A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 60 THROUGH 64 YEARS OF AGE
Phase: PHASE2
Conditions: Pneumococcal Infections
Sponsor: Pfizer

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A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE 
SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL 
CONJUGATE VACCINE IN ADULTS 60 THROUGH 64 YEARS OF AGE
Investigational Product Number:
PF-06482077
Investigational Product Name:
20-valent Pneumococcal Conjugate Vaccine
United States (US) Investigational New 
Drug (IND) Number:
European Clinical Trials Database 
(EudraCT) Number:
Not applicable (N/A)
Protocol Number:
B7471002
Phase:
2
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Document History
Document
Version Date
Summary of Changes
Original protocol
20 July 2017
Not applicable (N/A)

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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................7
APPENDICES ...........................................................................................................................7
SCHEDULE OF ACTIVITIES................................................................................................12
1. INTRODUCTION ...............................................................................................................15
1.1. Indication.................................................................................................................15
1.2. Background and Rationale ......................................................................................15
1.2.1. Pneumococcal Disease................................................................................15
1.2.2. Vaccines to Prevent Pneumococcal Disease...............................................16
1.2.2.1. Pneumococcal Polysaccharide Vaccines...................................16
1.2.2.2. Pneumococcal Polysaccharide Conjugate Vaccines .................17
1.2.2.3. Rationale for 20vPnC................................................................18
2. STUDY OBJECTIVES AND ENDPOINTS.......................................................................19
2.1. Primary Objective and Endpoints ...........................................................................19
2.1.1. Primary Objective.......................................................................................19
2.1.2. Primary Endpoints ......................................................................................19
2.2. Secondary Objective and Endpoints .......................................................................20
2.2.1. Secondary Objective...................................................................................20
2.2.2. Secondary Endpoints ..................................................................................20
3. STUDY DESIGN.................................................................................................................20
3.1. Duration of Subject Participation............................................................................22
3.2. Duration of Study....................................................................................................22
3.3. Number of Subjects.................................................................................................22
4. SUBJECT ELIGIBILITY CRITERIA.................................................................................22
4.1. Inclusion Criteria.....................................................................................................23
4.2. Exclusion Criteria....................................................................................................23
4.3. Temporary Delay Criteria .......................................................................................25
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4.3.1. Criteria for Temporarily Delaying Vaccine Administration (Visits 1 
and 2) ...............................................................................................................25
4.3.2. Criteria for Temporarily Delaying Blood Draw (Visits 1, 2, 3, and 5) ......25
4.4. Lifestyle Requirements ...........................................................................................25
4.4.1. Contraception..............................................................................................25
4.5. Sponsor’s Qualified Medical Personnel..................................................................26
5. INVESTIGATIONAL PRODUCTS ...................................................................................27
5.1. Allocation to Investigational Product......................................................................27
5.2. Blinding of the Site Personnel.................................................................................27
5.3. Blinding of the Sponsor...........................................................................................28
5.4. Breaking the Blind ..................................................................................................28
5.5. Subject Compliance.................................................................................................28
5.6. Investigational Product Supplies.............................................................................28
5.6.1. Dosage Form(s) and Packaging..................................................................29
5.6.2. Preparation and Dispensing........................................................................29
5.7. Administration.........................................................................................................30
5.8. Investigational Product Storage ..............................................................................30
5.9. Investigational Product Accountability...................................................................31
5.9.1. Destruction of Investigational Product Supplies ........................................31
5.10. Concomitant Treatment(s).....................................................................................31
5.10.1. Prohibited During the Study.....................................................................31
5.10.2. Permitted During the Study ......................................................................32
5.10.3. Recording Concomitant Treatments.........................................................32
6. STUDY PROCEDURES .....................................................................................................32
6.1. Visit 1 (Vaccination 1 – Day 1) ..............................................................................32
6.2. Visit 2 (Vaccination 2 – 28 to 35 Days After Visit 1).............................................34
6.3. Visit 3 (Follow-up Vaccination 2 – 28 to 35 Days After Visit 2)...........................35
6.4. Visit 4 (6-Month Safety Collection by Telephone – 168 to 196 Days After 
Visit 1).......................................................................................................................35
6.5. Visit 5 (Persistence Blood Draw and 12-Month Safety Collection – 350 to 
378 Days After Visit 1) .............................................................................................36
6.6. Unscheduled Visits..................................................................................................36

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6.7. Subject Withdrawal.................................................................................................37
7. ASSESSMENTS..................................................................................................................39
7.1. Safety Parameters....................................................................................................39
7.1.1. Subject Electronic Diary.............................................................................40
7.1.2. Grading Scale for Prompted Events ...........................................................40
7.1.2.1. Local Reactions.........................................................................40
7.1.2.2. Systemic Events ........................................................................41
7.1.2.3. Fever..........................................................................................42
7.1.2.4. Use of Antipyretic/Pain Medication..........................................43
7.2. Immunogenicity ......................................................................................................43
7.3. Biological Samples..................................................................................................43
8. ADVERSE EVENT REPORTING......................................................................................44
8.1. Requirements...........................................................................................................44
8.1.1. Additional Details on Recording Adverse Events on the CRF...................45
8.1.2. Eliciting Adverse Event Information..........................................................45
8.1.3. Withdrawal from the Study due to Adverse Events (see also the 
Subject Withdrawal Section) ...........................................................................45
8.1.4. Time Period for Collecting AE/SAE Information......................................45
8.1.4.1. Reporting SAEs to Pfizer Safety...............................................46
8.1.4.2. Recording Nonserious AEs and SAEs on the CRF...................46
8.1.5. Causality Assessment .................................................................................46
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities ..................46
8.2. Definitions...............................................................................................................47
8.2.1. Adverse Events...........................................................................................47
8.2.2. Abnormal Test Findings .............................................................................48
8.2.3. Serious Adverse Events ..............................................................................48
8.2.4. Hospitalization............................................................................................49
8.3. Severity Assessment................................................................................................50
8.4. Special Situations ....................................................................................................51
8.4.1. Protocol-Specified Serious Adverse Events...............................................51
8.4.2. Potential Cases of Drug-Induced Liver Injury............................................51

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8.4.3. Exposure to the Investigational Product during Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................52
8.4.3.1. Exposure during Pregnancy ......................................................53
8.4.3.2. Exposure during Breastfeeding .................................................54
8.4.3.3. Occupational Exposure .............................................................54
8.4.4. Medication Errors and Lack of Efficacy ....................................................55
8.4.4.1. Medication Errors......................................................................55
8.4.4.2. Lack of Efficacy........................................................................56
8.5. Medical Device Complaint Reporting Requirements .............................................56
9. DATA ANALYSIS/STATISTICAL METHODS...............................................................56
9.1. Sample Size Determination.....................................................................................56
9.2. Analysis Populations...............................................................................................56
9.3. Immunogenicity Analysis .......................................................................................57
9.4. Safety Analysis........................................................................................................58
9.5. Analysis Timing ......................................................................................................58
10. QUALITY CONTROL AND QUALITY ASSURANCE.................................................59
11. DATA HANDLING AND RECORD KEEPING .............................................................60
11.1. Case Report Forms/Electronic Data Record .........................................................60
11.2. Record Retention...................................................................................................60
12. ETHICS..............................................................................................................................61
12.1. Institutional Review Board/Ethics Committee......................................................61
12.2. Ethical Conduct of the Study ................................................................................61
12.3. Subject Information and Consent..........................................................................61
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH 
GCP ...........................................................................................................................62
13. DEFINITION OF END OF TRIAL...................................................................................62
13.1. End of Trial in the Participating Country..............................................................62
14. SPONSOR DISCONTINUATION CRITERIA ................................................................62
15. PUBLICATION OF STUDY RESULTS..........................................................................62
15.1. Communication of Results by Pfizer ....................................................................62
15.2. Publications by Investigators ................................................................................63
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16. REFERENCES ..................................................................................................................65
LIST OF TABLES
Table 1.
Time Points for Key Safety and Immunogenicity Objectives by 
Investigational Product .........................................................................................21
Table 2.
Grading Scales for Local Reactions .....................................................................41
Table 3.
Grading Scales for Systemic Events.....................................................................42
Table 4.
Ranges for Fever...................................................................................................42
APPENDICES
Appendix 1...............................................................................................................................73

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PROTOCOL SUMMARY
Background and Rationale
Streptococcus pneumoniae are gram-positive encapsulated cocci that have been a leading 
cause of bacteremia, bacterial meningitis, pneumonia, and acute otitis media (AOM) and 
continue to be a major global public health concern. Serious pneumococcal disease may 
occur at any age; however, children <5 years and adults 65 years of age are at particularly 
increased risk.  Individuals with certain comorbidities and immunocompromising conditions 
are also at risk.  Centers for Disease Control and Prevention (CDC) data estimated that in 
2015 there were 29,500 cases and 3350 deaths due to invasive pneumococcal disease (IPD) 
in the United States.  In 2008, the World Health Organization (WHO) estimated that 
1.6 million people die from pneumococcal disease each year.  S pneumoniae remains an 
important cause of serious disease in the United States and worldwide.
The polysaccharide capsule has been identified as an important virulence factor for this 
pathogen. While more than 95 pneumococcal serotypes differentiated by their capsular 
polysaccharide composition have been identified, only a subset of serotypes are more 
commonly associated with severe disease.  Pneumococcal disease can be prevented with 
polysaccharide-based vaccines that induce antibody responses with functional 
(opsonophagocytic) activity and target the capsular serotypes responsible for disease.  
Pneumococcal vaccines, such as the licensed 23-valent pneumococcal polysaccharide 
vaccine (PPSV23), containing free polysaccharides for 23 pneumococcal serotypes, elicit a 
T-cell–independent immune response.  These vaccines are poorly immunogenic for many of 
the serotypes contained in the vaccine in children less than 2 years of age, 
immunocompromised populations, and older adults. They do not induce memory responses 
in any population, and have limited or no protection against nonbacteremic disease, including 
community-acquired pneumonia (CAP). Pneumococcal conjugate vaccines, which contain 
capsular polysaccharides covalently linked to a protein carrier, elicit a T-cell–dependent 
immune response inducing protective responses in young children, older adults, and 
populations with high-risk conditions. 
Prevnar(7-valent pneumococcal conjugate vaccine), which was licensed in the United 
States in 2000, and Prevnar 13(13-valent pneumococcal conjugate vaccine [13vPnC]), 
which was licensed in the United States in 2010, are pneumococcal conjugate vaccines 
containing 7 and 13, respectively, pneumococcal capsular polysaccharides individually
conjugated to cross-reactive material 197 (CRM197), a nontoxic variant of diphtheria toxin.  
These vaccines target serotypes that caused the majority of pneumococcal disease in infants 
and older adults at the time of their introduction.  They have demonstrated 
efficacy/effectiveness against vaccine-type (VT) IPD, AOM, and pneumonia and the ability 
to reduce nasopharyngeal carriage and transmission, resulting in indirect beneficial effects.  

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Pfizer is developing a new 20-valent pneumococcal conjugate vaccine (20vPnC) candidate to 
further expand protection against the global burden of vaccine-preventable pneumococcal 
disease in children and adults over that of Prevnar 13. 20vPnC has the same composition as 
Prevnar 13, but contains an additional 7 pneumococcal conjugates to protect against 
serotypes responsible for a substantial burden of remaining pneumococcal disease.  20vPnC 
uses the same platform as Prevnar and Prevnar 13 and contains components that have 
undergone extensive clinical research. A Phase 1 study is being conducted in healthy adults 
18 to 49 years of age to support further development of 20vPnC. The purpose of the 
proposed Phase 2 study in older adults is to generate a safety and immunogenicity data set 
with 20vPnC to support and inform the design of the Phase 3 clinical development program 
for adults.
Study Design
This is a Phase 2, multicenter, randomized, active-controlled, double-blind study with a 
2-arm parallel design.  A total of 440 adults 60 through 64 years of age with no history of 
pneumococcal vaccination will be enrolled and randomized equally to receive an initial 
vaccination with either:
•
a single dose of 20vPnC followed 1 month later by saline (placebo) administration in 
the active vaccine group (20vPnC/saline group), or
•
a single dose of 13vPnC followed 1 month later by a dose of PPSV23 in the control 
group (13vPnC/PPSV23 group).
13vPnC will serve as a control for safety, as well as immunogenicity of the 13 serotypes in 
common with 20vPnC. PPSV23 will serve as a control for immunogenicity of the 7 
additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) in 20vPnC.
Blood samples will be collected on the day of investigational product administration prior to 
each study vaccination (Vaccination 1 and Vaccination 2), 1 month after Vaccination 2, and 
12 months after Vaccination 1 for immunogenicity assessments.  Prompted local reactions at 
the injection site and prompted systemic events will be collected daily for 10 and 7 days,
respectively, after Vaccination 1.  Adverse events (AEs) occurring from signed informed 
consent through 1 month after Vaccination 2 will be collected and serious adverse events 
(SAEs) and newly diagnosed chronic medical conditions (NDCMCs) will be collected from 
signed informed consent through 12 months after Vaccination 1.
 
