A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE
Phase: PHASE2
Conditions: Pneumococcal Infections
Sponsor: Pfizer

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A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE 
THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT 
PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 
THROUGH 85 YEARS OF AGE
Investigational Product Number:
PF-06842433
Investigational Product Name:
Complementary 7-valent Pneumococcal 
Conjugate Vaccine
United States (US) Investigational New 
Drug (IND) Number:
To Be Determined (TBD)
European Clinical Trials Database 
(EudraCT) Number:
Not Applicable (N/A)
Protocol Number:
C3571001
Phase:
1/2

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Document History
Document
Version Date
Summary of Changes
Original protocol
28 June 2017
N/A

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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................7
APPENDICES ...........................................................................................................................7
PROTOCOL SUMMARY.........................................................................................................8
SCHEDULE OF ACTIVITIES................................................................................................12
1. INTRODUCTION ...............................................................................................................16
1.1. Indication.................................................................................................................16
1.2. Background and Rationale ......................................................................................16
1.2.1. Disease and Disease Burden.......................................................................16
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 c7vPnC ................................................................18
2. STUDY OBJECTIVES AND ENDPOINTS.......................................................................18
2.1. Primary Objectives and Endpoints..........................................................................18
2.1.1. Primary Objectives .....................................................................................18
2.1.2. Primary Endpoints ......................................................................................19
2.2. Secondary Objectives and Endpoints......................................................................19
2.2.1. Secondary Objectives .................................................................................19
2.2.2. Secondary Endpoints ..................................................................................19
3. STUDY DESIGN.................................................................................................................20
3.1. Duration of Subject Participation............................................................................21
3.2. Duration of the Study ..............................................................................................21
3.3. Number of Subjects.................................................................................................22
4. SUBJECT ELIGIBILITY CRITERIA.................................................................................22
4.1. Inclusion Criteria.....................................................................................................22
4.2. Exclusion Criteria....................................................................................................24
4.3. Temporary Delay Criteria .......................................................................................26
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4.3.1. Criteria for Temporarily Delaying Vaccine Administration (Stage 1 
and Stage 2: Visit 1).........................................................................................27
4.3.2. Criteria for Temporarily Delaying Immunogenicity Blood Draw 
(Stage 1: Visit 1 and Visit 2; Stage 2: Visits 1, 2, and 4) ................................27
4.4. Lifestyle Requirements ...........................................................................................27
4.4.1. Contraception..............................................................................................27
4.5. Sponsor’s Qualified Medical Personnel..................................................................28
5. INVESTIGATIONAL PRODUCTS ...................................................................................29
5.1. Allocation to Investigational Product......................................................................29
5.2. Blinding of the Site Personnel.................................................................................29
5.3. Blinding of the Sponsor...........................................................................................30
5.4. Breaking the Blind ..................................................................................................30
5.5. Subject Compliance.................................................................................................30
5.6. Investigational Product Supplies.............................................................................30
5.6.1. Dosage Form(s) and Packaging..................................................................31
5.6.2. Preparation and Dispensing........................................................................31
5.7. Administration.........................................................................................................31
5.8. Investigational Product Storage ..............................................................................32
5.9. Investigational Product Accountability...................................................................33
5.9.1. Destruction of Investigational Product Supplies ........................................33
5.10. Prior Vaccination (Stage 2 Only)..........................................................................33
5.11. Concomitant Treatment(s).....................................................................................33
5.11.1. Prohibited Concomitant Treatments.........................................................33
5.11.2. Permitted Concomitant Treatments (Stage 1 and Stage 2 Subjects) ........34
5.11.3. Recording Concomitant Treatments.........................................................34
6. STUDY PROCEDURES .....................................................................................................34
6.1. Stage 1 Study Procedures........................................................................................34
6.1.1. Screening (14 to 2 Days Prior to Vaccination) – Clinic Visit ....................34
6.1.2. Visit 1 (Day 1; Day of Vaccination) – Clinic Visit ....................................35
6.1.3. Visit 2 (Month 1; 28 to 35 Days After Vaccination) – Clinic Visit ...........37
6.1.4. Visit 3 (Month 6; 168 to 196 Days After Vaccination) – Telephone 
Contact.............................................................................................................37
6.2. Stage 2 Study Procedures........................................................................................38

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6.2.1. Visit 1 (Day 1; Day of Vaccination) – Clinic Visit ....................................38
6.2.2. Visit 2 (Month 1; 28 to 35 Days After Vaccination) – Clinic Visit ...........39
6.2.3. Visit 3 (Month 6; 168 to 196 Days After Vaccination) – Telephone 
Contact.............................................................................................................40
6.2.4. Visit 4 (Month 12; 350 to 378 Days After Vaccination) – Clinic Visit .....40
6.3. Unscheduled Visits (Stage 1 and Stage 2) ..............................................................41
6.4. Subject Withdrawal.................................................................................................42
6.4.1. Withdrawal of Consent...............................................................................42
6.4.2. Lost to Follow-up .......................................................................................42
7. ASSESSMENTS..................................................................................................................43
7.1. Pregnancy Testing...................................................................................................43
7.2. Safety Parameters....................................................................................................44
7.2.2. Subject Electronic Diary.............................................................................46
7.2.3. Grading Scale for Prompted Events ...........................................................46
7.2.3.1. Local Reactions.........................................................................46
7.2.3.2. Systemic Events ........................................................................47
7.2.3.3. Fever..........................................................................................48
7.2.3.4. Use of Antipyretic/Pain Medication..........................................49
7.3. Immunogenicity ......................................................................................................49
7.4. Laboratory Tests:  Stage 1 Only..............................................................................49
7.5. Biological Samples..................................................................................................50
8. ADVERSE EVENT REPORTING......................................................................................50
8.1. Requirements...........................................................................................................50
8.1.1. Additional Details on Recording Adverse Events on the CRF...................51
8.1.2. Eliciting Adverse Event Information..........................................................52
8.1.3. Withdrawal From the Study Due to Adverse Events (see also the 
Subject Withdrawal Section) ...........................................................................52
8.1.4. Time Period for Collecting AE/SAE Information......................................52
8.1.4.1. Reporting SAEs to Pfizer Safety...............................................52
8.1.4.2. Recording Nonserious AEs and SAEs on the CRF...................52
8.1.5. Causality Assessment .................................................................................53
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities ..................53
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8.2. Definitions...............................................................................................................53
8.2.1. Adverse Events...........................................................................................53
8.2.2. Abnormal Test Findings .............................................................................54
8.2.3. Serious Adverse Events ..............................................................................54
8.2.4. Hospitalization............................................................................................55
8.3. Severity Assessment................................................................................................57
8.4. Special Situations ....................................................................................................57
8.4.1. Protocol-Specified Serious Adverse Events...............................................57
8.4.2. Potential Cases of Drug-Induced Liver Injury............................................57
8.4.3. Exposure to the Investigational Product During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................59
8.4.3.1. Exposure During Pregnancy......................................................59
8.4.3.2. Exposure During Breastfeeding ................................................60
8.4.3.3. Occupational Exposure .............................................................60
8.4.4. Medication Errors .......................................................................................61
8.5. Medical Device Complaint Reporting Requirements .............................................62
9. DATA ANALYSIS/STATISTICAL METHODS...............................................................62
9.1. Sample Size Determination.....................................................................................62
9.2. Analysis Populations...............................................................................................63
9.3. Immunogenicity Analysis .......................................................................................64
9.4. Safety Analysis........................................................................................................64
9.5. Analysis Timing ......................................................................................................65
10. QUALITY CONTROL AND QUALITY ASSURANCE.................................................66
11. DATA HANDLING AND RECORD KEEPING .............................................................66
11.1. Case Report Forms/Electronic Data Record .........................................................66
11.2. Record Retention...................................................................................................67
12. ETHICS..............................................................................................................................67
12.1. Institutional Review Board/Ethics Committee......................................................67
12.2. Ethical Conduct of the Study ................................................................................68
12.3. Subject Information and Consent..........................................................................68
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH 
GCP ...........................................................................................................................68
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13. DEFINITION OF END OF TRIAL...................................................................................69
13.1. End of Trial in the Participating Country..............................................................69
14. SPONSOR DISCONTINUATION CRITERIA ................................................................69
15. PUBLICATION OF STUDY RESULTS..........................................................................69
15.1. Communication of Results by Pfizer ....................................................................69
15.2. Publications by Investigators ................................................................................70
16. REFERENCES ..................................................................................................................72
LIST OF TABLES
Table 1.
Grading Scales for Local Reactions .....................................................................47
Table 2.
Grading Scales for Systemic Events.....................................................................48
Table 3.
Ranges for Fever...................................................................................................48
Table 4.
Probability of Observing at Least 1 AE, Local Reaction, or Systemic Event 
by Assumed True Event Rates With Different Sample Sizes...............................62
APPENDICES
Appendix 1. Abbreviations......................................................................................................79

