X 
X 
X 
Provide the participant with a contact card 
X 
Provide the participant with a memo,y aid 
X 
X 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
 Final Protocol, 22 January 2021 
 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 14 
 
 
 
Visit ID 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit Description 
Vaccination 
1 
Safety Follow-up 
Visit 
Vaccination 2 
Post-Vaccination 2 
Blood Draw 
Telephone Contact 
Approximate Month 
0 
1 
6 
7 
6 Months After Last 
Study Vaccination 
Visit Window 
Dayl 
28 to 42 Days 
After Visit 1 
173 to 194 Days 
After Visit 1 
28 to 42 Days Afte1· 
Visit 3 
168 to 196 Days Afte1· 
Visit 3 
Provide the participant with e-diary or ensure dia1y app 
downloaded 
X 
X 
Review and collect e-diary 
X 
X 
Provide caliper, measuring tape, and thermometer, if 
necessary 
X 
X 
Assess reactogenicity and record use of antipyretic 
medication' 
Daylto7 
Day 1 to 7 
Collect e-diary, if applicable 
X 
X 
Complete Study Visit/Telephone Contact AE Checklistd 
X 
X 
X 
X 
Record concomitant medications used to treat AEs 
X 
X 
X 
X 
X 
(S)AE collection appropriate for the visit• 
X 
X 
X 
X 
X 
Abbreviations: ACWY = Neisseria meningitidis serogroups A, C, W-135, and Y; e ia1y = electronic diary; IVRS = interactive voice response system; IWRS = interactive Web- 
based response system. 
a. 
 Ensure that the participant continues to be eligible for the study, does not meet anytempora1y delay criteria, and continues to comply with contraception requirements, as 
appropriate. 
b. 
Observe the participant for at least 30 minutes (or longer as per local practice) after the study intervention administration for any acute reactions. 
c. 
 Between visits, review the e-dia1y data online at frequent intervals. Contact the pa1ticipant/parent(s)/legal guardian in order to obtain stop dates for any local reactions, 
systemic events, or use of antipyretic medication that was ongoing on the last day that the e-dia1y was completed. 
d. 
 Checklist includes questions regarding newly diagnosed chronic medical conditions; hospitalizations, visits to other medical facilities, medication use, and missed days of 
school or work due to AEs; and neuroinflammatoryand autoinunune conditions, such as transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 
e. 
Afollow-up contact with the pa1ticipant must be scheduled at the end of the AE/SAE active collection period as defined in Se-ction 8.3.1. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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2. INTRODUCTION 
Bivalent rLP2086 (Trumenba®) is indicated for active immunization to prevent invasive 
disease caused by MnB. Trumenba is approved by the US FDA for use in individuals 10 
through 25 years of age and by the EMA in individuals 10 years of age and older. 
2.1. Study Rationale 
Individuals with anatomic asplenia or some degree of functional asplenia (eg, sickle cell 
anemia) or complement deficiencies (including but not limited to deficiencies in C5-C9, 
properdin, factor D, or factor H) are known to be at increased risk of severe infections caused 
by encapsulated bacteria, including S pneumoniae, N meningitidis, and Hib. 
This study, as described in Section 4, is a Phase 4, open-label, single-arm trial evaluating the 
safety, tolerability, and immunogenicity of 2 doses of Trumenba on a 0- and 6-month 
schedule in immunocompromised participants ≥10 years of age. Historical data from 
age-matched healthy participants from the Phase 3 MnB Study B1971057, which confirmed 
the safety and high degree of protective immunity achieved after vaccination with Trumenba 
on a 2-dose, 0- and 6-month schedule, will be used as a reference for the safety and 
immunogenicity of Trumenba in healthy adolescents and young adults when reporting the 
results from this study. 
2.2. Background 
2.2.1. Neisseria meningitidis Disease Background and Medical Need 
N meningitidis is a leading cause of bacterial meningitis in infants, adolescents, and young 
adults. Meningococcal disease incidence peaks in infants and children <5 years of age, 
adolescents and young adults 15 to 24 years of age, and adults ≥65 years of age. Currently, 
meningococcal serogroups A, B, C, W, and Y cause virtually all IMD globally.1,2,3 In 
particular, MnB was the most common cause of meningococcal infections in Europe between 
1999 and 2004, with an overall non–serogroup-specific case-fatality rate of 8% in 2004.4 In 
Europe during 2015, MnB accounted for approximately 50% of all deaths associated with 
IMD.5 In England between 2007 and 2011, among 5115 hospitalized cases of confirmed 
IMD, MnB accounted for 87% of cases overall and 94% of cases in those younger than 
15 years of age. For MnB, the overall case-fatality rate was 4.2% for IMD and the odds of 
death among adolescents and young adults (OR 2.49; 95% CI 1.60, 3.88; p<0.001) was 
higher than in infants.6 
From 2007 to 2018, IMD (including IMD caused by MnB) has been declining in general in 
Europe and in the United States.7,8,9,10 In 2017, the estimated incidence of IMD caused by 
MnB was 0.04 per 100,000 individuals in the US and 0.3 per 100,000 in Europe. Therefore, 
the overall risk of IMD during periods of stable endemicity in both the US and Europe is 
extremely low.11,12 However, during outbreaks at college campuses, incidence rates have 
been as high as 134 per 100,000 among undergraduates at Princeton University (2013/2014), 
21.1 per 100,000 among 17- to 22-year-olds at the University of California Santa Barbara 
(2013), and 44 per 100,000 among undergraduates at Providence College in Rhode Island 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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(2015).13,14,15 However, fluctuations in epidemiology, the unpredictable nature of the 
disease, and its potentially fatal consequences still pose a serious threat to public health. The 
need for a comprehensive approach to prevent meningococcal disease relies on vaccination 
and implementation of health authorities’ recommendations for immunization. 
Individuals with anatomic asplenia or some degree of functional asplenia (eg, sickle cell 
anemia) or complement deficiencies (including but not limited to deficiencies in C5-C9, 
properdin, factor D, or factor H) are known to be at increased risk of severe infections caused 
by encapsulated bacteria.16 S pneumoniae, N meningitidis, and Hib account for more than 
half of the severe bacterial infections in asplenic individuals, and the lifetime risk of infection 
is higher in children than in adults.17 It is therefore important to protect 
immunocompromised individuals, particularly those with asplenia or complement 
deficiencies, against encapsulated bacterial pathogens, such as N meningitidis, because of the 
increased risk of morbidity and mortality.17,18 In a previously conducted Phase 3, open-label, 
controlled study to evaluate the safety and immunogenicity of MenACWY-TT given on a 
0- and 2-month schedule in anatomically or functionally asplenic individuals (N=43) from 1 
to <18 years of age, hSBA response rates in this population for the 4 serogroups ranged from 
55.6% to 77.1% 1 month after Vaccination 1 and 73.0% to 100.0% 1 month after 
Vaccination 2. No safety signals were identified in this population. So far, no clinical study 
has been conducted in the immunocompromised population in the Trumenba development 
program. No additional adverse reactions to those already known for MenACWY-TT were 
identified in this population. 
Trumenba is currently licensed for active immunization to prevent IMD caused by MnB and 
can be administered either according to a 3-dose (0, 1-2, and 6 months) or a 2-dose (0 and 6 
months) schedule. Individuals with altered immunocompetence may have reduced immune 
responses to Trumenba, but that has not been evaluated prior to this proposed study. Because 
immunological clearance of N meningitidis from the bloodstream is complement-mediated 
and dependent on splenic production of antibodies and antigen processing by splenic 
macrophages for clearing opsonized encapsulated bacteria, adequate antibody production 
must be demonstrated in asplenic and complement-deficient individuals to assess the 
potential for protective immunity following vaccination. This can be assessed using hSBAs 
with exogenous complement in the same way this assay is utilized in assessing protective 
immunity in healthy, immunocompetent individuals. However, even if antibody levels are 
adequate, hSBA results may not be predictive of protection from disease in complement- 
deficient individuals because the assay employs exogenous complement. This is well 
reported and is borne out by the occurrence of IMD in complement-deficient individuals who 
have been vaccinated with 4CMenB.19 
This study is designed to functionally assess antibody production in asplenic and 
complement-deficient individuals. The 2-dose schedule, which is safe and well tolerated and 
provides protective immunity to a high proportion of healthy individuals, will be evaluated in 
this population. In Phase 3 Study B1971057, conducted in healthy adolescents and young 
adults, the proportion of participants achieving a 4-fold or higher rise in hSBA titer over 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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baseline 1 month after the second vaccination ranged from 67.4% to 95.0% for the 4 primary 
MenB test strains (A22, A56, B24, and B44) with a composite response (proportion of 
participants with hSBA titers ≥ LLOQ for all 4 MenB test strains) of 74.3%. Proportions of 
participants achieving hSBA titers ≥ LLOQ for 10 secondary strains (A29, A06, A12, A07, 
A15, A19, B16, B09, B03, and B15) were also high, ranging from 71.1% to 96.8%. These 
results are comparable to those obtained using the 3-dose schedule in pivotal Phase 3 clinical 
trials B1971009 and B1971016 in healthy adolescents and young adults, respectively, and 
support routine use of the 2-dose schedule over the 3-dose schedule outside of the setting of 
an outbreak. In the setting of an outbreak, 2 doses over a short period of time is desirable to 
afford more expeditious protection; those 2 doses during the outbreak should be followed by 
the third dose at 6 months to complete the series. 
There is no reason to expect that asplenic individuals’ immune responses, as measured by 
hSBA, would be significantly different from healthy individuals’ responses after MenB 
vaccination, given observations that 2 doses of 4CMenB were similarly immunogenic in this 
immunocompromised population compared to healthy children.20 Although there was a trend 
toward decreased hSBA responses in individuals taking eculizumab who had terminal 
complement deficiency, the small sample size necessitates further monitoring for vaccine 
failures.20 This study is therefore designed to evaluate the safety and immunogenicity of 
Trumenba when given on the same 2-dose schedule that proved safe and highly 
immunogenic in healthy adolescents and young adults who participated in Phase 3 Study 
B1971057. 
2.2.2. Bivalent rLP2086 (Trumenba) 
Trumenba (bivalent rLP2086), developed by Pfizer, is targeted to a conserved, surface- 
exposed lipoprotein, LP2086, a meningococcal virulence factor that binds human factor H, 
and therefore is designated as fHBP.21,22 The LP2086 gene is present in 100% of MnB 
strains in Pfizer’s strain collection of more than 1800 strains isolated from patients with 
invasive disease in the United States and Europe.23 The lipoproteins segregate into 
2 antigenically and immunologically distinct subfamilies, A and B.24,25 Trumenba is a sterile 
suspension composed of 2 recombinant lipidated fHBP variants from MnB, 1 from fHBP 
subfamily A and 1 from subfamily B (A05 and B01, respectively). 
Trumenba has been approved in the United States (October 2014) for active immunization to 
prevent invasive disease caused by MnB, for use in individuals 10 through 25 years of age. 
The US CDC’s ACIP gives a shared clinical decision-making recommendation for 
administration of a 2-dose series of Trumenba for adolescents and young adults 16 to 
23 years of age, with particular focus on the 16- to 18-year age group. ACIP also provides a 
stronger recommendation for vaccination of individuals ≥10 years of age at risk because of 
persistent complement component deficiencies, anatomic or functional asplenia, routine 
exposure as a microbiologist, or in the setting of a serogroup B meningococcal disease 
outbreak.26 Trumenba has also been approved by the EMA (May 2017) for use in individuals 
10 years of age and older in the EU and has now received regulatory approval in 47 countries 
and is currently marketed in 26 countries. Broad implementation of a safe and immunogenic 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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vaccine against diverse MnB strains is anticipated to provide substantial improvement in 
prevention of this uncommon but severe bacterial infection and a reduction in the burden of 
disease. Trumenba has not been previously evaluated in individuals with altered 
immunocompetence. 
2.2.3. Functional Antibody Assay as a Surrogate of Efficacy 
MnB clearance from the bloodstream is primarily by complement-dependent bacteriolysis. 
The in vivo complement-dependent bacteriolysis of MnB is mimicked by the in vitro hSBA, 
a functional serological assay shown to be the correlate of protection against IMD and 
recognized as the surrogate marker of vaccine efficacy.27,28,29,30 
Four primary MnB test strains for hSBA representative of LP2086 subfamily A and B 
variants were selected from the clinically relevant strain pool of 1263 MnB isolates,31 taking 
into account the population distribution of LP2086 surface expression. It was known from 
earlier studies that in vitro surface expression of LP2086 is an important predictor for 
susceptibility in hSBA. Thus, only MnB strains with LP2086 surface-expression levels 
above that threshold (majority of isolates) were candidates for random selection of primary 
MnB test strains to be used in hSBAs supporting late-phase clinical studies. This approach, 
coupled with identification of epidemiologically prevalent (circulating) strains in the United 
States and Europe, was used to select the 4 Phase 3 primary MnB test strains: 2 each from 
subfamilies A and B. Two MnB test strains (ie, 1 from subfamily A [PMB2001 (A56)] and 1 
from subfamily B [PMB2707 (B44)]) were selected in an unbiased fashion, while the other 2 
test strains (ie, 1 from subfamily A [PMB80 (A22)] and 1 from subfamily B [PMB2948 
(B24)]) were selected based on epidemiological prevalence. These 4 test strains will be used 
in the hSBA for determination of the immunogenicity endpoints. 
2.2.4. Clinical Overview 
Approval of Trumenba by the FDA was initially based on Phase 2 studies demonstrating its 
safety and ability to induce serum bactericidal activity against 4 MnB strains as analyzed by 
hSBA, which meets criteria for a serological correlate of protection against MnB 
IMD.27,28,29,30 Subsequently, as a requirement of US licensure, Phase 3 studies were 
conducted to confirm the safety and immune responses associated with the 3-dose schedule. 
Robust serum bactericidal activities were demonstrated not only by the 4 primary MnB 
strains (A22, A56, B24, and B44), but also by an additional 10 MnB strains (A29, A06, A12, 
A07, A15, A19, B16, B09, B03, and B15), all expressing heterologous LP2086 variants, 
suggesting broad coverage conferred by Trumenba against MnB. As of 28 October 2019, it 
is estimated that >23,500 participants have been vaccinated in the Trumenba clinical 
development program. 
Clinical studies also demonstrated that Trumenba may be coadministered with MCV4, Tdap, 
HPV4, and dTaP-IPV without meaningfully impacting the immunogenicity or safety of the 
vaccines, which may facilitate introduction of Trumenba into national immunization 
programs. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
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The safety data from the completed clinical studies in participants 10 years of age and older 
support an acceptable safety profile for Trumenba in the population age group proposed for 
this study. Overall, the rates of local reactions and systemic events are higher following 
administration of Trumenba than for saline control (but similar to the active control groups). 
AEs other than reactogenicity that have been considered related to Trumenba by investigators 
are infrequent, and SAEs are infrequent and mostly considered not related to Trumenba by 
investigators. The percentage of participants who withdraw from studies because of AEs is 
low. 
2.3. Benefit/Risk Assessment 
Common AEs noted after vaccination with Trumenba (licensed in the US, EU, and other 
countries) are primarily related to reactogenicity, including local reactions (pain, swelling, 
and redness around the injection site) and systemic events (headache, fatigue, myalgias, 
arthralgias, nausea/vomiting, diarrhea, chills, and fever). 
As with any vaccine, an allergic reaction may occur. Symptoms of an allergic reaction can 
include swelling of the lips, mouth, and throat, which may cause difficulty in swallowing or 
breathing; skin rash; swelling of the hands, feet, and ankles; dizziness; and fainting. A severe 
allergic shock (anaphylactic shock) may occur. There may also be additional risks related to 
the vaccines administered in the study that are unknown at this time. 
Risks that may be associated with study procedures include risk from blood sampling, such 
as feeling faint, dizziness, fainting, pain, swelling, bruising, and infection in the vicinity of 
the vein from where blood is taken. 
Safety assessments described in this protocol and ongoing safety data reviews by the 
investigator, and the sponsor’s global medical monitor, the internal safety data review 
subcommittee, the internal risk management committee, and the DMC, will serve to monitor 
and mitigate these risks. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of Trumenba may be found in the IB, which is the SRSD for this study. 

