A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Phase: PHASE2
Conditions: Pneumococcal Infections
Sponsor: Pfizer

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A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY 
AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL 
CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT 
PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Investigational Product Number:
PF-06842433
Investigational Product Name:
Complementary 7-valent Pneumococcal 
Conjugate Vaccine
United States (US) Investigational New 
Drug (IND) Number:
European Clinical Trials Database 
(EudraCT) Number:
Protocol Number:
C3571002
Phase:
2
This document and accompanying materials contain confidential information belonging to Pfizer.  Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this information in
confidence and not copy or disclose it to others (except where required by applicable law) or use it for 
unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Pfizer must be 
promptly notified.
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Document History
Document
Version Date
Summary of Changes and 
Rationale
Amendment 1
18 Feb 2020
Title Page: Added the US IND 
number, which was pending at the 
time of protocol finalization.
Protocol Summary and Section 3:
Removed the consideration of sites
from other countries outside of the 
United States as only US sites are 
participating in the study.  
Protocol Summary and Section 3:
Updated the total number of subjects
randomized from “approximately 
690” to “565” due to the adequacy 
of this study size to provide the
needed information to evaluate the 
endpoints and facilitate a timely 
readout for this descriptive study.  
The number of subjects per arm was 
also updated accordingly.
Section 4.2: Reworded exclusion 
criterion 5 to, “Prior receipt of 
hepatitis B vaccine at age ≥30 days” 
to further clarify the criterion.
Section 5.7.3: Clarified that a
licensed inactivated influenza 
vaccine may be given to eligible 
study subjects during influenza 
season.
Section 6: Clarified that the 
subject’s recorded demographic 
information will include race.
Section 8.2.1: Clarified that events
consistent with normal growth and 
development are generally not to be 
considered adverse events.
Sections 9.1, 9.3.1, and 9.3.2: 
Updated the number of subjects per 
arm and the probabilities of 
detecting AEs by frequency,
 
 
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Document
Version Date
Summary of Changes and 
Rationale
Original protocol
21 Dec 2017
Not applicable (N/A)
This amendment incorporates all revisions to date, including amendments made at the 
request of the country health authorities and institutional review boards (IRBs)/ethics 
committee (ECs). 

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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................9
APPENDICES ...........................................................................................................................9
PROTOCOL SUMMARY.......................................................................................................10
SCHEDULE OF ACTIVITIES................................................................................................14
1. INTRODUCTION ...............................................................................................................20
1.1. Indication.................................................................................................................20
1.2. Background and Rationale ......................................................................................20
1.2.1. Pneumococcal Disease................................................................................20
1.2.2. Vaccines to Prevent Pneumococcal Disease...............................................21
1.2.2.1. Pneumococcal Polysaccharide Vaccines...................................21
1.2.2.2. Pneumococcal Polysaccharide Conjugate Vaccines .................21
1.2.2.3. Rationale for c7vPnC ................................................................22
2. STUDY OBJECTIVES AND ENDPOINTS.......................................................................23
2.1. Primary Objective and Endpoints ...........................................................................23
2.1.1. Primary Objective.......................................................................................23
2.1.2. Primary Endpoints ......................................................................................23
2.2. Secondary Objective and Endpoints .......................................................................24
2.2.1. Secondary Objective...................................................................................24
2.2.2. Secondary Endpoints ..................................................................................24
3. STUDY DESIGN.................................................................................................................25
3.1. Duration of Subject Participation............................................................................26
3.2. Duration of Study....................................................................................................26
3.3. Number of Subjects.................................................................................................26
4. SUBJECT ELIGIBILITY CRITERIA.................................................................................27
4.1. Inclusion Criteria.....................................................................................................27
4.2. Exclusion Criteria....................................................................................................27
4.3. Temporary Delay Criteria .......................................................................................29
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4.3.1. Criteria for Temporarily Delaying Dose Administration (Doses 1, 2, 
3, and 4 and the Supplemental Dose)...............................................................29
4.3.2. Criteria for Temporarily Delaying Blood Draw (Prior to Dose 3, 1 
Month After Dose 3, Prior to Dose 4, and 1 Month After Dose 4 and the 
Supplemental Dose).........................................................................................29
4.4. Sponsor’s Qualified Medical Personnel..................................................................29
5. INVESTIGATIONAL PRODUCTS ...................................................................................30
5.1. Allocation to Investigational Product......................................................................30
5.2. Subject Compliance.................................................................................................30
5.3. Investigational Product Supplies.............................................................................30
5.3.1. Dosage Form(s) and Packaging..................................................................30
5.3.2. Preparation and Dispensing........................................................................31
5.4. Administration.........................................................................................................31
5.5. Investigational Product Storage ..............................................................................32
5.6. Investigational Product Accountability...................................................................33
5.6.1. Destruction of Investigational Product Supplies ........................................33
5.7. Concomitant Vaccines/Medications........................................................................33
5.7.1. Concomitant Vaccines to Be Administered at Study Visits .......................33
5.7.2. Prohibited Vaccines/Medications During the Study...................................33
5.7.3. Permitted Vaccines/Medications During the Study....................................34
5.7.4. Recording Prior and Concomitant Treatments ...........................................34
6. STUDY PROCEDURES .....................................................................................................35
6.1. Group 1 (Coadministration) Study Procedures .......................................................35
6.1.1. Group 1 Visit 1 (Dose 1: 2-Month Visit, Day 1)........................................35
6.1.2. Group 1 Visit 2 (Dose 2: 4-Month Visit, 42 to 63 Days After Dose 1)......36
6.1.3. Group 1 Visit 3 (Dose 3: 6-Month Visit, 42 to 63 Days After Dose 2)......37
6.1.4. Group 1 Visit 4 (Follow-up: 7-Month Visit, 28 to 42 Days After 
Dose 3).............................................................................................................38
6.1.5. Group 1 Visit 5 (Dose 4: 12-Month Visit, 365 to 386 Days of Age) .........39
6.1.6. Group 1 Visit 6 (Follow-up: 13-Month Visit, 28 to 42 Days After 
Dose 4).............................................................................................................40
6.1.7. Group 1 Visit 7 (Follow-up: 18-Month Phone Contact, 168 to 196 
Days After Dose 4) ..........................................................................................41
6.2. Group 2 (Staggered Administration) Study Procedures..........................................41

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6.2.1. Group 2 Visit 1 (Prevnar 13: 2-Month Visit, Day 1)..................................41
6.2.2. Group 2 Visit 2 (c7vPnC Dose 1: 3-Month Visit, 21 to 35 Days After 
Prevnar 13 at Visit 1).......................................................................................42
6.2.3. Group 2 Visit 3 (Prevnar 13: 4-Month Visit, 42 to 63 Days After 
Prevnar 13 at Visit 1).......................................................................................43
6.2.4. Group 2 Visit 4 (c7vPnC Dose 2: 5-Month Visit, 21 to 35 Days After 
Prevnar 13 at Visit 3).......................................................................................44
6.2.5. Group 2 Visit 5 (Prevnar 13: 6-Month Visit, 42 to 63 Days After 
Prevnar 13 at Visit 3).......................................................................................45
6.2.6. Group 2 Visit 6 (c7vPnC Dose 3: 7-Month Visit, 21 to 35 Days After 
Prevnar 13 at Visit 5).......................................................................................46
6.2.7. Group 2 Visit 7 (Follow-up: 8-Month Visit, 28 to 42 Days After 
Dose 3).............................................................................................................47
6.2.8. Group 2 Visit 8 (Prevnar 13: 12-Month Visit, 365 to 386 Days of 
Age)..................................................................................................................47
6.2.9. Group 2 Visit 9 (c7vPnC Dose 4: 13-Month Visit, 21 to 35 Days 
After Prevnar 13 at Visit 8)..............................................................................48
6.2.10. Group 2 Visit 10 (Follow-up: 14-Month Visit, 28 to 42 Days After 
Dose 4).............................................................................................................49
6.2.11. Group 2 Visit 11 (Follow-up: 19-Month Phone Contact, 168 to 196 
Days After Dose 4) ..........................................................................................50
6.3. Group 3 (Control With Supplemental Dose) Study Procedures .............................50
6.3.1. Group 3 Visit 1 (Dose 1: 2-Month Visit, Day 1)........................................50
6.3.2. Group 3 Visit 2 (Dose 2: 4-Month Visit, 42 to 63 Days After Dose 1)......51
6.3.3. Group 3 Visit 3 (Dose 3: 6-Month Visit, 42 to 63 Days After Dose 2)......52
6.3.4. Group 3 Visit 4 (Follow-up: 7-Month Visit, 28 to 42 Days After 
Dose 3).............................................................................................................53
6.3.5. Group 3 Visit 5 (Dose 4: 12-Month Visit, 365 to 386 Days of Age) .........54
6.3.6. Group 3 Visit 6 (Follow-up and Administration of the c7vPnC 
Supplemental Dose: 13-Month Visit, 28 to 42 Days After Dose 4)................55
6.3.7. Group 3 Visit 7 (Follow-up of the Supplemental Dose: 14-Month 
Visit, 28 to 42 Days After the Supplemental Dose).........................................56
6.3.8. Group 3 Visit 8 (Follow-up: 19-Month Phone Contact, 168 to 196 
Days After the Supplemental Dose) ................................................................57
6.4. Unscheduled Visits..................................................................................................57
6.5. Subject Withdrawal.................................................................................................58

