Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study
Conditions: Gonorrhea, Chlamydia, Meningococcal Vaccines
Sponsor: Pfizer

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NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study Information
Title
Effect of Trumenba on Gonococcal infections in 
adolescents and young adults in the United 
States: A retrospective cohort study
Protocol number
B1971066
Protocol version identifier
1.0
Date
18 April 2023
Medicinal product
Trumenba 
Research question and objectives
To examine the effect of Trumenba on
gonococcal infection in adolescents and young 
adults in the United States using a claims 
database.
Author
(Pfizer): 
(Pfizer): 
(Pfizer):
(Pfizer): 
This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, 
by accepting or reviewing this document, 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.
PPD
PPD
PPD
PPD
PPD
PPD
PPD

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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................2
2. LIST OF ABBREVIATIONS................................................................................................4
3. RESPONSIBLE PARTIES....................................................................................................6
4. ABSTRACT...........................................................................................................................7
5. AMENDMENTS AND UPDATES.......................................................................................8
6. MILESTONES.......................................................................................................................9
7. RATIONALE AND BACKGROUND................................................................................10
8. RESEARCH QUESTION AND OBJECTIVES .................................................................11
8.1. Objectives................................................................................................................11
8.1.1. Primary Objective.......................................................................................11
8.1.2. Secondary Objectives .................................................................................11
8.1.3. Exploratory Objectives ...............................................................................11
9. RESEARCH METHODS ....................................................................................................11
9.1. Study Design ...........................................................................................................11
9.2. Setting......................................................................................................................12
9.2.1. Inclusion Criteria ........................................................................................12
9.2.2. Exclusion Criteria.......................................................................................12
9.3. Variables..................................................................................................................12
9.4. Data Sources............................................................................................................17
9.5. Study Size................................................................................................................17
9.6. Data Management ...................................................................................................18
9.7. Data Analysis ..........................................................................................................18
9.8. Quality Control........................................................................................................18
9.9. Strengths and Limitations of the Research Methods...............................................19
9.10. Other Aspects ........................................................................................................19
10. PROTECTION OF HUMAN SUBJECTS ........................................................................19
10.1. Patient Information................................................................................................19
10.2. Patient Consent......................................................................................................19
10.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ............19
10.4. Ethical Conduct of the Study ................................................................................20

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11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................20
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........20
13. REFERENCES ..................................................................................................................21
14. LIST OF TABLES.............................................................................................................22
15. LIST OF FIGURES ...........................................................................................................22
ANNEX 1. LIST OF STAND ALONE DOCUMENTS .........................................................22

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2. LIST OF ABBREVIATIONS
Abbreviation
Definition
4CMenB
bexsero vaccine
CIOMS
International Ethical Guidelines for Epidemiological 
Research issued by the Council for International 
Organizations of Medical Sciences
CFR
Code of Federal Regulations
CPT
current procedural terminology
EMA
European Medicines Agency 
ENCePP
European Network of Centres for 
Pharmacoepidemiology and Pharmacovigilance
FDA
Food and Drug Administration
fHBP
factor H binding protein
GEP
Good Epidemiological Practice
GPP
Good Pharmacoepidemiology Practices
HRs
hazard ratios
HIPAA
Health Insurance Portability and Accountability Act
HIV
human immunodeficieny virus
ICD-10-CM
International Classification of Diseases, 10th
Revision, Clinical Modification
IEA
International Epidemiological Association
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISPE
International Society for Pharmacoepidemiology
ISPOR
Good Outcomes Research Practices issued by the 
International Society for Pharmacoeconomics and 
Outcomes Research
MenB
Meningococcal Serogroup B
MSM
men who have sex with men
NDC
National Drug Codes
OMV
outer membrane vesicle
PASS
Post-Authorization Safety Study

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Abbreviation
Definition
SAS
statistical analysis system
US
United States
VE
Vaccine effectiveness