 
PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
 
2.3.1. Risk Assessment 
 
Potential Risk of Clinical Significance 
Summary of Data/Rationale for Risk 
Mitigation Strategy 
Study Intervention - Trumenba 
Risks associated with Trumenba in adolescents and 
adults 10 years of age and older based on clinical 
trial experience with bivalent rLP2086 are 
headache, nausea, diarrhea, vomiting, myalgia, 
arthralgia, injection site pain, fatigue, chills, 
injection site swelling, injection site redness, and 
fever. 
Risks associated with Trumenba based on 
postmarketing experience are allergic reactions and 
syncope. 
The potential risks are based on the known safety 
profile of Trumenba as presented in the 
Trumenba IB (based on the bivalent rLP2086 
CDS). 
Eligibility criteria have been selected to ensure 
that only appropriate healthy participants are 
included in the study (see Section 5). 
E-diary and AE data will be monitored at frequent 
intervals by the investigator (or designee) after 
each vaccination (Section 8.2). 
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 the risk of bleeding, bruising, hematoma 
formation, and infection at the venipuncture site, 
as well as dizziness related to 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 country guidance will be 
allowed to draw blood, to minimize local 
complications. 
 
 
 
 
 
 
 
 
 
 
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PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
2.3.2. Benefit Assessment 
Based on the known degree of protective immunogenicity afforded by the licensed vaccine 
Trumenba, the potential benefits of participation in this study and receipt of all vaccination 
doses include potential protection against IMD caused by MenB. 
Other benefits to the individual participant may include physical examination by a medical 
provider at the start of the study, a thorough review of the participant’s vaccination status, 
and evaluation 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 to participants participating in this 
study, the potential risks identified in association with Trumenba 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 caused by MenB) that may be afforded to immunocompromised 
participants. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Protocol B1971060 
Final Protocol, 22 January 2021 
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3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS 
The objective of this study is to describe the immunogenicity and safety of Trumenba in individuals with asplenia or complement 
deficiencies with reference to historical data from randomly selected age-matched healthy participants. 
 
Objectives 
Estimands 
Endpoints 
Primary Immunogenicity: 
Primary Immunogenicity: 
Primary Immunogenicity: 
To describe the immune response induced 
by 2 doses of Trumenba in 
immunocompromised participants and 
historical age-matched healthy 
participants as measured by hSBA 
performed with 4 primary MnB test 
strains, 2 expressing an LP2086 subfamily 
A protein and 2 expressing an LP2086 
subfamily B protein. 
In immunocompromised participants or historical age-matched healthy 
participants separately, who are receiving 2 doses of study intervention and are in 
compliance with key protocol criteria (evaluable participants): 
• The proportion of participants with hSBA titer ≥ LLOQ (1:16 for A22 and 1:8 
for A56, B24, and B44) for each of the 4 primary MnB test strains 1 month 
after Vaccination 2. 
• hSBA titer for each of the 
primary MenB test strains 
(A22, A56, B24, and 
B44). 
Primary Safety: 
Primary Safety: 
Primary Safety: 
To evaluate the safety profile of Trumenba 
in immunocompromised participants and 
historical age-matched healthy 
participants. 
In immunocompromised participants or historical age-matched healthy 
participants separately, who are receiving at least 1 dose of study intervention: 
• The percentage of participants reporting local reactions, systemic events, and 
use of antipyretic medication within 7 days after each vaccination with 
Trumenba. 
• The percentage of participants with at least 1 SAE and at least 1 MAE during 
the following time periods: 
• 30 Days after each vaccination. 
• 30 Days after any vaccination. 
• During the vaccination phase (from Vaccination 1 through 1 month after 
Vaccination 2). 
• During the follow-up phase (from 1 month after Vaccination 2 through 
6 months after Vaccination 2). 
• From Vaccination 1 through 6 months after Vaccination 2. 
• Local reactions (pain at 
the injection site, 
redness, and swelling). 
• Systemic events (fever, 
vomiting, diarrhea, 
headache, fatigue, chills, 
muscle pain other than 
muscle pain at the 
injection site, and joint 
pain). 
• Use of antipyretic 
medication. 
• AEs. 
• SAEs. 

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Objectives 
Estimands 
Endpoints 
• The percentages of participants with at least 1 AE occurring during the 
following time periods: 
• 30 Days after each vaccination. 
• 30 Days after any vaccination. 
• During the vaccination phase (from Vaccination 1 through 1 month after 
Vaccination 2). 
• The percentage of participants with at least 1 immediate AE after each 
vaccination. 
• The percentage of participants with at least 1 NDCMC occurring during the 
following time periods: 
• During the vaccination phase (from Vaccination 1 through 1 month after 
Vaccination 2). 
• During the follow-up phase (from 1 month after Vaccination 2 through 
6 months after Vaccination 2). 
• From Vaccination 1 through 6 months after Vaccination 2. 
• Number of days participants missed school or work because of AEs during the 
vaccination phase (from Vaccination 1 through 1 month after Vaccination 2). 
• MAEs. 
• Immediate AEs. 
• NDCMCs. 
• Days missing from 
school or work because 
of AEs. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
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4. STUDY DESIGN 
4.1. Overall Design 
This is a Phase 4, open-label, single-arm, multicenter trial in which up to 50 
immunocompromised participants ≥10 years of age with asplenia (anatomic or functional) or 
complement deficiency will be enrolled and receive Trumenba on a 2-dose, 0- and 6-month 
schedule. All participants will be naive to any meningococcal serogroup B vaccine prior to 
enrollment. 
Historical data from age-matched healthy participants from 1 previously completed pivotal 
Phase 3 MnB study will be used as a reference for the safety and immunogenicity of 
Trumenba in the general population. Healthy adolescents and young adults (10 to <26 years 
of age) from Study B1971057 will be randomly selected. Details on how these participants 
will serve as controls are in Section 9.4.1. 
For this study, immunocompromised participants are individuals at increased risk for 
meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell 
anemia) or complement deficiencies (including but not limited to deficiencies in C5-C9, 
properdin, factor H, or factor D). 
Enrolled participants will be vaccinated with 2 doses of Trumenba at Months 0 and 6 
(Visits 1 and 3). Blood samples (approximately 20 mL per visit) for immunogenicity 
analysis by hSBA will be collected prior to Vaccination 1 and 1 month after Vaccination 2 
(Visits 1 and 4). Given the immunocompromised population enrolled in this study, 
participants will receive an on-site follow-up visit 1 month after Vaccination 1 (Visit 2). 
Participants will attend 4 study visits and a telephone contact will be made at Visit 5 
(6 months after the last vaccination). 
4.1.1. Approximate Duration of Participation for Each Participant 
The duration of study participation for each participant will be approximately 12 months, 
including a telephone contact 6 months after the last vaccination. 
The study duration will be approximately 3 years. The sponsor may decide to close 
recruitment if enrollment of 50 participants becomes challenging after 2 years of active 
enrollment. 
4.1.2. Approximate Number of Participants 
Up to 50 immunocompromised participants will be enrolled in the study. 
4.2. Scientific Rationale for Study Design 
This Phase 4 study will describe the immunogenicity, tolerability, and safety of Trumenba in 
individuals with asplenia or complement deficiencies with reference to historical data from 
randomly selected age-matched healthy participants. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
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Trumenba will be given in an open-label manner and on a 0- and 6-month schedule to 
immunocompromised participants ≥10 years of age. 
Refer to Section 2.1 for further detail about the rationale of the study design. 
Trumenba is approved for active immunization against IMD caused by serogroup B without 
any contraceptive precautions. There is no suspicion of human genotoxicity or teratogenicity 
based on the intended pharmacology and World Health Organization guidance.32 See 
Appendix 3 for contraceptive requirements. 
4.3. Justification for Dose 
Trumenba (120 µg, meningococcal group B vaccine) is indicated for active immunization to 
prevent invasive disease caused by MnB. Trumenba, supplied as a 0.5-mL dose PFS, 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. 
The safety, tolerability, and immunogenicity of Trumenba is well established in adolescents 
and young adults. With the exception of recommendations for use of the 3-dose (0, 1-2, and 
6 months) schedule to allow for more rapid increase in protective antibody responses after 
the second dose given at Month 2 in persons at increased risk for meningococcal disease 
during serogroup B meningococcal disease outbreaks (higher-intensity risk over shorter time 
period), the 2-dose, 0- and 6-month schedule is anticipated to provide similar hSBA 
responses among individuals with anatomic or functional asplenia and complement 
deficiencies as healthy individuals during lower-risk periods of low endemicity. 
4.4. End of Study Definition 
End of the trial in all participating countries is defined as the date of the last participant’s last 
visit for all scheduled procedures shown in the SoA. 
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. 