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PROTOCOL SUMMARY
Background and Rationale
Streptococcus pneumoniae are gram-positive encapsulated cocci that have been a leading 
cause of meningitis, bacteremia, 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. 
Data from the Centers for Disease Control and Prevention (CDC) estimated that in 2015
there were 29,500 cases and 3350 deaths due to invasive pneumococcal disease (IPD) in 
persons of all ages in the United States. S pneumoniae remains an important cause of serious 
disease in the United States and worldwide.
The S pneumoniae polysaccharide capsule has been identified as an important virulence 
factor for this pathogen. While there are more than 95 pneumococcal serotypes differentiated 
by their capsular polysaccharide composition, a subset is 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.  The licensed 23-valent pneumococcal 
polysaccharide vaccine (PPSV23), however, has substantial disadvantages because it 
contains polysaccharides in an unconjugated manner with its inherent limitations in terms of 
quantity and quality of immune responses. The incidence of IPD due to the serotypes unique 
to PPSV23 has remained relatively 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. Therefore, unconjugated polysaccharide vaccines have significant limitations.
Pneumococcal conjugate vaccines, which contain polysaccharide antigens 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, licensed in the United States in 2000, and Prevnar 13, licensed in the United 
States in 2010, are pneumococcal conjugate vaccines containing 7 and 13 pneumococcal 
polysaccharide conjugates, respectively.  These vaccines have demonstrated 
efficacy/effectiveness against vaccine-type (VT) IPD, AOM, and pneumonia in infants and 
older adults.  They also have demonstrated the ability to reduce nasopharyngeal carriage and 
transmission, resulting in indirect beneficial effects.
However, there continues to be pneumococcal disease due to other serotypes not included in 
either Prevnar or Prevnar 13 in various age groups and in different parts of the world. Seven 
serotypes, 8, 10A, 11A, 12F, 15B, 22F, and 33F, continue to be a cause of pneumococcal 
disease in both children and adults, across different geographic regions. These 7 serotypes 
are contained in PPSV23, a licensed vaccine in use for over 30 years, indicating that despite 
the evolving pneumococcal epidemiology and use of PPSV23, the significant disease burden 
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Pfizer is developing a new complementary 7-valent pneumococcal conjugate vaccine 
(c7vPnC) candidate to augment current pneumococcal coverage in children and adults. 
c7vPnC contains pneumococcal conjugates of 7 different serotypes (8, 10A, 11A, 12F, 15B, 
22F, and 33F) to protect against pneumococcal disease caused by these serotypes.  c7vPnC 
contains the same conjugate carrier protein and excipients and uses the same platform as 
Prevnar and Prevnar 13.
The purpose of this Phase 1/2 study is to provide safety, tolerability, and immunogenicity 
data for c7vPnC in adults 50 through 85 years of age and will support further clinical 
development.
Study Design
This is a 2-stage, Phase 1/2, randomized, active-controlled, observer-blinded study with a 
2-arm parallel design. It is planned to be conducted at investigator sites in the United States.  
The purpose of Stage 1 is to provide first-in-human (FIH) safety and immunogenicity data 
with the investigational pneumococcal vaccine c7vPnC in adults 50 to 64 years of age, and it 
serves as the Phase 1 part of the study.  Stage 2 functions as the Phase 2 part of the study and 
will provide additional safety and immunogenicity data with c7vPnC in adults 65 to 85 years 
of age, compared to PPSV23.
Stage 1:
In Stage 1 of the study, approximately 66 adults 50 through 64 years of age with no history 
of pneumococcal vaccination will be randomized equally to receive a dose of c7vPnC or 
licensed tetanus, diphtheria, and acellular pertussis vaccine (Tdap) as the control vaccine.  
 
 
  Subjects will have blood drawn for safety 
laboratory testing and immunogenicity assessments at protocol-specified time points.  
Prompted local reactions and systemic events occurring within 14 days after vaccination will 
be collected each day in an electronic diary (e-diary). Safety will be assessed through 
6 months after vaccination.
 
 
Stage 2:
In Stage 2 of the study, approximately 440 adults 65 through 85 years of age previously 
vaccinated with Prevnar 13 ≥2 months prior to investigational product administration, as part 
of their routine medical care, will be randomized equally to receive a dose of c7vPnC or 
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PPSV23 as the control vaccine.  Blood will be collected for immunogenicity assessments at
protocol-specified time points.  Prompted local reactions and systemic events occurring 
within 14 days of vaccination will be collected each day in the e-diary.  Safety will be 
assessed through 12 months after vaccination.
 
 
 