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7. ASSESSMENTS..................................................................................................................60
7.1. Safety Parameters....................................................................................................60
7.1.1. Subject Electronic Diary.............................................................................60
7.1.2. Grading Scale for Prompted Events ...........................................................61
7.1.2.1. Local Reactions.........................................................................61
7.1.2.2. Systemic Event Symptoms and Fever.......................................62
7.2. Immunogenicity ......................................................................................................64
7.3. Biological Samples..................................................................................................65
8. ADVERSE EVENT REPORTING......................................................................................67
8.1. Requirements...........................................................................................................67
8.1.1. Additional Details on Recording Adverse Events on the CRF...................68
8.1.2. Eliciting Adverse Event Information..........................................................68
8.1.3. Withdrawal From the Study Due to Adverse Events (see also the 
Subject Withdrawal Section) ...........................................................................68
8.1.4. Time Period for Collecting AE/SAE/NDCMC Information ......................68
8.1.4.1. Reporting SAEs to Pfizer Safety...............................................69
8.1.4.2. Recording Nonserious AEs and SAEs on the CRF...................69
8.1.5. Causality Assessment .................................................................................69
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities ..................70
8.2. Definitions...............................................................................................................70
8.2.1. Adverse Events ...........................................................................................70
8.2.2. Abnormal Test Findings .............................................................................71
8.2.3. Serious Adverse Events..............................................................................71
8.2.4. Hospitalization............................................................................................72
8.3. Severity Assessment................................................................................................73
8.4. Special Situations ....................................................................................................74
8.4.1. Protocol-Specified Serious Adverse Events...............................................74
8.4.2. Potential Cases of Drug-Induced Liver Injury............................................74
8.4.3. Exposure to the Investigational Product During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................76
8.4.3.1. Exposure During Pregnancy......................................................76
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8.4.3.2. Exposure During Breastfeeding ................................................77
8.4.3.3. Occupational Exposure .............................................................77
8.4.4. Medication Errors and Lack of Efficacy ....................................................77
8.4.4.1. Medication Errors......................................................................78
8.4.4.2. Lack of Efficacy........................................................................78
8.5. Medical Device Complaint Reporting Requirements .............................................79
9. DATA ANALYSIS/STATISTICAL METHODS...............................................................79
9.1. Sample Size Determination.....................................................................................79
9.2. Analysis Populations...............................................................................................79
9.3. Immunogenicity Analysis .......................................................................................81
9.3.1. Analyses of Secondary
 Endpoints ...................................81
9.4. Safety Analysis........................................................................................................83
10. QUALITY CONTROL AND QUALITY ASSURANCE.................................................84
11. DATA HANDLING AND RECORD KEEPING .............................................................85
11.1. Case Report Forms/Electronic Data Record .........................................................85
11.2. Record Retention...................................................................................................86
12. ETHICS..............................................................................................................................86
12.1. Institutional Review Board/Ethics Committee......................................................86
12.2. Ethical Conduct of the Study ................................................................................86
12.3. Subject Information and Consent..........................................................................87
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH 
GCP ...........................................................................................................................87
13. DEFINITION OF END OF TRIAL...................................................................................88
13.1. End of Trial in All Participating Countries ...........................................................88
14. SPONSOR DISCONTINUATION CRITERIA ................................................................88
15. PUBLICATION OF STUDY RESULTS..........................................................................88
15.1. Communication of Results by Pfizer ....................................................................88
15.2. Publications by Investigators ................................................................................89
16. REFERENCES ..................................................................................................................91
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LIST OF TABLES
Table 1.
Summary of Study Groups and Key Procedures ......................................25
Table 2.
Grading Scales for Local Reactions .........................................................62
Table 3.
Grading Scales for Systemic Events.........................................................63
Table 4.
Ranges for Fever.......................................................................................64
Table 5.
Probability of Observing at Least 1 AE, Local Reaction, or 
Systemic Event by Assumed True Event Rates........................................79
APPENDICES
Appendix 1. Abbreviations......................................................................................................98

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PROTOCOL SUMMARY
Background and Rationale
Streptococcus pneumoniae are gram-positive encapsulated cocci that are a leading cause of
bacteremia, bacterial meningitis, pneumonia, and acute otitis media (AOM) and continue to 
be a major global public health concern. Serious pneumococcal disease may occur at any 
age; however, children <5 years and adults 65 years of age are at particularly increased risk.  
Individuals with certain comorbidities and immunocompromising conditions are also at risk, 
especially persons with chronic heart, lung, liver, and renal disease, as well as those who are 
functionally asplenic. AOM carries the risk of complications such as tympanostomy tube 
placement, hearing loss, mastoiditis, and meningitis as well as being a significant burden on 
the healthcare system.  S pneumoniae remains an important cause of serious disease in the 
United States and worldwide.
The polysaccharide capsule has been identified as an important virulence factor for this 
pathogen.  While more than 95 pneumococcal serotypes, differentiated by their capsular
polysaccharide composition, have been identified, serious disease is generally caused by a 
smaller subset of serotypes.  Pneumococcal disease can be prevented with polysaccharide-
based vaccines that induce antibody responses with functional (opsonophagocytic) activity 
and target the capsular serotypes responsible for disease.  Pneumococcal vaccines containing 
free polysaccharides, such as the licensed 23-valent pneumococcal polysaccharide vaccine 
(PPSV23), are poorly immunogenic in immunocompromised populations, older adults, and 
children less than 2 years of age, and are not recommended in this younger age group.  This 
led to development of pneumococcal conjugate vaccines, which contain capsular 
polysaccharides covalently linked to a protein carrier, and which induce protective immune
responses in young children and older adults, as well as populations with high-risk 
conditions.  Prevnar® (7-valent pneumococcal conjugate vaccine), which was licensed in the 
United States in 2000, and Prevnar 13® (13-valent pneumococcal conjugate vaccine), which 
was licensed in the United States in 2010, are pneumococcal conjugate vaccines containing 7 
and 13 pneumococcal capsular polysaccharides, respectively, that are each covalently linked 
to a nontoxic variant of diphtheria toxin, cross-reactive material (CRM197).  These vaccines 
targeted serotypes that caused the majority of pneumococcal disease in infants and older 
adults at the time of their introduction.  They have demonstrated efficacy/effectiveness 
against vaccine-type (VT) invasive pneumococcal disease (IPD) such as bacteremia and 
meningitis, as well as AOM, and community-acquired pneumonia (CAP).  Additionally, they 
have been found to reduce nasopharyngeal carriage and transmission, resulting in beneficial 
indirect effects.
Pfizer is developing a new complementary 7-valent pneumococcal conjugate vaccine
(c7vPnC) candidate to expand protection against pneumococcal disease beyond that covered 
by current pneumococcal vaccines in children and adults.  c7vPnC contains pneumococcal 
conjugates of 7 different serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).  c7vPnC contains 
the same conjugate carrier protein and excipients and uses the same platform as Prevnar 13.  
A meta-analysis of serotypes causing IPD in children <5 years of age in regions of the world
that have introduced higher-valent pneumococcal conjugate vaccines (such as Prevnar 13)
showed that, overall, these 7 serotypes accounted for approximately 70% of disease not due 

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to the Prevnar 13 vaccine types.
 
 
 
The purpose of this Phase 2 study is to describe the safety and immunogenicity of c7vPnC 
coadministered with Prevnar 13 in infants at 2, 4, 6, and 12 months of age or given 1 month 
after Prevnar 13 at 3, 5, 7, and 13 months of age. 
 
 
 Safety and immunogenicity data from this study will 
inform further clinical development of c7vPnC in pediatric populations.
Additional information for this compound may be found in the single reference safety 
document (SRSD), which for this study is the c7vPnC investigator’s brochure (IB).  The 
SRSD for Prevnar 13 is the US package insert (USPI).
Study Design
This is a Phase 2, multicenter, randomized, active-controlled, open-label study with a 3-arm 
parallel design.  It is planned to be conducted at investigator sites in the United States.  A 
total of 565 infants aged ≥42 to ≤98 days will be randomized (1:1:1) to receive a vaccine 
series with:
•
c7vPnC coadministered with Prevnar 13 (Group 1 - coadministration);
•
c7vPnC given 1 month after Prevnar 13 (Group 2 - staggered administration); or
•
Prevnar 13 alone as the active control group (Group 3 - control with Supplemental 
Dose).  A single dose of c7vPnC will be administered after the Prevnar 13 series is 
completed in this group.
In all groups, Prevnar 13 will be administered at 2, 4, 6, and 12 months of age.  c7vPnC will 
be administered at 2, 4, 6, and 12 months of age in Group 1; at 3, 5, 7, and 13 months of age 
in Group 2; and at 13 months of age in Group 3.  Note: In this document, and related study 
documents, vaccine (investigational product) Doses 1, 2, 3, and 4 specifically refer to the 
doses of c7vPnC administered in Groups 1 and 2, or the doses of Prevnar 13 administered in
the control group (Group 3).  The dose of c7vPnC in Group 3 will be referred to as the
Supplemental Dose.
Vaccine containing diphtheria, tetanus, and acellular pertussis antigens will be administered 
at 2, 4, and 6 months of age.  This is part of routine standard of care in the United States,
 
  Other routine pediatric 
vaccines may be administered in this study, with or without certain restrictions.  Local 
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reactions (redness, swelling, and pain) at the injection site and systemic events (fever,
decreased appetite, drowsiness/increased sleep, and irritability) will be prompted for and 
collected by an electronic diary (e-diary; device or application) from Day 1 to Day 7 
following Doses 1 to 4 and the Supplemental Dose. Use of antipyretic/pain medications 
from Day 1 to Day 7 following vaccination will also be collected by an e-diary.  Adverse 
events (AEs) will be collected from the time of informed consent to 1 month after Dose 3 and 
from Dose 4 to 1 month after Dose 4 or 1 month after the Supplemental Dose in Group 3.  
Serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) 
will be collected from the time of informed consent through 6 months after Dose 4 or the 
Supplemental Dose.  Blood will be drawn for immunogenicity assessments 1 month after
Dose 3, prior to receipt of Dose 4, and 1 month after Dose 4 
 
.  In Group 2, blood will also be collected prior to Dose 3.  See Section 3, Table 1,
for an overview of the vaccinations and blood draws in the study.
 