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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 ≥10 years of age at the time of consent. 
• Refer to Appendix 3 for reproductive criteria for male (Section 10.3.1) and female 
(Section 10.3.2) participants. 
Type of Participant and Disease Characteristics: 
2. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, 
lifestyle considerations, and other study procedures. 
3. Participants with an increased risk for meningococcal disease due to anatomic asplenia or 
functional asplenia (eg, sickle cell anemia) or complement deficiencies (including but not 
limited to C5-C9, properdin, factor H, or factor D). 
4. Available for the entire study period and can be reached by telephone. 
5. Female participants of childbearing potential must agree to use a highly effective method 
of contraception through at least 28 days after the last study vaccination. A participant is 
of childbearing potential if, in the opinion of the investigator, she is biologically capable 
of having children and is sexually active. This criterion is not applicable to male 
participants. 
6. Negative urine pregnancy test for all female participants; pregnancy test is not applicable 
to male participants. 
Informed Consent: 
7. Participants who are, or whose parent(s)/legal guardian(s) are, capable of giving signed 
informed consent as described in Appendix 1, which includes compliance with the 
requirements and restrictions listed in the ICD and in this protocol. 
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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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3. History of microbiologically proven disease caused by N meningitidis or 
Neisseria gonorrhoeae. 
4. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 
5. Any neuroinflammatory or autoimmune condition, including, but not limited to, 
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. 
6. Any confirmed or suspected human immunodeficiency virus infection, based on medical 
history and physical examination (no laboratory testing required). 
7. 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: 
8. Previous vaccination with any meningococcal serogroup B vaccine. 
9. Participants who are receiving any allergen immunotherapy with a nonlicensed product 
or receiving allergen immunotherapy with a licensed product and are not on stable 
maintenance doses. 
10. Receipt of immunoglobulin infusion or injection during the 42 days preceding 
enrollment. 
11. Current chronic use of systemic antibiotics. 
12. Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab). 
Prior/Concurrent Clinical Study Experience: 
13. Participation in other studies involving investigational drug(s) within 28 days prior to 
study entry and/or during study participation. 
Diagnostic Assessments: 
Not applicable. 
Other Exclusions: 
14. Investigator site staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family members. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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15. Pregnant female participants; breastfeeding female participants; female participants of 
childbearing potential who are unwilling or unable to use a highly effective method of 
contraception (see Appendix 3). 
5.3. Lifestyle Considerations 
5.3.1. Contraception 
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual female 
participant and her partner(s) from the permitted list of contraception methods (see 
Appendix 3) 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. 
5.4. Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study. Screen failure data are collected and remain as 
source and are not reported to the clinical database. 
Individuals who do not meet the criteria for participation in this study (screen failure) may 
not be rescreened. 
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Study Intervention 
Administration 
5.5.1. Criteria for Temporarily Delaying Vaccine Administration 
The following conditions are temporary or self-limiting and may allow a participant to be 
vaccinated once the conditions have resolved and the participant is otherwise eligible for 
vaccination: 
• Current febrile illness (temperature ≥38.0°C [100.4°F]) or other acute illness within 
48 hours before study intervention administration. 
• Participant has received a nonlive vaccine (or intramuscular/sublingual allergen 
immunotherapy) within 14 days, or live vaccine within 28 days, before study intervention 
administration. 
• Participant has received systemic antibiotic therapy within 5 days before study 
intervention administration. 

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• Participant has received systemic (oral, intravenous, or intramuscular) corticosteroid 
therapy within the previous 28 days. 
If a participant meets any delay criteria for vaccination, all study procedures, including blood 
sample collection relating to that visit, should be delayed until the day of vaccination. Blood 
samples must always be collected prior to vaccination. 
5.5.2. Criteria for Temporarily Delaying Immunogenicity Blood Draw 
The following condition is temporary and blood may be drawn once the condition has 
resolved and the participant is eligible for blood collection: 
• Participant has received systemic antibiotic therapy within the last 5 days. 
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. 
6.1. Study Intervention(s) Administered 
For this study, the study intervention to be provided is Trumenba (bivalent rLP2086 and 
meningococcal serogroup B vaccine [Trumenba] may be used interchangeably). 
Trumenba is a 0.5-mL dose supplied as a PFS and formulated to contain 60 µg each of a 
purified subfamily A and a purified subfamily B rLP2086 protein, 0.15 M sodium chloride, 
2.8 molar ratio polysorbate 80, and 0.25 mg of Al3+ as AlPO4 in 10 mM histidine-buffered 
saline at pH 6.0. 
The study intervention will be provided by the sponsor to each study site. The study vaccine 
will be labeled as study intervention with a unique DU number in accordance with the 
current guidelines and applicable local and legal regulatory requirements. This study will be 
open-label. 
Immunocompromised participants will receive study intervention at each of the vaccination 
visits (Visits 1 and 3) according to Section 1.2. 
 
Intervention Name 
Trumenba 
Dose Formulation 
0.5 mL in a PFS 
Unit Dose Strength(s) 
60 µg each of a purified subfamily A and a purified subfamily B 
rLP2086 protein 
Dosage Level(s) 
0.5-mL dose at Visits 1 and 3 
Route of Administration 
Intramuscular 
IMP or NIMP 
IMP 
Sourcing 
Pfizer 
Packaging and Labeling 
Study intervention will be provided in a single-dose PFS. Each syringe 
will be labeled as required per country requirement. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
Final Protocol, 22 January 2021 
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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. 
Trumenba should be administered intramuscularly by injecting 0.5 mL into the upper deltoid 
muscle of the left or right arm. 
In the event of a product quality complaint, please refer to Section 10.5.4. 
6.1.2. Medical Devices 
1. In this study, the medical device being used will be a PFS for Trumenba. 
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 investigator throughout the clinical 
investigation (see Section 8.3.9) and appropriately managed by the sponsor. 
6.2. Preparation/Handling/Storage/Accountability 
1. The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study interventions received and any discrepancies are 
reported and resolved before use of the study intervention. 
2. Study intervention will be shipped to the study site after required regulatory and legal 
documents have been received by the sponsor. 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 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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temperatures since previously documented for all site storage locations upon return to 
business. 
4. Any excursions from the study intervention label storage conditions should be reported to 
Pfizer upon discovery along with any actions taken. The site should actively pursue 
options for returning the study intervention to the storage conditions described in the 
labeling, as soon as possible. Once an excursion is identified, the study intervention must 
be quarantined and not used until Pfizer provides permission to use the study 
intervention. Specific details regarding the definition of an excursion and information the 
site should report for each excursion will be provided to the site in the IP manual. 
5. Receipt of materials, door opening and closing, and other routine handling operations 
where the products are briefly out of the temperature range described in the labeling are 
not considered excursions. 
6. Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the label. 
7. Study interventions should be stored in their original containers. 
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 returned 
for 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 detals about accountability, storage, destruction, and excursion reporting can be 
found in the IP manual. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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6.2.1. Preparation and Dispensing 
The study intervention will be dispensed using an IRT drug management system at each 
vaccination visit (Visits 1 and 3). A qualified staff member will dispense the study 
intervention via the unique DU number provided. Study intervention should be prepared and 
dispensed by an 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. 
6.3. Measures to Minimize Bias: Randomization and Blinding 
This will be an open-label, single-arm study – participants will not be randomized to vaccine 
assignment. 
6.3.1. Allocation of Study Intervention 
This is an open-label study; however, allocation of vaccine to participants 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” (used as a participant 
identifier in this study) 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 investigator’s knowledge of the vaccine assignment should not influence the decision to 
enroll a particular participant or affect the order in which participants are enrolled. 
Study intervention will be dispensed at the study visits summarized in the SoA. 
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system. 
6.4. Study Intervention Compliance 
Both 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 Visit 4 will be recorded on the CRF. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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The name, start and stop dates, and route of administration for concomitant medications 
(prescription and nonprescription) used to treat an AE (excluding events recorded only in the 
e-diary) from the signing of the ICD to Visit 5 will be recorded in the CRF. 
The date and type of any blood transfusion (eg, whole blood, packed cells) received within 
the 3 months before enrollment through Visit 4 will be recorded on the CRF. 
6.5.1. Prohibited During the Study 
1. Nonlive vaccines are not permitted within 14 days before and through 14 days after any 
study vaccination; live nonstudy vaccines are not permitted within 28 days before and 
through 28 days after any study vaccination. 
2. Intramuscular/sublingual allergen immunotherapy is not permitted within 14 days before 
and through 14 days after any study vaccination. 
3. Systemic (oral, intravenous, or intramuscular) corticosteroid therapy is not permitted 
within 28 days before through 28 days after any study vaccination. 
6.5.2. Permitted During the Study 
1. All treatments that reflect standard of care for immunocompromised participants are 
permitted. 
2. Blood transfusions are permitted during the study. 
3. 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. 
4. Nonstudy vaccines that are part of recommended immunization schedules are allowed at 
any time during the study but should not be administered within 14 days (for nonlive 
vaccines) and 28 days (for live vaccines) of study intervention administration. 
5. Antipyretics and other pain medications to treat symptoms associated with study 
intervention are permitted. 
6. Local anesthetic may be applied before blood draw. 
7. Topical antibiotics are permitted. 
8. Topical and inhaled corticosteroids are permitted. 
6.5.3. Prior Treatment 
1. If the participant is known to have ever received prior vaccination with any of the 
following vaccines, the name of the vaccine and date of administration will be recorded 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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on the CRF. It is acceptable to obtain this information from a history obtained verbally 
from the participant, or via written vaccination record. 
• Pneumococcal vaccine 
• Meningococcal vaccines containing 1 or more ACWY serogroups 
2. The start date and type of blood transfusion (eg, whole blood, packed cells) that 
immunocompromised participants receive within the 3 months before enrollment in the 
study will be recorded on the CRF. 
6.6. Dose Modification 
Not applicable. 
6.7. Intervention After the End of the Study 
No intervention will be provided to study participant at the end of the study. 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1. Discontinuation of Study Intervention 
In rare instances, it may be necessary for a participant to permanently discontinue study 
intervention (definitive discontinuation). Reasons for definitive discontinuation of study 
intervention include the following: AEs; parent(s)/legal guardian 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 for data to be collected at 
the time of discontinuation of study intervention and follow-up for any further evaluations 
that need to be completed. 
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, postvaccination study follow-up, 
and/or future collection of additional information. 
Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the IRB/EC, or study intervention safety problems, or at the discretion 
of Pfizer. If a study is prematurely terminated, Pfizer will promptly notify the investigator. 
After notification, the investigator must contact all participating participants and the hospital 
pharmacy (if applicable) immediately. As directed by Pfizer, all study materials must be 
collected and all CRFs completed to the greatest extent possible. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
Final Protocol, 22 January 2021 
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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; 
• Protocol violation. 
If a participant does not return for a scheduled visit, every effort should be made to contact 
the participant or the participant’s parent(s)/legal guardian. All attempts to contact the 
participant and information received during contact attempts must be documented in the 
participant’s source document. In any circumstance, every effort should be made to 
document participant outcome, if possible. 
The participant or the participant’s parent(s)/legal guardian should be questioned regarding 
reason for 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, he/she 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 participant or the participant’s parent(s)/legal guardian should be requested to return for 
a final visit, if applicable, and the investigator will perform the procedures indicated for the 
next visit. Any AEs or SAEs that are continuing at the time of withdrawal from the study 
should be followed until resolution or, in case of permanent impairment, until the condition 
stabilizes. 
A final telephone contact 6 months after the last vaccination (Section 8.11.5) for the 
collection of safety information should be completed for all participants who withdraw or 
have been withdrawn 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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
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If the participant withdraws 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 who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures. The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information. Participants should notify the investigator in writing of the decision to 
withdraw consent from future follow-up, whenever possible. The withdrawal of consent 
should be explained in detail in the medical records by the investigator, as to whether the 
withdrawal is only from further receipt of study intervention or also from study procedures 
and/or 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 (or the participant’s parent[s]/legal guardian[s]) is unable 
to be contacted by the study site. 
The following actions must be taken if a participant 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 and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or should continue in 
the study; 
• Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record; 
• Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 