 
 
 
 
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Primary Objective and Endpoints
Primary Objective
•
To describe the safety profile of 20vPnC in the study population.
Primary Endpoints
•
Proportions of subjects reporting prompted local reactions within 10 days after 
vaccination (redness, swelling, and pain at the injection site).
•
Proportions of subjects reporting prompted systemic events within 7 days after 
vaccination (fever, headache, fatigue, muscle pain, and joint pain).
•
Proportions of subjects reporting adverse events (AEs) within 1 month after vaccination.
•
Proportions of subjects reporting serious adverse events (SAEs) and newly diagnosed 
chronic medical conditions (NDCMCs) within 6 months and 12 months after vaccination.
Secondary Objective and Endpoints
Secondary Objective
•
To describe the immunogenicity of 20vPnC in the study population.
Secondary Endpoints
•
Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers 
(GMTs) 1 month after vaccination.
•
Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) from before 
vaccination to 1 month after vaccination.
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Statistical Methods
An analysis of safety and immunogenicity data will be conducted when data are available as 
described in Section 9 and the statistical analysis plan (SAP).  All analyses will be 
descriptive.  No formal hypothesis tests between vaccine groups are planned; therefore, no 
power calculations for comparison of vaccine groups are included; however, the probabilities 
of at least 1 AE are calculated for range of assumed true event rates.
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SCHEDULE OF ACTIVITIES
The schedule of activities table provides an overview of the protocol visits and procedures.  Refer to the Study Procedures and 
Assessments sections of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed on the schedule of activities table, in order to 
conduct evaluations or assessments required to protect the well-being of the subject.
Visit Number
1
2
3
4
5
Visit Description
Vaccination 1
Vaccination 2
Follow-up 
Vaccination 2
6-Month Safety 
Collection
Persistence 
Blood Draw and 
12-Month 
Safety 
Collection
Visit Type
Clinic Visit
Clinic Visit
Clinic Visit
Telephone 
Contact
Clinic Visit
Visit Window (Days)
Day 1
28 to 35 Days
After Visit 1
28 to 35 Days 
After Visit 2
168 to 196 Days
After Visit 1
350 to 378 Days 
After Visit 1
Obtain informed consent
X
Record demography 
X
Obtain medical history data and record tobacco usage
X
Perform physical examination and measure height and 
weight
X
Measure prevaccination oral temperature 
X
X
Contraception check, if applicablea
X
X
X
Record nonstudy vaccinations and concomitant medicationsb
X
X
X
X
X
Review inclusion and exclusion criteria
X
Review continued eligibility 
X
X
X
Review temporary delay criteria
X
X
X
X
Assign a subject number
X

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Visit Number
1
2
3
4
5
Visit Description
Vaccination 1
Vaccination 2
Follow-up 
Vaccination 2
6-Month Safety 
Collection
Persistence 
Blood Draw and 
12-Month 
Safety 
Collection
Visit Type
Clinic Visit
Clinic Visit
Clinic Visit
Telephone 
Contact
Clinic Visit
Visit Window (Days)
Day 1
28 to 35 Days
After Visit 1
28 to 35 Days 
After Visit 2
168 to 196 Days
After Visit 1
350 to 378 Days 
After Visit 1
Assign randomization number
X
Obtain blood sample (~30 or ~50 mL per blood sample)
Xc,d
Xc,e
Xd
X
Administer investigational vaccine (20vPnC/saline or 
13vPnC /PPSV23)
X
(20vPnC or 
13vPnC)
Xf
(saline or 
PPSV23)
Assess and record acute reactions for at least 30 minutes 
after investigational vaccine administration
X
X
Provide subject with an e-diary, thermometer and measuring 
device and instruct how to collect prompted local reactions 
through Day 10 and systemic events through Day 7g
X
Review and/or collect e-diaryh
X
X
Record and report adverse eventsi
X----------------------------------------X
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Visit Number
1
2
3
4
5
Visit Description
Vaccination 1
Vaccination 2
Follow-up 
Vaccination 2
6-Month Safety 
Collection
Persistence 
Blood Draw and 
12-Month 
Safety 
Collection
Visit Type
Clinic Visit
Clinic Visit
Clinic Visit
Telephone 
Contact
Clinic Visit
Visit Window (Days)
Day 1
28 to 35 Days
After Visit 1
28 to 35 Days 
After Visit 2
168 to 196 Days
After Visit 1
350 to 378 Days 
After Visit 1
Record and report serious adverse events and newly 
diagnosed chronic medical conditionsj
X-----------------------------------------X
a.
The investigator or designee will inform the subject of the need to use highly effective contraception consistently and correctly until 28 days after vaccine 
administration and document the conversation and the subject’s affirmation in the subject’s chart.
b.
Record nonstudy vaccinations and concomitant medications as described in Section 5.10.3.
c.
Blood sample will be collected prior to vaccination.
d.
Obtain blood sample (~30 mL) for immunologic assessments.
f.
Subjects who received 20vPnC on Day 1 will receive saline; subjects who received 13vPnC on Day 1 will receive PPSV23.
g.
Subjects will record prompted local reactions and systemic events in an electronic diary (e-diary) for the 10 and 7 days, respectively, following the first 
vaccination. Subjects will be requested to contact the study staff if they experience redness or swelling measuring ≥21 caliper units or severe pain at the 
injection site or a fever >104.0°F (>40.0°C) or any Grade 4 prompted systemic event.
h.
Designated site staff will review e-diary data online at frequent intervals (daily is optimal) for the 10 days following vaccination to evaluate subject 
compliance and as part of the ongoing safety review and will collect the e-diary at Visit 2
i.
Adverse events include nonserious adverse events, serious adverse events, and newly diagnosed chronic medical conditions.
j.
A newly diagnosed chronic medical condition is defined as a disease or medical condition, not previously identified, that is expected to be persistent or 
otherwise long-lasting in its effects.
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1. INTRODUCTION
1.1. Indication
20-valent pneumococcal conjugate vaccine (20vPnC) is being developed for: 

Active immunization to prevent disease caused by the Streptococcus pneumoniae
serotypes in the vaccine.
1.2. Background and Rationale
1.2.1. Pneumococcal Disease
S pneumoniae are gram-positive encapsulated cocci that have been a leading cause of 
bacteremia, bacterial meningitis, pneumonia, and acute otitis media (AOM) and continue to 
be a major global public health concern.1,2,3  Serious pneumococcal disease may occur at any 
age; however, children <5 years and adults 65 years of age are at particularly increased 
risk.4  Individuals with certain comorbidities and immunocompromising conditions are also 
at risk.  The annual burden of pneumococcal disease in children and adults in the United 
States has been estimated, using 2004 healthcare utilization and disease data. There were
approximately 445,000 hospitalizations, 2.3 million hospital days, 5.0 million outpatient
visits, and 22,000 annual deaths, including 19,000 from pneumonia annually, with the
majority of the deaths (18,000) having occurred in persons 65 years of age.3 These data 
represent disease burden after a relatively short period of Prevnar(7-valent pneumococcal 
conjugate vaccine) use in the infant vaccine schedule (<5 years). A preliminary update of 
estimates in adults after introduction of Prevnar 13(13-valent pneumococcal conjugate 
vaccine [13vPnC]) suggests that although there has been a reduction in disease burden, 
207,000 hospitalizations for pneumococcal pneumonia, meningitis, and sepsis (plausibility 
range of 106,000-308,000) and 283,000 cases of pneumococcal disease (plausibility range of 
145,000-422,000) occurred in US adults in 2015.5 Surveillance studies conducted in 
2010-2012 by the Centers for Disease Control and Prevention (CDC) found that S 
pneumoniae remains among the most common pathogens identified in community-acquired 
pneumonia (CAP) requiring hospitalization in the United States in both children and adults.6,7
Bacteremic pneumococcal pneumonia (accounting for the majority of invasive pneumococcal 
disease [IPD] in adults) is less common than nonbacteremic pneumococcal pneumonia (an 
estimated 3 or more cases of nonbacteremic pneumococcal pneumonia occur for every 1 case 
of bacteremic pneumonia), but it is associated with significant morbidity and mortality1 in all 
age groups. The CDC estimated that in 2015 there were 29,500 cases and 3350 deaths due to 
IPD in the United States.8 In many regions of the world the disease burden is much higher, 
reflected in an assessment by the World Health Organization (WHO) in 2008 estimating that 
1.6 million people die from pneumococcal disease each year.9  As these numbers suggest, 
S pneumoniae remains an important cause of serious disease in the United States and 
worldwide.

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The polysaccharide capsule has been identified as an important virulence factor for this 
pathogen.  While more than 95 pneumococcal serotypes differentiated by their capsular 
polysaccharide composition have been identified, only a subset of serotypes are more 
commonly associated with severe disease.10,11  Anticapsular antibodies directed against the 
specific serotype bind to the capsule and promote complement-mediated opsonophagocytic 
killing and clearance of the organism.12  Pneumococcal disease can be prevented with 
polysaccharide-based vaccines that induce antibody responses with functional 
(opsonophagocytic) activity and target the capsular serotypes responsible for disease.13
1.2.2. Vaccines to Prevent Pneumococcal Disease
1.2.2.1. Pneumococcal Polysaccharide Vaccines
Vaccines containing free polysaccharides have been licensed since the 1970s.  One such 
vaccine, the 23-valent pneumococcal polysaccharide vaccine (PPSV23), has been licensed in 
the United States since 1983.14,15  PPSV23 contains capsular polysaccharides for 23 
serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 
22F, 23F, and 33F).  PPSV23 elicits a T-cell–independent immune response.  Unconjugated 
polysaccharide vaccines do not induce robust responses in certain populations
(eg, immunocompromised persons, children <2 years of age, and adults 65 years of age), 
nor do they generate immunologic memory, so their protective effect wanes over 2 to 
5 years.4,15,16,17 Moreover, their ability to prevent nonbacteremic pneumonia, CAP, AOM, 
and nasopharyngeal carriage is limited or lacking.13,17,18,19,20  Another limitation is that in 
several studies, individuals vaccinated with pneumococcal polysaccharide vaccine had lower 
functional antibody responses following subsequent vaccination with either another dose of
pneumococcal polysaccharide vaccine or a dose of pneumococcal conjugate vaccine,
compared to the first dose of polysaccharide vaccine.21,22,23 Such “hyporesponsiveness”
has been observed with other polysaccharide vaccines as well, and raises concern regarding 
the quality of response after revaccination or natural exposure to an invading vaccine-type 
(VT) pneumococcus.24 Despite these limitations, a number of national vaccine policy expert
bodies recommend PPSV23 vaccination of adults 65 years of age and/or in persons with
substantial risk factors for pneumococcal disease, to provide some degree of protection
against IPD due to serotypes not covered by existing pneumococcal conjugate vaccines.25
However, in the United States, the Advisory Committee on Immunization Practices (ACIP)
recommends that adults 65 years of age, or those with certain immunocompromising
conditions, receive 13vPnC first, followed by PPSV23 1 year later. Other countries have
similar recommendations for certain risk groups. In contrast, because of concerns of
hyporesponsiveness, as well as other factors, most recommendations restrict PPSV23 to a
single lifetime dose in adults 65 years of age and 1 to 2 doses in most other high-risk
populations.25,26,27

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1.2.2.2. Pneumococcal Polysaccharide Conjugate Vaccines
Pneumococcal conjugate vaccines contain polysaccharides that are covalently linked 
(conjugated) to an immunogenic protein.  This modification results in T-cell–dependent 
immune responses, which have been shown to be protective in young children, older adults, 
and populations with high-risk conditions.16,28  Prevnar was the first pneumococcal conjugate 
vaccine to be licensed (2000) and was indicated for prevention of pneumococcal disease in 
infants and young children on the basis of efficacy studies.  Prevnar contained capsular 
polysaccharide conjugates for 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F), 
each covalently linked to cross-reactive material 197 (CRM197), a nontoxic variant of 
diphtheria toxin.  These 7 serotypes were responsible for approximately 80% to 90% of IPD 
in children <5 years of age in the United States and approximately 60% to 80% of IPD in the 
same age group in Europe at that time (1998-2000).29,30,31,32,33  These serotypes also 
accounted for a high proportion of antibiotic-resistant strains.34  Prevnar demonstrated 
efficacy against VT IPD, pneumonia, and AOM in large randomized controlled efficacy 
studies in infants.35,36  The Prevnar components contained in a related pneumococcal 
conjugate vaccine also were demonstrated to be efficacious against 
clinically/radiographically defined pneumonia.37,38,39,40  Following introduction of Prevnar, 
reduction of nasopharyngeal carriage and transmission has resulted in indirect herd effects, 
with a 92% reduction of Prevnar VT IPD in older adults 65 years of age.41,42
Prevnar 13 was developed to expand serotype coverage and was licensed in the United States 
in 2010.  Prevnar 13 includes the same S pneumoniae serotypes as Prevnar and an additional 
6 polysaccharide conjugates for serotypes 1, 3, 5, 6A, 7F, and 19A.28,32,43  The vaccine was 
licensed for use in infants and young children based on comparisons of serotype-specific 
immunoglobulin G (IgG) to Prevnar, with supportive data to demonstrate the functional 
activity of the immune responses.  Prevnar 13 was later licensed in adults based on an 
accelerated approval pathway demonstrating comparable serotype-specific opsonophagocytic
activity (OPA) responses to PPSV23, followed by traditional approval based on 
demonstration of efficacy against VT CAP44 in CAPiTA (Community-Acquired Pneumonia 
Immunization Trial in Adults), a randomized controlled study of adults 65 years of age and 
older.  Prevention of nonbacteremic VT CAP in this older adult population was also 
demonstrated and protection was observed through 4 years of follow-up.  This is notable 
given the lack of definitive data showing that PPSV23 prevents nonbacteremic disease in 
older adults, and evidence that protection against IPD wanes significantly over time.15  
Prevnar 13 has replaced Prevnar and is licensed in the United States and many other 
countries, with national recommendations for use in children and older adults.45,46,47,48  It has 
also been prequalified by WHO for use in national infant immunization programs in lower-
and middle-income countries.49,50  Surveillance data from several countries following 
introduction of Prevnar 13 into the routine infant immunization program have demonstrated 
vaccine effectiveness against VT IPD in the vaccinated population.51,52,53

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Prevnar 13 was licensed for adults 50 years of age in 2011, and recommended by the ACIP 
for use in adults with immunocompromising conditions in 2012. In July 2016, it was also 
licensed for use in adults 18 to 49 years of age. The potential burden of VT CAP in adults in
the United States was demonstrated by a study conducted well after the introduction of
Prevnar into the routine infant immunization schedule, suggesting potential value in direct
immunization of adults rather than reliance solely on the herd effect.54 The data on disease
burden, combined with the results of the CAPiTA study, led to the August 2014 ACIP
recommendation for all adults aged 65 years to receive Prevnar 13, followed by PPSV23 six 
to twelve months later (except for those who had already received PPSV23 and for whom an
additional dose was not indicated). In 2015, a 12-month interval between vaccinations was 
recommended, based on demonstrated higher frequency of local reactions with short 
intervals, and theoretical immunogenicity considerations.27,55 The recommendation for 
Prevnar 13 was made based on the potential added benefit in protecting against disease, 
particularly nonbacteremic pneumonia caused by the vaccine serotypes. The continued 
recommendation for PPSV23 was intended to provide expanded protection against IPD for 
serotypes not in Prevnar 13. However, the prevalence of IPD due to most of the serotypes 
contained only in PPSV23 has remained stable or slightly increased over the past 15 years, 
despite continued recommendation and use of PPSV23 in adults 65 years of age and 
high-risk adults.56,57,58 The continued presence of IPD due to serotypes contained only in
PPSV23 is likely due to a combination of intrinsic population factors including age and
comorbidities, limitations in the ability of PPSV23 to prevent disease and reduce carriage,
limited duration of PPSV23 protection, and lack of boosting with subsequent doses, which
highlights the need for a better vaccine than PPSV23 and expanded coverage.
1.2.2.3. Rationale for 20vPnC
Because of the number of serotypes that may cause pneumococcal disease among different 
geographic regions, different age populations, and different environmental backgrounds, 
there remains value in expanding serotype coverage.
20vPnC is being developed to further expand protection against the global burden of 
vaccine-preventable pneumococcal disease in children and adults over that of Prevnar 13. 
20vPnC contains the serotypes present in Prevnar 13 plus 7 new serotypes (8, 10A, 11A, 
12F, 15B, 22F, and 33F), as well as the same excipients as the currently licensed conjugate 
vaccine.  The polysaccharides of the 20 capsular serotypes of S pneumoniae are each 
covalently linked to CRM197.  These 7 additional serotypes were selected based on their 
relative prevalence as a cause of IPD, their generalized geographic distribution, and other 
factors that would support inclusion, such as the presence of antibiotic resistance and greater 
disease severity (eg, meningitis, mortality).59,60,61,62,63,64,65,66,67,68,69,70 These 7 serotypes are 
also present in PPSV23.71 Adding these additional serotypes to the 13 serotypes in Prevnar 
13 is anticipated to further reduce the global burden of pneumococcal disease and provide 
protection comparable to, or greater than, that of PPSV23. 