Primary Objective and Endpoints
Primary Objective
•
To describe the safety profile of c7vPnC in healthy infants.
Primary Endpoints
•
Proportions of subjects reporting prompted local reactions (redness, swelling, and pain at 
the injection site) within 7 days of each dose.
•
Proportions of subjects reporting prompted systemic events (fever, decreased appetite, 
drowsiness/increased sleep, and irritability) within 7 days of each dose.
•
Proportions of subjects reporting AEs from Dose 1 to 1 month following Dose 3 and 
from Dose 4 to 1 month following Dose 4/Supplemental Dose.
•
Proportions of subjects reporting SAEs and NDCMCs from Dose 1 to 6 months 
following Dose 4/Supplemental Dose.
Secondary Objective and Endpoints
Secondary Objective
•
To describe the immunogenicity of c7vPnC in healthy infants.
Secondary Endpoints
•
Pneumococcal serotype-specific immunoglobulin G (IgG) concentrations 1 month after 
Dose 3.
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•
Pneumococcal serotype-specific IgG concentrations 1 month after Dose 4.
 
 
 
 
 
Statistical Methods
An analysis of safety and immunogenicity data will be conducted when data are available as 
described in Section 9 according to the statistical analysis plan (SAP).  All analyses will be 
descriptive. No hypothesis tests between vaccine groups are planned; therefore, no power 
calculations for comparison of vaccine groups are included.
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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.
Group 1 – Coadministration
Visit Number
1
2
3
4
5
6
7
Visit Description
Dose 1
2-Month Visit
Dose 2
4-Month Visit
Dose 3
6-Month Visit
Follow-up
7-Month Visit
Dose 4
12-Month Visit
Follow-up
13-Month Visit
Follow-up Phone 
Call
18-Month Phone 
Contact
Visit Window (Days)
Day 1
42 to 63 Days
After Dose 1
42 to 63 Days
After Dose 2
28 to 42 Days 
After Dose 3
365 to 386 Days 
of Age
28 to 42 Days 
After Dose 4
168 to 196 Days 
After Dose 4
Obtain informed consent
X
Record demography
X
Obtain medical history data
X
Perform physical examination
X
Obtain prevaccination rectal temperature
X
X
X
X
Record prior and interim vaccinations 
X
X
X
X
X
X
Review inclusion and exclusion criteria
X
Review temporary delay criteria
X
X
X
X
X
X
Review continued eligibility
X
X
X
X
X
Assign subject number and randomization 
number
X
Obtain blood sample (~5 mL)
X
Xa
X
Administer c7vPnC (in left thigh) and 
Prevnar 13 (in right thigh)
X
X
X
X
Administer DTaP-containing vaccine (at site
other than left leg)b
X
X
X
Administer other permitted concomitant 
vaccines (at site other than left leg)b
X
X
X
X
Assess and record acute reactions for at least 
30 minutes after vaccine administration
X
X
X
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Visit Number
1
2
3
4
5
6
7
Visit Description
Dose 1
2-Month Visit
Dose 2
4-Month Visit
Dose 3
6-Month Visit
Follow-up
7-Month Visit
Dose 4
12-Month Visit
Follow-up
13-Month Visit
Follow-up Phone 
Call
18-Month Phone 
Contact
Visit Window (Days)
Day 1
42 to 63 Days
After Dose 1
42 to 63 Days
After Dose 2
28 to 42 Days 
After Dose 3
365 to 386 Days 
of Age
28 to 42 Days 
After Dose 4
168 to 196 Days 
After Dose 4
Provide subject’s legally acceptable 
representative with an e-diary (device or 
application), thermometer, and measuring 
device and instruct how to collect prompted 
local reactions, systemic events, and 
antipyretic/pain medication use until Day 7c
X
X
Review e-diary events d,e
X
X
X
X
Collect e-diary (if device provided)
X
X
Record and report adverse events
X--------------------------------------------------------------X
X--------------------X
Record and report serious adverse events and 
newly diagnosed chronic medical 
conditionsf,g
X----------------------------------------------------------------------------------------------------------------------------------X
Abbreviations: DTaP = diphtheria, tetanus, and acellular pertussis; e-diary = electronic diary; NDCMC = newly diagnosed chronic medical condition.
a.
Blood sample will be collected prior to vaccination.
b.
The subject may receive vaccines with inactivated poliovirus, hepatitis B, or Haemophilus influenzae type b (either separately or in the diphtheria, tetanus, 
and pertussis combination vaccine) at 2, 4, and 6 months of age. Measles, mumps, and rubella (MMR) vaccination may be administered concomitantly at 
12 months of age or according to the permitted treatment windows in Section 5.7.3. Rotavirus vaccine may be administered orally at any time.
c.
The subject’s legally acceptable representative will record prompted local reactions and systemic events in an e-diary for the 7 days following each dose of 
c7vPnC.  The subject’s legally acceptable representative will be instructed to contact the study staff if the subject experiences redness or swelling >14 caliper 
units, severe pain at the injection site, or a fever >104.0°F (>40.0°C), or has an emergency room visit or hospitalization.
d.
Designated site staff will review e-diary data online at frequent intervals (daily is optimal) for the 7 days following each dose of c7vPnC to evaluate subject 
compliance and reported events as part of the ongoing safety review.
 
f.
Record concomitant medications used to treat SAEs and NDCMCs as described in Section 5.7.4.
g.
A newly diagnosed chronic medical condition is defined as a disease or medical condition, not previously identified, that is expected to be persistent or 
otherwise long-lasting in its effects.
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Group 2 – Staggered Administration
Visit Number
1
2
3
4
5
6
7
8
9
10
11
Visit Description
Prevnar 
13
2-Month 
Visit
c7vPnC
Dose 1
3-Month 
Visit
Prevnar 
13
4-Month 
Visit
c7vPnC
Dose 2
5-Month 
Visit
Prevnar 
13
6-Month 
Visit
c7vPnC
Dose 3
7-Month 
Visit
Follow-up
8-Month
Visit
Prevnar 
13
12-
Month 
Visit
c7vPnC
Dose 4
13-Month 
Visit
Follow-up
14-Month 
Visit
Follow-
up Phone 
Call
19-Month 
Phone 
Contact
Visit Window (Days)
Day 1
21 to 35 
Days
After 
Prevnar 
13 at 
Visit 1
42 to 63 
Days 
After 
Prevnar 
13 at 
Visit 1
21 to 35
Days
After 
Prevnar 
13 at 
Visit 3
42 to 63 
Days
After 
Prevnar 
13 at 
Visit 3
21 to 35 
Days 
After 
Prevnar
13 at 
Visit 5
28 to 42 
Days
After 
Dose 3
365 to 
386 Days 
of Age
21 to 35 
Days 
After 
Prevnar 
13 at 
Visit 8
28 to 42 
Days 
After 
Dose 4
168 to 
196 Days
After 
Dose 4
Obtain informed consent
X
Record demography
X
Obtain medical history data
X
Perform physical examination
X
Obtain prevaccination rectal temperature
X
X
X
X
Record prior and interim vaccinations 
X
X
X
X
X
X
X
X
X
X
Review inclusion and exclusion criteria
X
Review temporary delay criteria
X
X
X
X
X
X
Review continued eligibility
X
X
X
X
X
X
X
X
X
Assign subject number and randomization number
X
Obtain blood sample (~5 mL)
Xa
X
Xa
X
Administer Prevnar 13 (in right thigh)
X
X
X
X
Administer c7vPnC (in left thigh)
X
X
X
X
Administer DTaP-containing vaccine (at site other 
than left leg)b
X
X
X
Administer other permitted concomitant vaccines 
(at site other than left leg)b
X
X
X
X
Assess and record acute reactions for at least 30 
minutes after vaccine administration
X
X
X
X
Provide subject’s legally acceptable representative 
with an e-diary (device or application), thermometer, 
and measuring device and instruct how to collect 
prompted local reactions, systemic events, and 
antipyretic/pain medication use until Day 7c
X
X

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Visit Number
1
2
3
4
5
6
7
8
9
10
11
Visit Description
Prevnar 
13
2-Month 
Visit
c7vPnC
Dose 1
3-Month 
Visit
Prevnar 
13
4-Month 
Visit
c7vPnC
Dose 2
5-Month 
Visit
Prevnar 
13
6-Month 
Visit
c7vPnC
Dose 3
7-Month 
Visit
Follow-up
8-Month
Visit
Prevnar 
13
12-
Month 
Visit
c7vPnC
Dose 4
13-Month 
Visit
Follow-up
14-Month 
Visit
Follow-
up Phone 
Call
19-Month 
Phone 
Contact
Visit Window (Days)
Day 1
21 to 35 
Days
After 
Prevnar 
13 at 
Visit 1
42 to 63 
Days 
After 
Prevnar 
13 at 
Visit 1
21 to 35
Days
After 
Prevnar 
13 at 
Visit 3
42 to 63 
Days
After 
Prevnar 
13 at 
Visit 3
21 to 35 
Days 
After 
Prevnar
13 at 
Visit 5
28 to 42 
Days
After 
Dose 3
365 to 
386 Days 
of Age
21 to 35 
Days 
After 
Prevnar 
13 at 
Visit 8
28 to 42 
Days 
After 
Dose 4
168 to 
196 Days
After 
Dose 4
Review e-diary eventsd,e
X
X
X
X
Collect e-diary (if device provided)
X
X
Record and report adverse events
X---------------------------------------------------------------------------X
X-------------X
Record and report serious adverse events and newly 
diagnosed chronic medical conditionsf,g
X-------------------------------------------------------------------------------------------------------------------------------X
Abbreviations: DTaP = diphtheria, tetanus, and acellular pertussis; e-diary = electronic diary; NDCMC = newly diagnosed chronic medical condition.
a.
Blood sample will be collected prior to vaccination. 
b.
The subject may receive vaccines with inactivated poliovirus, hepatitis B, or Haemophilus influenzae type b (either separately or in the diphtheria, tetanus, 
and pertussis combination vaccine) at 2, 4, and 6 months of age.  Measles, mumps, and rubella (MMR) vaccination may be administered concomitantly at 
12 months of age or according to the permitted treatment windows in Section 5.7.3. Rotavirus vaccine may be administered orally at any time.
c.
The subject’s legally acceptable representative will record prompted local reactions and systemic events in an e-diary for the 7 days following each dose of 
c7vPnC.  The subject’s legally acceptable representative will be instructed to contact the study staff if the subject experiences redness or swelling >14 caliper 
units, severe pain at the injection site, or a fever >104.0°F (>40.0°C), or has an emergency room visit or hospitalization.
d.
Designated site staff will review e-diary data online at frequent intervals (daily is optimal) for the 7 days following each dose of c7vPnC to evaluate subject
compliance and reported events as part of the ongoing safety review.
 