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8. STUDY ASSESSMENTS AND PROCEDURES 
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures. 
The date of birth will be collected to critically evaluate the immune response and safety 
profile by age. 
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed. 
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention. 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner. 
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study. 
The total blood sampling volume for individual participants in this study is approximately 
40 mL. 
8.1. Efficacy and/or Immunogenicity Assessments 
To facilitate immunogenicity analyses, participants will have approximately 20 mL of blood 
collected at Visits 1 and 4 during the study as described in Section 8.11 and the SoA. Sample 
collection, storage, and shipping information can be found in the ISF. 
Sera obtained at these study visits will be used in immunogenicity assays as described below. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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8.1.1. Serum Bactericidal Assays 
For assessment of the immune response, functional antibodies will be analyzed in hSBAs 
with MnB test strains. The hSBA measures antibodies in human sera that result in 
complement-dependent killing of the target MnB strain. 
Sera obtained from participants at all time points as shown in Section 1.2 will be used in 
these assays. Validated MnB hSBAs will be performed using the 4 primary MnB test strains. 
Validated hSBA LODs and LLOQs for the 4 primary MnB strains are shown in Table 1. 
 
Table 1. 
Validated hSBA LODs and LLOQs for the 4 Primary MnB Strains 
 
Strain LP2086 Variant 
LOD 
LLOQ 
A22 
1:4 
1:16 
A56 
1:4 
1:8 
B24 
1:4 
1:8 
B44 
1:4 
1:8 
Abbreviations: hSBA = serum bactericidal assay using human complement; LLOQ = lower limit of 
quantitation; LOD = limit of detection; LP2086 = lipoprotein 2086; MnB = Neisseria meningitidis 
serogroup B. 
 
8.1.2. Biological Samples 
Blood samples will be used only for scientific research. Each sample will be labeled with a 
code so that the laboratory personnel testing the samples will not know the participant’s 
identity. Samples that remain after performing assays outlined in the protocol may be stored 
by Pfizer. Unless a time limitation is required by local regulations or ethical requirements, 
the samples will be stored for up to 15 years after the end of the study and then destroyed. If 
allowed by the ICD, stored samples may be used for additional testing to better understand 
the immune responses to the vaccine(s) under study in this protocol, to inform the 
development of other products, and/or for vaccine-related assay work supporting vaccine 
programs. No testing of the participant’s genetic material will be performed. 
The participant may request that his or her samples, if still identifiable, be destroyed at any 
time; however, any data already collected from those samples will still be used for this 
research. The biological samples may be shared with other researchers as long as 
confidentiality is maintained and no testing of the participant’s genetic material is performed. 
A mechanism (eg, appropriate wording within the study ICD) will be established that enables 
testing of serum samples obtained during the study to assess for the preexistence of select 
AEs reported during study participation. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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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. 
• Reactogenicity: local reactions and systemic events, including fever. 
• Use of antipyretic medication. 
• Unsolicited AEs and SAEs. 
A medical history will be obtained and a physical examination will be performed on all 
participants at Visit 1 to establish a baseline. When taking the medical history and 
performing the physical examination, particular care must be taken to note any 
neuroinflammatory and autoimmune conditions, such as transverse myelitis, uveitis, optic 
neuritis, and multiple sclerosis. Significant medical history and observations from the 
physical examination will be documented on the CRF. 
The safety parameters include reactogenicity, ie, both local reactions and systemic events that 
occur in the 7 days (Days 1 through 7, where Day 1 is the day of vaccination) after study 
intervention administration. These prompted e-diary events are: 
• Local reactions at the site of study intervention administration (redness, swelling, and 
pain at the injection site). 
• Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other 
than muscle pain at the injection site, and joint pain). 
Local reactions, systemic events, and use of antipyretic medication will be collected using an 
e-diary. For events that resolve after Day 7, the end date will be collected in the CRF. If a 
participant does not complete the e-diary for 7 days, end dates of local reactions, systemic 
events, or antipyretic medication use that was ongoing on the last day the e-diary was 
completed by the participant will be collected on the CRF. 
Immediate AEs, defined as AEs occurring within the first 30 minutes after study intervention 
administration, will be assessed and documented on the AE CRF. The time of onset will be 
recorded for any AEs that occur on the same day as study intervention administration. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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MAEs and NDCMCs will also be assessed throughout the study and documented on the 
appropriate AE CRF. An MAE is defined as a nonserious AE that results in an evaluation at 
a medical facility. An NDCMC is defined as a disease or medical condition, not previously 
identified, that is expected to be persistent or otherwise long-lasting in its effects. 
AEs (serious and nonserious), NDCMCs, and visits to other medical facilities will be 
assessed at study visits as specified in the SoA and reported as defined in Section 8.3. 
AE-related hospitalizations, visits to other medical facilities, medication use, and days of 
school or work missed will be collected and recorded in the CRF. 
Hospitalizations and visits to medical facilities not associated with an AE, such as elective 
hospitalizations, healthcare visits for preventive care, or routine physical examinations, will 
not be collected. Non–AE-related concomitant medications and days of school or work 
missed not associated with an AE will not be collected. 
A Study Visit/Telephone Contact AE Checklist will be used as a guide, will be completed at 
each scheduled study visit/telephone contact (except at Visit 1), and will be included in the 
source documentation. Please refer to the ISF for details. 
The participant or participant’s parent(s)/legal guardian will be given a memory aid at 
Visits 2 and 4. The memory aid will be used to remind participants to review any significant 
illnesses, hospitalizations, NDCMCs, or visits to a medical facility with study site personnel. 
Participants may use the memory aid as needed between Visits 2 and 3, or during the 
telephone contact at Visit 5, to prompt recall of events. These may be used to assist in 
reporting and discussion of events with study staff, but these memory aids will not be 
considered source documents and will not be collected at study visits. Only information 
collected by study staff as part of a study visit (Visit 1 through Visit 4) or telephone contact 
(Visit 5) will be included in the source documents and entered into the CRF. 
In addition, AEs and SAEs will be collected as defined in Section 8.3. 
8.2.1. Electronic Diary 
The participant or parent(s)/legal guardian will be required to use an e-diary, installed on a 
provisioned device or an app on a personal device, and will be asked to monitor and record 
local reactions, systemic events, and antipyretic medication usage for 7 days following 
vaccination (Days 1 through 7, where Day 1 is the day of vaccination). The e-diary allows 
recording of these assessments only within a fixed time window, thus providing the accurate 
representation of the participant’s experience at that time. 
For local reactions, systemic events, and use of antipyretic medication that resolve after 
Day 7, the end date will be collected on the CRF. The investigator or designee should 
contact the parent(s)/legal guardian or participant in order to obtain stop dates for any 
solicited reactions or other solicited data ongoing on the last day that the e-diary was 
completed; these stop dates will be collected in the CRF. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
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Data reported in the e-diary will be transferred electronically to the e-diary vendor (a trusted 
third party), where they will be available for review by investigators at all times via an 
internet-based portal. At intervals agreed upon between the vendor and Pfizer, these data 
will be transferred electronically into Pfizer’s database for analysis and reporting. These data 
do not need to be reported by the investigator on the CRF. 
Investigators will be required to review the e-diary data online at frequent intervals to 
evaluate participant compliance and as part of the ongoing safety review. 
8.2.1.1. Local Reactions 
Local reactions (redness, swelling, and pain) at the site of study intervention administration 
will be recorded daily for 7 days (Days 1 through 7, where Day 1 is the day of vaccination) 
after each vaccination. Only local reactions at the injection site of study intervention 
administration will be recorded. 
8.2.1.2. Redness and Swelling 
Redness and swelling will be measured and recorded in caliper units (range: 1 to 21+), and 
then categorized as none, mild, moderate, or severe based on the scale given in Table 2. 
Each caliper unit represents 0.5 cm. A caliper will be issued with instructions for measuring 
any redness or swelling at the injection site. The caliper will be used to measure and to 
report the largest diameter of a local reaction. In the event that a caliper measurement is 
between 2 values, the higher value should be reported. The measurements will then be 
recorded in the e-diary. 
In the event the reaction exceeds the maximum size the caliper is able to measure 
(>21 caliper units), the parent(s)/legal guardian or participant will also measure the 
maximum diameter of the redness and/or swelling at the injection site using the measuring 
tape/ruler provided and report this immediately to the investigator. 
The parent(s)/legal guardian or participant will report the maximum diameter of the redness 
and/or swelling at the injection site to the investigator daily until the reaction becomes 
≤21 caliper units. These measurements will be recorded in the CRF. 
 
Table 2. 
Grading of Redness and Swelling 
None 
0 to 2.0 cm (0 to 4 caliper units) 
Mild 
>2.0 to 5.0 cm (5 to 10 caliper units) 
Moderate 
>5.0 to 10.0 cm (11 to 20 caliper units) 
Severe 
>10.0 cm (>20 caliper units) 

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8.2.1.2.1. Injection Site Pain 
If the participant experiences injection site pain, the pain will be graded using the scale in 
Table 3. The assessment will then be recorded in the e-diary. 
 
Table 3. 
Grading of Pain 
Mild 
Does not interfere with activity 
Moderate 
Interferes with activity 
Severe 
Prevents daily activity 
 
8.2.1.3. Systemic Events 
8.2.1.3.1. Temperature 
A digital thermometer will be given to the parent(s)/legal guardian or the participant with 
instructions on how to measure the participant’s oral temperature at home. Oral temperature 
will be collected in the evening daily for 7 days (Day 1 through Day 7, where Day 1 is the 
day of vaccination) after each vaccination, and at any time during the 7 days when fever is 
suspected. The highest temperature for each day will be recorded in the e-diary. Fever is 
defined as temperature of ≥38.0°C (100.4°F). 
Temperature will be measured and recorded to 1 decimal place and then categorized 
according to the severity scale in Table 4. 
 
Table 4. 
Severity Scale for Fever 
Temperature 38.0°C to 38.4°C (100.4°F to 101.1°F) 
Temperature >38.4°C to 38.9°C (101.2°F to 102.0°F) 
Temperature >38.9°C to 40.0°C (102.1°F to 104.0°F) 
Temperature >40.0°C (>104.0°F) 
 
8.2.1.3.2. Other Systemic Events 
The e-diary will be used to record the presence of other systemic events, including vomiting, 
diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, 
and joint pain, daily for 7 days (Day 1 through Day 7, where Day 1 is the day of vaccination) 
after each vaccination, using the scales in Table 5. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Table 5. 
Grading of Other Systemic Events 
 
Grade 1 (Mild) 
Grade 2 (Moderate) 
Grade 3 (Severe) 
Vomiting 
1 to 2 times in 24 hours 
>2 times in 24 hours 
Requires IV hydration 
Diarrhea 
2 to 3 loose stools in 
24 hours 
4 to 5 loose stools in 
24 hours 
6 or more loose stools in 
24 hours 
Headache 
Does not interfere with 
activity 
Some interference with 
activity 
Prevents daily routine 
activity 
Fatigue 
Does not interfere with 
activity 
Some interference with 
activity 
Prevents daily routine 
activity 
Chills 
Does not interfere with 
activity 
Some interference with 
activity 
Prevents daily routine 
activity 
Muscle pain (other than 
muscle pain at the injection 
site) 
Does not interfere with 
activity 
Some interference with 
activity 
Prevents daily routine 
activity 
Joint pain 
Does not interfere with 
activity 
Some interference with 
activity 
Prevents daily routine 
activity 
Abbreviation: IV = intravenous. 
 