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The 20vPnC candidate is modeled after Prevnar and Prevnar 13, and contains 
polysaccharides of capsular serotypes of S pneumoniae, each covalently linked to CRM197. 
 
 
 
 
A Phase 1 study is being conducted in healthy adults 18 to 49 years of age to support further 
development of 20vPnC. The details of this study can be found in the IB. 
The purpose of this study is to assess the safety, tolerability, and immunogenicity of 20vPnC 
in adults 60 to 64 years of age and to generate a safety and immunogenicity data set with 
20vPnC to support and inform the design of the Phase 3 clinical development program for 
adults. The targeted age of the population for this study, adults 60 through 64 years of age, 
has been selected as this approximates the population (≥65 years of age) who are 
recommended for vaccination with 13vPnC and PPSV23 by ACIP, but are unlikely to have 
already received a pneumococcal vaccine. All subjects will receive either 20vPnC or 
13vPnC for the initial vaccination. 13vPnC will serve as a reference vaccine for safety and 
tolerability assessments and for immunogenicity of the 13 common serotypes in 20vPnC. At 
the second vaccination, 1 month later, the 20vPnC recipients will receive saline and the 
13vPnC recipients will receive PPSV23. PPSV23 will provide a reference for the immune 
responses to the 7 additional serotypes in the 20vPnC. Subjects will also return 12 months 
after Vaccination 1 for measurement of circulating antibodies at that time.
Additional information for this compound may be found in the single reference safety 
document (SRSD), which for this study is the 20vPnC IB. The SRSD for 13vPnC and 
PPSV23 are the US package inserts (USPIs).
2. STUDY OBJECTIVES AND ENDPOINTS
2.1. Primary Objective and Endpoints
2.1.1. Primary Objective
•
To describe the safety profile of 20vPnC in the study population.
2.1.2. Primary Endpoints
•
Proportions of subjects reporting prompted local reactions within 10 days after 
vaccination (redness, swelling, and pain at the injection site).
•
Proportions of subjects reporting prompted systemic events within 7 days after 
vaccination (fever, headache, fatigue, muscle pain, and joint pain).
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•
Proportions of subjects reporting adverse events (AEs) within 1 month after vaccination.
•
Proportions of subjects reporting serious adverse events (SAEs) and newly diagnosed 
chronic medical conditions (NDCMCs) within 6 months and 12 months after vaccination.
2.2. Secondary Objective and Endpoints
2.2.1. Secondary Objective
•
To describe the immunogenicity of 20vPnC in the study population.
2.2.2. Secondary Endpoints
•
Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers 
(GMTs) 1 month after vaccination.
•
Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) from before 
vaccination to 1 month after vaccination.
3. STUDY DESIGN
This will be a Phase 2, multicenter, randomized, active-controlled, double-blind study with a 
2-arm parallel design, conducted at investigative sites in the United States.  A total of 440 
adults 60 through 64 years of age with no history of pneumococcal vaccination will be 
enrolled and randomized equally to receive an initial vaccination with either:
o
a single dose of 20vPnC followed 1 month later by saline (placebo) administration in 
the active vaccine group (20vPnC/saline group), or 
o
a single dose of 13vPnC followed 1 month later by a dose of PPSV23 in the control 
group (13vPnC/PPSV23 group).  
13vPnC will serve as a control for safety, as well as immunogenicity of the 13 serotypes in 
common with 20vPnC. PPSV23 will serve as a control for immunogenicity of the 7 
additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) in 20vPnC as described in 
Table 1.
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Table 1.
Time Points for Key Safety and Immunogenicity Objectives by 
Investigational Product
20vPnC
Control – 13vPnCa
Control – PPSV23b
Prompted local reactions
X
(10 days after Visit 1)
X
(10 days after Visit 1)
Prompted systemic 
events
X
(7 days after Visit 1)
X
(7 days after Visit 1)
Adverse eventsc
X
(1 month after Visits 1 
and 2)
X
(1 month after Visit 1)
X
(1 month after Visit 2)
Immune responses to 
serotypes in common 
with 13vPnC: 1, 3, 4, 5, 
6A, 6B, 7F, 9V, 14, 18C, 
19A, 19F, 23F
X
(1 month after Visit 1)
X
(1 month after Visit 1)
Immune responses to 
additional 7 serotypes: 8, 
10A, 11A, 12F, 15B, 
22F, 33F
X
(1 month after Visit 1)
X
(1 month after Visit 2)
a.
Control group from enrollment and vaccination with 13vPnC at Visit 1 until vaccination with PPSV23 at 
Visit 2.
b.
Control group after vaccination with PPSV23 at Visit 2.
c.
SAEs and newly diagnosed chronic medical conditions (NDCMCs) will be collected through Visit 5 
(12 months after Visit 1).
On Day 1 (Visit 1), subjects will have blood drawn for immunogenicity assessments, receive 
an investigational product (20vPnC or 13vPnC; the investigational products have the same 
appearance and can be administered by unblinded or blinded site staff), be observed for 
30 minutes after vaccination, and receive safety follow-up and electronic diary (e-diary) 
instructions.  Local reactions (pain, redness, and swelling) at the injection site will be 
prompted for and collected daily in an e-diary from Day 1 through Day 10 after the Visit 1 
vaccination.  Systemic events (fever, fatigue, headache, muscle pain, and joint pain) and use 
of antipyretic medications will be prompted for and collected daily in an e-diary from Day 1 
through Day 7 after the Visit 1 vaccination.  AEs (including nonserious AEs, SAEs, and 
NDCMCs) will be assessed for approximately 1 month after the Visit 1 vaccination (through 
Visit 2). Refer to Section 8.1.4 for the definition of an NDCMC.
At Visit 2 (28-35 days after Visit 1), subjects will return for follow-up.  Information will be 
collected from the subjects on AEs and e-diary follow-up (as needed), blood will be drawn 
for immunogenicity assessments (this represents the 1-month post–Vaccination 1 time point), 
a dose of saline will be administered to subjects who received 20vPnC at Visit 1, and 
PPSV23 will be administered to subjects who received 13vPnC at Visit 1.  The subjects will 
be observed for 30 minutes and will receive safety follow-up instructions.  The 
investigational product will be prepared at this visit by a designated unblinded site staff 
member.  AEs (including nonserious AEs, SAEs, and NDCMCs) will be assessed for 
approximately 1 month after the Visit 2 vaccination (through Visit 3).

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At Visit 3 (28-35 days after Visit 2), subjects will return for safety follow-up and a blood 
draw for immunogenicity assessments.
At Visit 4 (approximately 6 months after the first vaccination), the sites will contact the 
subject via telephone to inquire about SAEs and NDCMCs.
At Visit 5 (12 months [350 to 378 days] after the first vaccination), subjects will return to 
have a blood draw for immunogenicity assessments.  SAEs and NDCMCs will also be 
collected at this visit.
 
 
 
 
 
 
 
 
3.1. Duration of Subject Participation
Each subject will participate in the study for approximately 12 months. 
3.2. Duration of Study
The study duration will be approximately 16 months.
3.3. Number of Subjects
Approximately 440 subjects (220 per group) will be randomized for a total of approximately 
400 evaluable subjects (assuming a 10% dropout rate).  Subjects who withdraw or are 
withdrawn from the study after randomization will not be replaced, regardless of the reason 
for withdrawal. 
4. SUBJECT ELIGIBILITY CRITERIA
This study can fulfill its objectives only if appropriate subjects are enrolled.  The following 
eligibility criteria are designed to select subjects 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 subject is suitable for this protocol.
Subject eligibility should be reviewed and documented by an appropriate member of the 
investigator’s study team before subjects are included in the study.
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4.1. Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the 
study:
1. Evidence of a personally signed and dated informed consent document indicating that the 
subject has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and 
other study procedures including completion of the e-diary.
3. Expected to be available for the duration of the study and can be contacted by telephone 
during study participation.
4. Male or female adults 60 to 64 years of age (from the 60th birthday up to, but not 
including, the 65th birthday) at enrollment.
5. Healthy adults, including adults with preexisting stable disease, defined as disease not 
requiring significant change in therapy or requiring hospitalization within 3 months 
before receipt of investigational product, as determined by medical history, physical 
examination, laboratory screening, and clinical judgment of the investigator. 
6. Female subjects who are not of childbearing potential must (ie, meet at least 1 of the 
following criteria):
a.
Have achieved postmenopausal status, defined as follows: cessation of regular 
menses for at least 12 consecutive months with no alternative pathological or 
physiological cause; status may be confirmed by having a serum follicle-stimulating 
hormone (FSH) level confirming the postmenopausal state;
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; 
c.
Have medically confirmed ovarian failure. 
All other female subjects (including female subjects with tubal ligations) are considered to be 
of childbearing potential. 
4.2. Exclusion Criteria
Subjects with any of the following characteristics/conditions will not be included in the 
study:
1. Investigator site staff members directly involved in the conduct of the study and their 
family members, site staff members otherwise supervised by the investigator, or subjects 
who are Pfizer employees, including their family members, directly involved in the 
conduct of the study.

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2. Participation in other studies involving investigational drug(s), investigational vaccines, 
or investigational devices within 28 days prior to study entry and/or during study 
participation. Participation in purely observational studies is acceptable.
3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive 
pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with 
or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the 
investigator’s opinion, excludes the subject from participating in the study.
4. Other acute or chronic medical or psychiatric condition including recent (within the past 
year) or active suicidal ideation or behavior or laboratory abnormality that may increase 
the risk associated with study participation or investigational product administration or 
may interfere with the interpretation of study results and, in the judgment of the 
investigator, would make the subject inappropriate for entry into this study.
5. Previous vaccination with any licensed or investigational pneumococcal vaccine, or 
planned receipt through study participation.
6. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of 13vPnC, 20vPnC, or PPSV23.
7. History of microbiologically proven invasive disease caused by S pneumoniae.
8. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic 
agents or systemic corticosteroids, or planned receipt through the last postvaccination 
blood draw. If systemic corticosteroids have been administered short term (<14 days) for 
treatment of an acute illness, subjects should not be enrolled into the study until 
corticosteroid therapy has been discontinued for at least 28 days before investigational 
product administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or 
eyes) corticosteroids are permitted.
9. Subjects with known or suspected immunodeficiency or other conditions associated with 
immunosuppression, including, but not limited to, immunoglobulin class/subclass 
deficiencies, generalized malignancy, human immunodeficiency virus (HIV) infection, 
leukemia, lymphoma, or organ or bone marrow transplant.  
10. Bleeding diathesis or condition associated with prolonged bleeding that would in the 
opinion of the investigator contraindicate intramuscular injection.
11. Receipt of blood/plasma products or immunoglobulin, from 60 days before 
investigational product administration, or planned receipt through study participation.
12. Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing 
potential and fertile male subjects with partners of childbearing potential who are, in the 
opinion of the investigator, sexually active and at risk of pregnancy with their partners 
and are unwilling or unable to use a highly effective method of contraception as outlined 
in this protocol for at least 28 days after the last dose of investigational product.

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4.3. Temporary Delay Criteria
The following conditions are temporary or self-limiting and a subject may be vaccinated 
and/or have blood drawn in the study once the condition(s) has/have resolved and no other 
exclusion criteria are met. The blood draws prior to Vaccinations 1 and 2 and the respective 
vaccinations should take place on the same day (Visit 1 and Visit 2). 
4.3.1. Criteria for Temporarily Delaying Vaccine Administration (Visits 1 and 2)

Febrile illness (oral temperature 100.4F [38C]) or other acute illness within 48 hours 
before investigational product administration.

Receipt of any inactivated vaccine within 14 days or any live vaccine within 28 days 
before investigational product administration.