f.
Record concomitant medications used to treat SAEs and NDCMCs as described in Section 5.7.4.
g.
A newly diagnosed chronic medical condition is defined as a disease or medical condition, not previously identified, that is expected to be persistent or 
otherwise long-lasting in its effects.
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Group 3 – Control Group With Supplemental Dose
Visit Number
1
2
3
4
5
6
7
8
Visit Description
Dose 1
2-Month Visit
Dose 2
4-Month Visit
Dose 3
6-Month Visit
Follow-up
7-Month Visit
Dose 4
12-Month Visit
Follow-up and 
Supplemental 
Dose
13-Month Visit
Follow-up of 
Supplemental 
Dose
14-Month Visit
Follow-up 
Phone Call
19-Month 
Phone Contact
Visit Window (Days)
Day 1
42 to 63 Days
After Dose 1
42 to 63 Days
After Dose 2
28 to 42 Days 
After Dose 3
365 to 386 
Days of Age
28 to 42 Days 
After Dose 4
28 to 42 Days 
After 
Supplemental 
Dose
168 to 196 
Days After 
Supplemental 
Dose
Obtain informed consent
X
Record demography
X
Obtain medical history data
X
Perform physical examination
X
Obtain prevaccination rectal temperature
X
X
X
X
X
Record prior and interim vaccinations 
X
X
X
X
X
X
X
Review inclusion and exclusion criteria
X
Review temporary delay criteria
X
X
X
X
X
X
X
Review continued eligibility
X
X
X
X
X
X
Assign subject number and randomization 
number
X
Obtain blood sample (~5 mL)
X
Xa
Xa
Administer Prevnar 13 (in left thigh)
X
X
X
X
Administer DTaP-containing vaccine (at 
site other than left leg)b
X
X
X
Administer other permitted concomitant 
vaccines (at site other than left leg)b
X
X
X
X
Administer c7vPnC (in left thigh)
X
Assess and record acute reactions for at 
least 30 minutes after vaccine 
administration
X
X
X
X
X
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Visit Number
1
2
3
4
5
6
7
8
Visit Description
Dose 1
2-Month Visit
Dose 2
4-Month Visit
Dose 3
6-Month Visit
Follow-up
7-Month Visit
Dose 4
12-Month Visit
Follow-up and 
Supplemental 
Dose
13-Month Visit
Follow-up of 
Supplemental 
Dose
14-Month Visit
Follow-up 
Phone Call
19-Month 
Phone Contact
Visit Window (Days)
Day 1
42 to 63 Days
After Dose 1
42 to 63 Days
After Dose 2
28 to 42 Days 
After Dose 3
365 to 386 
Days of Age
28 to 42 Days 
After Dose 4
28 to 42 Days 
After 
Supplemental 
Dose
168 to 196 
Days After 
Supplemental 
Dose
Provide subject’s legally acceptable 
representative with an e-diary (device or 
application), thermometer, and measuring 
device and instruct how to collect 
prompted local reactions, systemic events, 
and antipyretic/pain medication use until 
Day 7c
X
X
Review e-diary eventsd
X
X
X
X
X
Collect e-diary (if device provided)
X
X
Record and report adverse events
X--------------------------------------------------------------X
X------------------------------------------X
Record and report serious adverse events 
and newly diagnosed chronic medical 
conditionse,f
X--------------------------------------------------------------------------------------------------------------------------------------------X
Abbreviations: DTaP = diphtheria, tetanus, and acellular pertussis; e-diary = electronic diary; NDCMC = newly diagnosed chronic medical condition.
a.
Blood sample will be collected prior to vaccination. 
b.
The subject may receive vaccines with inactivated poliovirus, hepatitis B, or Haemophilus influenzae type b (either separately or in the diphtheria, tetanus, 
and pertussis combination vaccine) at 2, 4, and 6 months of age.  Measles, mumps, and rubella (MMR) vaccination may be administered concomitantly at 
12 months of age or according to the permitted treatment windows in Section 5.7.3. Rotavirus vaccine may be administered orally at any time.
c.
The subject’s legally acceptable representative will record prompted local reactions and systemic events in an e-diary for the 7 days following each dose of 
Prevnar 13 and c7vPnC Supplemental Dose.  For the c7vPnC Supplemental Dose only, the subject’s legally acceptable representative will be instructed to 
contact the study staff if the subject experiences redness or swelling >14 caliper units, severe pain at the injection site, or a fever >104.0°F (>40.0°C), or has 
an emergency room visit or hospitalization.
d.
Designated site staff will review e-diary data online at frequent intervals (daily is optimal) for the 7 days following each dose of Prevnar 13 and c7vPnC 
Supplemental Dose to evaluate subject compliance and reported events as part of the ongoing safety review.
e.
Record concomitant medications used to treat SAEs and NDCMCs as described in Section 5.7.4.
f.
A newly diagnosed chronic medical condition is defined as a disease or medical condition, not previously identified, that is expected to be persistent or 
otherwise long-lasting in its effects.

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1. INTRODUCTION
1.1. Indication
Complementary 7-valent pneumococcal conjugate vaccine (c7vPnC) is being developed for:

Active immunization to prevent disease caused by the Streptococcus pneumoniae 
serotypes in the vaccine.
1.2. Background and Rationale
1.2.1. Pneumococcal Disease
S pneumoniae are gram-positive encapsulated cocci that are a leading cause of bacteremia, 
bacterial meningitis, pneumonia, and acute otitis media (AOM) and continue to be a major 
global public health concern.1,2,3 Serious pneumococcal disease may occur at any age; 
however, children <5 years and adults 65 years of age are at particularly increased risk.4  
Individuals with certain comorbidities and immunocompromising conditions are also at risk, 
especially persons with chronic heart, lung, liver, and renal disease, as well as those who are 
functionally asplenic. The global burden of pneumococcal disease has been substantially 
impacted by pneumococcal conjugate vaccines.  S pneumoniae caused an estimated 
14.5 million cases of serious disease and 826,000 deaths annually in children <5 years of age
prior to introduction of pneumococcal conjugate vaccines.2 A recent estimate suggested that 
in 2015, several years following introduction of pneumococcal conjugate vaccines into the 
national infant immunization programs of more than 100 countries, the global disease burden 
had declined, but S pneumoniae still accounted for 2.6 million cases of severe pneumococcal 
disease, 332,000 deaths in children <5 years of age, and 11% of deaths in children between 
the ages of 1 and 5 years.5
The overall invasive pneumococcal disease (IPD) burden was estimated in 2014 to have
decreased approximately 90% in the population <5 years of age in the United States since the 
introduction of pneumococcal conjugate vaccines.6 Even after the introduction of 
Prevnar 13(13-valent pneumococcal conjugate vaccine), a significant proportion of IPD 
cases in persons <18 years of age is associated with hospitalization (71%), with a case 
fatality rate of 3%.7 This is due to the decrease in disease due to the serotypes in Prevnar
(7-valent pneumococcal conjugate vaccine) and Prevnar 13; however, disease due to 
serotypes not covered by those vaccines remains, and causes significant morbidity and 
mortality.  Pediatric surveillance studies conducted between 2007 and 2013 in 8 US 
children’s hospitals, and between 1997 and 2010 in a referral center in Utah, found case 
fatality rates of 10% and 13% with pneumococcal meningitis, respectively.  These studies 
also found that between 52% and 63% of children surviving pneumococcal meningitis
experience neurologic sequelae.8,9 Surveillance studies conducted in 2010-2012 by the 
Centers for Disease Control and Prevention (CDC) found that S pneumoniae remains among 
the most common pathogens identified in community-acquired pneumonia (CAP) requiring 
hospitalization in the United States in both children and adults.10,11  These data suggest that 
S pneumoniae remains an important cause of serious disease in the United States and 
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AOM is a common childhood illness, with the 2011 visit rates of 0.82 and 0.81 visits for 
AOM/child-year in children <2 years of age and 2 to 6 years of age, respectively, and
represents a significant medical burden.12  While AOM is generally not considered a serious 
disease, it does carry the risk of more serious complications.  These complications can range 
from the development of chronic or recurrent otitis media necessitating surgical intervention
(tympanostomy tube placement), and accompanied by hearing losses with potential 
developmental and language delays, to invasive extension leading to mastoiditis and 
meningitis.
Although the introduction of pneumococcal conjugate vaccines into the US and other 
national infant immunization programs has brought about substantial reductions in the 
various manifestations of pneumococcal disease in pediatric (and to some extent adult) 
populations, a substantial burden of pneumococcal disease remains.
1.2.2. Vaccines to Prevent Pneumococcal Disease
The polysaccharide capsule has been identified as an important virulence factor for this 
pathogen.  While more than 95 pneumococcal serotypes, differentiated by their capsular 
polysaccharide composition, have been identified, only a subset of serotypes are more
commonly associated with severe disease.13,14  Anticapsular antibodies directed against the 
specific serotype bind to the capsule and promote complement-mediated opsonophagocytic 
killing and clearance of the organism.15  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.16
1.2.2.1. Pneumococcal Polysaccharide Vaccines
Vaccines containing free polysaccharides have been licensed since the 1970s. One such 
vaccine, 23-valent pneumococcal polysaccharide vaccine (PPSV23), has been licensed in the 
United States since 1983.17,18  PPSV23 contains capsular polysaccharides for 23 serotypes 
(1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 
and 33F).  Pneumococcal vaccines containing free polysaccharides such as PPSV23 elicit a 
T-cell–independent immune response.  Unconjugated polysaccharide vaccines do not induce 
robust responses in certain populations (eg, immunocompromised persons, children <2 years 
of age, and adults 65 years of age), nor do they generate immunologic memory, so that their 
protective effect wanes over 2 to 5 years.4,18,19,20  Moreover, their ability to prevent 
nonbacteremic pneumonia, CAP, and AOM is limited or lacking.16,20,21,22,23  In addition, 
polysaccharide vaccines do not reduce vaccine-type (VT) nasopharyngeal carriage, which is 
important for herd immunity.23  PPSV23 is not recommended for children <2 years of age
and is only recommended in children >2 years of age who are at high risk for IPD to provide 
some degree of protection from disease caused by serotypes not covered by existing 
pneumococcal conjugate vaccines.16
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, 