 
8.2.1.3.3. Use of Antipyretic Medication 
The use of antipyretic medication will be recorded in the e-diary daily during the active 
safety observation period (Day 1 through Day 7, where Day 1 is the day of vaccination) for 
each vaccination. 
8.2.2. Pregnancy Testing 
Pregnancy tests may be urine or serum tests, but must 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. 
In the case of a positive confirmed pregnancy at Visit 1, the participant will not be eligible 
for participation. 
8.3. Adverse Events and Serious Adverse Events 
The definitions of an AE and an SAE can be found in Appendix 2. 
The definitions of device-related safety events (ADEs and SADEs) can be found in 
Appendix 5. Device deficiencies are covered in Section 8.3.9. 
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or 
the participant's legally authorized representative). 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study (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 
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant/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 4. 
At Month 12 (Visit 5, telephone contact), the parent(s)/legal guardian or participant will be 
contacted by telephone to inquire about SAEs, NDCMCs, or AEs that resulted in evaluation 
at a medical facility since Visit 4. 
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator and Pfizer concurs with that assessment. 
For participants who are screen failures, the active collection period ends when screen failure 
status is determined. 
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn. 
If a participant definitively discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the Vaccine SAE Reporting Form. 
Investigators are not obligated to actively seek AEs or SAEs after the participant has 
concluded study participation. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has completed the study, and he/she considers the event 
to be reasonably related to the study intervention, the investigator must promptly report the 
SAE to Pfizer using the Vaccine SAE Reporting Form. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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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 2. 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 as 
described in Section 8.3.1 are recorded on the CRF. AEs and SAEs that begin after obtaining 
informed consent but before the start of administration of study intervention will be recorded 
on the Medical History/Current Medical Conditions section of the CRF, not the AE section. 
AEs and SAEs that begin after the start of administration of study intervention are 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. 
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 2. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences. 
8.3.3. Follow-up of AEs and SAEs 
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3). 
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Appendix 2. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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8.3.4. Regulatory Reporting Requirements for SAEs 
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a 
study intervention under clinical investigation are met. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements. 
8.3.5. Exposure During Pregnancy or Breastfeeding, 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 
exposure during pregnancy: 
• 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 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
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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. 
• 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 ISF. 
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 

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the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner. 
8.3.5.2. Exposure During Breastfeeding 
Per exclusion criterion 15, breastfeeding and pregnancy are exclusionary, and pregnant 
participants will be withdrawn from the study prior to 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 ISF. 
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 ISF. 
8.3.6. Cardiovascular and Death Events 
Not applicable. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs 
Not applicable. 
8.3.8. Adverse Events of Special Interest 
Not applicable. 
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 purpose of administering 
study intervention. In order to fulfill regulatory reporting obligations worldwide, the 
investigator is responsible for the detection and documentation of events meeting the 
definitions of device deficiency that occur during the study with such devices. 
The definition of a medical device deficiency can be found in Appendix 5. 
NOTE: Deficiencies fulfilling the definition of an AE/SAE will also follow the processes 
outlined in Section 8.3.1 through 8.3.4 and Appendix 2 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 5. 
8.3.9.2. Follow-up of Medical Device Deficiencies 
Follow-up applies to all participants, including those who discontinue study intervention. 
The investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency. 
New or updated information will be recorded on a follow-up form with all changes signed 
and dated by the investigator. 

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

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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• The administration of expired study intervention; 
• The administration of an incorrect study intervention; 
• The administration of an incorrect dosage; 
• The administration of study intervention that has undergone temperature excursion from 
the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use. 
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page. 
In the event of a medication dosing error, the sponsor should be notified within 24 hours. 
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF. 
Medication errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Reporting Form only when associated with an SAE. 
8.4. Treatment of Overdose 
For this study, any dose of study intervention greater than 1 dose of study intervention 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. 

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8.6. Pharmacodynamics 
Pharmacodynamic parameters are not evaluated in this study. 
8.7. Genetics 
Genetics (specified analyses) are not evaluated in this study. 
8.8. Biomarkers 
Biomarkers are not evaluated in this study. 
8.9. Immunogenicity Assessments 
Immunogenicity assessments are described in Section 8.1. 
8.10. Health Economics 
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study. 
8.11. Study Procedures 
8.11.1. Visit 1 (Day 1): Vaccination 1 
In the case of temporary delay of vaccination, the procedures and assessments below will be 
redone or reconfirmed, as applicable, on the day of vaccination. 
• 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 sex, race, ethnicity, and the 
complete date of birth (birth day, month, and year 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 pneumococcal and meningococcal serogroup ACWY (containing 1 or 
more ACWY serogroups) vaccinations as described in the Prior Treatment section 
(Section 6.5.3). 
• Record blood transfusions received within 3 months prior to enrollment as described in 
the Prior Treatment section (Section 6.5.3). 
• Perform physical examination evaluating any clinically significant abnormalities within 
the following body systems: general appearance; skin; head, eyes, ears, nose, and throat; 
heart; lungs; abdomen; extremities; neurological; musculoskeletal; and lymph nodes, 
including worsening of medical history conditions. Results must be recorded on source 

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Protocol B1971060 
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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 for all female participants. A 
negative pregnancy test result is required before the participant may receive the study 
intervention. 
• On the day of and before vaccination, measure and record the participant’s oral 
temperature. 
• Ensure that all of the inclusion criteria, none of the exclusion criteria, and none of the 
temporary delay criteria are met. 
• If a participant is eligible for the study, randomize the participant using an IVRS, an 
IWRS, or an IRT equivalent system. 
• On the day of and before vaccination, collect a blood sample (approximately 20 mL) 
from the participant only if the participant is eligible for vaccination on the same day. 
• Administer a single 0.5-mL intramuscular injection of Trumenba into the upper deltoid 
muscle of the left or right arm. The time of 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 8.3). 
• Record AEs as described in the AE reporting requirements section (Section 8.3) and the 
SoA. Time of onset will be recorded for any AEs that occur on the same day as study 
intervention administration. 
• Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5). 
• Assist the participant or participant’s parent(s)/legal guardian in downloading the e-diary 
app onto the participant/parent/legal guardian’s own device or issue a provisioned device 
if required (see Section 8.2). 
• Provide instruction regarding e-diary completion. Ask the parent(s)/legal guardian or 
participant to complete the e-diary from Days 1 through 7 after vaccination. Day 1 is the 
day of vaccination. Instructions on daily transfer of data and charging the battery should 
also be provided. 

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• Issue a caliper, measuring tape/ruler, and digital thermometer and provide instructions on 
their use. 
• Measurement of any redness or swelling at the injection site must be collected by the 
parent(s)/legal guardian for minor participants. All data must be recorded in the e-diary 
by the parent(s)/legal guardian for minor participants. 
• Ask the parent(s)/legal guardian or the participant to use the caliper to measure the 
maximum diameter of redness and swelling at the injection site each day for the 7 days 
after study vaccination and record in the e-diary as described in Section 8.2.1. 
• Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if the participant experiences a severe redness or swelling (>20 caliper units) at the 
injection site, a fever ≥39.0°C (102.1°F), or a severe headache within 7 days after 
vaccination, as an unscheduled visit should be arranged (Section 8.12). 
 
o If the reaction exceeds the maximum size the caliper is able to measure (>21 caliper 
units, Section 8.2.1.2), the parent(s)/legal guardian or the participant should also use 
the measuring tape/ruler to measure the maximum diameter of redness and/or swelling 
at the injection site, and report this immediately to the investigator. 
 
o Ask the parent(s)/legal guardian or participant to report the maximum diameter of the 
redness and/or swelling at the injection site to the investigator daily until the reaction 
becomes ≤21 caliper units. 
• Provide the participant with a contact card (Section 10.1.10). 
• Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs. 
• Schedule an appointment for the next study visit and confirm that it is scheduled within 
the time window per protocol. 
• Remind the parent(s)/legal guardian or participant to bring the e-diary to the next study 
visit. 
• Complete the source documents. 
• Complete the CRF and update the study intervention accountability records. 
Between visits, review the e-diary data online at frequent intervals. Contact the 
parent(s)/legal guardian or the participant to obtain stop dates for any local reactions, 
systemic events, or use of antipyretic medication that was ongoing on the last day that the 
e-diary was completed. The stop dates should be documented in the source documents and 
the information entered into the CRF at the next study visit of the participant. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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8.11.2. Visit 2 (28 to 42 Days After Visit 1): Safety Follow-up Visit 
• Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements as detailed in Section 5.3.1. 
• Ensure that the participant continues to meet none of the withdrawal criteria as described 
in Section 7.2. 
• If previously provided to the participant’s parent(s)/legal guardian, collect the 
provisioned e-diary device. 
• Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication. 
• Complete the Study Visit/Telephone Contact AE Checklist to: 
 
o 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. 
 
o 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 the AE reporting requirements section (Section 8.3) and the 
SoA. 
• Report any SAEs to the sponsor as defined in Section 8.3. 
• Review AEs that were ongoing since the previous visit and record their end dates or 
confirm that they are still continuing. 
• Record nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5). 
• Record any blood transfusion (eg, whole blood, packed cells) received by the participant 
as described in the Concomitant Therapy section (Section 6.5). 
• Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5). 
• Provide the parent(s)/legal guardian or the participant with a memory aid. Instruct the 
participant 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 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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study site personnel. The memory aid is not a diary for the collection of reactogenicity. 
Please refer to the ISF and Section 8.2 for additional details. 
• Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs. 
• Schedule an appointment for the next study visit and confirm that it is scheduled within 
the time window per protocol. 
• Complete the source documents. 
• Complete the CRFs. 
8.11.3. Visit 3 (173 to 194 Days After Visit 1): Vaccination 2 
• Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements detailed in Section 5.3.1. 
• Ensure that the participant continues to meet none of the withdrawal criteria as described 
in Section 7.2 and none of the temporary delay of vaccination criteria as described in 
Section 5.5. 
• Complete the Study Visit/Telephone Contact AE Checklist to: 
 
o 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. 
 
o 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 the AE reporting requirements section (Section 8.3) and the 
SoA. Time of onset will be recorded for any AEs that occur on the same day as study 
intervention administration. 
• Report any SAEs to the sponsor as defined in Section 8.3. 
• Review AEs that were ongoing from the previous visit and record their end dates or 
confirm that they are still continuing. 
• Record nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5). 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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• Record any blood transfusion (eg, whole blood, packed cells) received by the participant 
as described in the Concomitant Therapy section (Section 6.5). 
• Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5). 
• On the day of vaccination, perform a urine pregnancy test on female participants. A 
negative pregnancy test result is required before the participant may receive the study 
intervention. 
• On the day of and before vaccination, measure and record the participant’s oral 
temperature. 
• Allocate a vaccine kit to the participant using an IVRS, IWRS, or equivalent IRT system. 
• Administer a single 0.5-mL intramuscular injection of Trumenba into the upper deltoid 
muscle of the left or right arm. The time of 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 8.3). 
• Issue an e-diary to the participant or the participant’s parent(s)/legal guardian (or ensure 
that the diary app is downloaded) and provide instruction on its completion. Ask the 
parent(s)/legal guardian or participant to complete the e-diary from Day 1 through Day 7 
after vaccination. Day 1 is the day of vaccination. Instructions on daily transfer of data 
and charging the battery should also be provided. 
• Issue a caliper, measuring tape/ruler, and digital thermometer (if required) and provide 
instructions on their use. 
• Measuring tape/ruler data must be collected by the parent(s)/legal guardian for minor 
participants. All data must be recorded in the e-diary by the parent(s)/legal guardian for 
minor participants. 
• Ask the parent(s)/legal guardian or the participant to use the caliper to measure the 
maximum diameter of redness and swelling at the injection site each day for the 7 days 
after study vaccination and record in the e-diary as described in Section 8.2.1. 
• Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if the participant experiences a severe redness or swelling (>20 caliper units) at the 
injection site, a fever ≥39.0°C (102.1°F), or a severe headache within 7 days after 
vaccination, as an unscheduled visit should be arranged (Section 8.12). 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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o If the reaction exceeds the maximum size the caliper is able to measure 
(>21 caliper units, Section 8.2.1.2), the parent(s)/legal guardian or the participant 
should also use the measuring tape/ruler to measure the maximum diameter of 
redness and/or swelling at the injection site, and report this immediately to the 
investigator. 
 