Receipt of short-term (<14 days) systemic corticosteroids. Investigational product 
administration should be delayed until systemic corticosteroid use has been discontinued 
for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or 
eyes) corticosteroids are permitted.
4.3.2. Criteria for Temporarily Delaying Blood Draw (Visits 1, 2, 3, and 5)

Receipt of antibiotic therapy within 72 hours before blood draw.
4.4. Lifestyle Requirements 
4.4.1. Contraception
All male subjects who are able to father children and who are, in the opinion of the 
investigator, sexually active and at risk for pregnancy with their partner(s) must agree to use 
a highly effective method of contraception consistently and correctly for at least 28 days after 
the last dose of investigational product.  The investigator or his or her designee, in 
consultation with the subject, will confirm that the subject has selected an appropriate 
method of contraception for the individual subject and his partner from the permitted list of 
contraception methods (see below) and will confirm that the subject has been instructed in its 
consistent and correct use.  At time points indicated in the Schedule of Activities, the 
investigator or designee will inform the subject of the need to use highly effective 
contraception consistently and correctly and document the conversation and the subject’s 
affirmation in the subject’s chart (subjects needs to affirm their or their partners consistent 
and correct use of at least 1 of the selected methods of contraception).  In addition, the 
investigator or designee will instruct the subject to call immediately if the selected 
contraception method is discontinued or if pregnancy is known or suspected in the subject’s
partner.
Highly effective methods of contraception are those that, alone or in combination, result in a 
failure rate of less than 1% per year when used consistently and correctly (ie, perfect use) and 
include the following:

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1. Established use of hormonal methods of contraception associated with inhibition of 
ovulation (eg, oral, inserted, injected, implanted, transdermal), provided the subject or 
male subject’s female partner plans to remain on the same treatment throughout the entire 
study and has been using that hormonal contraceptive for an adequate period of time to 
ensure effectiveness.
2. Correctly placed copper-containing intrauterine device (IUD).
3. Male condom or female condom used WITH a separate spermicide product (ie, foam, gel, 
film, cream, or suppository). For countries where spermicide is not available or condom 
plus spermicide is not accepted as highly effective contraception, this option is not 
appropriate.
4. Male sterilization with absence of sperm in the postvasectomy ejaculate.
5. Bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure 
(provided that occlusion has been confirmed in accordance with the device’s label).
6. Female partner who meets the criteria for nonchildbearing potential, as described below:

Achieved postmenopausal status, defined as follows: cessation of regular menses for 
at least 12 consecutive months with no alternative pathological or physiological 
cause; status may be confirmed by having an FSH level confirming the 
postmenopausal state;

Have undergone a documented hysterectomy and/or bilateral oophorectomy;

Have medically confirmed ovarian failure.
NOTE: Sexual abstinence, defined as completely and persistently refraining from all 
heterosexual intercourse (including during the entire period of risk associated with the study 
treatments) may obviate the need for contraception ONLY if this is the preferred and usual 
lifestyle of the subject.
All sexually active male subjects must agree to prevent potential transfer to and exposure of 
partner(s) to drug through ejaculate by using a condom consistently and correctly, beginning 
with the first dose of investigational product and continuing for at least 28 days after the last 
dose of investigational product.
4.5. 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 supporting study documentation.
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, subjects are provided with a contact card.  The contact card contains, 
at a minimum, protocol and investigational product identifiers, subject study numbers, 
contact information for the investigator site, and contact details for a contact center in the 

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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 
subject’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 subject directly, and if a subject calls that number, he 
or she will be directed back to the investigator site.
5. INVESTIGATIONAL PRODUCTS
For the purposes of this study, and per International Council for Harmonisation (ICH)
guidelines, investigational product is defined as a pharmaceutical form of an active 
ingredient or placebo being tested or used as a reference/comparator in a clinical trial, 
including a product with a marketing authorization when used or assembled (formulated or 
packaged) in a way different from the approved form, when used for an unapproved 
indication, or when used to gain further information about an approved use (ICH E6 1.33).
For this study, the investigational products are 20vPnC, 13vPnC, PPSV23 and saline.
5.1. Allocation to Investigational Product
Allocation of subjects to vaccine groups will proceed through the use of an interactive 
response technology (IRT) system (interactive Web-based response [IWR]).  The site
personnel will be required to enter or select information including but not limited to the 
user’s identification (ID) and password, the protocol number, and the subject number. The 
site personnel will then be provided with a randomization number and dispensable unit (DU) 
or container number when investigational product is being supplied via the IRT system.  The 
IRT system will provide a confirmation report containing the subject number, randomization 
number, and DU or container number assigned. The confirmation report must be retained in
the site files.
The study-specific IRT reference manual will provide the contact information and further 
details on the use of the IRT system. 
5.2. Blinding of the Site Personnel
Site personnel taking part in any subject randomization, assessments, interviews, data 
collection, or case report form (CRF) data entry, including the investigator and investigator 
staff, will be blinded to investigational product assignments during the study. 
Vaccination 1 will be administered in a double-blind fashion as the appearance of 20vPnC 
and 13vPnC are identical (prefilled syringes packaged in blinded cartons). 
Vaccination 2 will be prepared by an unblinded site staff member. Vaccination 2 will be
administered to blinded subjects; the 2 investigational products will have an identical 

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appearance after preparation. The study staff administering the vaccines can be blinded or
unblinded, but only the designated unblinded site staff member assigned to prepare 
Vaccination 2 will be unblinded (see Section 5.6.2). All other study personnel including the 
principal investigator (PI), and the subject, will be blinded.  The PI will assign the 
responsibility of preparing Vaccination 2 to unblinded persons who will not participate in the 
evaluation of any study subject.  More than 1 unblinded site staff member may be assigned.  
A member of the study site staff or clinic pharmacy should fulfill this role.  Contact between 
the unblinded staff member who will prepare Vaccination 2 and study subjects should be 
kept to a minimum.
The investigator, study coordinator, and any site staff other than the unblinded site staff 
member must not be allowed to know the investigational product assigned to any study 
subject and must not be allowed to see the inner packaging containing the investigational 
product. The outer investigational product cartons will be blinded.
5.3. Blinding of the Sponsor
Sponsor personnel directly involved in evaluating subject data will be blinded to vaccine
assignment until the analysis of all available data through Visit 2 is available, following the 
principles outlined in ICH E9 guideline on Statistical Principles for Clinical Trials. A data 
blinding plan will be created to describe the blinding requirements and unblinding events.  
The plan to control distribution of unblinded data among designated Pfizer personnel and 
core study team members will be specified in the data dissemination plan.  Laboratory 
personnel performing the immunologic assays will be blinded until the database has been 
locked and unblinded.
5.4. Breaking the Blind 
The study will be subject and investigator blinded.
At the initiation of the study, the investigator site will be instructed on the method for 
breaking the blind for an individual subject.  The method will be an electronic process.  
Blinding codes should be broken only in exceptional circumstances when knowledge of the 
actual treatment code is absolutely essential for further management of the subject.
Investigators are encouraged to discuss with a member of the study team if they believe that 
unblinding is necessary. When the blinding code is broken, the reason must be fully 
documented and entered on the CRF.
5.5. Subject Compliance
All doses of investigational product will be administered by the appropriately designated 
study staff at the investigator site.
5.6. Investigational Product Supplies
20vPnC, 13vPnC, PPSV23, and saline will be provided by the sponsor to the study sites.

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Study vaccines will be packed and labeled as investigational product in accordance with 
current guidelines and applicable local and legal regulatory requirements.  The formulation 
of the investigational products is described below.
5.6.1. Dosage Form(s) and Packaging
20vPnC contains saccharides from pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 
10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F individually conjugated to 
CRM197. 
 
 
 
 
 
 
20vPnC and 13vPnC will be supplied to the site as packaged, single-use prefilled syringes 
and labeled according to local regulatory requirements.
PPSV23 is a licensed commercial product (Pneumovax, Merck) and is a clear, sterile solution 
consisting of a mixture of purified capsular polysaccharides from 23 types of S pneumoniae: 
1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 
and 33F. The vaccine is formulated to contain 25 μg of each of the 23 purified
polysaccharide serotypes per 0.5-mL dose of vaccine in an isotonic saline solution containing 
0.25% phenol as a preservative. PPSV23 will be supplied by the sponsor to the site as 
packaged vials and labeled according to local regulatory requirements.
The placebo will consist of a sterile normal saline solution for injection (0.9% sodium 
chloride injection) and will be supplied to the site as packaged vials and labeled according to 
local regulatory requirements.
5.6.2. Preparation and Dispensing
See the Investigational Product Manual (IP manual) or package insert for instructions on how 
to prepare the investigational product for administration.  Investigational product 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.  
CCI
CCI

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Investigational product will be prepared by qualified site personnel according to the IP
manual. The investigational product will be administered to blinded subjects.
5.7. Administration
All subjects will receive a single dose (0.5 mL) of investigational product administered 
intramuscularly into the deltoid muscle, preferably in the nondominant arm, at Visit 1 and 
Visit 2.
Standard vaccination practices must be observed and vaccine must not be injected into blood 
vessels.  Appropriate medication and other supportive measures for management of an acute 
hypersensitivity reaction should be available in accordance with local guidelines for standard 
immunization practices.
Administration of investigational products should be performed by an appropriately 
qualified, Good Clinical Practice (GCP)-trained, and vaccine-experienced member of the 
study staff (eg, physician, nurse, physician’s assistant, nurse practitioner, pharmacist, or 
medical assistant) as allowed by local, state, and institutional guidance. 
Investigational product administration details will be recorded on the CRF.
5.8. Investigational Product Storage 
The investigator or an approved representative, eg, pharmacist, unblinded 
dispenser/administrator, will ensure that all investigational products, including any 
comparator and/or marketed products, are stored in a secured area with controlled access 
under required storage conditions and in accordance with applicable regulatory requirements.
Investigational products should be stored in their original containers and in accordance with 
the labels.
20vPnC, 13vPnC, PPSV23, and saline will be shipped to the study site after required 
regulatory and legal documents have been received by the sponsor.
 
 
 
Any storage conditions stated in the SRSD (20vPnC IB, 13vPnC USPI, and PPSV23 USPI)
will be superseded by the storage conditions stated on the product label.
Site systems must be capable of measuring and documenting (for example, via a log), at a 
minimum, daily minimum and maximum temperatures for all site storage locations (as 
applicable, including frozen, refrigerated, and/or room-temperature products).  This should 
be captured from the time of investigational product receipt throughout the study.  Even for 
continuous-monitoring systems, a log or site procedure that ensures active evaluation for 
excursions should be available.  The intent is to ensure that the minimum and maximum 
temperature is checked each business day to confirm that no excursion occurred since the last 
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evaluation and to provide the site with the capability to store or view the minimum/maximum 
temperature for all nonworking days upon return to normal operations.  The operation of the 
temperature-monitoring device and storage unit (for example, refrigerator), as applicable, 
should be regularly inspected to ensure they are maintained in working order.
Any excursions from the product label storage conditions should be reported to Pfizer upon 
discovery. The site should actively pursue options for returning the product to the storage 
conditions described in the labeling, as soon as possible.  Deviations from the storage 
requirements, including any actions taken, must be documented and reported to Pfizer.
Once an excursion is identified, the investigational product must be quarantined and not used 
until Pfizer provides permission to use the investigational product.  It will not be considered a 
protocol deviation if Pfizer approves the use of the investigational product after the 
temperature excursion. Use of the investigational product prior to Pfizer approval will be 
considered a protocol deviation. Specific details regarding information the site should report 
for each excursion will be provided to the site.
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.
5.9. Investigational Product Accountability 
The unblinded dispenser/administrator at the investigator site must maintain adequate records 
documenting the receipt, use, loss, or other disposition of the investigational product 
supplies.  All investigational products will be accounted for using a drug accountability 
form/record.
Used needles and syringes should be disposed of according to local practice.  Empty outer 
investigational product containers must be retained until reviewed by the sponsor's unblinded 
site staff and then may be destroyed after the sponsor’s unblinded site staff has performed 
accountability.  Investigational product return/destruction must be documented on the 
accountability log.
5.9.1. Destruction of Investigational Product Supplies 
The sponsor or designee will provide guidance on the destruction of unused investigational 
product (eg, at the site). If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with applicable 
environmental regulations, institutional policy, and any special instructions provided by 
Pfizer, and all destruction must be adequately documented.
5.10. Concomitant Treatment(s)
5.10.1. Prohibited During the Study

Receipt of any investigational vaccines, drugs, or medical devices is prohibited 
during subject participation in the study.

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
Receipt of any nonstudy pneumococcal vaccine is prohibited during subject 
participation in the study.

Receipt of any licensed vaccine, with the exception of licensed inactivated influenza 
vaccine, is prohibited from Visit 1 to Visit 4 (6 months after Vaccination 1).

Receipt of blood/plasma products, immunoglobulins, and/or immunosuppressive 
therapy (including a 14-day course of systemic corticosteroids) is prohibited during 
subject participation in the study.  
5.10.2. Permitted During the Study

Licensed inactivated influenza vaccine may be given >14 days prior to or >14 days 
after investigational vaccine administration (Visit 1 and Visit 2). If medically 
necessary (eg, pandemic), influenza vaccine may be given at any time.

Prescription and nonprescription medications, vitamins, minerals, and herbal 
remedies are permitted during subject participation in the study.

The use of prophylactic antipyretic medication, while permitted, is not recommended 
on the day prior to vaccination or the day of investigational product administration.

Inhaled/nebulized, topical (skin, eyes or ears), or localized injections of 
corticosteroids (eg, intra-articular or intrabursal administration) are permitted during 
subject participation in the study.
5.10.3. Recording Concomitant Treatments
The name and date of administration for all nonstudy vaccinations received from the time of 
signing of the informed consent document to Visit 5 will be collected and recorded in the 
CRF (per Section 5.10.1 and Section 5.10.2).
Medications taken to treat SAEs or NDCMCs from the time of signing of the informed 
consent document to Visit 5 will be recorded in the CRF.
6. STUDY PROCEDURES 
The study procedures are summarized in the Schedule of Activities.  The day of vaccination 
is considered to be Day 1.
6.1. Visit 1 (Vaccination 1 – Day 1)
Prior to vaccination:

Obtain written informed consent before performing any study-specific procedures. 

Ensure and document that all of the inclusion criteria and none of the exclusion criteria 
are met and that none of the temporary delay criteria are met.

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
Assign a subject number via the IRT.

Obtain and record the subject demography (sex, birth date, ethnicity, race, racial 
designation).

Assess and record tobacco usage.

Obtain and record the medical history including the presence of chronic conditions
(eg, diabetes, hypertension, atherosclerosis, COPD) and/or medical history of 
significance such as relevant surgical procedures).  

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; musculoskeletal; extremities; neurological; and lymph nodes.  
Abnormal results will be recorded in the CRF. 