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and populations with high-risk conditions.19,24  Prevnar was the first pneumococcal conjugate 
vaccine to be licensed (2000) and was indicated for prevention of pneumococcal disease in 
infants and young children on the basis of efficacy studies.  Prevnar contained capsular 
polysaccharide conjugates for 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F), 
each covalently linked to cross-reactive material 197 (CRM197), a nontoxic variant of 
diphtheria toxin.  These 7 serotypes were responsible for approximately 80% to 90% of IPD 
in children <5 years of age in the United States and approximately 60% to 80% of IPD in the 
same age group in Europe at that time (1998-2000).25,26,27,28,29  These serotypes also 
accounted for a high proportion of antibiotic-resistant strains.30  Prevnar demonstrated 
efficacy against VT IPD, pneumonia, and AOM in large randomized, controlled efficacy 
studies in infants.31,32  The Prevnar components contained in a related pneumococcal 
conjugate vaccine also were demonstrated to be efficacious against 
clinically/radiographically defined pneumonia.33,34,35,36  Following introduction of Prevnar, 
reduction of nasopharyngeal carriage and transmission has resulted in indirect herd effects, 
with a 92% reduction of IPD due to Prevnar serotypes in older adults 65 years of age.37
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.24,28,38  The vaccine was 
licensed for use in infants and young children based on comparisons of serotype-specific 
serum immunoglobulin G (IgG) concentrations to Prevnar, with supportive data to 
demonstrate the functional activity of the immune responses.  Prevnar 13 was later licensed 
in adults based on demonstration of efficacy against VT CAP in adults 65 years of age and 
older.39  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.40,41,42,43  It has 
also been prequalified by the World Health Organization (WHO) for use in national infant 
immunization programs in lower- and middle-income countries.44,45  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.46,47,48  
1.2.2.3. Rationale for c7vPnC
c7vPnC is being developed 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) individually conjugated to CRM197.  c7vPnC uses the same platform 
and contains the same excipients as Prevnar and Prevnar 13. These 7 additional serotypes 
were selected based on their relative prevalence as a cause of IPD, their generalized 
geographic distribution, and other factors that would support inclusion, such as the presence 
of antibiotic resistance and greater disease severity (eg, meningitis, 
mortality).49,50,51,52,53,54,55,56,57,58,59,60  These 7 serotypes have a long-standing association with
serious pneumococcal disease. The incidence of IPD due to these 7 serotypes in children <5 
years of age has remained relatively stable or slightly increased over the past several years, 
and these serotypes cause a significant amount of IPD in children.61,62,63,64,65,66,67  A 
meta-analysis of serotypes causing IPD in children <5 years of age in regions of the world 
that have introduced higher-valent pneumococcal conjugate vaccines (such as Prevnar 13)

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showed that, overall, these 7 serotypes accounted for approximately 70% of disease not due 
to the Prevnar 13 vaccine types.63 Additional epidemiology data for the 7 serotypes and the 
preclinical program are described in the c7vPnC investigator’s brochure (IB).
 
 
 
 
.
The purpose of this study is to assess the safety and immunogenicity of c7vPnC in infants, 
and to generate a safety and immunogenicity data set with c7vPnC to support and inform the 
design of the Phase 3 clinical development program.  The targeted age of the population for 
this study, infants 2 months of age, has been selected as this is the indicated and 
recommended age of Prevnar 13 immunization in infants.  Subjects will receive a 4-dose
series of: c7vPnC coadministered with Prevnar 13 in Group 1; c7vPnC administered 1 month
after Prevnar 13 in Group 2; or Prevnar 13 administered alone in Group 3 (control group). 
 
Additional information for this compound may be found in the single reference safety 
document (SRSD), which for this study is the c7vPnC IB.  The SRSD for the Prevnar 13 
control vaccine is the US package insert (USPI).
2. STUDY OBJECTIVES AND ENDPOINTS
2.1. Primary Objective and Endpoints
2.1.1. Primary Objective
•
To describe the safety profile of c7vPnC in healthy infants.
2.1.2. Primary Endpoints
•
Proportions of subjects reporting prompted local reactions (redness, swelling, and pain at 
the injection site) within 7 days of each dose.
•
Proportions of subjects reporting prompted systemic events (fever, decreased appetite, 
drowsiness/increased sleep, and irritability) within 7 days of each dose.
•
Proportions of subjects reporting adverse events (AEs) from Dose 1 to 1 month following 
Dose 3 and from Dose 4 to 1 month following Dose 4/Supplemental Dose.
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•
Proportions of subjects reporting serious adverse events (SAEs) and newly diagnosed 
chronic medical conditions (NDCMCs) from Dose 1 to 6 months following 
Dose 4/Supplemental Dose.
2.2. Secondary Objective and Endpoints
2.2.1. Secondary Objective 
•
To describe the immunogenicity of c7vPnC in healthy infants.
2.2.2. Secondary Endpoints
•
Pneumococcal serotype-specific IgG concentrations 1 month after Dose 3.
•
Pneumococcal serotype-specific IgG concentrations 1 month after Dose 4.
 
 
 
 
 
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3. STUDY DESIGN
This will be a Phase 2, multicenter, randomized, active-controlled, open-label study with a 
3-arm parallel design, conducted at investigator sites in the United States.  A total of 
565 infants ≥42 to ≤98 days of age at the time of consent will be enrolled and randomized in 
a 1:1:1 ratio to receive a vaccine series with:
•
c7vPnC coadministered with Prevnar 13 (Group 1 - coadministration);
•
c7vPnC given 1 month after Prevnar 13 (Group 2 - staggered administration); or
•
Prevnar 13 alone as the active control group (Group 3 - control with Supplemental Dose).  
A single dose of c7vPnC will be administered after the Prevnar 13 series is completed in 
this group.
In all groups, Prevnar 13 will be administered at 2, 4, 6, and 12 months of age.  c7vPnC will 
be administered at 2, 4, 6, and 12 months of age in Group 1; at 3, 5, 7, and 13 months of age 
in Group 2; and at 13 months of age in Group 3.  Note: In this document, and related study
documents, vaccine (investigational product) Doses 1, 2, 3, and 4 specifically refer to the 
doses of c7vPnC administered in Groups 1 and 2, or the doses of Prevnar 13 administered in 
the control group (Group 3).  The dose of c7vPnC administered in Group 3 will be referred to 
as the Supplemental Dose. See Table 1 for a summary of study groups and key procedures.
Table 1.
Summary of Study Groups and Key Procedures
Abbreviations: Coadmin. = coadministered; mo/o = months old; Prev13 = Prevnar 13; Suppl. = supplemental.
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Vaccine containing diphtheria, tetanus, and acellular pertussis antigens will be administered 
at 2, 4, and 6 months of age.  This is as part of routine standard of care in the United States,
  Other routine 
pediatric vaccines may be administered in this study, with or without certain restrictions.
Subjects will be observed for 30 minutes after each dose of c7vPnC in Groups 1 and 2, and 
after Prevnar 13 and the Supplemental Dose of c7vPnC in Group 3.  In all groups, prompted 
local reactions (pain, redness, and swelling at the injection site), systemic events (fever, 
decreased appetite, drowsiness/increased sleep, and irritability), and use of antipyretic/pain 
medications occurring within 7 days after Doses 1 to 4 and the Supplemental Dose will be 
collected each day in the electronic diary (e-diary).  SAEs and NDCMCs will be collected for 
the entire duration of the study.  AEs (including nonserious AEs, SAEs, and NDCMCs) will 
be collected from the signing of the informed consent document to 1 month after Dose 3 and 
from Dose 4 to 1 month after Dose 4 or 1 month after the Supplemental Dose in Group 3.  
Approximately 6 months after Dose 4 or the Supplemental Dose, the sites will contact the
subject’s legally acceptable representative via telephone to inquire about SAEs and 
NDCMCs.  Blood will be drawn for immunogenicity assessments 1 month after Dose 3, prior 
to receipt of Dose 4, and 1 month after Dose 4
.  In 
Group 2, blood will also be collected prior to Dose 3.
 