Primary Objectives and Endpoints
Primary Objectives
•
Stage 1: To describe the safety profile of c7vPnC in adults 50 through 64 years of age.
•
Stage 2: To describe the safety profile of c7vPnC in adults 65 through 85 years of age.
Primary Endpoints
•
Proportions of subjects reporting prompted local reactions within 14 days after 
vaccination (redness, swelling, and pain at the injection site).
•
Proportions of subjects reporting prompted systemic events within 14 days after 
vaccination (fever, headache, fatigue, muscle pain, and joint pain).
•
Proportions of subjects reporting AEs within 1 month after vaccination.
•
Proportions of subjects reporting serious adverse events (SAEs) and newly diagnosed 
chronic medical conditions (NDCMCs) within 6 months after vaccination (both Stage 1 
and Stage 2) and within 12 months after vaccination (Stage 2 only).
Secondary Objectives and Endpoints
Secondary Objectives
•
Stage 1: To describe the immunogenicity of c7vPnC in adults 50 through 64 years of age.
•
Stage 2: To describe the immunogenicity of c7vPnC in adults 65 through 85 years of age.
Secondary Endpoints
•
Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers 
(GMTs) at 1 month after vaccination.
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•
Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) from before 
vaccination to 1 month after vaccination.
Statistical Methods
All safety and immunogenicity analyses will be descriptive and will be summarized by group 
with point estimates and 95% confidence intervals.
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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.
Stage 1:
Visit Identifier
Screening
1
2
3
Visit Description
Screening
Day 1
Month 1
Month 6
Visit Type
Clinic Visit
Clinic Visit
Clinic Visit
Telephone Contact
Visit Window
14 to 2 Days Before Day 
1
Day of Vaccination
28 to 35 Days
After Vaccination
168 to 196 Days After 
Vaccination
Obtain informed consent
X
Assign subject number
X
Record demography
X
Obtain medical history
X
Perform physical examination 
X
Measure prevaccination oral temperature
X
Perform urine pregnancy test for female subjects of childbearing 
potential
X
Contraception check, if applicablea
X
X
X
Record nonstudy vaccinations and concomitant medications
X
X
X
X
Review inclusion and exclusion criteria
X
X
Review temporary delay criteria
X
X
Review continued eligibility
X
Obtain blood sample for safety laboratory assessments (~10 mL)
X
Assign randomization number
X
Obtain blood sample for immunogenicity (~50 mL)
Xb
X
Administer investigational product (c7vPnC or Tdap)
X
Assess and record acute reactions for at least 30 minutes after 
investigational product administration
X
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Visit Identifier
Screening
1
2
3
Visit Description
Screening
Day 1
Month 1
Month 6
Visit Type
Clinic Visit
Clinic Visit
Clinic Visit
Telephone Contact
Visit Window
14 to 2 Days Before Day 
1
Day of Vaccination
28 to 35 Days
After Vaccination
168 to 196 Days After 
Vaccination
Provide subject with e-diary, thermometer, and measuring device,
provide instructions on use, and instruct subject to collect prompted 
local reactions and systemic events daily until Day 14c
X
Review e-diary eventsd,e
X
X
Collect e-diary
X
Record and report AEsf,g
X-------------------------------------------------------X
Record and report SAEs and NDCMCsh
X------------------------------X
Abbreviations: e-diary = electronic diary; NDCMC = newly diagnosed chronic medical condition.
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.
Blood sample will be collected prior to vaccination.
c.
Subjects will record prompted local reactions, systemic events, fever, and antipyretic/pain medication used to treat symptoms in an e-diary each evening for 14 days following 
vaccination.  Subjects will be asked to contact the study staff if they experience a Grade 3 or possible Grade 4 reaction at the injection site, fever >104.0F (>40.0C), or any 
possible Grade 4 prompted systemic event.
d.
Designated site staff will review e-diary data online at frequent intervals (daily is optimal) for the 14 days following vaccination to evaluate subject compliance and as part of 
the ongoing safety review.
e.
If a stopping rule is confirmed, the subject(s) will be asked to return to the site as soon as possible for further evaluation of reported events.
f.
Subjects will be asked to contact the study staff if they experience a severe nonprompted AE or any SAE during the 14-day postvaccination period.
g.
Adverse events include nonserious AEs, SAEs, and NDCMCs.
h.
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects.

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Stage 2:
Visit Identifier
1
2
3
4
Visit Description
Day 1
Month 1
Month 6
Month 12
Visit Type
Clinic Visit
Clinic Visit
Telephone Contact
Clinic Visit
Visit Window
Day of Vaccination
28 to 35 Days
After Vaccination
168 to 196 Days
After Vaccination
350 to 378 Days
After Vaccination
Obtain informed consent
X
Assign subject number
X
Record demography
X
Obtain medical history
X
Record prior Prevnar 13 vaccination
X
Perform physical examination 
X
Measure prevaccination oral temperature
X
Contraception check, if applicablea
X
X
Record nonstudy vaccinations and concomitant medications
X
X
X
X
Review inclusion and exclusion criteria
X
Review temporary delay criteria
X
X
X
Review continued eligibility
X
X
Assign randomization number
X
Obtain blood sample for immunogenicity (~50 mL)
Xb
X
Administer investigational product (c7vPnC or PPSV23)
X
Assess and record acute reactions for at least 30 minutes after 
investigational product administration
X
Provide subject with e-diary, thermometer, and measuring device,
provide instructions on use, and instruct subject to collect prompted 
local reactions and systemic events daily until Day 14c
X
Review e-diary eventsd
X
X
C
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Visit Identifier
1
2
3
4
Visit Description
Day 1
Month 1
Month 6
Month 12
Visit Type
Clinic Visit
Clinic Visit
Telephone Contact
Clinic Visit
Visit Window
Day of Vaccination
28 to 35 Days
After Vaccination
168 to 196 Days
After Vaccination
350 to 378 Days
After Vaccination
Collect e-diary
X
Record and report AEse,f
X---------------------------X
Record and report SAEs and NDCMCsg
X--------------------------------------------------------------X
Abbreviations: e-diary = electronic diary; NDCMC = newly diagnosed chronic medical condition.
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.
Blood sample will be collected prior to vaccination.
c.
Subjects will record prompted local reactions, systemic events, fever, and antipyretic/pain medication used to treat symptoms in an e-diary each evening for 14 days following 
vaccination.  Subjects will be asked to contact the study staff if they experience a Grade 3 or possible Grade 4 reaction at the injection site, fever >104.0F (>40.0C), or any 
possible Grade 4 prompted systemic event.
d.
Designated site staff will review e-diary data online at frequent intervals (daily is optimal) for the 14 days following vaccination to evaluate subject compliance and as part of 
the ongoing safety review.
e.
Subjects will be asked to contact the study staff if they experience a severe nonprompted AE during the 14-day postvaccination period.
f.
Adverse events include nonserious AEs, SAEs, and NDCMCs.
g.
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects.

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1. INTRODUCTION
1.1. Indication
Complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) is being developed for:

Active immunization to prevent invasive disease and pneumonia caused by the 
Streptococcus pneumoniae serotypes in the vaccine.
1.2. Background and Rationale
1.2.1. Disease and Disease Burden
S pneumoniae are gram-positive encapsulated cocci that have been a leading cause of 
meningitis, bacteremia, 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.  
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.5,6  
Although invasive pneumococcal disease (IPD) is less common than pneumococcal 
pneumonia, particularly with the introduction of the efficacious pneumococcal conjugate 
vaccines described below, there remains a burden of disease in all age groups and associated 
morbidity and mortality.7  Data from the Centers for Disease Control and Prevention (CDC) 
estimated that in 2015 there were 29,500 cases and 3350 deaths due to IPD in persons of all 
ages 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  These data show that 
S pneumoniae remains an important cause of serious disease in the United States and 
worldwide.
The S pneumoniae polysaccharide capsule has been identified as an important virulence 
factor for this pathogen. While there are more than 95 pneumococcal serotypes differentiated 
by their capsular polysaccharide composition, a subset is more commonly associated with 
severe disease.10,11 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.
1.2.2. Vaccines to Prevent Pneumococcal Disease
1.2.2.1. Pneumococcal Polysaccharide Vaccines
Vaccines containing unconjugated 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 1983.12,13 PPSV23 contains unconjugated 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.  PPSV23 induces only limited responses to many important pneumococcal 
serotypes in children less than 2 years of age and does not induce a memory response in any 