o Ask the parent(s)/legal guardian or participant to report the maximum diameter of the 
redness and/or swelling at the injection site to the investigator daily until the reaction 
becomes ≤21 caliper units. 
• Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs. 
• Schedule an appointment for the next study visit and confirm that it is scheduled within 
the time window per protocol. 
• Ask the parent(s)/legal guardian or the participant to bring the e-diary to the next visit. 
• Complete the source documents. 
• Complete the CRF and update the study intervention accountability records. 
• Between visits, review the e-diary data online at frequent intervals. Contact the 
parent(s)/legal guardian or the participant to obtain stop dates for any local reactions, 
systemic events, or use of antipyretic medication that was ongoing on the last day that the 
e-diary was completed. The stop dates should be documented in the source documents 
and the information entered into the CRF at the next study visit of the participant. 
8.11.4. Visit 4 (28 to 42 Days After Visit 3): Post–Vaccination 2 Blood Draw 
• Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements as detailed in Section 5.3.1. 
• Ensure that the participant continues to meet none of the withdrawal criteria as described 
in Section 7.2 and none of the temporary delay of blood draw criteria as described in 
Section 5.5. 
• If previously provided to the participant’s parent(s)/legal guardian, collect the 
provisioned e-diary device. 
• Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication. 
• Complete the Study Visit/Telephone Contact AE Checklist to: 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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o 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. 
 
o 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 the AE reporting requirements section (Section 8.3) and the 
SoA. 
• Report any SAEs to the sponsor as defined in Section 8.3. 
• Review AEs that were ongoing since the previous visit and record their end dates or 
confirm that they are still continuing. 
• Record nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5). 
• Record any blood transfusion (eg, whole blood, packed cells) received by the participant 
as described in the Concomitant Therapy section (Section 6.5). 
• Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5). 
• Provide the parent(s)/legal guardian or the participant with a memory aid. Instruct the 
participant to use the memory aid between Visits 4 and 5 to remind him or her to review 
any significant illnesses, hospitalizations, NDCMCs, or visits to a medical facility with 
study site personnel. The memory aid is not a diary for the collection of reactogenicity. 
Please refer to the ISF and Section 8.2 for additional details. 
• Collect a blood sample (approximately 20 mL). 
• Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs. 
• Schedule a telephone contact and confirm that it is scheduled within the time window per 
protocol. 
• Complete the source documents. 
• Complete the CRFs. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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8.11.5. Visit 5 (168 to 196 Days After Last Vaccination): Telephone Contact 
• This telephone contact should occur approximately 6 months after the last vaccination 
(Visit 3); this contact should be attempted for all participants who have received at least 
1 study vaccination, unless they have withdrawn consent. 
• Contact the parent(s)/legal guardian or the participant by telephone. 
• Complete the Study Visit/Telephone Contact AE Checklist to: 
 
o Inquire about SAEs, NDCMCs, or AEs that resulted in evaluation at a medical 
facility since the last visit. Please refer to the ISF for additional details. 
 
o Inquire about neuroinflammatory and autoimmune conditions, such as transverse 
myelitis, uveitis, optic neuritis, and multiple sclerosis. A checklist will be provided 
as a guide. Please refer to the ISF for additional details. 
• Report any SAEs to the sponsor as defined in Section 8.3. 
• Record AEs as described in the AE reporting requirements section (Section 8.3) and the 
SoA. 
• Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5). 
• Review AEs that were ongoing since the previous visit and record their end dates or 
confirm that they are still continuing. 
• Complete the source documents. 
• Complete the CRFs. 
8.12. Unscheduled Visits 
If the participant experiences a severe redness or swelling at the injection site (>20 caliper 
units), a temperature ≥39.0°C (102.1°F), or a severe headache in the 7 days after vaccination, 
a study site visit should be arranged as soon as possible to assess the extent of the event. The 
parent(s)/legal guardian or participant contact will be documented in the CRF. 
If the reaction exceeds the maximum size the caliper is able to measure (>21 caliper units, 
Section 8.2.1.2), ensure the parent(s)/legal guardian or participant has also measured the 
maximum diameter of the redness and/or swelling at the injection site using the measuring 
tape/ruler provided. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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Ask the parent(s)/legal guardian or participant to report the maximum diameter of the redness 
and/or swelling at the injection site daily until the reaction becomes ≤20 caliper units. 
Record these measurements in the CRF. 
At an unscheduled visit, the participant’s oral temperature should be measured and the 
symptom that prompted the visit should be assessed by a medically qualified member of the 
study staff. Findings will be recorded on the CRF. If the participant experiences any AEs, 
these should be recorded on the AE CRF. 
If the unscheduled visit does not take place following participant report of fever ≥39.0°C, 
severe redness/swelling, or severe headache, the reason must be documented in the CRF 
(for example, reaction no longer present or e-diary entry error). 
For the purpose of assessments performed during unscheduled visits, a medically qualified 
member of the study staff is a study physician or a study nurse, as applicable to the 
investigator’s local practice. 
9. STATISTICAL CONSIDERATIONS 
Methodology for summary and statistical analyses of the data collected in this study is 
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 objective are described in the table in 
Section 3. The estimand to evaluate the immunogenicity objective is based on the evaluable 
population (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. The study aims to 
enroll up to 50 participants to allow for sufficient numbers when describing findings with 
regard to this particular population. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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The probability of observing at least 1 occurrence of any AE for true event percentages 
between 1.0% and 5.0%, when Trumenba is administered to 50 participants, is displayed in 
Table 6. 
 
Table 6. 
Probability of Observing at Least 1 Event by Assumed True Event Rates 
 
Assumed True Event Percentage 
Probability (N=50) 
1.0% 
0.39 
1.5% 
0.53 
2.0% 
0.64 
3.2% 
0.80 
5.0% 
0.92 
 
In order to share the expected precision for the primary immunogenicity endpoint (proportion 
of participants achieving hSBA titer ≥ LLOQ at 1 month after the second vaccination), the 
width of the exact 95% CIs is calculated for 50 participants when the proportion ranges from 
0.5 to 0.9 (see Table 7). 
 
Table 7. 
Width of 95% Exact Confidence Interval by Response Rate 
 
Assumed Proportion 
Width of Exact 95% Confidence Interval 
(N=50) 
0.5 
0.289 
0.6 
0.284 
0.7 
0.267 
0.8 
0.237 
0.9 
0.185 
 
9.3. Analysis Sets 
For purposes of analysis, the following analysis sets are defined: 
 
Participant Analysis Set 
Description 
Enrolled 
All participants who sign the ICD, or whose parent(s)/legal 
guardian(s) sign the ICD. 
Study intervention 
allocated 
All participants who are assigned a randomization 
(participant identification) number in the IRT system. 
Evaluable 
All participants who were eligible, received all doses of the 
study intervention according to the vaccine schedule, had 
blood drawn for assay testing within the required time 
frames, had valid and determinate assay results for the 
proposed analysis, and had no major protocol deviations. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Participant Analysis Set 
Description 
A major protocol deviation is one that, in the opinion of the 
sponsor’s global medical monitor, would materially affect 
assessment of immunogenicity, eg, participant receipt of a 
prohibited vaccine or medication that might affect immune 
response or a medication error with suspected decrease in 
potency of the vaccine. Prior to the immunogenicity analysis, 
major protocol deviations will be identified, documented, and 
evaluated, using predefined protocol deviation categories and 
subcategories. Detailed analyses for each immunogenicity 
endpoint will be addressed in the SAP. 
mITT 
All participants who have at least 1 valid and determinate 
MnB assay result available at any time point from Day 1 
through 1 month after the second vaccination (Visit 4 for this 
study). 
Safety 
All enrolled participants who receive at least 1 dose of the 
study intervention and have safety data reported after 
vaccination. 
 
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 objectives. 
9.4.1. Historical Age-Matched Healthy Controls 
Historical data from age-matched healthy participants from Study B1971057, a pivotal 
Phase 3 MnB study that has previously completed the primary analysis, will be used as a 
reference for safety and immunogenicity of Trumenba. Healthy adolescents and young 
adults (10 to <26 years of age) from B1971057 will be randomly selected and a historical 
age-matched healthy control group will be used to provide context and assist with the 
interpretation of the immunogenicity and safety data for the immunocompromised 
participants. The safety and immunogenicity data will be reported separately for the 
immunocompromised and healthy control participants. The selection of the participants for 
the historical age-matched controls is based on 1 previously completed Phase 3 MnB study, 
B1971057 (Stage 1). Study B1971057 followed the same 0- and 6-month dosing schedule 
and used the same methodology for assessment of immunogenicity and safety as in this 
study. Healthy adolescents and young adults (10 to <26 years of age) were enrolled in 
B1971057 and the immunopersistence stage of the study (Stage 2) is ongoing. The same age 
distribution will be ensured for both the healthy controls and the immunocompromised 
participants by randomly selecting age-matched healthy participants from Study B1971057 

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rLP2086; subfamily A and B; E coli]) 
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who were randomized to Trumenba. For immunocompromised participants 10 to <26 years 
of age in this study, age-matched control participants will be randomly selected from Study 
B1971057. For immunocompromised participants older than 25 years of age in this study, 
the controls will be randomly selected from participants 25 years of age from Study 
B1971057. No participants will be randomly selected as control more than once. For Study 
B1971057, only participants randomized to Group 2 or Group 4 (Trumenba groups) will be 
eligible to be selected as healthy controls. Further details will be available in the SAP. 
9.4.2. Immunogenicity Analyses 
The immunogenicity data for the immunocompromised participants will be reported 
separately from historical data of the age-matched healthy participants. The immunogenicity 
will be reported in the historical age-matched controls for the time points corresponding to 
those for the immunocompromised participants. 
 
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 will be calculated. 
The primary analysis for the primary MenB strains is based on the 
evaluable population. 
Exact 2-sided 95% CIs for the percentages will be provided using the 
Clopper-Pearson method. A supportive analysis will be performed based 
on the mITT population. Missing serology data will not be imputed. The 
immunogenicity analysis will be based on observed, valid, and 
determinate assay results. Descriptive summaries will show the reasons 
for missing hSBA data for each primary strain and the percentages for 
each reason. 
 
9.4.3. 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. The safety data for the immunocompromised participants will be reported separately 
from the historical data of the age-matched healthy participants. The safety will be reported 
in the historical age-matched controls for corresponding analysis intervals to those for the 
immunocompromised participants. 
 
Endpoint 
Statistical Analysis Methods 
Primary 
The proportion of participants reporting local reactions at the study 
intervention administration site and systemic events within the 7-day 
period after each vaccination will be descriptively summarized. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Endpoint 
Statistical Analysis Methods 
Two- sided 95% CIs based on the Clopper Pearson method will be 
presented with the proportions. Severities of local reactions and 
systemic events reported after each vaccination will also be 
descriptively summarized. 
The proportion of participants reporting the use of antipyretic 
medication for Days 1 through 7 will be summarized after each 
vaccination. 
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) 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. 
Missing AE dates will be handled according to the Pfizer safety rules. 
Detailed analyses for each safety endpoint will be addressed in the SAP. 
 