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3. RESPONSIBLE PARTIES
Principal Investigator(s) of the Protocol
Name, degree(s)
Job Title
Affiliation
Address
Myint Tin Tin Htar
Epidemiology Lead
Pfizer
23-25 Avenue Docteur 
Lannelongue 75014 
Paris, France
Mohammad Ali, PhD
Statistician
Pfizer
500 Arcola Rd 
Collegeville, PA
Angela Quinn, BS
Clincal Scientist
Pfizer
500 Arcola Rd 
Collegeville, PA 
Sarah Jeanette Willis 
Director, Vaccines
RWE Scientist
Pfizer
Remote, 
 
PPD

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4. ABSTRACT
Not required.

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5. AMENDMENTS AND UPDATES
None.

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6. MILESTONES
Milestone
Planned date
Start of data collection 
20 April 2023
End of data collection
30 April 2023
Final study report
31 October 2023

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7. RATIONALE AND BACKGROUND
This study is not a Post-Authorization Safety Study (PASS) and is not a commitment to any 
regulatory authority.
Meningococcal B outer membrane vesicle (OMV) vaccines have been created, developed 
and used to control outbreaks of meningococcal B diseases in New Zealand, Norway and 
Cuba. Studies suggested that OMV vaccines could potentially protect against gonococcal 
infections in New Zealand and Norway.1
Recently 4 studies described the effect of Bexsero (4CMenB) on gonococcal infection in 
adolescents and young adults (2 studies in the United States (US), 1 in Australia and 1 in 
Italy). The vaccine coverage differed by studies (69% in Australia, 33% in men who have sex 
with men (MSM) living with human immunodeficiency virus (HIV) in Italy and 1.8% in 
New York City & Philadelphia. The direct effect of 4CMenB (vaccine effectiveness) ranged 
from 32 to 74% for 2 full doses and 33 to 71% for at least 1 dose.2-5
Abara et al studied the effectiveness of 4CMenB and factor H binding protein (fHbp)
vaccines in 2 separate studies using the same methodology in New York and Philadelphia 
regions for the period of 2016-2018 (the first 2 years of meningococcal serogroup B [MenB] 
vaccines use in the US). The vaccine coverage was 7.4% and 1.6% for at least one dose for 
4CMenB and fHbp vaccines respectively. The effectiveness of 4CMenB was 40% (95% CI 
23; 53) for full dose and 26% (95% CI 12; 37) for only 1 dose. The effectiveness of fHbp 
vaccine was 3% (95%CI: +19; 21).6 6These results were based on data during the period 
where fHbp had extremely low vaccine coverage (<2%). 
The vaccine effectiveness for 4CMenB varied highly according to study types, age of the 
study population and the vaccine coverage rate. The vaccine coverage had increased to 
32% for any MenB vaccines in 2021 while it was 14% and 17% in 2017 and 2018 
respectively. The effectiveness of fHbp vaccine observed in Abara et al study could be 
confirmed in a larger population with higher vaccine coverage. The purpose of the study will 
be to evaluate the effect of fHbp vaccine in prevention of gonococcal infection among 
15-30 years in the US using the claim database. 