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population.4,14,15  In addition, 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
conjugate vaccine, compared to the first dose of polysaccharide vaccine, resulting in 
hyporesponsiveness.16,17,18  Furthermore, several studies have failed to demonstrate the 
effectiveness of PPSV23 in preventing nonbacteremic CAP pneumonia in older 
individuals.4,19,20  Several studies have shown that its effectiveness against IPD declines 
within 5 years.4,13,15  Therefore, unconjugated polysaccharide vaccines have significant 
limitations.
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.14,21  Prevnar(7-valent pneumococcal conjugate 
vaccine [7vPnC]) was the first pneumococcal conjugate vaccine to be licensed (2000) and 
was indicated for the 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 the 
cross-reactive material 197 (CRM197), a nontoxic variant of diphtheria toxin. Prevnar 
demonstrated efficacy against vaccine-type (VT) IPD, pneumonia, and AOM in large 
randomized controlled efficacy/effectiveness studies in infants.22,23,24  The Prevnar 
components contained in a related pneumococcal conjugate vaccine also were demonstrated 
to be efficacious against clinically/radiographically defined pneumonia.25,26,27,28  Following 
introduction of Prevnar, reduction of nasopharyngeal carriage and transmission has resulted 
in indirect herd effects, with a 92% reduction of 7vPnC VT IPD in older adults 65 years of 
age.29,30
At the time of introduction, Prevnar covered the majority of serotypes responsible for IPD in 
US infants; however, additional serotypes not included in Prevnar accounted for a significant 
proportion of AOM in that population, as well as IPD in older adults in the United States and 
children outside of the United States.  Therefore, 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).21,31  The addition of the 6 serotypes expanded the 
percentage of vaccine-preventable IPD cases to 90% in most regions of the world.21,31
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.32,33,34,35 It has 
also been prequalified by WHO for use in national infant immunization programs in lower-
and middle-income countries.36,37  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 as well as decreases in 
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1.2.2.3. Rationale for c7vPnC
The purpose of this study is to assess the safety and tolerability of c7vPnC in healthy adults 
50 through 85 years of age.  This study represents the initial evaluation of c7vPnC in 
humans.  In addition to safety, immunogenicity of c7vPnC will also be described. In Stage 1, 
the inclusion of a control group receiving tetanus, diphtheria, and acellular pertussis vaccine 
(Tdap) will serve as a benchmark for the rates of local reactions that may be observed with a 
vaccine that contains CRM197 and has been evaluated and is licensed and recommended for 
use in this age group. In Stage 2, the inclusion of a control group receiving PPSV23 will 
serve as a benchmark for safety and the rates of local reactions that may be observed with a 
licensed and recommended pneumococcal vaccine containing the serotypes that are in 
common with c7vPnC.
Additional information for c7vPnC may be found in the single reference safety document 
(SRSD), which for this study is the c7vPnC IB.  The SRSDs for the Tdap and PPSV23 
control vaccines are the US package inserts (USPIs).
2. STUDY OBJECTIVES AND ENDPOINTS
2.1. Primary Objectives and Endpoints
2.1.1. Primary Objectives
•
Stage 1: To describe the safety profile of c7vPnC in adults 50 through 64 years of age.
•
Stage 2: To describe the safety profile of c7vPnC in adults 65 through 85 years of age.
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2.1.2. Primary Endpoints
•
Proportions of subjects reporting prompted local reactions within 14 days after 
vaccination (redness, swelling, and pain at the injection site).
•
Proportions of subjects reporting prompted systemic events within 14 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 after vaccination (both Stage 1 
and Stage 2) and within 12 months after vaccination (Stage 2 only).
2.2. Secondary Objectives and Endpoints
2.2.1. Secondary Objectives
•
Stage 1: To describe the immunogenicity of c7vPnC in adults 50 through 64 years of age.
•
Stage 2: To describe the immunogenicity of c7vPnC in adults 65 through 85 years of age.
2.2.2. Secondary Endpoints
•
Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers 
(GMTs) at 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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3. STUDY DESIGN
This is a 2-stage, Phase 1/2, randomized, active-controlled, observer-blinded study with a 
2-arm parallel design. It is planned to be conducted at investigator sites in the United States.
The purpose of Stage 1 is to provide first-in-human (FIH) safety and immunogenicity data 
with the investigational pneumococcal vaccine c7vPnC in healthy adults 50 to 64 years of 
age, and it serves as the Phase 1 part of the study.  Stage 2 functions as the Phase 2 part of the 
study and will provide additional safety and immunogenicity data with c7vPnC in healthy 
adults 65 to 85 years of age, compared to PPSV23.
Stage 1:
In Stage 1 of the study, approximately 66 healthy adults 50 through 64 years of age with no 
history of pneumococcal vaccination will be enrolled, screened, and randomized equally in a 
1:1 ratio to receive a dose of c7vPnC or Tdap as the control vaccine.  The rate of vaccination 
in Stage 1 will be limited to ≤5 subjects per day until all subjects have been enrolled in this 
stage of the study.  Subjects will be enrolled and have blood drawn for baseline safety 
laboratory testing (hematology and tests for liver and renal function) at the screening visit 
(14 to 2 days prior to vaccination).  On Day 1 (Visit 1), subjects will have blood drawn for 
immunogenicity assessments, receive investigational product, be observed for 30 minutes 
after vaccination, and receive safety follow-up and electronic diary (e-diary) instructions.  
Prompted local reactions (redness, swelling, and pain at the injection site) and systemic 
events (fever, headache, fatigue, muscle pain, and joint pain) occurring within 14 days after
vaccination will be collected each day in the e-diary.  Approximately 1 month after 
vaccination (Visit 2), subjects will return to the study site for safety follow-up (ie, collection 
of AEs [including nonserious AEs, SAEs, and NDCMCs]) and a blood draw (safety 
laboratory testing [hematology and tests for liver and renal function] and immunogenicity).  
A telephone contact will occur 6 months after vaccination (Visit 3) to collect any SAEs or 
NDCMCs that occurred since the 1-month follow-up visit.
 
  
 
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Stage 2:
In Stage 2 of the study, approximately 440 healthy adults 65 through 85 years of age
previously vaccinated with Prevnar 13 ≥2 months prior to investigational product
administration, as part of their routine medical care, will be enrolled and randomized equally
in a 1:1 ratio to receive a dose of c7vPnC or PPSV23 as the control vaccine.  On Day 1 
(Visit 1), subjects will have blood drawn for immunogenicity assessments, receive 
investigational product, be observed for 30 minutes after vaccination, and receive safety 
follow-up and e-diary instructions.  Prompted local reactions and systemic events occurring 
within 14 days of vaccination will be collected each day in the e-diary.  Subjects will return 
to the investigator site for safety follow-up (AEs [including nonserious AEs, SAEs, and 
NDCMCs]) and a blood draw for immunogenicity approximately 1 month after vaccination 
(Visit 2).  A telephone contact will occur 6 months after vaccination (Visit 3) to collect any 
SAEs or NDCMCs that occurred since the 1-month follow-up visit.  Subjects will return 
approximately 12 months after vaccination (Visit 4)
 
and any SAEs or NDCMCs occurring in the interim since the 6-month 
telephone contact will be recorded.
 
 
 safety and immunogenicity data 
reviews/analyses will be performed at various time points as described in Section 9.
3.1. Duration of Subject Participation
Stage 1: Each subject will participate in the study for approximately 7 months.
Stage 2: Each subject will participate in the study for approximately 12 months.
3.2. Duration of the Study
The study duration (first subject enrolled in Stage 1 until last subject completing Stage 2)
will be approximately 20 months.
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3.3. Number of Subjects
Stage 1: Assuming a 10% dropout rate, approximately 66 subjects will be randomized to 
ensure approximately 60 evaluable subjects, with approximately 30 subjects in each of 2
groups.
Stage 2: Assuming a 10% dropout rate, approximately 440 subjects will be randomized to 
ensure approximately 400 evaluable subjects, with approximately 200 subjects in each of 2
groups.
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.
4.1. Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the 
study:
Stage 1
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 able to be contacted by 
telephone during study participation.
4. Male or female adults 50 to <65 years of age (from the 50th 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 in the last 12 weeks or not worsening or requiring 
hospitalization within 6 months before investigational product administration, as 
determined by medical history, physical examination, laboratory screening, and clinical 
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6. Male subjects able to father children and female subjects of childbearing potential must 
agree to use a highly effective method of contraception as outlined in the protocol from 
the time of informed consent through at least 28 days after the last dose of investigational 
product.
7. Negative urine pregnancy test at Day 1 (prior to vaccination) for all female subjects who 
are of childbearing potential.
8. Female subjects of nonchildbearing potential must meet at least 1 of the following 
criteria:
a.
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.
Stage 2
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 able to be contacted by 
telephone during study participation.
4. Male or female adults 65 to <86 years of age (from the 65th birthday up to but not 
including the 86th birthday) at enrollment.
5. Healthy adults, including adults with preexisting stable disease, defined as disease not 
requiring significant change in therapy in the last 6 weeks or not worsening or requiring 
hospitalization within 6 months before investigational product administration, as 
determined by medical history, physical examination, and clinical judgment of the 
investigator.
6. Vaccination with Prevnar 13 2 months prior to investigational product administration.