9.4.4. Demographic and Baseline Characteristics 
The following demographic characteristics will be descriptively summarized for the 
immunocompromised participants: sex, race, ethnicity, and age at first vaccination. Medical 
history and baseline physical examination data will also be descriptively summarized. The 
same demographic and baseline characteristics will be reported separately for participants in 
the historical age-matched control group. 
9.5. Interim Analyses 
No interim analysis is planned for the study. Only 1 analysis will be performed at the 
completion of the study. As this is an open-label study, the sponsor may conduct unblinded 
reviews of the data during the course of the study for the purpose of safety assessment. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
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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. 
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 of safety 
data, to regulatory authorities, as appropriate. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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10.1.2. Financial Disclosure 
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study. 
10.1.3. Informed Consent Process 
The investigator or his/her representative will explain the nature of the study to the 
participant or parent(s)/legal guardian and answer all questions regarding the study. The 
participant or 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. 
Participants must be informed that their participation is voluntary. Participants or 
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 or parent/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 must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant. 
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities. 
The investigator further must ensure that each study participant or parent/legal guardian is 
fully informed about his or her right to access and correct his or her personal data and to 
withdraw consent for the processing of his or her personal data. 
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained. 
The authorized person obtaining the informed consent must also sign the ICD. 
Participants must be reconsented to the most current version of the ICD(s) during their 
participation in the study. 
A copy of the ICD(s) must be provided to the participant or parent(s)/legal guardian. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
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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. 
Participants who are rescreened are required to sign a new ICD. 
Unless prohibited by local requirements or IRB/EC decision, the ICD will contain a separate 
section that addresses the use of samples for optional additional research. The optional 
additional research does not require the collection of any further samples. The investigator 
or authorized designee will explain to each participant the objectives of the additional 
research. Participants will be told that they are free to refuse to participate and may 
withdraw their consent at any time and for any reason during the storage period. 
10.1.4. Data Protection 
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data. 
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law. 
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to his or her actual identity and medical record identification. In 
case of data transfer, the sponsor will protect the confidentiality of participants’ personal data 
consistent with the clinical study agreement and applicable privacy laws. 
10.1.5. Dissemination of Clinical Study Data 
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT, and/or 
www.pfizer.com, and other public registries in accordance with applicable local 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
Final Protocol, 22 January 2021 
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laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs. 
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted. 
www.clinicaltrials.gov 
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law. 
EudraCT 
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements. 
www.pfizer.com 
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov. 
Documents within marketing authorization packages/submissions 
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the EMA website. Clinical data, under Phase 1 of this policy, 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. 

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Protocol B1971060 
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Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes. 
10.1.6. Data Quality Assurance 
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF. 
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. 
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties. 
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. It is important that the investigator(s) 
and their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process. 
Monitoring details describing strategy (eg, risk-based initiatives in operations and quality 
such as risk management and mitigation strategies and analytical risk-based monitoring), 
methods, responsibilities, and requirements, including handling of noncompliance issues and 
monitoring techniques (central, remote, or on-site monitoring), are provided in the 
monitoring plan. 
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data. 
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements. 
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 

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investigator must ensure that the records continue to be stored securely for as long as they are 
maintained. 
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems. 
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 Study Reference Manual. 
Description of the use of computerized system is documented in the Data Management Plan. 
10.1.8. Study and Site Start and Closure 
The study start date is the date on which the clinical study will be open for recruitment of 
participants. 
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date. 
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon 
study completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time upon notification to the sponsor 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Reasons for the early closure of a study site by the sponsor may include but are not limited 
to: 
• Failure of the investigator to comply with the protocol, the requirements of the IRB/EC 
or local health authorities, the sponsor's procedures, or GCP guidelines; 
• Inadequate recruitment of participants by the investigator; 
• Discontinuation of further study intervention development. 
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. 

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If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply. 
10.1.10. Sponsor’s Qualified Medical Personnel 
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the ISF. 
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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting 
10.2.1. Definition of AE 
 
AE Definition 
• 
 An AE is any untoward medical occunence in a patient or clinical study 
paiiicipant, 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 
abno1mal laborato1y finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention. 
 
 
Events Meeting the AE Definition 
• 
 Any abno1mal laborato1y test results (hematology, clinical chemistiy, 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 abnonnal laborato1y 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 medicaVsurgical inte1vention. 
• 
 Leads to a change in study dosing (outside of any protocol-specified dose 
adjustinents) or discontinuation from the study, significant additional 
concomitant diug ti·eatment, or other therapy. 
• 
Exacerbation of a chronic or intennittent preexisting condition including either an 
increase in frequency and/or intensity of the condition. 
• 
New conditions detected or diagnosed after study inte1vention adininisti·ation even 
though it may have been present before the staii of the study. 
• 
Signs, symptoms, or the clinical sequelae of a suspected diug-diug interaction. 
• 
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
inte1vention or a concomitant medication. Overdose per se will not be repo1ied as 
an AE/SAE unless it is an intentional overdose taken with possible 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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Protocol B1971060 
Final Protocol, 22 January 2021 
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suicidal/self-harming intent. Such overdoses should be reported regardless of 
sequelae. 
• 
The signs, symptoms, and/or clinical sequelae resulting from lack of efficacy will 
be reported as an AE or SAE if they fulfill the definition of an AE or SAE and meet 
the requirements as per Section 8.3.8.1. Also, "lack of efficacy" or "failure of 
expected phannacological action" constitutes an AE or SAE. 
 
 
Events Meeting the AE Definition 
• 
Any clinically significant abno1mal laborato1y findings or other abno1mal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the paiiicipant'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 
paiiicipant's condition. 
• 
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 
• 
 Situations in which an untowai·d medical occunence 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 staii of the study that do not worsen. 
 
10.2.2. 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 othe1wise long-lasting in its effects. 
10.2.3. 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 te1m "life-threatening" in the definition of "serious" refers to an event in which the 
paiticipant 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 pa1ticipant 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" occmTed or was necessa1y, 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 tenn disability means a substantial disrnption of a person's ability to conduct 
n01mal life functions. 
• 
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diaIThea, 
influenza, and accidental trauma (eg, sprained ankle) which may interfere with or 
prevent eve1yday life functions but do not constitute a substantial disrnption. 
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 paiticipant 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. 

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• 
 Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
dyscrasias or convulsions that do not result in hospitalization, or development of 
chug dependency or chug 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 laborato1y findings indicating an infection in a patient exposed to a 
Pfizer product. The te1ms "suspected transmission" and "transmission" are 
considered synonymous. These cases are considered unexpected and handled as 
serious expedited cases by pha1macovigilance personnel. Such cases are also 
considered for repo1iing as product defects, if appropriate. 
 
 
10.2.4. Recording/Reporting and Follow-up of AEs and/or SAEs 
 
AE and SAE Recording/Reporting 
The table below summarizes the requirements for recording adverse events on the CRF 
and for repo1iing serious adverse events on the Vaccine SAE Reporting F01m to Pfizer 
Safety. These requirements are delineated for 3 types of events: (1) SAEs; (2) nonserious 
adverse events (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 Repo1iing Fo1m for repo1iing of SAE info1mation 
is not the same as the AE page of the CRF. When the same data are collected, the fo1ms 
must be completed in a consistent manner. AEs should be recorded using concise medical 
te1minology and the same AE te1m should be used on both the CRF and the Vaccine SAE 
Repo1iing Fo1m for repo1iing of SAE info1mation. 
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 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
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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 
fonn for EDP) 
Note: Include all SAEs 
associated with exposure 
during pregnancy or 
breastfeeding. Include all 
AEs/SAEs associated with 
occupational exposure. 
• 
 When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laborat01y reports, and diagnostic 
repo1is) related to the event. 
• 
The investigator will then record all relevant AE/SAE infonnation in the CRF. 
• 
It is not acceptable for the investigator to send photocopies of the paiiicipant's 
medical records to Pfizer Safety in lieu of completion of the Vaccine SAE 
Repo1iing Fonn/AE/SAE CRF page. 
• 
There may be instances when copies of medical records for ce1iain cases ai·e 
requested by Pfizer Safety. In this case, all paiiicipant identifiers, with the 
exception of the paiticipant 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 infonnation. 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 repo1ted 
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 ai·e 
defined as follows: 
1 
MILD 
Does not interfere with paiiicipant's usual 
function. 
2 
MODERATE 
Interferes to some extent with paiticipant's usual 
function. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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3 
SEVERE 
Interferes significantly with pa1ticipant's usual 
function. 
 
 
Assessment of Causality 
• 
The investigator is obligated to assess the relationship between study intervention 
and each occmTence 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 rnled 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 infonnation, 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 occmTed and the investigator has 
minimal infonnation to include in the initial repo1t 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 
infonnation and send an SAE follow-up repo1t with the updated causality 
assessment. 
• 
The causality assessment is one of the criteria used when detennining regulato1y 
repo1ting 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 
repo1ting pmposes, as defined by the sponsor. In addition, if the investigator 
determines that an SAE is associated with study procedmes, the investigator must 
record this causal relationship in the somce documents and CRF, and repo1t such 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 81 
 
 
 
an assessment in the dedicated section of the Vaccine SAE Repo1iing Fo1m and in 
accordance with the SAE repo1iing requirements. 
 
 
Follow-up of AEs and SAEs 
• 
 The investigator is obligated to perfo1m or anange 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 laborato1y tests or 
investigations, histopathological examinations, or consultation with other 
healthcare providers. 
• 
 If a participant dies during paiiicipation in the study or during a recognized 
follow-up period, the investigator will provide Pfizer Safety with a copy of any 
postmo1iem findings including histopathology. 
• 
New or updated info1mation 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 info1mation. 
 
10.2.5. Reporting of SAEs 
 
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool 
• 
The prima1y mechanism for repo1iing 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 repo1i 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 entiy of new data or changes to existing data. 
• 
 If a site receives a repo1i of a new SAE from a study participant or receives 
updated data on a previously reported SAE after the electi·onic data collection tool 
has been taken off-line, then the site can repo1i this infonnation on a paper SAE 
fo1m (see next section) or to Pfizer Safety by telephone. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 82 
 
 
 
SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form 
• 
Facsimile transmission of the Vaccine SAE Repo1iing Fonn is the prefe1Ted 
method to transmit this info1mation to Pfizer Safety. 
• 
In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Reporting Fo1m sent by overnight mail 
or cou . r serv.ce. 
ne 
i 
• 
 Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Repo1iing Fonn pages within the designated 
repo1iing time frames. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 83 
 
 
10.3. Appendix 3: Contraceptive Guidance 
10.3.1. Male Participant Reproductive Inclusion Criteria 
No contraception methods are required for male participants in this study, as there is no 
reasonable expectation of genotoxicity and teratogenicity/fetotoxicity was not observed in 
animal studies with Trumenba. Please refer to the Trumenba IB for further details. 
10.3.2. 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 10.3.3). 
OR 
• Is a WOCBP and using an acceptable contraceptive method as described below during 
the intervention period (for a minimum of 28 days after the last dose of study 
intervention). The investigator should evaluate the effectiveness of the contraceptive 
method in relationship to the first dose of study intervention. 
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
10.3.3. Woman of Childbearing Potential (WOCBP) 
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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 84 
 
 
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. 
10.3.4. 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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 85 
 
 
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation: 
• Oral; 
• Intravaginal; 
• Transdermal; 
• Injectable. 
7. Progestogen-only hormone contraception associated with inhibition of ovulation: 
• Oral; 
• Injectable. 
8. Sexual abstinence: 
• Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant. 
9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action. 
10. Male or female condom with or without spermicide. 
11. Cervical cap, diaphragm, or sponge with spermicide. 
12. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods). 
10.4. Appendix 4 : 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.” 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 86 
 
 
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). 
• 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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 87 
 
 
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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 88 
 
 
10.5. Appendix 5: 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 repo1iing 
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). 
10.5.1. Definition of AE and ADE 
 
AE and ADE Definition 
• 
An AE is defined as any untoward medical occunence, unintended disease or 
injmy, or untoward clinical signs (including abnonnal laborato1y finding) in study 
paiiicipants, users, or other persons, whether or not related to the investigational 
medical device. This definition includes events related to the investigational 
medical device or compai·ator for study paiiicipants, users, and other persons. This 
definition also includes events considered related to procedures for study 
paiiicipants only. 
• 
An ADE is defined as an adverse event related to the use of an investigational 
medical device. This definition includes any adverse events resulting from 
insufficient or inadequate instmctions for use, deployment, implantation, 
installation, or operation, or any malfunction of the investigational medical device 
as well as any event resulting from use enor or from intentional Inisuse of the 
investigational medical device. 
 