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8. RESEARCH QUESTION AND OBJECTIVES
8.1. Objectives
8.1.1. Primary Objective
To examine the effect of at least 1 dose of Trumenba on gonococcal infection in adolescents 
and young adults of 15-30 years in the US.
8.1.2. Secondary Objectives 
1. To examine the effect of at least 2 doses of Trumenba on gonococcal infection in 
adolescents and young adults of 15-30 years in the US.
2. To examine the effect of at least 1 dose of Trumenba on chlamydial infection in 
adolescents and young adults of 15-30 years in the US.
3. To examine the effect of at least 2 doses of Trumenba on chlamydial infection in 
adolescents and young adults of 15-30 years in the US.
8.1.3. Exploratory Objectives
1. To examine the effect of at least 1 dose of Trumenba on gonococcal infection in 
adolescents and young adults of 16-23 years in the US.
2. To examine the effect of 1 dose of Trumenba on gonococcal infection in adolescents 
and young adults of 15-30 years in the US at 12 months, 24 months, 36 months and 
48 months following the index vaccination.
9. RESEARCH METHODS 
9.1. Study Design
This is a retrospective cohort study using health care administrative claims data as described 
in Section 9.4 Data Sources.
Adolescents and young adults approximately 15 to 30 years of age at their individual time 
zero (calculated based on birth year) will be identified from administrative claims during 
01 January 2016 and 31 December 2021.
The exposure cohort will be the individuals who have received at least 1 dose of Trumenba 
and at least 1 dose of MenACWY (Menactra®, Menveo®, or MenQuadfi®) prior to the 
Trumenba vaccination, between 01 January 2016 and 31 December 2021. The index date 
(zero time) for the exposed cohort is the last date of vaccination, and the cohort will be 
followed from 14 days after vaccination to the end of the study period (31 December 2022). 
The individuals in the cohort will be censored by the event of interest, death date (if known), 
plan disenrollment (if known) or the end of the study period, whichever comes first.

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The reference cohort will be those with at least 1 dose of MenACWY vaccine, but no doses 
of Trumemba during the observation period, received between 01January 2016 and 
31 December 2021. The MenACWY-only vaccinated cohort is used as a reference cohort 
rather than an unvaccinated cohort in order to help control for theoretical differences in 
health seeking and risk behaviors between vaccinated and unvaccinated individuals. The 
index date (zero time) of the reference cohort is the last dose of MenACWY and these 
individuals will be followed from 14 days after zero time until the earliest occurrence of the 
following: outcome of interest, death date (if known), plan disenrollment (if known) or 
31 December 2022 (end of study period). 
The outcomes of interest are gonococcal and chlamydial infections and only the first episode
within the study period will be considered as event in case of repeated infections. 
9.2. Setting
IQVIA PharMetrics® Plus is a longitudinal health plan database of adjudicated medical and 
pharmacy claims, including patient enrollment data for national and sub-national health plans 
and self-insured employer groups in the US. Administrative claims and enrollment data 
available during 01 January 2016 and 31 December 2022 will be used in this study.
9.2.1. Inclusion Criteria
Patient records must meet all of the following inclusion criteria to be eligible for inclusion in
the study:
1. Individuals of approximately 15-30 years old (using July 1 of birth year) enrolled in a 
health plan available in PharMetrics Plus database during 01 January 2016 and 
31 December 2021.
2. Individuals having at least 1 dose of MenACWY during 01 January 2016 and 
31 December 2021.
9.2.2. Exclusion Criteria
Patients meeting any of the following criteria will not be included in the study:
Individuals having any dose of Bexsero at any time during 01 January 2016 and 
31 December 2021 and prior to the study
Individuals with missing demographic variables or dates of outcome diagnoses or vaccine 
administration (listed in Section 9.3). 
9.3. Variables
In this study, the variables of interest are age, gender, state of residence, date of vaccination 
and the date of disease diagnosis.

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Table 1.
Variable List
Variable
Role
Operational Definition
Birth Year 
Covariate 
Birth year (age to be 
calculated based on July
1 of birth year)
Gender
Covariate 
Male, Female, Unknown
Residence (ZIP code)
Covariate 
First 3 digits of the zip 
code from individuals’
most recent enrollment 
MenACWY vaccination
Non-exposure
Current procedural 
terminology (CPT) codes 
and National Drug 
Codes (NDC) listed 
below
Trumemba vaccination
Exposure 
CPT and 
NDCs listed below
Gonococcal infection
Primary Outcome
ICD-10-CM codes listed 
below
Chlamydial infection
Reference disease
Outcome
ICD-10-CM codes listed 
below