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7. Male subjects able to father children must agree to use a highly effective method of 
contraception as outlined in the protocol from the time of informed consent through at 
least 28 days after the last dose of investigational product.
8. Female subjects of nonchildbearing potential must meet at least 1 of the following 
criteria:
a.
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;
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:
Stage 1
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.
2. Participation in other studies involving investigational drug(s), vaccines, or medical 
device(s) within 28 days prior to study entry and/or during study duration.  Participation 
in purely observational studies is acceptable.
3. Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, 
gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunologic, 
metabolic, urological, dermatologic, or allergic disease (including drug allergies, but 
excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or any other 
major disease.
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.

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5. Baseline laboratory test results outside of the normal reference range considered 
clinically significant by the investigator (see Section 6.1.1 and Section 7.4).
6. Previous vaccination, or planned receipt through study participation, with any licensed or 
investigational pneumococcal vaccine other than study vaccine.
7. Vaccination within 12 months before investigational product administration, or planned 
receipt through study participation, with diphtheria-, pertussis-, or tetanus-containing 
vaccine(s) other than study vaccine.
8. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the investigational products or any other 
diphtheria toxoid–containing vaccine.
9. History of microbiologically proven invasive disease caused by S pneumoniae.
10. 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.
11. 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.
12. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular injection.
13. Receipt of blood/plasma products or immunoglobulin, within 60 days before
investigational product administration, or planned receipt through study participation.
14. Pregnant female subjects or breastfeeding female subjects (known or suspected).
Stage 2
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.
2. Participation in other studies involving investigational drug(s), vaccines, or medical 
device(s) within 28 prior to study entry and/or during study duration.  Participation in 
purely observational studies is acceptable.

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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 pneumococcal vaccine other than a single prior dose of 
Prevnar 13 (2 months prior to investigation product administration) or investigational 
pneumococcal vaccine other than study vaccines, 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 the investigational products (ie, c7vPnC 
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, 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.
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 prevaccination immunogenicity blood draw must occur on 
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4.3.1. Criteria for Temporarily Delaying Vaccine Administration (Stage 1 and Stage 2: 
Visit 1)
•
Febrile illness (body 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 Immunogenicity Blood Draw (Stage 1: Visit 1 
and Visit 2; Stage 2: Visits 1, 2
)
•
Receipt of antibiotic therapy within 72 hours before blood draw for immunogenicity 
samples.
4.4. Lifestyle Requirements
4.4.1. Contraception
All male subjects who are able to father children and all female subjects who are of 
childbearing potential 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 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 their 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 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 or the 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:
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 
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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.
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 
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 
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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, or 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 c7vPnC, Tdap (Stage 1 only), and PPSV23
(Stage 2 only).
5.1. Allocation to Investigational Product
Allocation of subjects to vaccine groups will occur 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
This is an observer-blinded study, as the appearance of c7vPnC, Tdap, and PPSV23 will not 
be matched. Prefilled syringes will be packaged in blinded cartons.  The study staff 
administering the vaccine will be unblinded, but all other study personnel including the 
principal investigator (PI), and the subject, will be blinded. The PI will assign the 
responsibility of unblinded administrator to persons who will not participate in the evaluation 
of any study subject. More than 1 unblinded administrator may be assigned. A member of 
the study site staff or clinic pharmacy should fulfill this role. Contact between the unblinded 
administrator and study subjects should be kept to a minimum. The investigator, study 
coordinator, and any site staff other than the unblinded administrator must not be allowed to 
know the investigational product assigned to any study subject and must not be allowed to 
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5.3. Blinding of the Sponsor
In Stage 1, certain sponsor staff outside of the core study team will monitor unblinded safety 
data for events that trigger stopping rules or for unexpected safety findings as the data are 
collected. Sponsor core study team members will remain blinded to vaccine 
assigned/received at the subject level, following the principles outlined in ICH E9 guideline 
on Statistical Principles for Clinical Trials, Section 2.3.1,60 until the analysis of all available 
safety data 1 month after vaccination. Study team members will review analyses in an 
unblinded manner.
In Stage 2, certain sponsor staff outside of the core study team will monitor unblinded safety 
data prior to the 1-month postvaccination analysis as the data are collected.  Sponsor core 
study team members will remain blinded to vaccine assigned/received at the subject level 
until the analysis of all available safety and immunogenicity data 1 month after vaccination.  
Study team members will review analyses in an unblinded manner.
In both stages, sponsor personnel directly involved in evaluating subject data will be blinded 
to vaccine assignment as described above, following the principles outlined in ICH E9 
guideline on Statistical Principles for Clinical Trials.60  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 study 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 case report form (CRF).
5.5. Subject Compliance
The dose of investigational product will be administered by the appropriately designated 
study staff at the investigator site.
5.6. Investigational Product Supplies
c7vPnC, Tdap (control for Stage 1), and PPSV23 (control for Stage 2) will be provided by 
the sponsor to the study sites.
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.

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5.6.1. Dosage Form(s) and Packaging
c7vPnC contains saccharides of the capsular antigens to S pneumonia serotypes 8, 10A, 11A, 
12F, 15B, 22F, and 33F individually conjugated to CRM197.  
 
 
 
 
 c7vPnC will be supplied by 
the sponsor to the sites as packaged single-use prefilled syringes and labeled according to 
local regulatory requirements.
Tdap is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens 
adsorbed on aluminum phosphate, for intramuscular injection. Tdap will be provided by the 
sponsor to the sites 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 serotypes of 
S pneumoniae: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 
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 sites as 
packaged single-use prefilled syringes and labeled according to local regulatory 
requirements.
5.6.2. Preparation and Dispensing
See the investigational product manual 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.
Investigational product will be prepared by qualified unblinded site personnel according to 
the investigational product manual.
5.7. Administration
All subjects will receive a single dose (0.5 mL) of investigational product intramuscularly 
into the deltoid muscle, preferably in the nondominant arm, at Visit 1.  The injection will be 
administered to the blinded subject by the designated unblinded administrator.
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 
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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 administrator) will 
ensure that all investigational 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.
c7vPnC, Tdap, and PPSV23 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 (c7vPnC IB, Tdap 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 
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.
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5.9. Investigational Product Accountability
The designated staff 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 site staff 
and then may be destroyed after the sponsor’s 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. Prior Vaccination (Stage 2 Only)
The date of the Prevnar 13 vaccination received prior to study enrollment must be recorded 
in the CRF.
5.11. Concomitant Treatment(s)
5.11.1. Prohibited Concomitant Treatments

Stage 1 and Stage 2 subjects:
o
Receipt of blood/plasma products, immunoglobulins, and/or immunosuppressive 
therapy (including a 14-day consecutive course of systemic corticosteroids) is 
prohibited until after Visit 2 of the study.
o
Receipt of any nonstudy investigational vaccines, drugs, or medical devices is 
prohibited during subject participation in the study.
o
Receipt of nonstudy pneumococcal vaccine is prohibited during subject participation 
in the study.
o
Receipt of any licensed vaccine, with the exception of licensed inactivated influenza 
vaccine (see Permitted Concomitant Treatments), is prohibited until after Visit 2 of 
the study.