Measure and record the subject’s height, weight, and oral temperature (F/C).

Record nonstudy vaccinations and medications as described in Section 5.10.3.

Assign a randomization number and an investigational product container number via the 
IRT.  This must be the last step before proceeding.  A blinded or unblinded site staff 
member will prepare the investigational product according to the IP manual.
After randomization:

Collect a blood sample of approximately 30 mL for immunogenicity assessments prior to 
vaccination. 

The blinded/unblinded dispenser/administrator will administer a single 0.5-mL injection 
of investigational product into the deltoid muscle (preferably in the nondominant arm). 

Blinded site staff will observe the subject for at least 30 minutes after investigational 
product administration for any acute reactions.  Record any acute reactions on the AE 
CRF and on an SAE form as applicable.

Issue the subject a measuring device to measure injection site reactions and a digital 
thermometer and provide instructions on their use.

Issue the subject an e-diary and provide instructions on its use and completion.  Ask the 
subject to complete the e-diary from Day 1 to Day 10, with Day 1 being the day of 
vaccination.

Ask the subject to contact the investigator site staff or investigator immediately during 
the 10-day postvaccination period if he or she experiences redness or swelling at the 
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(prevents daily activity), a fever of >104F, or any Grade 4 prompted systemic event to 
determine if the event requires further assessment by the investigator.

Ask the subject to contact the investigator or investigator site staff immediately if any 
significant illness or medical event (eg, emergency room visit or hospitalization) occurs 
during the study period.

Remind the subject to use appropriate contraceptives until 28 days after vaccination, if 
applicable, and document the conversation and the subject’s affirmation in the subject’s 
chart.

Record AEs, SAEs, and NDCMCs as described in Section 8.

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.

The investigator or appropriately qualified designee reviews the e-diary data online at 
frequent intervals (daily is optimal) for the 10 days following vaccination to evaluate 
subject compliance and as part of the ongoing safety review.
6.2. Visit 2 (Vaccination 2 – 28 to 35 Days After Visit 1)
Prior to vaccination:

Ensure and document that all of the inclusion criteria and none of the exclusion criteria 
are met and that none of the temporary delay criteria are met.

Measure and record the subject’s oral temperature (F/C).

Record nonstudy vaccinations and medications as described in Section 5.10.3.

Collect a blood sample of approximately 50 mL for immunogenicity assessments prior to 
vaccination. 

Review the subject’s e-diary data and collect the e-diary. Collect stop dates of any 
e-diary events ongoing on the last day that the e-diary was completed and record stop 
dates in the CRF.

Determine whether any AEs, SAEs, or NDCMCs have occurred since Visit 1 and follow 
up on any previously reported events to determine the outcome (ie, record stop dates or 
confirm if they are still continuing) and record as described in Section 8. 

An unblinded site staff member will prepare the investigational product according to the 
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After vaccination (including investigational product administration):

The blinded/unblinded dispenser/administrator will administer a single 0.5-mL injection 
of investigational product into the deltoid muscle (preferably in the nondominant arm). 

Blinded investigator site staff will observe the subject for at least 30 minutes after 
investigational product administration for any acute reactions.  Record any acute 
reactions on the AE CRF and on an SAE form as applicable.

Remind the subject to contact the investigator or investigator site staff immediately if any 
significant illness or medical event (eg, emergency room visit or hospitalization) occurs 
during the study period.

Remind the subject to use appropriate contraceptives until 28 days after vaccination, if 
applicable, and document the conversation and the subject’s affirmation in the subject’s 
chart.

The investigator or an authorized designee completes the CRF.
6.3. Visit 3 (Follow-up Vaccination 2 – 28 to 35 Days After Visit 2)

Ensure and document that all of the inclusion criteria and none of the exclusion criteria 
are met and that none of the temporary delay criteria are met.

Record nonstudy vaccinations and medications as described in Section 5.10.3.

Perform a contraception check, if applicable, and document the conversation and the 
subject’s affirmation in the subject’s chart.

Collect a blood sample of approximately 30 mL for immunogenicity assessments. 

Determine whether any AEs, SAEs, or NDCMCs have occurred since Visit 2 and follow 
up on any previously reported events to determine the outcome (ie, record stop dates or 
confirm if they are still continuing) and record as described in Section 8.

Remind the subject to contact the investigator or investigator site staff immediately if any 
significant illness or medical event (eg, emergency room visit or hospitalization) occurs 
during the study period.

The investigator or an authorized designee completes the CRF.
6.4. Visit 4 (6-Month Safety Collection by Telephone – 168 to 196 Days After Visit 1)

Record nonstudy vaccinations and medications as described in Section 5.10.3.

Determine whether any SAEs or NDCMCs have occurred since Visit 3 and follow up on 
any previously reported events to determine the outcome (ie, record stop dates or confirm 
if they are still continuing) and record as described in Section 8.  

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
Remind the subject to contact the investigator or investigator site staff immediately if any 
significant illness or medical event (eg, emergency room visit or hospitalization) occurs 
during the study period.

The investigator or an authorized designee completes the CRF.
6.5. Visit 5 (Persistence Blood Draw and 12-Month Safety Collection – 350 to 378 Days 
After Visit 1)

Ensure and document that all of the inclusion criteria and none of the exclusion criteria 
are met and that none of the temporary delay criteria are met.

Record nonstudy vaccinations and medications as described in Section 5.10.3.

Determine whether any SAEs or NDCMCs have occurred since Visit 4 and follow up on 
any previously reported events to determine the outcome (ie, record stop dates or confirm 
if they are still continuing) and record as described in Section 8.

Collect a blood sample of approximately 50 mL for immunogenicity assessments. 

The investigator or an authorized designee completes the CRF.
6.6. Unscheduled Visits
If the subject reports redness or swelling at the injection site measuring 21 measuring 
device units (10.5 cm) or severe injection site pain during the 10-day post–Vaccination 1 
period, a telephone contact must occur as soon as possible between the investigator or 
medically qualified designee and subject to assess if an unscheduled investigator site visit is 
required.  An investigator site visit should be scheduled as soon as possible to assess the 
extent of the reaction unless any of the following is true:

The subject is unable to attend the unscheduled visit.

The reaction is no longer present at the time of the telephone contact.

The subject recorded an incorrect value in the e-diary (confirmation of an e-diary data 
entry error).

The PI or authorized designee determined it was not needed.
This telephone contact will be recorded in the subject’s source documentation and the CRF.
If the subject is unable to attend the unscheduled visit, or the PI or authorized designee 
determined it was not needed, any ongoing reactions must be assessed at Visit 2.

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During the investigator site visit, the reactions should be assessed by the investigator or a 
medically qualified member of the study staff such as a study physician or a study nurse, as 
applicable to the investigator’s local practice, who will:

Measure oral temperature (F/C).

Measure minimum and maximum diameters of redness (if present).

Measure minimum and maximum diameters of swelling (if present).

Assess injection site pain (if present) in accordance with the grades provided in 
Section 7.1.2.1.

Assess for other findings associated with the reaction and record on the AE page of the 
CRF, if appropriate.
The investigator or an authorized designee will complete the unscheduled visit assessment 
page of the CRF.
Subjects will also be instructed to contact investigator site staff if they experience a fever 
>104.0F or any possible Grade 4 prompted systemic event (ie, emergency room visit or 
hospitalization for headache, fatigue, muscle pain, joint pain) within 7 days after vaccination.
Subjects will also be instructed to contact the investigator site to report any significant 
illness, medical event, or hospitalization that occurs during the study period.  The 
investigator site should determine if an unscheduled visit to further evaluate the event is 
warranted in all such cases.
Additionally, study staff may contact the subject to obtain additional information on Grade 3 
events entered into the e-diary.
6.7. Subject Withdrawal
An investigator and/or sponsor can withdraw a subject from the study if deemed appropriate.  
In addition, if a subject fails to continue to meet the inclusion criteria, new information 
becomes available that would exclude the subject, or the subject develops a condition or 
situation that would meet exclusion criteria, the subject may be considered for withdrawal.
Reasons why a subject may discontinue or be withdrawn from the study include, but are not 
limited to, failure to meet entrance criteria (screening failure), AE, death, pregnancy, 
protocol deviation, lost to follow-up, no longer willing to participate in the study, study 
terminated by the sponsor,  or any other reason.  Subjects who have received the 
investigational product will not be replaced regardless of the reason for withdrawal.

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The investigator should capture the reason for withdrawal in the CRF for all subjects and a 
6-month post–Vaccination 1 follow-up telephone contact for the collection of safety 
information should be completed for all subjects who have been withdrawn after 
administration of investigational product unless the subject has withdrawn consent for any 
future contact.
Subjects may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety (see also 
Withdrawal From the Study Due to Adverse Events, Section 8.1.3) or behavioral reasons, or 
the inability of the subject to comply with the protocol-required schedule of study visits or 
procedures at a given investigator site. 
If a subject does not return for a scheduled visit, every effort should be made to contact the 
subject. All attempts to contact the subject and information received during contact attempts 
must be documented in the subject’s medical record. In any circumstance, every effort 
should be made to document subject outcome, if possible.  The investigator should inquire 
about the reason for withdrawal, request that the subject return for a final visit, if applicable, 
and follow up with the subject regarding any unresolved AEs.
If the subject withdraws from the study, and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent.
Withdrawal of Consent:
Subjects who request to discontinue receipt of investigational product 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 subject specifically withdraws consent for any further 
contact with him or her or persons previously authorized by the subject to provide this 
information. Subjects 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 investigational product or also from study procedures and/or 
posttreatment study follow-up. In the event that vital status (whether the subject 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.
Lost to follow-up: 
All reasonable efforts must be made to locate subjects to determine and report their ongoing
status. This includes follow-up with persons authorized by the subject as noted above. Lost 
to follow-up is defined by the inability to reach the subject after a minimum of 2 documented 
phone calls, faxes, or emails as well as lack of response by the subject to 1 registered mail 
letter. All attempts should be documented in the subject’s medical records. If it is 
determined that the subject has died, the investigator site may use locally permissible 
methods to obtain the date and cause of death. If the investigator’s use of a third-party 

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representative to assist in the follow-up portion of the study has been included in the 
subject’s informed consent, then the investigator may use a sponsor-retained third-party 
representative to assist investigator site staff with obtaining the subject’s contact information 
or other public vital status data necessary to complete the follow-up portion of the study. 
The investigator site staff and representative may consult publicly available sources, such as 
public health registries and databases, in order to obtain updated contact information. If,
after all attempts, the subject remains lost to follow-up, then the last-known-alive date as 
determined by the investigator should be reported and documented in the subject’s medical 
records.
7. ASSESSMENTS
Every effort should be made to ensure that the protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside of the control of the investigator that may make it unfeasible to 
perform the test. In these cases the investigator will take all steps necessary to ensure the 
safety and well-being of the subject. When a protocol-required test cannot be performed, the 
investigator will document the reason for this and any corrective and preventive actions that 
he or she has taken to ensure that normal processes are adhered to as soon as possible. The 
study team will 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. Serum samples should be processed and stored as indicated in the 
study reference manual (SRM) or equivalent document.
7.1. Safety Parameters
Safety parameters will be assessed as described in the Schedule of Activities, Section 6, and 
below.
A medical history, physical examination, and measurement of oral temperature will be 
performed on all subjects prior to Vaccination 1 to determine subject eligibility and to 
establish a clinical baseline. Significant medical history and observations from the physical 
examination and temperature measurement will be documented and recorded in the CRF.
Acute reactions within the first 30 minutes after investigational product administration will 
be assessed and documented as an AE or SAE, as appropriate, in the CRF.
Prompted e-diary events, including local reactions and systemic events that occur 10 and 
7 days, respectively, after investigational product administration at Visit 1, are graded as 
described in Section 7.1.2.  In addition, AEs, SAEs, and NDCMCs will be collected as 
defined in Section 8.

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7.1.1. Subject Electronic Diary
The subject will be asked to monitor and record local reactions for 10 days and systemic 
events and antipyretics/pain medication used to treat symptoms for 7 days, each evening 
following Vaccination 1 (Day 1 through Day 10 or Day 7, respectively, where Day 1 is the 
day of vaccination) on a system that uses a personal digital assistant (PDA) or other 
technology.  This system, hereafter referred to as the subject’s e-diary, allows recording of 
these assessments only within a fixed time window, thus providing the accurate 
representation of the subject’s experience at that time.  Data on local reactions, systemic 
events, and antipyretics/pain medication used to treat symptoms reported in the e-diary will 
be transferred electronically to the e-diary vendor, where they will be available for review by 
investigators, their qualified designees, and sponsor staff at all times via an internet-based 
portal.  At intervals agreed to by the vendor and Pfizer, these data will be transferred 
electronically to Pfizer for analysis and reporting. 
The e-diary data do not need to be reported by the investigator in the CRF.  However, if a 
subject withdraws because of prompted events reported in the e-diary, the event(s) should be 
recorded on the AE page of the CRF, regardless of whether the investigator considers the 
event(s) to be clinically significant.
Investigators (or an appropriately qualified designee) are required to review the e-diary data 
online at frequent intervals (daily is optimal) to evaluate subject compliance and as part of 
the ongoing safety review.
The investigator or designee must obtain stop dates for any reactions ongoing on the last day 
that the e-diary was completed.  The stop dates should be entered in the CRF at Visit 2.
7.1.2. Grading Scale for Prompted Events
The grading scales used in this study to assess prompted AEs as described below are based 
on concepts outlined in the Food and Drug Administration (FDA) Center for Biologics 
Evaluation and Research (CBER) guidelines on toxicity grading scales for healthy adult 
volunteers enrolled in preventive vaccine clinical trials.72
7.1.2.1. Local Reactions
From Day 1 through Day 10, where Day 1 is the day of Vaccination 1, subjects will be asked 
to assess redness, swelling, and pain at the injection site and to record the symptoms in the 
e-diary in the evening.  
Redness and swelling will be measured and recorded in measuring device units (range: 1 to 
21+), and then categorized during analysis as mild, moderate, or severe based on the grading 
scale in Table 2 below.  Measuring device units can be converted to centimeters according to 
the following scale: 1 measuring device unit = 0.5 cm.