 
 
3.1. Duration of Subject Participation
Each subject will participate in the study for approximately 16 to 17 months.
3.2. Duration of Study
The study duration is estimated to be approximately 25 months.
3.3. Number of Subjects
A total of 565 subjects will be randomized (approximately 188 subjects per arm).  Assuming 
a 15% dropout rate at the time of Dose 3, approximately 160 subjects per arm would be 
evaluable for immunogenicity.  Subjects who withdraw or are withdrawn from the study after 
randomization will not be replaced, regardless of the reason for withdrawal.
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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:
1. Evidence of a personally signed and dated informed consent document indicating that the 
subject’s legally acceptable representative has been informed of all pertinent aspects of 
the study.
2. Subjects whose legally acceptable representative is willing and able to comply with 
scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 
98 days) at the time of consent (the day of birth is considered day of life 1).
4. Healthy infant determined by medical history, physical examination, and clinical 
judgment.
5. Expected to be available for the duration of the study and whose legally acceptable 
representative can be contacted by telephone during study participation.
4.2. Exclusion Criteria
Subjects with any of the following characteristics/conditions will not be included in the 
study:
1. Subjects who are direct descendants (child or grandchild) of: investigational site staff 
members directly involved in the conduct of the study; site staff members otherwise 
supervised by the investigator; or Pfizer employees directly involved in the conduct of 
the study.
2. Previous vaccination with licensed or investigational pneumococcal vaccine.
3. Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
4. Previous receipt of >1 dose of hepatitis B vaccine.
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6. Contraindication to immunization with diphtheria, tetanus, pertussis, or 13-valent 
pneumococcal conjugate vaccines, according to each vaccine’s product information.
7. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the investigational product or any 
diphtheria toxoid-containing vaccine.
8. History of microbiologically proven invasive disease caused by S pneumoniae.
9. Major known congenital malformation or serious chronic disorder.
10. Significant neurological disorder or history of seizure including febrile seizure, or 
significant stable or evolving disorders such as cerebral palsy, encephalopathy, 
hydrocephalus, or other significant disorders. Does not include resolving syndromes due 
to birth trauma, such as Erb’s palsy and/or hypotonic-hyporesponsive episodes.
11. Other acute or chronic medical or psychiatric condition 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.
12. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic 
agents or systemic corticosteroids, or planned receipt through the last study visit. 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, eyes, or ears) 
corticosteroids are permitted.
13. Subjects with known or suspected immunodeficiency or other conditions associated with 
immunosuppression, including, but not limited to, immunoglobulin class/subclass 
deficiencies, DiGeorge syndrome, generalized malignancy, human immunodeficiency 
virus infection, leukemia, lymphoma, or organ or bone marrow transplant.
14. Bleeding diathesis or condition associated with prolonged bleeding time that would in the 
opinion of the investigator contraindicate intramuscular injection.
15. Receipt of blood/plasma products or immunoglobulins (including hepatitis B 
immunoglobulin) since birth, or planned receipt through the last study visit.
16. Participation in other studies involving investigational drug(s) or interventional studies or 
receipt of any other investigational vaccines, drugs, or medical devices prior to study 
entry and/or during study participation.  Participation in purely observational studies is 
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4.3. Temporary Delay Criteria
The following conditions are temporary or self-limiting and a subject may be vaccinated
and/or have blood drawn at the visit once the condition(s) has/have resolved and no other 
exclusion criteria are met.  The blood draw prior to Dose 3 (in Group 2 only) and prior to 
Dose 4/Supplemental Dose should take place on the same day as the administration of 
investigational product.
4.3.1. Criteria for Temporarily Delaying Dose Administration (Doses 1, 2, 3, and 4 and 
the Supplemental Dose)

Febrile illness (eg, rectal temperature 100.4F [38C]) or other acute illness within 
48 hours before each dose.

Receipt of any inactivated vaccine within 14 days or any live vaccine within 28 days 
before each dose. 

Receipt of short-term (<14 days) systemic corticosteroids.  Dose administration should be
delayed until systemic corticosteroid use has been discontinued for at least 28 days 
(inhaled/nebulized, intra-articular, intrabursal, or topical [skin, eyes, or ears] 
corticosteroids are permitted).
4.3.2. Criteria for Temporarily Delaying Blood Draw (Prior to Dose 3, 1 Month After 
Dose 3, Prior to Dose 4, and 1 Month After Dose 4 and the Supplemental Dose)

Receipt of antibiotic therapy within 72 hours before blood draw.
4.4. 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, the subject’s legally acceptable representative is 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 established communication pathways between the 
investigator site and the study team for advice on medical questions or problems that may 
arise during the study. The contact number is not intended for use by the subject’s legally 
acceptable representative directly, and if the subject’s legally acceptable representative calls 
that number, he or she will be directed back to the investigator site.

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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 and Prevnar 13.
5.1. Allocation to Investigational Product
The investigator’s knowledge of the treatment should not influence the decision to enroll a 
particular subject or affect the order in which subjects are enrolled.
Allocation of subjects to vaccine groups will proceed through the use of an interactive
response technology (IRT) system (interactive Web-based response [IWR]).  The site 
personnel (study coordinator or specified designee) 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 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 container number assigned. The confirmation 
report must be stored in the site’s files.
The study-specific IRT reference manual will provide the contact information and further 
details on the use of the IRT system. 
5.2. Subject Compliance
All doses of vaccine will be administered by the appropriately designated study staff at the 
investigator site.
5.3. Investigational Product Supplies
Study vaccines will be packed and labeled as investigational product in accordance with 
current guidelines and applicable local and legal regulatory requirements.  The formulations
of c7vPnC and Prevnar 13 are described below.
5.3.1. Dosage Form(s) and Packaging
c7vPnC contains saccharides of the capsular antigens to S pneumoniae serotypes 8, 10A, 
11A, 12F, 15B, 22F, and 33F individually conjugated to nontoxic diphtheria toxin CRM197.  
 
 
 
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Prevnar 13 contains saccharides from pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 
18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria toxin CRM197.  The 
vaccine is a sterile suspension formulated to contain 2.2 µg of each saccharide, except for 
4.4 µg of 6B, per 0.5-mL dose.  The vaccine contains 295 g succinate buffer, 0.85% sodium 
chloride, 100 g polysorbate 80, 0.125 mg aluminum as aluminum phosphate, and 34 g
CRM197, per 0.5-mL dose.68
c7vPnC and Prevnar 13 will be supplied to the site as packaged single-use prefilled syringes 
and labeled according to local regulatory requirements.
5.3.2. Preparation and Dispensing
See the Investigational Product Manual (IP manual) for instructions on how to prepare 
c7vPnC and Prevnar 13 for administration.  c7vPnC and Prevnar 13 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.
5.4. Administration
Investigational product, ie, c7vPnC for Groups 1 and 2 and the Supplemental Dose
(Group 3), and Prevnar 13 (control) in Group 3, will be administered into the thigh of the left 
leg as specified below.

Group 1: Each dose (0.5 mL) of c7vPnC will be administered intramuscularly (IM) into 
the anterolateral thigh muscle of the left leg and each dose (0.5 mL) of Prevnar 13 will be 
administered IM into the anterolateral thigh muscle of the right leg.

Group 2: Each dose (0.5 mL) of Prevnar 13 (given 1 month before the c7vPnC dose) will 
be administered IM into the anterolateral thigh muscle of the right leg and each dose 
(0.5 mL) of c7vPnC will be administered IM into the anterolateral thigh muscle of the left 
leg.

Group 3: Prevnar 13 (0.5 mL) and the Supplemental Dose of c7vPnC will be 
administered IM into the anterolateral thigh muscle of the left leg.
Other permitted routine pediatric injectable vaccines (including diphtheria, tetanus, and 
acellular pertussis [DTaP]-containing vaccines) must be administered in a different limb 
from the site of administration of c7vPnC in Groups 1 and 2 or Prevnar 13/c7vPnC 
Supplemental Dose in Group 3.  Concomitant injectable vaccines will be administered with 
Prevnar 13 (not c7vPnC) in Group 2.  The location of the injection of each vaccine 
administered (investigational product and other) will be recorded.
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 
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Administration of vaccines in this study should be performed by an appropriately qualified, 
Good Clinical Practice (GCP)-trained, and vaccine-experienced member of the study staff
(eg, physician, nurse, physician’s assistant, nurse practitioner, pharmacist, or medical 
assistant) as allowed by local, state, and institutional guidance.
Vaccine administration details will be recorded on the case report form (CRF).
5.5. Investigational Product Storage
The investigator or an approved representative, eg, pharmacist, will ensure that all 
investigational products, including any comparator and/or marketed products, are stored in a 
secured area with controlled access under required storage conditions and in accordance with 
applicable regulatory requirements.
Investigational products should be stored in their original containers and in accordance with 
the labels.
Investigational products 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 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 
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temperature excursion. Use of the investigational product prior to Pfizer approval will be 
considered a protocol deviation. Specific details regarding information the site should report 
for each excursion will be provided to the site.
Receipt of materials, door opening and closing, and other routine handling operations where
the products are briefly out of the temperature range described in the labeling are not 
considered excursions.
5.6. Investigational Product Accountability
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.
5.6.1. 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.
5.7. Concomitant Vaccines/Medications
5.7.1. Concomitant Vaccines to Be Administered at Study Visits
DTaP-containing vaccine (in combination with other antigens, such as polio) will be 
administered concomitantly at 2, 4, and 6 months of age. 
All vaccines administered will be recorded in the CRFs.
5.7.2. Prohibited Vaccines/Medications During the Study
•
Receipt of any investigational vaccines, drugs, or medical devices is prohibited during 
subject participation in the study.
•
Receipt of any nonstudy pneumococcal vaccine is prohibited during subject participation 
in the study.
•
Receipt of blood/plasma products, immunoglobulins, and/or immunosuppressive therapy 
(including a ≥14-day course of systemic corticosteroids) is prohibited during subject 
participation in the study.  
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5.7.3. Permitted Vaccines/Medications During the Study
•
If not in the DTaP-combination vaccine, polio, hepatitis B, and Haemophilus influenzae
type b vaccines may be given at 2, 4, and 6 months of age.
•
Measles, mumps, and rubella (MMR) vaccine may be administered concomitantly at 
12 months of age or according to the permitted treatment windows for other
nonprohibited licensed vaccines below.
•
Rotavirus vaccine may be given at any time throughout the study.
•
Receipt of quadrivalent meningococcal conjugate vaccine is permitted during the study 
only after blood is collected at the visit occurring 1 month after Dose 4
 
•
Other nonprohibited licensed vaccines may be given between the blood draw 1 month 
after Dose 3 and 14 days before Dose 4 for inactivated vaccines or 28 days before Dose 4 
for live vaccines, according to local or national recommendations.  Following the blood 
draw performed 1 month after Dose 4
 
 all licensed vaccines are permitted.
•
Licensed inactivated influenza vaccine may be given to eligible study subjects during 
influenza season.
•
Use of a topical anesthetic is permitted.
•
The use of prophylactic antipyretic/pain medication, while permitted, is not 
recommended on the day of investigational product administration (before or after 
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.
•
Prescription and nonprescription medications, vitamins, minerals, and herbal remedies 
are permitted during subject participation in the study.
5.7.4. Recording Prior and Concomitant Treatments
The name and date of administration for all vaccinations should be collected from the time of 
signing of the informed consent document to 1 month after Dose 4/Supplemental Dose and 
will be recorded in the CRF.  At Visit 1, information on prior vaccinations will also be 
recorded in the CRF.
Concomitant medications used to treat an NDCMC or SAE should be collected from the 
signing of informed consent through 6 months after Dose 4/Supplemental Dose (telephone 
contact) and will be recorded in the CRF.
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6. STUDY PROCEDURES
The study procedures described by assigned group are provided below and summarized in 
the Schedule of Activities.  The day of the first investigational product vaccination is 
considered to be Day 1.
Prior to randomization, all subjects undergo the same procedures.
6.1. Group 1 (Coadministration) Study Procedures
6.1.1. Group 1 Visit 1 (Dose 1: 2-Month Visit, Day 1)
Prior to randomization:

A personally signed and dated informed consent document indicating that the subject’s 
legally acceptable representative has been informed of all pertinent aspects of the study 
before performing any study-specific procedures.