Stage 1 subjects only:  Receipt of nonstudy vaccines containing tetanus, diphtheria, or 
pertussis is prohibited during subject participation in the study.

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5.11.2. Permitted Concomitant Treatments (Stage 1 and Stage 2 Subjects)

Licensed inactivated influenza vaccine may be given >14 days prior to or after 
investigational product administration. 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 the vaccination.

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.
5.11.3. 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 3 (Stage 1) or Visit 4 (Stage 2) will be 
collected and recorded in the CRF (per Section 5.11.1 and Section 5.11.2).
Medications taken to treat SAEs or NDCMCs from the signing of the informed consent 
document to Visit 3 (Stage 1) or Visit 4 (Stage 2) 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. Stage 1 Study Procedures
6.1.1. Screening (14 to 2 Days Prior to Vaccination) – Clinic Visit
Subjects will be screened 2 to 14 days prior to administration of the investigational product 
to confirm that they meet the subject selection criteria for the study. If the time between 
screening and vaccination is >14 days but 28 days as a result of unexpected delays 
(eg, delayed vaccine shipment), then qualified subjects do not require rescreening if the 
screening visit safety laboratory results and review of recent medical history meet the 
eligibility criteria.
The following procedures will be performed:

Obtain written informed consent before performing any study-specific procedures.

Assign subject number via the IRT.

Obtain and record the subject demography (sex, birth date, ethnicity, race, racial 
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•
Obtain and record any medical history of clinical significance.
•
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.  Vital signs (sitting blood pressure, pulse
rate, and respiratory rate) should also be assessed and recorded in the source documents.
•
Record nonstudy vaccinations and concomitant medications as described in
Section 5.11.3.
•
Ensure and document that all of the inclusion criteria and none of the exclusion criteria 
are met.
•
Obtain a blood sample for 
 hematology and chemistry.  Subjects with 
abnormal laboratory results (Section 7.4) outside of normal reference ranges that are 
considered to be clinically significant by the investigator will not be eligible for
randomization.
•
If abnormal laboratory parameters are reported at screening and the investigator 
believes the results to be erroneous or represent stable Grade 1 abnormalities
(see Section 7.4), a retest of the abnormal laboratory parameters may be conducted.
Subjects with stable Grade 1 abnormalities may be considered eligible at the 
discretion of the investigator.  A “stable” Grade 1 laboratory abnormality is defined 
as a report of Grade 1 on an initial blood sample that remains ≤Grade 1 upon repeat
testing on a second sample from the same subject.
•
Record AEs as described in Section 8.
•
Remind the subject to use appropriate contraceptives until 28 days after vaccination, if 
applicable.
•
The investigator or an authorized designee completes the CRF.
6.1.2. Visit 1 (Day 1; Day of Vaccination) – Clinic Visit
•
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).
•
Perform urine pregnancy test for female subjects of childbearing potential
(see Section 7.1).
•
Perform a contraception check (see Section 4.4.1), if applicable.
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
Record nonstudy vaccinations and concomitant medications as described in
Section 5.11.3.

Assign randomization number and investigational product container number via the 
IRT.  This must be the last step before proceeding.  The unblinded site staff member 
will prepare the investigational product according to the investigational product 
manual.

After randomization:

Collect a blood sample of approximately 50 mL for immunogenicity assessments
prior to vaccination.

The unblinded 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 14, with Day 1 being the day 
of vaccination.

Ask the subject to contact the site staff or investigator immediately during the 14-day 
postvaccination period if he or she experiences fever >104.0F (>40.0C) or a 
Grade 3 local reaction (ie, redness or swelling at the injection site measuring 
21 measuring device units [10.5 cm], or severe injection site pain [prevents daily 
activity]) to determine if the event requires further assessment by the investigator.

Subjects will also be instructed to contact site staff if they experience any possible 
Grade 4 prompted local reaction or systemic event (refer to Section 7.2.3) or any 
severe nonprompted AE or any SAE during the 14-day postvaccination period.

Remind the subject that study staff may assess him or her to obtain additional 
information on Grade 3 events entered into the e-diary.

Ask the subject to contact the investigator or 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.

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•
Record AEs 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 14 days following vaccination to evaluate 
subject compliance and as part of the ongoing safety review.
6.1.3. Visit 2 (Month 1; 28 to 35 Days After Vaccination) – Clinic Visit
•
Ensure and document that the subject continues to be eligible for the study and that none 
of the temporary blood draw delay criteria are met.
•
Perform a contraception check (see Section 4.4.1), if applicable.
•
Record nonstudy vaccinations and concomitant medications as described in
Section 5.11.3.
•
•
Collect a blood sample of approximately 50 mL for immunogenicity assessments.
•
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 ongoing AEs, SAEs, or NDCMCs 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 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.
6.1.4. Visit 3 (Month 6; 168 to 196 Days After Vaccination) – Telephone Contact
•
Record nonstudy vaccinations and medications as described in Section 5.11.3.
•
Determine whether any NDCMCs or SAEs have occurred since Visit 2 and follow up on 
any previously reported ongoing AEs, SAEs, or NDCMCs to determine the outcome 
(ie, record stop dates or confirm if they are still continuing) and record as described in 
Section 8.
•
The investigator or an authorized designee completes the CRF.
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6.2. Stage 2 Study Procedures
6.2.1. Visit 1 (Day 1; Day of Vaccination) – Clinic Visit

Prior to vaccination:

Obtain written informed consent before performing any study-specific procedures.

Assign a subject number via the IRT.

Obtain and record the subject demography (sex, birth date, ethnicity, race, racial 
designation).

Obtain and record any medical history of clinical significance.

Obtain and record the date of Prevnar 13 vaccination received prior to study 
enrollment.

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. Vital signs (sitting 
blood pressure, pulse rate, and respiratory rate) should also be assessed and recorded 
in the source documents.

Measure and record the subject’s prevaccination oral temperature (F/C).

Record nonstudy vaccinations and concomitant medications as described in
Section 5.11.3.

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.

Assign a randomization number and investigational product container number via the 
IRT. This must be the last step before vaccinating the subject.  The unblinded site 
staff member will prepare the investigational product according to the investigational 
product manual.

After randomization:

Collect a blood sample of approximately 50 mL for immunogenicity assessments
prior to vaccination.

The unblinded administrator will administer a single 0.5-mL injection of 
investigational product into the deltoid muscle (preferably in the nondominant arm).

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
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 14, with Day 1 being the day 
of vaccination.

Ask the subject to contact the site staff or investigator immediately if he or she 
experiences fever >104.0F (>40.0C) or Grade 3 local reaction (ie, redness or 
swelling at the injection site measuring 21 measuring device units [10.5 cm], or 
severe injection site pain [prevents daily activity]) to determine if the event requires 
further assessment by the investigator.

Subjects will also be instructed to contact site staff if they experience any possible 
Grade 4 prompted local reaction or systemic event (refer to Section 7.2.3).

Remind the subject that study staff may assess him or her to obtain additional 
information on Grade 3 events entered into the e-diary.

Ask the subject to notify the investigator or 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.

Record AEs 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 14 days following vaccination to evaluate 
subject compliance and as part of the ongoing safety review.
6.2.2. Visit 2 (Month 1; 28 to 35 Days After Vaccination) – Clinic Visit

Ensure and document that the subject continues to be eligible for the study and that none 
of the temporary blood draw delay criteria are met.

Perform a contraception check (see Section 4.4.1), if applicable.