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Pain at the vaccine injection site will be assessed by the subject as mild, moderate, or severe 
according to the grading scale in Table 2.  A subject with a severe (Grade 3 or above) local 
reaction will be prompted to contact the investigator to assess the reaction and perform an 
unscheduled assessment or visit as appropriate. 
Only an investigator is able to classify a subject’s local reaction as Grade 4, after physical 
examination of the subject or documentation from another medically qualified source 
(eg, emergency room or hospital record), or, in the case of pain at the injection site only, 
telephone contact with the subject.  If a subject experiences a Grade 4 local reaction, the 
investigator must immediately notify the sponsor.  Investigator site staff must educate the 
subject regarding signs and symptoms that would prompt investigator site contact. 
The procedure for notification of the sponsor is provided in the SRM or equivalent. 
Table 2.
Grading Scales for Local Reactions
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Redness
(synonymous with 
erythema)
5 to 10 measuring 
device units 
=
2.5 to 5.0 cm
11 to 20 measuring 
device units
=
5.5 to 10.0 cm
21 measuring 
device units
=
10.5 cm
Necrosis or exfoliative 
dermatitis
Swelling
(synonymous with 
edema)
5 to 10 measuring 
device units
=
2.5 to 5.0 cm
11 to 20 measuring 
device units
=
5.5 to 10.0 cm
21 measuring 
device units
=
10.5 cm
Necrosis
Pain at injection site Does not interfere 
with activity
Interferes with 
activity
Prevents daily 
activityc
Emergency room visit 
or hospitalization
Abbreviations: CRF = case report form; e-diary = electronic diary.
Note: If the size of the redness and/or swelling falls between 2 measuring device units, the higher measuring 
device unit number will be recorded in the e-diary.
a.
Subjects experiencing Grade 3 local reactions will be asked to contact the investigator site.  In the event 
that the subject does not call, the investigator will call the subject.
b.
Grade 4 assessment should be made by the investigator. Grade 4 will not be collected in the e-diary but as 
an AE on the CRF.  The severity of the local reaction should be graded using the AE severity grading scale 
in Section 8.3. 
c.
Prevents daily activity, ie, results in missed days of work or school or is otherwise incapacitating.
7.1.2.2. Systemic Events
From Day 1 through Day 7, where Day 1 is the day of Vaccination 1, subjects will be asked 
to assess headache, fatigue, muscle pain, and joint pain and to record the symptoms in the 
e-diary in the evening.  The symptoms will be assessed by the subject as mild, moderate, or 
severe according to the grading scale in Table 3 below.  Subjects will also be instructed to 
contact investigator site staff if they experience any possible Grade 4 prompted systemic 
event (ie, emergency room visit or hospitalization for headache, fatigue, muscle pain, or joint 
pain) within 7 days after vaccination.  Study staff may also contact the subject to obtain 
additional information on Grade 3 events entered into the e-diary.

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Only an investigator is able to classify a subject’s systemic event as Grade 4, after physical 
examination of the subject or documentation from another medically qualified source 
(eg, emergency room or hospital record) or telephone contact with the subject.  If a subject 
experiences a Grade 4 systemic event, the investigator must immediately notify the sponsor. 
The procedure for notification of the sponsor is provided in the SRM or equivalent.
Table 3.
Grading Scales for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Fatigue 
(synonymous
with tiredness)
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Headache
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Muscle pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Joint pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Abbreviations: CRF = case report form; e-diary = electronic diary.
a.
Prevents daily routine activity, ie, results in missed days of work or school or is otherwise incapacitating.
b.
Grade 4 assessment should be made by the investigator; Grade 4 will not be collected in the e-diary but will 
be collected as an AE on the CRF. The severity of the systemic event should be graded using the AE 
severity grading scale in Section 8.3.
7.1.2.3. Fever
In order to record information on fever, a digital thermometer will be given to the subject 
with instructions on how to measure oral temperature at home.  Temperature will be 
collected in the evening daily for 7 days following Vaccination 1 (Days 1 through 7, where 
Day 1 is the day of vaccination) and at any time during the 7 days that fever is suspected.  
Fever is defined as an oral temperature of 100.4F (38.0C).  The highest temperature for 
each day will be recorded in the e-diary.  In the event of a fever on Day 7, temperature will 
be collected daily until fever has resolved (1 day of temperature less than 100.4F [38.0C]) 
in order to collect a stop date in the CRF.  A subject with a fever >104.0F (>40.0C) will be 
prompted to contact the investigator to assess the fever.  Study staff may also contact the 
subject to obtain additional information if a temperature of >102F is entered into an e-diary.  
Temperature will be measured and recorded to 1 decimal place and then grouped into ranges 
for the analysis according to Table 4 below. 
Table 4.
Ranges for Fever
100.4F to 101.1F (38.0C to 38.4C)
101.2F to 102.0F (38.5C to 38.9C)
102.1F to 104.0F (39.0C to 40.0C)
>104.0F (>40.0C)

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7.1.2.4. Use of Antipyretic/Pain Medication
From Day 1 through Day 7, where Day 1 is the day of Vaccination 1, the subject will be 
asked to record the use of antipyretic and/or pain medication used to treat symptoms (yes/no)
in the e-diary in the evening.
7.2. Immunogenicity
Blood samples (approximately 30 or 50 mL/visit) for immunogenicity assessments will be 
collected from all subjects prior to Vaccination 1, prior to Vaccination 2
(post-Vaccination 1/pre–Vaccination 2), approximately 1 month (28 to 35 days) after 
Vaccination 2, and approximately 1 year after Vaccination 1.  Sample collection, processing, 
storage, and shipping information can be found in the SRM or equivalent manual.
The total volume of blood collected from each subject completing participation through 
Visit 5 will be approximately 160 mL. Sera will be used for immunogenicity assessments 
and vaccine development research (eg, assay development to support vaccine programs).  
 
 
Immunogenicity assays will be performed at Pfizer Vaccine Research & Development 
Laboratory located at 401 North Middletown Road, Pearl River, NY 10965 and/or at a 
facility designated by Pfizer.
7.3. Biological Samples 
Blood samples will be used only for scientific research.  Each sample will be labeled with a 
code so that the laboratory personnel testing the samples will not know the subject’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 informed consent document, 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 subject’s genetic material will be performed.  
The subject 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 subject’s genetic material is performed.
CCI

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8. ADVERSE EVENT REPORTING
8.1. Requirements
The table below summarizes the requirements for recording safety events on the CRF and for 
reporting safety events on the Clinical Trial (CT) Serious Adverse Event (SAE) Report Form 
to Pfizer Safety.  These requirements are delineated for 3 types of events: (1) SAEs; (2) 
nonserious AEs; and (3) exposure to the investigational product under study during 
pregnancy or breastfeeding, and occupational exposure.  
Safety Event
Recorded on the CRF
Reported on the CT SAE Report 
Form to Pfizer Safety Within 24 
Hours of Awareness
SAE
All
All
Nonserious AEa
All
None
Exposure to the investigational 
product under study during 
pregnancy or breastfeeding, and 
occupational exposure
All (regardless of whether 
associated with an AE), except 
occupational exposure
Exposure during pregnancy, 
exposure via breastfeeding, 
occupational exposure (regardless 
of whether associated with an AE)
a.
Nonserious AEs will be recorded from the time the subject provides informed consent through and 
including Visit 3.  After Visit 3, only newly diagnosed chronic medical conditions (can be nonserious) and 
SAEs will be reported.
All observed or volunteered events regardless of vaccine group or suspected causal 
relationship to the investigational product(s) will be reported as described in the following 
paragraphs.
Events listed in the table above that require reporting to Pfizer Safety on the CT SAE Report 
Form within 24 hours of awareness of the event by the investigator are to be reported 
regardless of whether the event is determined by the investigator to be related to an 
investigational product under study.  In particular, if the SAE is fatal or life-threatening, 
notification to Pfizer Safety must be made immediately, irrespective of the extent of available 
event information.  This time frame also applies to additional new (follow-up) information on 
previously forwarded reports.  In the rare situation that the investigator does not become 
immediately aware of the occurrence of an event, the investigator must report the event 
within 24 hours after learning of it and document the time of his or her first awareness of the 
event.
For each event, the investigator must pursue and obtain adequate information both to 
determine the outcome and to assess whether it meets the criteria for classification as an SAE 
(see the Serious Adverse Events section below).  In addition, the investigator may be 
requested by Pfizer Safety to obtain specific follow-up information in an expedited fashion.  
This information is more detailed than that recorded on the CRF.  In general, this 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 
subject death, a summary of available autopsy findings must be submitted as soon as possible 

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to Pfizer Safety. Any pertinent additional information must be reported on the CT SAE 
Report Form; additional source documents (eg, medical records, CRF, laboratory data) are to 
be sent to Pfizer Safety ONLY upon request.
As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE.  To assist 
in the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
8.1.1. Additional Details on Recording Adverse Events on the CRF
All events detailed in the table above will be recorded on the AE page(s) of the CRF.  It 
should be noted that the CT SAE Report Form for reporting of SAE information is not the 
same as the AE page of the CRF.  When the same data are collected, the forms must be 
completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE Report 
Form for reporting of SAE information.
8.1.2. Eliciting Adverse Event Information
The investigator is to record on the CRF all directly observed AEs and all AEs spontaneously 
reported by the study subject.  In addition, each study subject will be questioned about the 
occurrence of AEs in a nonleading manner.
8.1.3. Withdrawal from the Study due to Adverse Events (see also the Subject 
Withdrawal Section)
Withdrawal due to AEs should be distinguished from withdrawal due to other causes,
according to the definition of AE noted below, and recorded on the CRF.
When a subject withdraws from the study because of an SAE, the SAE must be recorded on 
the CRF and reported, as appropriate, on the CT SAE Report Form, in accordance with the 
Requirements section above.
8.1.4. Time Period for Collecting AE/SAE Information
The time period for actively eliciting and collecting AEs and SAEs and NDCMCs (“active 
collection period”) for each subject begins from the time the subject provides informed 
consent, which is obtained before the subject’s participation in the study (ie, before 
undergoing any study-related procedure and/or receiving investigational product), through 
and including Visit 3. Between Visit 3 and Visit 5, only NDCMCs and SAEs will be 
reported. An NDCMC is defined as a disease or medical condition, not previously identified, 
that is expected to be persistent or is otherwise long-lasting in its effects.  At Visit 4
(6 months after Vaccination 1), the subject will be contacted by telephone to inquire about 
SAEs, including hospitalizations and NDCMCs since Visit 3. At Visit 5 (12 months after 
Vaccination 1), the subject will be asked about SAEs, including hospitalizations and 
NDCMCs since Visit 4.

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For subjects who are screen failures, the active collection period ends when screen failure 
status is determined.
8.1.4.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a subject during the active collection period are reported to Pfizer 
Safety on the CT SAE Report Form.
SAEs occurring in a subject after the active collection period has ended are reported to Pfizer 
Safety if the investigator becomes aware of them; at a minimum, all SAEs that the 
investigator believes have at least a reasonable possibility of being related to investigational 
product must be reported to Pfizer Safety.
Follow-up by the investigator continues throughout and after the active collection period and 
until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and 
Pfizer concurs with that assessment.
8.1.4.2. Recording Nonserious AEs and SAEs on the CRF
During the active collection period, both nonserious AEs and SAEs are recorded on the CRF.
Follow-up by the investigator may be required until the event or its sequelae resolve or 
stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.
8.1.5. Causality Assessment
The investigator’s assessment of causality must be provided for all AEs (serious and 
nonserious); the investigator must record the causal relationship on the CRF, and report such 
an assessment in accordance with the SAE reporting requirements, if applicable.  An 
investigator’s causality assessment is the determination of whether there exists a reasonable 
possibility that the investigational product caused or contributed to an AE; generally the facts 
(evidence) or arguments to suggest a causal relationship should be provided.  If the 
investigator does not know whether or not the investigational product caused the event, then 
the event will be handled as “related to investigational product” for reporting purposes, as 
defined by the sponsor.  If the investigator's causality assessment is “unknown but not 
related” to investigational product, this should be clearly documented on study records.  
In addition, if the investigator determines that an SAE is associated with study procedures, 
the investigator must record this causal relationship in the source documents and CRF, and 
report such an assessment in the dedicated section of the CT SAE Report Form and in 
accordance with the SAE reporting requirements.
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities
AE reporting, including suspected unexpected serious adverse reactions, will be carried out 
in accordance with applicable local regulations.

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8.2. Definitions
8.2.1. Adverse Events
An AE is any untoward medical occurrence in a study subject administered a product or 
medical device; the event need not necessarily have a causal relationship with the treatment 
or usage.  Examples of AEs include, but are not limited to: 

Abnormal test findings;

Clinically significant signs and symptoms;

Changes in physical examination findings;

Hypersensitivity;

Progression/worsening of underlying disease;

Drug abuse;

Drug dependency.
Additionally, AEs may include signs and symptoms resulting from:

Drug overdose;

Drug withdrawal;

Drug misuse; 

Drug interactions;

Extravasation;

Exposure during pregnancy (EDP);

Exposure via breastfeeding;

Medication error;

Occupational exposure.

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8.2.2. Abnormal Test Findings
Abnormal objective test findings should be recorded as AEs when any of the following 
conditions are met: 

Test result is associated with accompanying symptoms; and/or

Test result requires additional diagnostic testing or medical/surgical intervention; 
and/or

Test result leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional concomitant 
drug treatment, or other therapy; and/or

Test result is considered to be an AE by the investigator or sponsor.
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an AE.  Any abnormal test result that is determined to be an error does not require 
recording as an AE.
8.2.3. Serious Adverse Events
An SAE is any untoward medical occurrence at any dose that:

Results in death;

Is life-threatening (immediate risk of death);

Requires inpatient hospitalization or prolongation of existing hospitalization;

Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions);

Results in congenital anomaly/birth defect.
Or that is considered to be:

An important medical event.
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event.  An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization.  However, if it is determined that the event may jeopardize 
the subject or may require intervention to prevent one of the other AE outcomes, the 
important medical event should be reported as serious.
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; 
or development of drug dependency or drug abuse.