Record the subject’s demographic information (including date of birth, sex, race, and 
ethnicity).

Obtain and record the subject’s medical history including prior vaccinations.

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.  
Clinically significant abnormal results will be recorded in the CRF. 

Measure and record the subject’s rectal temperature (F/C).

Ensure that all inclusion criteria, none of the exclusion criteria, and none of the temporary 
delay criteria are met.

Assign randomization number and investigational product container numbers via the IRT.  
This must be the last step before proceeding.  A site staff member will prepare the 
investigational product according to the IP manual.
After randomization:

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh and a 
single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the site of c7vPnC injection).

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
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
Issue the subject’s legally acceptable representative a measuring device to measure 
injection site reactions and a digital thermometer and provide instructions on their use.

Issue the subject’s legally acceptable representative an e-diary (device or application).
Provide instructions on use and completion of the e-diary.  Ask the subject’s legally 
acceptable representative to complete the e-diary from Day 1 to Day 7, with Day 1 being 
the day of vaccination.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator as soon as possible during the 7-day postvaccination period if the subject has 
a fever >104.0F (>40.0C), redness and/or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

Ask the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

Inform the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.1.2. Group 1 Visit 2 (Dose 2: 4-Month Visit, 42 to 63 Days After Dose 1)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 1 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative;
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 (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs
and NDCMCs.

Measure and record the subject's rectal temperature (F/C).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh and a 
single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

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
Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the site of c7vPnC injection).
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

Confirm that the e-diary is working and review instructions if necessary.  Remind the 
subject’s legally acceptable representative to complete the e-diary from Day 1 to Day 7, 
with Day 1 being the day of vaccination.  Provide thermometer or measuring device if 
needed.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator as soon as possible during the 7-day postvaccination period if the subject
experiences fever >104.0F (>40.0C), redness or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.
6.1.3. Group 1 Visit 3 (Dose 3: 6-Month Visit, 42 to 63 Days After Dose 2)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 2 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative;
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 (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
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
Measure and record the subject's rectal temperature (F/C).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh and a 
single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the site of c7vPnC injection).
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

Confirm that the e-diary is working and review instructions if necessary. Remind the 
subject’s legally acceptable representative to complete the e-diary from Day 1 to Day 7, 
with Day 1 being the day of vaccination.  Provide thermometer or measuring device if 
needed.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator as soon as possible during the 7-day postvaccination period if the subject 
experiences fever >104.0F (>40.0C), redness or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.
6.1.4. Group 1 Visit 4 (Follow-up: 7-Month Visit, 28 to 42 Days After Dose 3)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 3 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative; 
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.

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
Collect the e-diary (if device provided).

Determine whether any AEs (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Collect a blood sample of approximately 5 mL for immunogenicity (a topical anesthetic 
is permitted).

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF.
6.1.5. Group 1 Visit 5 (Dose 4: 12-Month Visit, 365 to 386 Days of Age)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 4 as described in Section 5.7.4.

Determine whether any SAEs or NDCMCs have occurred since the previous visit and 
follow up on any previously reported events to determine the outcome (ie, record stop 
dates or confirm if they are still continuing) and record as described in Section 8, and 
record concomitant medications used to treat SAEs and NDCMCs.

Measure and record the subject’s rectal temperature (F/C).

Collect a blood sample of approximately 5 mL for immunogenicity prior to vaccination 
(a topical anesthetic is permitted).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh and a 
single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

Administer permitted vaccines (to be administered into a limb other than the site of 
c7vPnC injection).

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After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

Issue the subject’s legally acceptable representative an e-diary (if device needed). Provide 
and review instructions on use and completion of the e-diary.  Ask the subject’s legally 
acceptable representative to complete the e-diary from Day 1 to Day 7, with Day 1 being 
the day of vaccination. Provide thermometer or measuring device if needed.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator immediately during the 7-day postvaccination period if the subject 
experiences fever >104.0F (>40.0C), redness or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.1.6. Group 1 Visit 6 (Follow-up: 13-Month Visit, 28 to 42 Days After Dose 4)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 5 as described in Section 5.7.4.

Review the subject's e-diary data with the subject’s legally acceptable representative;
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.

Collect the e-diary (if device provided).

Determine whether any AEs (includes nonserious AEs, SAEs, or NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

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Collect a blood sample of approximately 5 mL for immunogenicity assessments (a topical
anesthetic is permitted).

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff immediately if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

The investigator or an authorized designee completes the CRF.
6.1.7. Group 1 Visit 7 (Follow-up: 18-Month Phone Contact, 168 to 196 Days After
Dose 4)

Contact the subject’s legally acceptable representative by telephone approximately 
6 months after the last dose of c7vPnC; this contact should be attempted for all subjects
who have received at least 1 dose of c7vPnC, unless the subject’s legally acceptable
representative has withdrawn consent.

Determine whether any SAEs or NDCMCs have occurred since the previous visit and 
follow up on any previously reported events to determine the outcome (ie, record stop 
dates or confirm if they are still continuing) and record as described in Section 8, and 
record concomitant medications used to treat SAEs and NDCMCs.

The investigator or an authorized designee completes the CRF.
6.2. Group 2 (Staggered Administration) Study Procedures
6.2.1. Group 2 Visit 1 (Prevnar 13: 2-Month Visit, Day 1)
Prior to randomization:

A personally signed and dated informed consent document indicating that the subject’s 
legally acceptable representative has been informed of all pertinent aspects of the study 
before performing any study-specific procedures.

Record the subject’s demographic information (including date of birth, sex, race, and
ethnicity).

Obtain and record the subject’s medical history including prior vaccinations.

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.  
Clinically significant abnormal results will be recorded in the CRF.

Ensure that all inclusion criteria and none of the exclusion criteria are met.

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Assign randomization number and investigational product container number via the IRT.  
This must be the last step before proceeding.  A site staff member will prepare the 
investigational product according to the IP manual.
After randomization:

Administer a single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the left leg).

Ask the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

Inform the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.2.2. Group 2 Visit 2 (c7vPnC Dose 1: 3-Month Visit, 21 to 35 Days After Prevnar 13 at 
Visit 1)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 1 as described in Section 5.7.4.

Determine whether any AEs (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Measure and record the subject's rectal temperature (F/C).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh.
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

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
Issue the subject’s legally acceptable representative a measuring device to measure 
injection site reactions and a digital thermometer and provide instructions on their use.

Issue the subject’s legally acceptable representative an e-diary (device or application).
Provide instructions on use and completion of the e-diary.  Ask the subject’s legally 
acceptable representative to complete the e-diary from Day 1 to Day 7, with Day 1 being 
the day of vaccination.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator as soon as possible during the 7-day postvaccination period if the subject has 
a fever >104.0F (>40.0C), redness and/or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

Ask the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.2.3. Group 2 Visit 3 (Prevnar 13: 4-Month Visit, 42 to 63 Days After Prevnar 13 at 
Visit 1)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information).

Record vaccines administered since Visit 2 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative;
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 (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Administer a single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the left leg).

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After vaccination:

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.
6.2.4. Group 2 Visit 4 (c7vPnC Dose 2: 5-Month Visit, 21 to 35 Days After Prevnar 13 at 
Visit 3)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 3 as described in Section 5.7.4.

Determine whether any AEs (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Measure and record the subject's rectal temperature (F/C).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh.
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

Confirm that the e-diary is working and review instructions if necessary.  Remind the
subject’s legally acceptable representative to complete the e-diary from Day 1 to Day 7, 
with Day 1 being the day of vaccination. Provide thermometer or measuring device if 
needed.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator as soon as possible during the 7-day postvaccination period if the subject 
experiences fever >104.0F (>40.0C), redness or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

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
Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.
6.2.5. Group 2 Visit 5 (Prevnar 13: 6-Month Visit, 42 to 63 Days After Prevnar 13 at 
Visit 3)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information).

Record vaccines administered since Visit 4 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative;
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 (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Administer a single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the left leg).
After vaccination:

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.

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6.2.6. Group 2 Visit 6 (c7vPnC Dose 3: 7-Month Visit, 21 to 35 Days After Prevnar 13 at 
Visit 5)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 5 as described in Section 5.7.4.

Determine whether any AEs (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Measure and record the subject's rectal temperature (F/C).

Collect a blood sample of approximately 5 mL for immunogenicity prior to vaccination 
(a topical anesthetic is permitted).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh.
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

Confirm that the e-diary is working and review instructions if necessary.  Remind the 
subject’s legally acceptable representative to complete the e-diary from Day 1 to Day 7, 
with Day 1 being the day of vaccination.  Provide thermometer or measuring device if 
needed.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator as soon as possible during the 7-day postvaccination period if the subject 
experiences fever >104.0F (>40.0C), redness or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

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
The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.
6.2.7. Group 2 Visit 7 (Follow-up: 8-Month Visit, 28 to 42 Days After Dose 3)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 6 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative; 
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.