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•
Record nonstudy vaccinations and concomitant medications as described in
Section 5.11.3.
•
Collect a blood sample of approximately 50 mL for immunogenicity assessments.
•
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 ongoing AEs, SAEs, or NDCMCs 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 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.
6.2.3. Visit 3 (Month 6; 168 to 196 Days After Vaccination) – Telephone Contact
•
Record nonstudy vaccinations and concomitant medications as described in
Section 5.11.3.
•
Ensure and document that the subject continues to be eligible for the study.
•
Determine whether any NDCMCs or SAEs have occurred since Visit 2 and follow up on 
any previously reported ongoing AEs, SAEs, or NDCMCs to determine the outcome 
(ie, record stop dates or confirm if they are still continuing) and record as described in
Section 8.
•
The investigator or an authorized designee completes the CRF.
6.2.4. Visit 4 (Month 12; 350 to 378 Days After Vaccination) – Clinic Visit
•
Ensure and document that none of the temporary blood draw delay criteria are met.
•
Record nonstudy vaccinations and concomitant medications as described in
Section 5.11.3.
•
•
Determine whether any SAEs or NDCMCs have occurred since Visit 3 and follow up on 
any previously reported AEs, SAEs, or NDCMCs to determine the outcome (ie, record 
stop dates or confirm if they are still continuing) and record as described in Section 8.
•
The investigator or an authorized designee completes the CRF.
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6.3. Unscheduled Visits (Stage 1 and Stage 2)
If the subject reports redness or swelling at the injection site measuring 21 measuring 
device units (10.5 cm), severe injection site pain, or fever >104.0F (>40.0C) during the 
14-day postvaccination period, a telephone contact must occur as soon as possible between 
the investigator or appropriately qualified designee and subject to assess if an unscheduled 
site visit is required.  A site visit must 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.
During the unscheduled 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 7.2.3.1.

Assess for other findings associated with the reaction (eg, lymphadenopathy) 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 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) or local reaction (ie, necrosis, exfoliative dermatitis, or emergency 
room visit/hospitalization for injection site pain) within 14 days after vaccination.  Study 
staff may contact the subject to obtain additional information on Grade 3 events entered into 

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the e-diary.  Lastly, subjects will be instructed to contact the site to report any significant 
illness, medical event, or hospitalization that occurs during the study period.  The site should 
determine if an unscheduled visit to further evaluate the event is warranted in all such cases.
6.4. 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.
The investigator should capture the reason for withdrawal in the database for all subjects and 
a 6-month postvaccination 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.
6.4.1. Withdrawal of Consent
Subjects who request to discontinue after 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 and entered on the appropriate 
CRF page.  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.
6.4.2. 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 site will use locally permissible methods to obtain
the date and cause of death. If the investigator’s use of a third-party 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 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 site staff and representative will consult 

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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.
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 study 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.
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.
7.1. Pregnancy Testing
For female subjects of childbearing potential, a urine pregnancy test, with sensitivity of at 
least 25 mIU/mL, will be performed immediately before administration of the investigational 
product.  A negative pregnancy test result is required before the subject may receive the 
investigational product. Pregnancy tests may also be repeated if requested by institutional 
review boards (IRBs)/ethics committees (ECs) or if required by local regulations. In the case 
of a positive confirmed pregnancy at Visit 1, the subject will be withdrawn from 
administration of investigational product and from the study.  In the case of a positive 

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confirmed pregnancy after administration of investigational product, the subject may remain 
in the study for safety monitoring.
7.2. 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 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 in the 
14 days after investigational product administration at Visit 1, are graded as described in
Section 7.2.3.  In addition, safety laboratory testing as described in Section 7.4 will be 
performed in Stage 1.  Furthermore, AEs, SAEs, and NDCMCs will be collected as defined 
in Section 8.
 
 
 
 
 
 
 
 
 
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7.2.2. Subject Electronic Diary
The subject will be asked to monitor and record local reactions, systemic events, fever, and 
antipyretic/pain medication used to treat symptoms, each evening for 14 days following 
vaccination (Day 1 through Day 14, 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, fever, and antipyretic/pain medication used to treat 
symptoms reported on the e-diary will be transferred electronically to the e-diary vendor, 
where they will be available for review by investigators, their appropriately 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.
These 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 appropriately qualified designees) 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 (see Stopping Rules in Section 7.2.1).
The investigator or designee must contact the subject in order to 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.
7.2.3. Grading Scale for Prompted Events
The grading scales used in this study to assess 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.61
7.2.3.1. Local Reactions
From Day 1 to Day 14, where Day 1 is the day of vaccination, 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 1 below.  Measuring device units can be converted 
to centimeters according to the following scale: 1 measuring device unit = 0.5 cm.  Pain at 
the vaccine injection site will be assessed by the subject as mild, moderate, or severe 
according to the grading scale in Table 1.  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 
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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. Site staff will educate the subject 
regarding signs and symptoms that would prompt site contact.
The procedure for notification of the sponsor is provided in the study reference manual 
(SRM) or equivalent.
Table 1.
Grading Scales for Local Reactions
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Redness
(synonym 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
(synonym 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 study 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 
will be collected 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.
7.2.3.2. Systemic Events
From Day 1 to Day 14, where Day 1 is the day of vaccination, 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 2 below. Subjects will also be instructed to 
contact 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 14 days after vaccination.  Study staff may also contact the subject to obtain additional 
information on Grade 3 events entered into the e-diary.
Only an investigator is able to classify a subject’s systemic event as Grade 4, after physical 
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(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 2.
Grading Scales for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Fatigue
(synonym 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.
7.2.3.3. 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 14 days following vaccination (Days 1 to 14, where Day 1 
is the day of vaccination) and at any time during the 14 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 14, temperature will be 
collected daily until fever has resolved (1 day of temperature <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 and perform an unscheduled assessment or visit 
as appropriate. 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 3 below.
Table 3.
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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7.2.3.4. Use of Antipyretic/Pain Medication
From Day 1 to Day 14, where Day 1 is the day of vaccination, 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.
7.3. Immunogenicity
Blood samples (approximately 50 mL/visit) for immunogenicity assessments will be 
collected from all subjects prior to vaccination (Visit 1/Day 1), at Visit 2 approximately 
1 month after vaccination, 
 
.  Serum samples should be processed and stored as indicated in the SRM.
The total volume of blood collected from each subject will be approximately 120 mL
(Stage 1 subjects) or 150 mL (Stage 2 subjects) (~50 mL/visit).  Sera will be used for 
immunogenicity assessments and assay development purposes.
OPA titers for the 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) will be 
determined in all subjects for each blood sample.  Results will be reported as OPA titers.
 
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.
7.4. Laboratory Tests:  Stage 1 Only
The safety laboratory tests will be performed at times defined in the Schedule of Activities
and Section 6 of the protocol.
The FDA toxicity grading scale61 for healthy adult and adolescent volunteers enrolled in 
preventive vaccine clinical trials will be used to grade abnormalities.
If abnormal laboratory parameters are reported at screening 
and the investigator 
believes the results to be erroneous or to represent stable Grade 1 abnormalities, the 
abnormal laboratory parameters may be retested. Subjects with stable Grade 1 abnormalities 
may be considered eligible at the discretion of the investigator.  A “stable” Grade 1 
laboratory abnormality is defined as a report of Grade 1 on an initial blood sample that 
remains ≤Grade 1 upon repeat testing on a second sample from the same subject.
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Hematology
Chemistrya
Hemoglobin
Hematocrit
RBC count
Platelet count
WBC count with differential
BUN/urea and creatinine
AST, ALT
Total bilirubin
Alkaline phosphatase
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; BUN = blood urea 
nitrogen; RBC = red blood cell; WBC = white blood cell.
a.
Please refer to Section 8.4.2 for additional testing required for subjects who meet Hy’s law criteria.
7.5. 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.
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) 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 2.  After Visit 2, only NDCMCs (can be nonserious) and SAEs will be reported.