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Medical device complaints may meet the SAE reporting requirement criteria (see the Medical 
Device Complaint Reporting Requirements section).  An incident is any malfunction (ie, the 
failure of a device to meet its performance specifications or to perform as intended; 
performance specifications include all claims made in the labeling for the device) that, 
directly or indirectly, might lead to or might have led to the death of a subject, or user, or of 
other persons, or to a serious deterioration in their state of health.  
A serious injury that can cause a serious deterioration in state of health can include:

A life-threatening illness, even if temporary in nature;

A permanent impairment of a body function or permanent damage to a body 
structure; 

A condition necessitating medical or surgical intervention to prevent the above 
2 bulleted items;

Examples: clinically relevant increase in the duration of a surgical procedure; a 
condition that requires hospitalization or significant prolongation of existing 
hospitalization;

Any indirect harm as a consequence of an incorrect diagnostic or in vitro diagnostic 
device test results when used within the manufacturer’s instructions for use;

Fetal distress, fetal death, or any congenital abnormality or birth defects.
8.2.4. Hospitalization
Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or 
equivalent healthcare facility, or any prolongation of an existing admission.  Admission also 
includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a 
tuberculosis unit).  An emergency room visit does not necessarily constitute a hospitalization; 
however, the event leading to the emergency room visit is assessed for medical importance.
Hospitalization does not include the following:

Rehabilitation facilities;

Hospice facilities;

Respite care (eg, caregiver relief);

Skilled nursing facilities;

Nursing homes;

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
Same-day surgeries (as outpatient/same-day/ambulatory procedures).
Hospitalization or prolongation of hospitalization in the absence of a precipitating clinical 
AE is not in itself an SAE.  Examples include:

Admission for treatment of a preexisting condition not associated with the 
development of a new AE or with a worsening of the preexisting condition (eg, for 
workup of a persistent pretreatment laboratory abnormality);

Social admission (eg, subject has no place to sleep);

Administrative admission (eg, for yearly physical examination);

Protocol-specified admission during a study (eg, for a procedure required by the study 
protocol);

Optional admission not associated with a precipitating clinical AE (eg, for elective 
cosmetic surgery);

Hospitalization for observation without a medical AE;

Preplanned treatments or surgical procedures.  These should be noted in the baseline 
documentation for the entire protocol and/or for the individual subject.
Diagnostic and therapeutic noninvasive and invasive procedures, such as surgery, should not 
be reported as SAEs.  However, the medical condition for which the procedure was 
performed should be reported if it meets the definition of an SAE.  For example, an acute 
appendicitis that begins during the reporting period should be reported if the SAE 
requirements are met, and the resulting appendectomy should be recorded as treatment of the 
AE.
8.3. Severity Assessment
GRADE 
If required on the AE page of the CRF, the investigator will use the adjectives MILD, 
MODERATE, or SEVERE to describe the maximum intensity of the AE. For purposes of 
consistency, these intensity grades are defined as follows:
1
MILD
Does not interfere with subject's usual function.
2
MODERATE
Interferes to some extent with subject's usual function.
3
SEVERE
Interferes significantly with subject's usual function.
Note the distinction between the severity and the seriousness of an AE.  A severe event is not 
necessarily an SAE.  For example, a headache may be severe (interferes significantly with 
the subject's usual function) but would not be classified as serious unless it met one of the 
criteria for SAEs, listed above.

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8.4. Special Situations
8.4.1. Protocol-Specified Serious Adverse Events
There are no protocol-specified SAEs in this study.  All SAEs will be reported to Pfizer 
Safety by the investigator as described in previous sections, and will be handled as SAEs in 
the safety database. 
8.4.2. 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 subjects, transaminase elevations are a harbinger of a more 
serious potential outcome.  These subjects fail to adapt and therefore are "susceptible" to 
progressive and serious liver injury, commonly referred to as drug-induced liver injury 
(DILI).  Subjects who experience a transaminase elevation above 3 times the upper limit of 
normal (× ULN) should be monitored more frequently to determine if they are an “adaptor” 
or are “susceptible.”
Liver function tests (LFTs) are not required as a routine safety monitoring procedure in this 
study.  However, should an investigator deem it necessary to assess LFTs because a subject 
presents with clinical signs/symptoms, such LFT results should be managed and followed as 
described below.
In the majority of DILI cases, elevations in aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) precede total bilirubin (TBili) elevations (>2 × ULN) by several 
days or weeks.  The increase in TBili typically occurs while AST/ALT is/are still elevated 
above 3 × ULN (ie, AST/ALT and TBili values will be elevated within the same laboratory
sample).  In rare instances, by the time TBili elevations are detected, AST/ALT values might 
have decreased.  This occurrence is still regarded as a potential DILI.  Therefore, abnormal 
elevations in either AST OR ALT in addition to TBili that meet the criteria outlined below 
are considered potential DILI (assessed per Hy’s law criteria) cases and should always be 
considered important medical events, even before all other possible causes of liver injury 
have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the subject’s 
individual baseline values and underlying conditions.  Subjects 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:

Subjects 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 subjects 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:

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o
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).
o
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 subject should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results.  This evaluation should 
include laboratory tests, detailed history, and physical assessment.
In addition to repeating measurements of AST and ALT and TBili, laboratory tests should 
include albumin, creatine kinase (CK), direct and indirect bilirubin, gamma-glutamyl 
transferase (GGT), prothrombin time (PT)/international normalized ratio (INR), total bile 
acids, alkaline phosphatase, and acetaminophen drug and/or protein adduct levels.  
Consideration should also be given to drawing a separate tube of clotted blood and an 
anticoagulated tube of blood for further testing, as needed, for further contemporaneous 
analyses at the time of the recognized initial abnormalities to determine etiology.  A detailed 
history, including relevant information, such as review of ethanol, acetaminophen (either by 
itself or as a coformulated product in prescription or over-the-counter medications), 
recreational drug, supplement (herbal) use and consumption, family history, sexual history, 
travel history, history of contact with a jaundiced person, surgery, blood transfusion, history 
of liver or allergic disease, and potential occupational exposure to chemicals, should be 
collected.  Further testing for acute hepatitis A, B, C, D, and E infection and liver imaging 
(eg, biliary tract) 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.
8.4.3. Exposure to the Investigational Product during Pregnancy or Breastfeeding, and 
Occupational Exposure
Exposure to the investigational product under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness.

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8.4.3.1. Exposure during Pregnancy
For both unapproved/unlicensed products and for marketed products, an EDP occurs if:

A female becomes, or is found to be, pregnant either while receiving or having been 
exposed (eg, because of treatment or environmental exposure) to the investigational 
product; or the female becomes or is found to be pregnant after discontinuing and/or 
being exposed to the investigational product;
o
An example of environmental exposure would be a case involving direct contact with 
a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant and has 
been exposed to chemotherapeutic products).

A male has been exposed (eg, because of treatment or environmental exposure) to the 
investigational product prior to or around the time of conception and/or is exposed during 
his partner’s pregnancy.
If a subject or subject’s partner becomes or is found to be pregnant during the subject’s 
treatment with the investigational product, the investigator must report this information to 
Pfizer Safety on the CT SAE Report Form and an EDP supplemental form, regardless of 
whether an SAE has occurred.  In addition, the investigator must submit information 
regarding environmental exposure to a Pfizer product in a pregnant woman (eg, a subject 
reports that she is pregnant and has been exposed to a cytotoxic product by inhalation or 
spillage) to Pfizer Safety using the EDP supplemental form.  This must be done irrespective 
of whether an AE has occurred and within 24 hours of awareness of the exposure.  The 
information submitted should include the anticipated date of delivery (see below for 
information related to termination of pregnancy).
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP supplemental form.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a 
live-born baby, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
investigator should follow the procedures for reporting SAEs.

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Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs 
follows: 

Spontaneous abortion includes miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the investigational product.
Additional information regarding the EDP may be requested by the sponsor.  Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  In the case of paternal exposure, the 
investigator will provide the subject with the Pregnant Partner Release of Information Form 
to deliver to his partner.  The investigator must document in the source documents that the 
subject was given the Pregnant Partner Release of Information Form to provide to his 
partner.
8.4.3.2. Exposure during Breastfeeding
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated SAE, to Pfizer Safety within 24 hours of the investigator’s awareness, using the 
CT SAE Report Form.  An exposure during breastfeeding report is not created when a Pfizer 
drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in 
accord with authorized use.  However, if the infant experiences an SAE associated with such 
a drug’s administration, the SAE is reported together with the exposure during breastfeeding.
8.4.3.3. Occupational Exposure
An occupational exposure occurs when, during the performance of job duties, a person 
(whether a healthcare professional or otherwise) gets in unplanned direct contact with the 
product, which may or may not lead to the occurrence of an AE.
An occupational exposure is reported to Pfizer Safety within 24 hours of the investigator’s 
awareness, using the CT SAE Report Form, regardless of whether there is an associated 
SAE.  Since the information does not pertain to a subject enrolled in the study, the 
information is not recorded on a CRF; however, a copy of the completed CT SAE Report 
Form is maintained in the investigator site file.

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8.4.4. Medication Errors and Lack of Efficacy
Other exposures to the investigational product under study may occur in clinical trial settings, 
such as medication errors and lack of efficacy.
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer Safety 
Within 24 Hours of Awareness
Medication errors and lack of 
efficacy.a
All (regardless of whether 
associated with an AE)
Only if associated with an 
SAE
a.
For lack of efficacy (particularly for studies conducted with vaccines, contraceptives, and products used 
in the treatment of life-threatening diseases or conditions [eg, anti-infectives]), see the Lack of Efficacy 
section below.
8.4.4.1. Medication Errors
Medication errors may result from the administration or consumption of the investigational 
product by the wrong subject, or at the wrong time, or at the wrong dosage strength.  
Medication errors include:

Medication errors involving subject exposure to the investigational product;

Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the participating subject;

The administration of expired investigational product;

The administration of an incorrect investigational product;

The administration of an incorrect dosage;

The administration of investigational product that has undergone temperature 
excursion from the specified storage range, unless it is determined by the sponsor that 
the investigational product under question is acceptable for use.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified immediately.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on an AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.

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8.4.4.2. Lack of Efficacy
Lack of efficacy in an approved indication should be reported as an SAE to Pfizer Safety.
8.5. Medical Device Complaint Reporting Requirements
All medical device complaints, regardless of whether the medical device complaint is 
associated with an AE, will be recorded on the applicable pages within the CRF.  This 
includes potential incidents or malfunctions associated with the use of a medical device 
product.  An incident or malfunction is an event that might have led to death or serious 
deterioration in health, or if it occurred again might lead to death or serious deterioration in 
health.
Pfizer is to be notified of all medical device complaints within 24 hours of the investigator’s 
awareness of the event. 
9. DATA ANALYSIS/STATISTICAL METHODS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a statistical analysis plan (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. Sample Size Determination
The study size is not based on any formal statistical hypothesis test.  Approximately 220 
adults per vaccine group are planned to be randomized.  No formal statistical comparisons 
between vaccine groups are planned. Therefore, no power calculations for comparison of 
vaccine groups are included; however, the probabilities of at least 1 AE are calculated for 
range of assumed true event rates.
With approximately 200 subjects per vaccine group, the probabilities of observing at least
1 AE, local reaction, or systemic event where the true rate is 0.1%, 0.5%, 1%, and 5% are 
0.198, 0.668, 0.890, and >0.999, respectively. 
9.2. Analysis Populations
The safety population will include all subjects who receive 1 dose of 20vPnC or 13vPnC.  
Subjects will be assigned to vaccine groups corresponding to the vaccine actually received.  
The safety population will be the only analysis population for the primary endpoints.  
The evaluable immunogenicity population will generally include any subject:
1. who receives the assigned vaccine as randomized, 
2. whose has either Visit 2 or Visit 3 blood collection within 27 to 49 days, inclusive, after 
vaccination, and

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3. who has 
 OPA titers
for at least 1 serotype for either the 
Visit 2 time point (which is 1 month after Vaccination 1) or the Visit 3 time point (which 
is 1 month after Vaccination 2); however, at least 1 nonmissing value must be obtained 
27 to 49 days, inclusive, after the indicated vaccination.
A subject may be included in the evaluable population even if one of the Visit 2 or Visit 3 
blood collections is outside the window.  However, titers 
 obtained outside 
the window will be excluded from the evaluable population analysis.  Additional criteria 
(eg, without major protocol violations) are described in the SAP.
The evaluable immunogenicity population will be the primary analysis population for 
immunogenicity results.
The all-available immunogenicity population will include all subjects who receive 20vPnC or 
13vPnC and have 
 1 valid and determinate OPA titer 
 after either 
vaccination. The all-available immunogenicity population will be the secondary analysis 
population for immunogenicity results.  Subjects will be assigned to their randomized 
vaccine.
9.3. Immunogenicity Analysis
Geometric means (GMs) will be calculated for
 OPA 
 results at every time point
by vaccine group, as well as the 95% confidence intervals (CIs). Each serotype will be 
analyzed separately.
GMFRs will be calculated for the OPA 
 results.  GMFRs will be calculated for 
change in value from before the first vaccination until 1 month after the first vaccination
(Visit 2), from before the first vaccination (Visit 1) until 1 month after the second vaccination
(Visit 3),
 
  GMFRs will 
be defined as the latter result divided by the earlier result.
GMs and their confidence intervals (CIs) will be obtained by taking log transforms of titers 
, calculating the 95% CI with reference to the t-distribution, then 
exponentiating the mean and the limits. The GMFR and its CI will be calculated using the 
same method.
The proportions of subjects with OPA titers ≥the lower limit of quantitation (LLOQ) will be 
calculated for each time point and each serotype.  The 95% CIs will be obtained using the 
Clopper-Pearson method.
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Reverse cumulative distribution curves (RCDCs) will be compiled for each serotype.  The 
visits in each RCDC will depend on the serotype.  RCDCs for the 13 shared serotypes will be 
limited to before vaccination, 1 month after Vaccination 1, 
 