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Table 2.
Diagnosis Codes for Identifying Gonococcal Infections
Code
Type
A540
ICD-10-CM
A5400
ICD-10-CM
A5401
ICD-10-CM
A5402
ICD-10-CM
A5403
ICD-10-CM
A5409
ICD-10-CM
A541
ICD-10-CM
A542
ICD-10-CM
A5421
ICD-10-CM
A5422
ICD-10-CM
A5423
ICD-10-CM
A5424
ICD-10-CM
A5429
ICD-10-CM
A543
ICD-10-CM
A5430
ICD-10-CM
A5431
ICD-10-CM
A5432
ICD-10-CM
A5433
ICD-10-CM
A5439
ICD-10-CM
A544
ICD-10-CM
A5440
ICD-10-CM
A5441
ICD-10-CM
A5442
ICD-10-CM
A5443
ICD-10-CM
A5449
ICD-10-CM
A545
ICD-10-CM
A546
ICD-10-CM
A548
ICD-10-CM
A5481
ICD-10-CM
A5482
ICD-10-CM
A5483
ICD-10-CM
A5484
ICD-10-CM
A5485
ICD-10-CM
A5486
ICD-10-CM
A5489
ICD-10-CM
A549
ICD-10-CM

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Table 3.
Diagnosis Codes for Identifying Chlamydial Infections
Code
Type
A55
ICD-10-CM
A560
ICD-10-CM
A5600
ICD-10-CM
A5601
ICD-10-CM
A5602
ICD-10-CM
A5609
ICD-10-CM
A561
ICD-10-CM
A5611
ICD-10-CM
A5619
ICD-10-CM
A562
ICD-10-CM
A563
ICD-10-CM
A564
ICD-10-CM
A568
ICD-10-CM
A71
ICD-10-CM
A710
ICD-10-CM
A711
ICD-10-CM
A719
ICD-10-CM
A74
ICD-10-CM
A740
ICD-10-CM
A748
ICD-10-CM
A7481
ICD-10-CM
A7489
ICD-10-CM
A749
ICD-10-CM

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Table 4.
Current Procedural Terminal Codes and National Drug Codes for 
Identifying MenACWY Vaccination
Code
Type
Description
90734
CPT
Menactra/Menveo Vaccination
90619
CPT
Menquadfi Vaccine
49281-0589-05
NDC
Menactra Vaccine
46028-0208-01
NDC
Menveo Vaccine
58160-0955-09
NDC
Menveo Vaccine
49281-0589-58
NDC
Menactra Vaccine
49281-0590-58
NDC
Menquadfi Vaccine
46028-0218-11
NDC
Menveo Vaccine
58160-0958-01
NDC
Menveo Vaccine
58160-0959-01
NDC
Menveo Vaccine
46028-0219-11
NDC
Menveo Vaccine
54569-5687-01
NDC
Menactra Vaccine
50090-1890-01
NDC
Menactra Vaccine
49281-0590-05
NDC
Menquadfi Vaccine
Table 5.
Current Procedural Terminal Codes and National Drug Codes for
Identifying Trumemba (fHbp) Vaccination
Code
Type
Description
90621
CPT
Trumenba Vaccination
00005-0100-01
NDC
Trumenba Vaccine
00005-0100-02
NDC
Trumemba Vaccine
00005-0100-05
NDC
Trumenba Vaccine
00005-0100-10
NDC
Trumenba Vaccine