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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/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 
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.
For Stage 1 subjects, the investigator must contact the Pfizer study physician directly as soon 
as possible after becoming aware of a nonprompted severe AE or SAE occurring within 
14 days after vaccination.  Additional information regarding such events and the reporting 
requirements can be found in the SRM or equivalent.
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.

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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, 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 2.  Between Visit 2 and Visit 3 (Stage 1) and Visit 2 and Visit 4 
(Stage 2), 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.
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.

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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.
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;

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
Drug withdrawal;

Drug misuse; 

Drug interactions;

Extravasation;

Exposure during pregnancy (EDP);

Exposure via breastfeeding;

Medication error;

Occupational exposure.
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);

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
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.
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;
o
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 

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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;

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.

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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.
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 
Stage 2 of 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.

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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:
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) 

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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.
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;

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).

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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.
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.

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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.
8.4.4. Medication Errors
Other exposures to the investigational product under study may occur in clinical trial settings, 
such as medication errors.
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer Safety 
Within 24 Hours of Awareness
Medication errors
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors 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 AEs, serious and nonserious, are recorded on an AE page of the 
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Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
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. In Stage 1, 
approximately 33 adults per vaccine group are planned to be randomized in order to have 
approximately 30 evaluable subjects per vaccine group.  In Stage 2, approximately 220 adults 
per vaccine group are planned to be randomized in order to have approximately 200 
evaluable subjects per vaccine group.  No formal statistical comparisons between vaccine 
groups are planned.
Table 4 shows the probability of observing at least 1 AE, local reaction, or systemic event for 
a given true event rate of a particular event, at various sample sizes of each study stage. For 
example, if the true chance of an event is 5%, the probability of observing at least 1 such 
event is 0.816 for a Stage 1 sample size of 30 subjects and 0.999 for a Stage 2 sample size 
of 200 subjects.
Table 4.
Probability of Observing at Least 1 AE, Local Reaction, or Systemic Event 
by Assumed True Event Rates With Different Sample Sizes
Sample Size
Assumed True Event Rate of at Least 1 AE, Local Reaction, or Systemic Event
Stage 1
3%
5%
10%
12%
N = 33
0.634
0.816
0.969
0.985
Stage 2
1%
3%
5%
N = 220
0.890
0.999
0.999

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9.2. Analysis Populations
In Stage 1, the safety population will include all subjects who receive at least 1 dose of 
c7vPnC or Tdap. In Stage 2 the safety population will include all subjects who receive at 
least 1 dose of c7vPnC or PPSV23.  Subjects will be assigned to vaccine groups
corresponding to the vaccine actually received within each of the 2 study stages, respectively.  
The safety population will be the only analysis population for the primary endpoints for each 
study stage.
 evaluable immunogenicity populations are defined: the 1-month postvaccination 
evaluable immunogenicity population in each of Stage 1 and Stage 2
. The evaluable 
immunogenicity population for each study stage will generally include any subject
•
who does not meet any exclusion criteria and meets all inclusion criteria, 
•
who has no major protocol deviations as determined by the clinician, and 
•
who receives the assigned vaccine, as randomized.
Furthermore, for the 1-month postvaccination evaluable immunogenicity populations in 
Stage 1 and Stage 2, separately, 
•
whose Visit 2 at the 1-month blood draw collection is within 27 to 49 days, inclusive, 
after vaccination, and 
•
who has at least 1 valid and determinate assay result for at least 1 serotype for Visit 2 
(1 month after vaccination).
 
 
 
 
The evaluable immunogenicity populations will be the primary analysis populations for 
immunogenicity results.
The all-available immunogenicity population will be defined for each postvaccination blood 
draw collection visit.  Each all-available population will include all subjects who receive 
vaccine and have at least 1 valid and determinate assay result at the indicated visit. The all-
available immunogenicity populations will be the secondary analysis populations for 
immunogenicity results. Subjects will be assigned to their randomized study vaccination.
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9.3. Immunogenicity Analysis
Secondary endpoints include both GMTs 1 month after vaccination and GMFRs measured 
from before vaccination to 1 month after vaccination.  GMTs and GMFRs will be calculated 
for each OPA assay within each study stage age group separately.  Ninety-five percent
confidence intervals (CIs) will also be obtained.  Each serotype will be analyzed separately.
 
 
GMTs and their 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. GMFRs 
and their CIs will be obtained by first dividing the indicated postbaseline titer (at 1 month 
 
by the baseline titer and log transforming the ratios.  The GMFR and its CI will 
be calculated using the same method as for GMTs.
 
 
 
 
 
 
 
 
9.4. Safety Analysis
Descriptive statistics will be compiled for each safety endpoint for each vaccine group within 
each age group, separately. In each of Stage 1 and Stage 2 groups, local reactions and 
systemic events from Day 1 to Day 14 after study vaccination 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 until Visit 2, approximately 1 month (28-35 days) after 
vaccination for Stage 1 and Stage 2. Additionally, SAEs and NDCMCs will be presented 
from vaccination until approximately 6 months after vaccination (both Stage 1 and Stage 2) 
and 12 months after vaccination (Stage 2 only).  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.
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9.5. Analysis Timing
During this multistage study, the following analyses will occur:
Stage 1
1. Unblinded descriptive analyses of Stage 1 safety data through the 1-month 
postvaccination visit to permit start of Stage 2.
2. Unblinded immunogenicity data from the 1-month postvaccination visit from Stage 1 will 
be analyzed when it is available.  Analyses will be descriptive.
3. Unblinded descriptive analyses of the 6-month postvaccination safety data will be
conducted when data are available.
Stage 2
1. Unblinded descriptive analyses for the 1-month postvaccination time point for Stage 2 
will be conducted when the safety and immunogenicity data are available. This analysis 
will inform internal program development decisions and provide safety and 
immunogenicity data to support end–of–Phase 2 regulatory interactions for development 
of an adult indication.
2. Unblinded descriptive analyses of the 6-month and 12-month postvaccination safety data 
will be conducted when data are available.
 
There will be no alpha adjustments for these analyses.
Investigator sites and laboratory personnel directly conducting the immunogenicity assays 
will remain blinded until the study database has been locked and unblinded.
 
 
 
 
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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 IRB/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.
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.
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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.
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 
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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.
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.

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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
c7vPnC 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.
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.

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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 have 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.
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.

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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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39
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41
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Appendix 1. Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
7vPnC
7-valent pneumococcal conjugate vaccine
AE
adverse event
ALT
alanine aminotransferase
AOM
acute otitis media
AST
aspartate aminotransferase
c7vPnC
complementary 7-valent pneumococcal conjugate vaccine
CAP
community-acquired pneumonia
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
EDP
exposure during pregnancy
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration
FIH
first-in-human
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMFR
geometric mean fold rise
GMT
geometric mean titer
HIV
human immunodeficiency virus
IB
investigator’s brochure
ICH
International Council for Harmonisation
ID
identification
IND
investigational new drug application
INR
international normalized ratio
CCI
CCI

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Abbreviation
Term
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
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
SAE
serious adverse event
SAP
statistical analysis plan
SRM
study reference manual
SRSD
single reference safety document
TBD
to be determined
TBili
total bilirubin
Tdap
tetanus, diphtheria, and acellular pertussis vaccine
ULN
upper limit of normal
US
United States
USPI
US package insert
VT
vaccine-type
WHO
World Health Organization
CCI
CCI

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