.  RCDCs for the additional 7 serotypes will be limited to before vaccination, 1 month after 
Vaccination 1 or 1 month after Vaccination 2 (depending on the investigational products
received), 
.  Further details will be specified in the SAP. 
9.4. Safety Analysis 
Descriptive statistics will be compiled for each safety endpoint for each vaccine group 
separately. In each group, local reactions and systemic events from Day 1 to Day 10 and 
from Day 1 to Day 7, respectively, after Vaccination 1 only, will be presented by severity 
and cumulatively across severity levels.  Descriptive statistics will include proportions of 
subjects with the indicated endpoint and the associated Clopper-Pearson 95% CIs.
AEs (including nonserious AEs, SAEs, and NDCMCs) with causality and severity will be 
summarized from Vaccination 1 until Visit 2, approximately 1 month (up to 35 days) after 
Vaccination 1. AEs will also be summarized from Vaccination 2 until Visit 3, approximately 
2 months after 20vPnC (and 1 month after saline) administration in the 20vPnC/saline group, 
and 1 month after PPSV23 administration in the 13vPnC/PPSV23 group.  Additionally, 
SAEs and NDCMCs will be presented for 2 intervals: from Vaccination 1 until Visit 4
(6 months after 20vPnC administration) and from Vaccination 1 until Visit 5 (12 months 
after 20vPnC administration).  The descriptive statistics for AEs will be summarized as the 
number and percentage of subjects reporting at least 1 event of each preferred term with the 
associated Clopper-Pearson 95% CIs, arranged by system organ class, and will also be 
summarized as the number of occurrences of the event.
9.5. Analysis Timing
1. Unblinded descriptive analyses of safety data for the first 30 subjects through 10 days of 
follow-up after Vaccination 1. These analyses will be performed by a designated 
unblinded statistician.
2. Unblinded safety and immunogenicity data from Visit 1 through Visit 2 will be analyzed 
when available.  The analyses will be descriptive.  This analysis will inform internal 
program development decisions and potentially support regulatory interactions.
3. Unblinded safety and immunogenicity data from Visit 2 to Visit 3 will be analyzed when 
available.  The analyses will be descriptive.  This analysis will also inform internal 
program development decisions and potentially support regulatory interactions.
4. Safety data from Visit 3 through Visit 4 (6-month telephone call) will be analyzed when 
available.
5. Safety 
 data from Visit 4 through Visit 5 will be analyzed when 
available. These will be the final analyses.
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There will be no alpha adjustments for these analyses.
Laboratory personnel directly conducting the immunogenicity assays will remain blinded 
until the last subject completes the 12-month visit.
 
 
 
 
 
 
 
 
10. QUALITY CONTROL AND QUALITY ASSURANCE
Pfizer or its agent will conduct periodic monitoring visits during study conduct to ensure that 
the protocol and GCPs are being followed.  The monitors may review source documents to 
confirm that the data recorded on CRFs are accurate.  The investigator and institution will 
allow Pfizer monitors/auditors or its agents and appropriate regulatory authorities direct 
access to source documents to perform this verification.  This verification may also occur 
after study completion.
During study conduct and/or after study completion, the investigator site may be subject to 
review by the institutional review board (IRB)/ethics committee (EC), and/or to quality 
assurance audits performed by Pfizer, or companies working with or on behalf of Pfizer, 
and/or to inspection by appropriate regulatory authorities.
The investigator(s) will notify Pfizer or its agents immediately of any regulatory inspection 
notification in relation to the study. Furthermore, the investigator will cooperate with Pfizer 
or its agents to prepare the investigator site for the inspection and will allow Pfizer 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 subject's medical records.  The investigator will promptly provide copies of the 
inspection findings to Pfizer or its agent.  Before response submission to the regulatory 
authorities, the investigator will provide Pfizer or its agents with an opportunity to review 
and comment on responses to any such findings.
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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.
11. DATA HANDLING AND RECORD KEEPING
11.1. Case Report Forms/Electronic Data Record
As used in this protocol, the term CRF should be understood to refer to either a paper form or 
an electronic data record or both, depending on the data collection method used in this study.
A CRF is required and should be completed for each included subject.  The completed 
original CRFs are the sole property of Pfizer and should not be made available in any form to 
third parties, except for authorized representatives of Pfizer or appropriate regulatory 
authorities, without written permission from Pfizer.
The investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs and any other data collection forms (source 
documents) and ensuring that they are accurate, authentic/original, attributable, complete, 
consistent, legible, timely (contemporaneous), enduring, and available when required.  The 
CRFs must be signed by the investigator or by an authorized staff member to attest that the 
data contained on the CRFs are true. Any corrections to entries made in the CRFs or source 
documents must be dated, initialed, and explained (if necessary) and should not obscure the 
original entry. 
In most cases, the source documents are the hospital or the physician subject chart.  In these 
cases, data collected on the CRFs must match the data in those charts. 
In some cases, the CRF may also serve as the source document.  In these cases, a document 
should be available at the investigator site and at Pfizer that clearly identifies those data that 
will be recorded on the CRF, and for which the CRF will stand as the source document.
11.2. Record Retention
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the 
investigator agrees to keep records, including the identity of all participating subjects 
(sufficient information to link records, eg, CRFs and hospital records), all original signed 
informed consent documents, copies of all CRFs, safety reporting forms, source documents, 
and detailed records of treatment disposition, and adequate documentation of relevant 
correspondence (eg, letters, meeting minutes, and telephone call reports).  The records should 
be retained by the investigator according to the ICH guidelines, according to local 
regulations, or as specified in the clinical study agreement (CSA), whichever is longer.
If the investigator becomes unable for any reason to continue to retain study records for the 
required period (eg, retirement, relocation), Pfizer should be prospectively notified.  The 
study records must be transferred to a designee acceptable to Pfizer, such as another 
investigator, another institution, or an independent third party arranged by Pfizer. 

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Investigator records must be kept for a minimum of 15 years after completion or 
discontinuation of the study or for longer if required by applicable local regulations.
The investigator must obtain Pfizer's written permission before disposing of any records, 
even if retention requirements have been met.
12. ETHICS
12.1. Institutional Review Board/Ethics Committee
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, informed consent documents, and other relevant documents, eg,
recruitment advertisements, if applicable, from the IRB/EC.  All correspondence with the
IRB/EC should be retained in the investigator file.  Copies of IRB/EC approvals should be 
forwarded to Pfizer.
The only circumstance in which an amendment may be initiated prior to IRB/EC approval is 
where the change is necessary to eliminate apparent immediate hazards to the subjects.  In 
that event, the investigator must notify the IRB/EC and Pfizer in writing immediately after 
the implementation.
12.2. Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, legal and regulatory 
requirements, and the general principles set forth in the International Ethical Guidelines for 
Biomedical Research Involving Human Subjects (Council for International Organizations of 
Medical Sciences [CIOMS] 2002), ICH Guideline for Good Clinical Practice, and the 
Declaration of Helsinki.
12.3. Subject Information and Consent
All parties will ensure protection of subject personal data and will not include subject names 
or other identifiable data in any reports, publications, or other disclosures, except where
required by law.
When study data are compiled for transfer to Pfizer and other authorized parties, subject 
names, addresses, and other identifiable data will be replaced by numerical codes based on a 
numbering system provided by Pfizer in order to de-identify study subjects. The investigator
site will maintain a confidential list of subjects who participated in the study, linking each 
subject’s numerical code to his or her actual identity.  In case of data transfer, Pfizer will 
maintain high standards of confidentiality and protection of subjects’ personal data consistent 
with applicable privacy laws.
The informed consent documents and any subject recruitment materials must be in 
compliance with ICH GCP, local regulatory requirements, and legal requirements, including 
applicable privacy laws.

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The informed consent documents used during the informed consent process and any subject 
recruitment materials must be reviewed and approved by Pfizer, approved by the IRB/EC
before use, and available for inspection
The investigator must ensure that each study subject is fully informed about the nature and 
objectives of the study and possible risks associated with participation.
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each subject before any study-specific activity is performed. The investigator 
will retain the original of each subject's signed consent document.
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the investigational 
product, Pfizer should be informed immediately.
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study subjects against any immediate hazard, and of 
any serious breaches of this protocol or of ICH GCP that the investigator becomes aware of.
13. DEFINITION OF END OF TRIAL
13.1. End of Trial in the Participating Country
End of trial in all participating countries is defined as last subject last visit (LSLV).  After 
this time, sites will be closed out, the IRB/EC will be informed, and no further CIOMS 
reports will be sent.
14. SPONSOR DISCONTINUATION CRITERIA
Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the IRB/EC, or investigational product safety problems, or at the 
discretion of Pfizer.  In addition, Pfizer retains the right to discontinue development of 
20vPnC at any time.
If a study is prematurely terminated, Pfizer will promptly notify the investigator.  After 
notification, the investigator must contact all participating subjects and the hospital pharmacy 
(if applicable) within 30 days.  As directed by Pfizer, all study materials must be collected 
and all CRFs completed to the greatest extent possible.
15. PUBLICATION OF STUDY RESULTS
15.1. Communication of Results by Pfizer
Pfizer fulfills its commitment to publicly disclose clinical trial results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials 
Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance with 
applicable local laws/regulations. 

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In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial US Basic Results on www.clinicaltrials.gov for Pfizer-sponsored 
interventional studies (conducted in patients) that evaluate the safety and/or efficacy of a 
Pfizer product, regardless of the geographical location in which the study is conducted.  US 
Basic Results are submitted for posting within 1 year of the primary completion date (PCD) 
for studies in adult populations or within 6 months of the PCD for studies in pediatric 
populations.
PCD is defined as the date that the final subject was examined or received an intervention for 
the purposes of final collection of data for the primary outcome, whether the clinical study 
concluded according to the prespecified protocol or was terminated.
EudraCT
Pfizer posts European Union (EU) Basic Results on EudraCT for all Pfizer-sponsored 
interventional studies that are in scope of EU requirements.  EU Basic Results are submitted 
for posting within 1 year of the PCD for studies in adult populations or within 6 months of 
the PCD for studies in pediatric populations.
www.pfizer.com
Pfizer posts Public Disclosure Synopses (clinical study report synopses in which any data 
that could be used to identify individual patients has been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the US Basic Results document is 
posted to www.clinicaltrials.gov.
15.2. Publications by Investigators
Pfizer supports the exercise of academic freedom and has no objection to publication by the 
PI of the results of the study based on information collected or generated by the PI, whether 
or not the results are favorable to the Pfizer product.  However, to ensure against inadvertent 
disclosure of confidential information or unprotected inventions, the investigator will provide 
Pfizer an opportunity to review any proposed publication or other type of disclosure of the 
results of the study (collectively, “publication”) before it is submitted or otherwise disclosed.
The investigator will provide any publication to Pfizer at least 30 days before it is submitted 
for publication or otherwise disclosed. If any patent action is required to protect intellectual 
property rights, the investigator agrees to delay the disclosure for a period not to exceed an 
additional 60 days.

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The investigator will, on request, remove any previously undisclosed confidential 
information before disclosure, except for any study- or Pfizer product-related information 
necessary to the appropriate scientific presentation or understanding of the study results.
If the study is part of a multicenter study, the investigator agrees that the first publication is 
to be a joint publication covering all investigator sites, and that any subsequent publications 
by the PI will reference that primary publication. However, if a joint manuscript has not 
been submitted for publication within 12 months of completion or termination of the study at 
all participating sites, the investigator is free to publish separately, subject to the other 
requirements of this section.
For all publications relating to the study, the institution 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.
Publication of study results is also provided for in the CSA between Pfizer and the 
institution.  In this section entitled Publications by Investigators, the defined terms shall have 
the meanings given to them in the CSA.
If there is any conflict between the CSA and any attachments to it, the terms of the CSA 
control.  If there is any conflict between this protocol and the CSA, this protocol will control 
as to any issue regarding treatment of study subjects, and the CSA will control as to all other 
issues.

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contribution of specific pneumococcal serogroups to different disease 
manifestations: implications for conjugate vaccine formulation and use, 
part II. Clin Infect Dis. 2000;30(1):122-140.
32
Nuorti JP, Whitney CG. Prevention of pneumococcal disease among 
infants and children - use of 13-valent pneumococcal conjugate vaccine 
and 23-valent pneumococcal polysaccharide vaccine - recommendations 
of the Advisory Committee on Immunization Practices (ACIP). MMWR 
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33
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Appendix 1.
The following is a list of abbreviations that may be used in the protocol. 
Abbreviation
Term
13vPnC
13-valent pneumococcal conjugate vaccine
20vPnC
20-valent pneumococcal conjugate vaccine
ACIP
Advisory Committee on Immunization Practices
AE
adverse event
ALT
alanine aminotransferase
AOM
acute otitis media
AST
aspartate aminotransferase
CAP
community-acquired pneumonia
CAPiTA
Community-Acquired Pneumonia Immunization Trial in Adults
CBER
Center for Biologics Evaluation and Research
CDC
Centers for Disease Control and Prevention
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
COPD
chronic obstructive pulmonary disease
CRF
case report form
CRM197
cross-reactive material 197
CSA
clinical study agreement
CT
clinical trial
DILI
drug-induced liver injury
DU
dispensable unit
EC
ethics committee
e-diary
electronic diary
E-DMC
external data monitoring committee
EDP
exposure during pregnancy
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GM
geometric mean
GMFR
geometric mean fold rise
GMT
geometric mean titer
HIV
human immunodeficiency virus
IB
investigator’s brochure
ICH
International Council for Harmonisation
CCI

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Abbreviation
Term
ID
identification
IgG
immunoglobulin G
IND
investigational new drug application
INR
international normalized ratio
IP
investigational product
IPD
invasive pneumococcal disease
IRB
institutional review board
IRC
internal review committee
IRT
interactive response technology
IUD
intrauterine device
IWR
interactive Web-based response
LFT
liver function test
LLOQ
lower limit of quantitation
LSLV
last subject last visit 
N/A
not applicable
NDCMC
newly diagnosed chronic medical condition
OPA
opsonophagocytic activity
PCD
primary completion date
PDA
personal digital assistant
PI
principal investigator
PPSV23
23-valent pneumococcal polysaccharide vaccine
PT
prothrombin time
RCDC
reverse cumulative distribution curve
SAE
serious adverse event
SAP
statistical analysis plan
SRM
study reference manual
SRSD
single reference safety document
TBili
total bilirubin
ULN
upper limit of normal
US
United States
USPI
US package insert
VT
vaccine-type
WHO
World Health Organization

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