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Table 6.
Current Procedural Terminal Codes and National Drug Codes for 
Identifying Bexsero 4CMenB Vaccination
Code
Type
Description
90620
CPT
Meningococcal recombinant 
protein and outer membrane 
vesicle (OMV) vaccine, 
serogroup B (MenB-4C), 2 
dose schedule, for 
intramuscular use
46028011401
NDC
Bexsero vaccine
46028011402
NDC
Bexsero vaccine
46028011411
NDC
Bexsero vaccine
58160097602
NDC
Bexsero vaccine
58160097606
NDC
Bexsero vaccine
58160097620
NDC
Bexsero vaccine
Additional details will be include in the Statistical Analysis Plan (SAP).
9.4. Data Sources
The data for this retrospective secondary data analysis is a large third party payer database, 
the IQVIA PharMetrics Plus (Pfizer 03 April 2023 version). PharMetrics Plus is a health plan
claims database comprised of fully adjudicated medical and pharmacy claims for more than 
210 million unique enrollees since 2006. Data contributors to the database are largely 
commercial health plans. It is representative of the commercially insured US national 
population for patients under 65 years of age. It contains a longitudinal view of inpatient and 
outpatient services, prescription and office/outpatient administered drugs, costs, and detailed 
enrollment information. All data are compliant to the Health Insurance Portability and 
Accountability Act (HIPAA) to protect patient privacy. The database is used in a variety of 
life sciences and commercial effectiveness studies. Over 250 peer reviewed publications have 
used PharMetrics Plus data.
9.5. Study Size
This is an exploratory study, thus no hypothesis was generated. All eligible individuals will 
be included in the study.
For the sample size estimation, we wished to detect a vaccine effectiveness against 
gonococcal infection of 20% or more with an onset from 14 days after receipt of both 
TRUMENBA and MenACWY. A Cox regression of the log hazard ratio on a covariate with 
a standard deviation of 1.50 to achieve 80% power at a 0.05 significance level to detect a 
regression coefficient equal to -0.2200, we need a sample of 15,669. The sample size was 
adjusted for an anticipated overall event rate of 0.0046. We will have 520,392 samples in the 
study database illustrating that we have adequate samples to conduct the analysis. 

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9.6. Data Management 
This study will use secondary data collected in the PharMetrics Plus database, which is 
de-identified and HIPAA compliant. The data will be made accessible only to individuals 
working on the current study. No attempt will be made to identify individual patients, 
hospitals, or physicians. Analyses will be conducted using Statistical Analysis System (SAS)
9.4 (SAS Institute, Cary, NC). 
The analytic files will include person-level data, including information on baseline 
demographic and clinical characteristics, study outcomes, and vaccination information as 
described in the variable section above. Data for this study will be processed and managed by 
Pfizer, Inc., and all analyses will be performed by Pfizer.
9.7. Data Analysis 
The zero time is the date of Trumenba vaccination for the exposed group and the date of
MenACWY for the unexposed group. We will assess gonococcal infections that occurred 
between i) 14 days after zero time and 365 days ii) 14 days after zero time and 730 days, iii) 
14 days after zero time and 1095 days, and iv) 14 days after zero time and till end of the 
study period (31Dec2022). We will censor the data in the event of interest, death date (if 
known), plan disenrollment (if known), target end date, or the end of the study period, 
whichever comes first. In descriptive analyses, we will fit Kaplan-Meier curves. We will also 
create unadjusted and covariate adjusted Cox proportional hazard regression models 
verifying first that the proportionality assumption was satisfied for all independent variables. 
Hazard ratios (HRs) will be estimated by exponentiation of the coefficient for the vaccine 
variable in these models, with vaccine effectiveness estimated as (1–HR)×100%. SEs for the 
coefficients will be used to estimate p values and CIs for the HRs. If a covariate does not
satisfy the assumption of proportionality, we will exclude the variable for the multivariable 
model and will perform the stratified analysis using the covariate. 
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in a statistical analysis plan (SAP), which will be dated, filed and maintained 
by Pfizer. The SAP may modify the plans outlined in the protocol; any major modifications 
of primary endpoint definitions or their analyses would be reflected in a protocol amendment.
9.8. Quality Control
Only observed data will be used in measuring study variables. It is anticipated that 
demographic information will be available for nearly all individuals in the study population. 
All other variables will be defined based on the presence of specific data (eg, diagnosis, 
procedure, and drug codes) in the analytic file; the absence of such data will be assumed to 
indicate the absence of the characteristic/event captured by the variable.