10.5.2. 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). 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
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Page 89 
 
 
 
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 injmy. The te1m "life-threatening" in the definition 
of serious refers to an event in which the paiiicipant 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 pe1manent impaiiment of a body stmcture or a body function. 
•  Inpatient or prolonged hospitalization. Planned hospitalization for a preexisting 
condition, or a procedure requii·ed by the protocol, without serious deterioration in 
health, is not considered an SAE. 
• Medical or surgical intervention to prevent life-threatening illness or injmy or 
pennanent impai1ment to a body stmcture or a body function. 
C. Led to fetal distress, fetal death, or a congenital abno1mality or bi1ih defect. 
SADE Definition 
• An SADE is defined as an adverse device effect that has resulted in any of the 
consequences chai·acteristic of a serious adverse event. 
USADE Definition 
• A USADE is a serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the cmTent version of the risk 
analysis management file. 
 
 
10.5.3. 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 perfonnance. Device 
deficiencies include malfunctions, use enors, and inadequate labeling. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 90 
 
 
10.5.4. Recording/Reporting and Follow-up of AEs and/or SAEs and Device 
Deficiencies 
 
AE and 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, laborato1y 
reports, and diagnostic reports) related to the event. 
• 
The investigator will then record all relevant AE/SAE/device deficiency 
infonnation in the paiiicipant's medical records, in accordance with the 
investigator's nonnal clinical practice and on the appropriate fo1m of the CRF. 
• 
It is not acceptable for the investigator to send photocopies of the participant's 
medical records to Pfizer Safety in lieu of following the repo1iing process described 
in the IP Manual and completing the Medical Device Complaint CRF. 
• 
There may be instances when copies of medical records for certain cases ai·e 
requested by Pfizer Safety. In this case, all paiiicipant identifiers, with the 
exception of the paiiicipant 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 infonnation. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE/SAE. 
• 
For device deficiencies, it is ve1y impo1iant that the investigator describes any 
conective or remedial actions taken to prevent recmTence of the incident. 
• 
A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessaiy to prevent recunence of a device 
deficiency. This includes any ainendment to the device design to prevent 
recmTence. 
Assessment of Intensity 
The investigator will make an assessment of intensity for each AE/SAE/device deficiency 
repo1ied during the study and assign it to 1 of the following categories: 
• 
Mild: An event that is easily tolerated by the paiiicipant, causing minimal 
discomfo1i and not interfering with eve1yday activities. 
• 
Moderate: An event that causes sufficient discomfort and interferes with n01mal 
eve1yday activities. 
• 
Severe: An event that prevents nonnal eve1yday activities. An AE that is assessed 
as severe should not be confused with an SAE. Severe is a catego1y utilized for 
rating the intensity of an event; and both AEs and SAEs can be assessed as severe. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 91 
 
 
 
• 
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 occmTence 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 mled out. 
• 
The investigator will use clinical judgment to detennine 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 infonnation, 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 occmTed and the investigator has 
minimal infonnation to include in the initial repo1i to the sponsor. However, it is 
ve1y impo1iant that the investigator always make an assessment of causality for 
eve1y 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 
infonnation and send an SAE follow-up repo1i with the updated causality 
assessment. 
• 
The causality assessment is one of the criteria used when detennining regulato1y 
repo1iing requirements. 
 
 
Follow-up of AE/SAE/Device Deficiency 
• 
The investigator is obligated to perfo1m or aITange for the conduct of supplemental 
measmements 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 laborato1y tests or investigations, 
histopathological examinations, or consultation with other healthcare providers. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 92 
 
 
 
• 
 If a paiiicipant dies during paiiicipation 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 infonnation 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 info1mation. 
 
 
10.5.5. Reporting of SAEs 
 
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool 
• 
The primaiy mechanism for repo1iing 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 repo1i 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 entiy of new data or changes to existing data. 
• 
 If a site receives a repo1i of a new SAE from a study paiiicipant or receives updated 
data on a previously repo1ied SAE after the electronic data collection tool has been 
taken off-line, then the site can repo1i this info1mation on a paper SAE fo1m (see 
next section) or to Pfizer Safety by telephone. 
 
 
SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form 
• 
Facsimile ti·ansinission of the Vaccine SAE Repo1iing Fo1m is the prefened method 
to ti·ansinit this infonnation to Pfizer Safety. 
• 
In circumstances when the facsimile is not working, notification by telephone is 
accepta.ble with a copy of the Vaccine SAE Repo1iing Fo1m sent by overnight mail 
or conner serv.ce. 
i 
• 
 Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Repo1iing Fo1m pages within the designated 
reporting time fraines. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (15 May 2020) 
Page 93 
 
 
10.5.6. Reporting of SADEs 
 
SADE Reporting to Pfizer Safety 
NOTE: There are additional repo1iing obligations for medical device incidents that are 
potentially related to SAEs that must fulfill the legal responsibility to notify appropriate 
regulato1y authorities and other entities about ce1iain safety infonnation relating to medical 
devices being used in clinical studies. 
• 
Any device deficiency that is associated with an SAE must be repo1ied to the 
sponsor within 24 homs after the investigator determines that the event meets the 
definition of a device deficiency. 
• 
The sponsor shall review all device deficiencies and detennine and doclllllent in 
writing whether they could have led to an SAE. These shall be reported to the 
regulato1y authorities and IRBs/ECs as required by national regulations. 

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10.6. Appendix 6: 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 and will become effective for other public emergencies only upon 
written notification from Pfizer. 
Use of these alternative study measures are expected to cease upon the return of business as 
usual (including the lifting of any quarantines and travel bans/advisories). 
10.6.1. 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, videoconferencing 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 3. 
Study participants must be reminded to promptly notify site staff about any change in their 
health status. 
10.6.2. Home Health Visits 
A home health care service may be utilized to facilitate scheduled visits per the SoA. Home 
health visits include a healthcare provider conducting an in-person study visit at the 
participant’s location, rather than an in-person study visit at the site. The following may be 
performed during a home health visit: 
• Ensure that the participant continues to be eligible for the study, and continues to comply 
with contraception requirements as detailed in Section 5.3.1. 
• Ensure that the participant continues to meet none of the withdrawal criteria as described 
in Section 7.2. 
• If previously provided to the participant’s parent(s)/legal guardian, collect the 
provisioned e-diary device. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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• Review the participant’s e-diary data since the previous visit and follow up on any 
ongoing reactogenicity or use of antipyretic medication. 
• Complete the Study Visit/Telephone Contact AE Checklist to: 
• Inquire whether the participant had any NDCMCs since the last visit. Inquire 
whether the participant had any of the following related to an AE since the last visit: 
hospitalizations, visits to other medical facilities, medication use, or missed days of 
school or work. Please refer to the 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 the AE reporting requirements section (Section 8.3) and the 
SoA. 
• Report any SAEs to the sponsor as defined in Section 8.3. 
• Review AEs that were ongoing since the previous visit and record their end dates or 
confirm that they are still continuing. 
• Record nonstudy vaccinations as described in the Concomitant Therapy section 
(Section 6.5). 
• Record any blood transfusion (eg, whole blood, packed cells) received by the participant 
as described in the Concomitant Therapy section (Section 6.5). 
• Record concomitant medications used to treat AEs as described in the Concomitant 
Therapy section (Section 6.5). 
• Provide the parent(s)/legal guardian or the participant with a memory aid. Instruct the 
participant to use the memory aid between visits (Visits 2 and 3, or Visits 4 and 5, as 
applicable) 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 and Section 8.2 for 
additional details. 
• Ask the parent(s)/legal guardian or the participant to contact the investigator immediately 
if any significant illness or hospitalization occurs. 
• Schedule an appointment for the next study visit and confirm that it is scheduled within 
the time window per protocol. 
• Complete the source documents. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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• Complete the CRFs. 
10.6.3. 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 intervention 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. 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
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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 
4CMenB 
4-component meningococcal serogroup B vaccine 
ACIP 
Advisory Committee on Immunization Practices 
ACWY 
Neisseria meningitidis serogroups A, C, W-135, and Y 
ADE 
adverse device effect 
AE 
adverse event 
AlPO4 
aluminum phosphate 
ALT 
alanine aminotransferase 
app 
application 
AST 
aspartate aminotransferase 
bivalent rLP2086 
Neisseria meningitidis serogroup B bivalent recombinant lipoprotein 
2086 vaccine (bivalent rLP2086; subfamily A and B; Escherichia 
coli) 
CDC 
Centers for Disease Control and Prevention 
CDS 
core data sheet 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CK 
creatine kinase 
COVID-19 
coronavirus disease 19 
CRF 
case report form 
CRO 
contract research organization 
CSR 
clinical study report 
DILI 
drug-induced liver injury 
DMC 
data monitoring committee 
dTaP-IPV 
diphtheria, tetanus, acellular pertussis, and inactivated poliomyelitis 
virus vaccine 
DU 
dispensable unit 
EC 
ethics committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
e-diary 
electronic diary 
EDP 
exposure during pregnancy 
EMA 
European Medicines Agency 
EU 
European Union 
EudraCT 
European Clinical Trials Database 
FDA 
Food and Drug Administration 
fHBP 
factor H binding protein 
FSH 
follicle-stimulating hormone 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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Abbreviation 
Term 
GCP 
Good Clinical Practice 
GGT 
gamma-glutamyl transferase 
Hib 
Haemophilus influenzae type b 
HIPAA 
Health Insurance Portability and Accountability Act 
HPV4 
quadrivalent 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 
INR 
international normalized ratio 
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 
IVRS 
interactive voice response system 
IWRS 
interactive Web-based response system 
LFT 
liver function test 
LLOQ 
lower limit of quantitation 
LOD 
limit of detection 
LP2086 
lipoprotein 2086 
MAE 
medically attended adverse event 
MCV4 
quadrivalent meningococcal polysaccharide conjugate vaccine 
MedDRA 
Medical Dictionary for Regulatory Activities 
MenACWY-TT 
meningococcal polysaccharide groups A, C, W, and Y tetanus 
toxoid conjugate vaccine 
mITT 
modified intent-to-treat 
MnB 
Neisseria meningitidis serogroup B 
N/A 
not applicable 
NDCMC 
newly diagnosed chronic medical condition 
NIMP 
noninvestigational medicinal product 
OR 
odds ratio 
PFS 
prefilled syringe 
PT 
prothrombin time 
SADE 
serious adverse device effect 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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Abbreviation 
Term 
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 
Tdap 
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis 
vaccine, adsorbed 
ULN 
upper limit of normal 
US 
United States 
USADE 
unanticipated serious adverse device effect 
WOCBP 
woman of childbearing potential 

PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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11. REFERENCES 
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PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
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PF-05212366 (Neisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine [Bivalent 
rLP2086; subfamily A and B; E coli]) 
Protocol B1971060 
Final Protocol, 22 January 2021 
PFIZER CONFIDENTIAL 
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31. Murphy E, Andrew L, Lee KL, et al. Sequence diversity of the factor H binding vaccine 
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ANNEX%201Nonclinical.P31-63.pdf?ua=1. Accessed: 19 Jan 2021. 

 
Signed By: 
Date(GMT) 
Signing Capacity 
 
Document Approval Record 
 
 
B1971060 Clinical Protocol, 22Jan2021 
 
A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE 
SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA 
® WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPA 
NTS ೦10 YEARS OF AGE 
 
 
PPD 
 
PPD 
 
 
24- Jan-2021 14 19 49 
Final Approval 
 
25- Jan-2021 10 56 41 
Final Approval 
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