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9.9. Strengths and Limitations of the Research Methods
Strengths 
A significant strength of observational retrospective analyses is that they provide a better 
understanding of the study population in real world clinical practice as compared to the 
controlled conditions of a clinical trial.
Limitations
There are several limitations in this study. Given that this is an observational study using 
health care administrative claims data, residual confounding due to missing or unmeasured 
information is possible. To examine this, we will assess the effect of meningococcal 
vaccination on another sexually transmitted disease occuring, at the same age group, as 
reference disease outcome. If the HRs in any of these models are less than 1.0, it would 
indicate that residual confounding exists and may result in adjustment of our vaccine 
effectiveness (VE) estimates.
Second, health care administrative claims data will be available from 01 January 2016
through 31 December 2022. It is possible that some participants may have received a 
Trumenba vaccination prior to January 1, 2016 or during a period in which we do not have 
their claims data and be misclassified as unvaccinated with Trumenba. This may 
underestimate Trumenba vaccine effectiveness because the Men-ACWY-only cohort will 
include Trumenba vaccinated patients.
9.10. Other Aspects
Not applicable.
10. PROTECTION OF HUMAN SUBJECTS
10.1. Patient Information 
This study involves data that exist in anonymized structured format and contain no patient 
personal information. 
10.2. Patient Consent
As this study involves anonymized structured data, which according to applicable legal 
requirements do not contain data subject to privacy laws, obtaining informed consent from 
patients by Pfizer is not required.
10.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
The study databases will be de-identified prior to their release to study investigators, as set 
forth in the corresponding Data Use Agreement. The study databases have been evaluated 
and certified by an independent third party to be compliant with the HIPAA of 
1996 statistical de-identification standards and to satisfy the conditions set forth in Sections 
164.514 (a)-(b)1ii of the HIPAA Privacy Rule regarding the determination and 

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documentation of statistically de-identified data. Use of the study databases for health 
services research is therefore fully compliant with the HIPAA Privacy Rule and federal 
guidance on Public Welfare and the Protection of Human Subjects (45 Code of Federal 
Regulations [CFR] 46 §46.101) and IRB approval is not required. 
10.4. Ethical Conduct of the Study
The study will be conducted in accordance with legal and regulatory requirements, as well as 
with scientific purpose, value and rigor and follow generally accepted research practices 
described in Good Pharmacoepidemiology Practices (GPP) issued by the International 
Society for Pharmacoepidemiology (ISPE), Good Epidemiological Practice (GEP) guidelines 
issued by the International Epidemiological Association (IEA), Good Outcomes Research 
Practices issued by the International Society for Pharmacoeconomics and Outcomes 
Research (ISPOR), International Ethical Guidelines for Epidemiological Research issued by 
the Council for International Organizations of Medical Sciences (CIOMS), European 
Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and 
Pharmacovigilance (ENCePP) Guide on Methodological Standards in 
Pharmacoepidemiology, and Food and Drug Administration (FDA) Guidance for Industry: 
Good Pharmacovigilance and Pharmacoepidemiologic Assessment, and FDA Draft Guidance 
for Industry and FDA Staff: Best Practices for Conducting and Reporting of 
Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets and/or 
equivalent.
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS 
This study involves data that exist as structured data by the time of study start.
In these data sources, individual patient data are not retrieved or validated, and it is not 
possible to link (ie, identify a potential association between) a particular product and medical 
event for any individual. Thus, the minimum criteria for reporting an adverse event (AE) 
(ie, identifiable patient, identifiable reporter, a suspect product, and event) cannot be met.
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
Formal communication of the results of this research will be done by Pfizer authors through 
peer-reviewed publications. For all publications relating to the Study, Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including Section II -
“Ethical Considerations in the Conduct and Reporting of Research” of the Uniform 
Requirements for Manuscripts Submitted to Biomedical Journals, 
http://www.icmje.org/index.html#authorship, established by the International Committee of 
Medical Journal Editors.
In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
competent authority in any area of the world, or if party responsible for collecting data from 
the participant is aware of any new information which might influence the evaluation of the 
benefits and risks of a Pfizer product, Pfizer should be informed immediately. 

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13. REFERENCES
1.
Kuhdari P, Stefanati A, Lupi S, Valente N, Gabutti G. Meningococcal B vaccination: 
real-world experience and future perspectives. Pathog Glob Health. 2016 Jun-Jul;110(4-
5):148-56. doi: 10.1080/20477724.2016.1195072. Epub 2016 Jun 16. PMID: 27309042; 
PMCID: PMC5072112.
2.
Wang B, Giles L, Andraweera P, McMillan M, Almond S, Beazley R, Mitchell J, Lally 
N, Ahoure M, Denehy E, Koehler A, Flood L, Marshall H. Effectiveness and impact of 
the 4CMenB vaccine against invasive serogroup B meningococcal disease and 
gonorrhoea in an infant, child, and adolescent programme: an observational cohort and 
case-control study. Lancet Infect Dis. 2022 Jul;22(7):1011-1020. doi: 10.1016/S1473-
3099(21)00754-4. Epub 2022 Apr 12. PMID: 35427492.
3.
Abara WE, Bernstein KT, Lewis FMT, Schillinger JA, Feemster K, Pathela P, Hariri S, 
Islam A, Eberhart M, Cheng I, Ternier A, Slutsker JS, Mbaeyi S, Madera R, Kirkcaldy 
RD. Effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine 
against gonorrhoea: a retrospective observational study. Lancet Infect Dis. 2022 
Jul;22(7):1021-1029. doi: 10.1016/S1473-3099(21)00812-4. Epub 2022 Apr 12. PMID: 
35427490.
4.
Raccagni AR, Galli L, Spagnuolo V, Bruzzesi E, Muccini C, Bossolasco S, Ranzenigo 
M, Gianotti N, Lolatto R, Castagna A, Nozza S. Meningococcus B Vaccination 
Effectiveness against Neisseria gonorrhoeae Infection in People Living with HIV: a 
Case-control Study. Sex Transm Dis. 2023 Jan 13. doi: 
10.1097/OLQ.0000000000001771. Epub ahead of print. PMID: 36728240.
5.
Bruxvoort KJ, Lewnard JA, Chen LH, Tseng HF, Chang J, Veltman J, Marrazzo J, Qian 
L. Prevention of Neisseria gonorrhoeae With Meningococcal B Vaccine: A Matched 
Cohort Study in Southern California. Clin Infect Dis. 2023 Feb 8;76(3):e1341-e1349. 
doi: 10.1093/cid/ciac436. Erratum in: Clin Infect Dis. 2023 Jan 11;: PMID: 35642527.
6.
Abara WE, Bernstein KT, Lewis FMT, Pathela P, Islam A, Eberhart M, Cheng I, 
Ternier A, Sanderson Slutsker J, Madera R, Kirkcaldy R. Healthy vaccinee bias and 
MenB-FHbp vaccine effectiveness against gonorrhea. Sex Transm Dis. 2023 Mar 2. 
doi: 10.1097/OLQ.0000000000001793. Epub ahead of print. PMID: 36863060.

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14. LIST OF TABLES 
Table 1.
Variable List
Table 2.
Diagnosis Codes for Identifying Gonococcal Infections
Table 3.
Diagnosis Codes for Identifying Chlamydial Infections
Table 4.
Current Procedural Terminal Codes and National Drug Codes for Identifying 
MenACWY Vaccination
Table 5.
Current Procedural Terminal Codes and National Drug Codes for Identifying 
Trumemba (fHbp) Vaccination
Table 6.
Current Procedural Terminal Codes and National Drug Codes for Identifying 
Bexsero 4CMenB Vaccination
15. LIST OF FIGURES
None.
ANNEX 1. LIST OF STAND ALONE DOCUMENTS
None.

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