Collect the e-diary (if device provided).

Determine whether any AEs (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Collect a blood sample of approximately 5 mL for immunogenicity (a topical anesthetic 
is permitted).

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF.
6.2.8. Group 2 Visit 8 (Prevnar 13: 12-Month Visit, 365 to 386 Days of Age)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information).

Record vaccines administered since Visit 7 as described in Section 5.7.4.

Determine whether any SAEs or NDCMCs have occurred since the previous visit and 
follow up on any previously reported events to determine the outcome (ie, record stop 
dates or confirm if they are still continuing) and record as described in Section 8, and
record concomitant medications used to treat SAEs and NDCMCs.

Administer a single 0.5-mL injection of Prevnar 13 into the right anterolateral thigh.

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
Administer permitted vaccines (to be administered into a limb other than the left leg).
After vaccination:

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.2.9. Group 2 Visit 9 (c7vPnC Dose 4: 13-Month Visit, 21 to 35 Days After Prevnar 13
at Visit 8)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 8 as described in Section 5.7.4.

Determine whether any SAEs or NDCMCs have occurred since the previous visit and 
follow up on any previously reported events to determine the outcome (ie, record stop 
dates or confirm if they are still continuing) and record as described in Section 8, and 
record concomitant medications used to treat SAEs and NDCMCs.

Measure and record the subject’s rectal temperature (F/C).

Collect a blood sample of approximately 5 mL for immunogenicity prior to vaccination 
(a topical anesthetic is permitted).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh.
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

Issue the subject’s legally acceptable representative an e-diary (if device needed). Provide
and review instructions on use and completion of the e-diary.  Ask the subject’s legally 
acceptable representative to complete the e-diary from Day 1 to Day 7, with Day 1 being 
the day of vaccination. Provide thermometer or measuring device if needed.

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
Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator immediately during the 7-day postvaccination period if the subject
experiences fever >104.0F (>40.0C), redness or swelling at the injection site measuring 
>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.2.10. Group 2 Visit 10 (Follow-up: 14-Month Visit, 28 to 42 Days After Dose 4)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 9 as described in Section 5.7.4.

Review the subject's e-diary data with the subject’s legally acceptable representative; 
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.

Collect the e-diary (if device provided).

Determine whether any AEs (includes nonserious AEs, SAEs, or NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Collect a blood sample of approximately 5 mL for immunogenicity assessments (a topical
anesthetic is permitted).

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff immediately if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

The investigator or an authorized designee completes the CRF.

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6.2.11. Group 2 Visit 11 (Follow-up: 19-Month Phone Contact, 168 to 196 Days After 
Dose 4)

Contact the subject’s legally acceptable representative by telephone approximately 
6 months after the last dose of c7vPnC; this contact should be attempted for all subjects 
who have received at least 1 dose of c7vPnC, unless the subject’s legally acceptable
representative has withdrawn consent.

Determine whether any SAEs or NDCMCs have occurred since the previous visit and 
follow up on any previously reported events to determine the outcome (ie, record stop 
dates or confirm if they are still continuing) and record as described in Section 8, and 
record concomitant medications used to treat SAEs and NDCMCs.

The investigator or an authorized designee completes the CRF.
6.3. Group 3 (Control With Supplemental Dose) Study Procedures
6.3.1. Group 3 Visit 1 (Dose 1: 2-Month Visit, Day 1)
Prior to randomization:

A personally signed and dated informed consent document indicating that the subject’s 
legally acceptable representative has been informed of all pertinent aspects of the study 
before performing any study-specific procedures.

Record the subject’s demographic information (including date of birth, sex, race, and 
ethnicity).

Obtain and record the subject’s medical history including prior vaccinations.

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.  
Clinically significant abnormal results will be recorded in the CRF.

Measure and record the subject’s rectal temperature (F/C).

Ensure that all inclusion criteria, none of the exclusion criteria, and none of the temporary 
delay criteria are met.

Assign randomization number and investigational container number via the IRT.  This 
must be the last step before proceeding. A site staff member will prepare the 
investigational product according to the IP manual.
After randomization:

Administer a single 0.5-mL injection of Prevnar 13 into the left anterolateral thigh.

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
Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the site of Prevnar 13 injection).

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable.  Record 
concomitant medications used to treat SAEs and NDCMCs.

Issue the subject’s legally acceptable representative a measuring device to measure 
injection site reactions and a digital thermometer and provide instructions on their use.

Issue the subject’s legally acceptable representative an e-diary (device or application).
Provide instructions on use and completion of the e-diary.  Ask the subject’s legally 
acceptable representative to complete the e-diary from Day 1 to Day 7, with Day 1 being 
the day of vaccination.

Ask the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

Inform the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.3.2. Group 3 Visit 2 (Dose 2: 4-Month Visit, 42 to 63 Days After Dose 1)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 1 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative;
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 (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Measure and record the subject's rectal temperature (F/C).

Administer a single 0.5-mL injection of Prevnar 13 into the left anterolateral thigh.

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
Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the site of Prevnar 13 injection).
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable.  Record 
concomitant medications used to treat SAEs and NDCMCs.

Confirm that the e-diary is working and review instructions if necessary.  Remind the 
subject’s legally acceptable representative to complete the e-diary from Day 1 to Day 7, 
with Day 1 being the day of vaccination.  Provide thermometer or measuring device if 
needed.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.
6.3.3. Group 3 Visit 3 (Dose 3: 6-Month Visit, 42 to 63 Days After Dose 2)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 2 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative;
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 (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Measure and record the subject's rectal temperature (F/C).

Administer a single 0.5-mL injection of Prevnar 13 into the left anterolateral thigh.

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
Administer DTaP-containing vaccine and other permitted vaccines (to be administered 
into a limb other than the site of Prevnar 13 injection).
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable.  Record 
concomitant medications used to treat SAEs and NDCMCs.

Confirm that the e-diary is working and review instructions if necessary.  Remind the 
subject’s legally acceptable representative to complete the e-diary from Day 1 to Day 7,
with Day 1 being the day of vaccination.  Provide thermometer or measuring device if 
needed.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event
(eg, emergency room visit or hospitalization) occurs during the study period.

Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF and updates the
investigational product accountability records.
6.3.4. Group 3 Visit 4 (Follow-up: 7-Month Visit, 28 to 42 Days After Dose 3)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 3 as described in Section 5.7.4.

Review the subject’s e-diary data with the subject’s legally acceptable representative; 
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.

Collect the e-diary (if device provided).

Determine whether any AEs (includes nonserious AEs, SAEs, and NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Collect a blood sample of approximately 5 mL for immunogenicity (a topical anesthetic 
is permitted).

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
Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs during the study period.

Inform the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).

The investigator or an authorized designee completes the CRF.
6.3.5. Group 3 Visit 5 (Dose 4: 12-Month Visit, 365 to 386 Days of Age)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 4 as described in Section 5.7.4.

Determine whether any SAEs or NDCMCs have occurred since the previous visit and
follow up on any previously reported events to determine the outcome (ie, record stop 
dates or confirm if they are still continuing) and record as described in Section 8, and 
record concomitant medications used to treat SAEs and NDCMCs.

Measure and record the subject’s rectal temperature (F/C).

Collect a blood sample of approximately 5 mL for immunogenicity prior to vaccination 
(a topical anesthetic is permitted).

Administer a single 0.5-mL injection of Prevnar 13 into the left anterolateral thigh.

Administer permitted vaccines (to be administered into a limb other than the site of 
Prevnar 13 injection).
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record 
concomitant medications used to treat SAEs and NDCMCs.

Issue the subject’s legally acceptable representative an e-diary (if device needed). Provide 
and review instructions on use and completion of the e-diary.  Ask the subject’s legally 
acceptable representative to complete the e-diary from Day 1 to Day 7, with Day 1 being 
the day of vaccination. Provide thermometer or measuring device if needed.

Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff as soon as possible if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.

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
Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination). 

The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.3.6. Group 3 Visit 6 (Follow-up and Administration of the c7vPnC Supplemental 
Dose: 13-Month Visit, 28 to 42 Days After Dose 4)

Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.

Record vaccines administered since Visit 5 as described in Section 5.7.4.

Review the subject's e-diary data with the subject’s legally acceptable representative; 
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 (includes nonserious AEs, SAEs, or NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.

Measure and record the subject’s rectal temperature (F/C).

Collect a blood sample of approximately 5 mL for immunogenicity prior to vaccination 
(a topical anesthetic is permitted).

Administer a single 0.5-mL injection of c7vPnC into the left anterolateral thigh.
After vaccination:

Site staff will observe the subject for at least 30 minutes after vaccination for any acute 
reactions.  Record any AEs on the CRF and on an SAE form as applicable. Record
concomitant medications used to treat SAEs and NDCMCs.

Confirm that the e-diary is working and review instructions if necessary.  Remind the 
subject’s legally acceptable representative to complete the e-diary from Day 1 to Day 7, 
with Day 1 being the day of vaccination.  Provide thermometer or measuring device if 
needed.

Ask the subject’s legally acceptable representative to contact the investigator site staff or 
investigator as soon as possible during the 7-day postvaccination period if the subject
experiences fever >104.0F (>40.0C), redness or swelling at the injection site measuring 

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>14 measuring device units (>7 cm), or severe injection site pain (causes limitation of 
limb movement) to determine if the event requires further assessment by the investigator.
•
Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff immediately if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.
•
Remind the subject’s legally acceptable representative that use of prophylactic 
antipyretic/pain medication, while permitted, is not recommended on the day of 
investigational product administration (before or after vaccination).
•
The investigator or an authorized designee completes the CRF and updates the 
investigational product accountability records.
6.3.7. Group 3 Visit 7 (Follow-up of the Supplemental Dose: 14-Month Visit, 28 to 
42 Days After the Supplemental Dose)
•
Ensure and document that the subject continues to be eligible for the study (see 
Section 6.5 for withdrawal information), and none of the temporary delay criteria are met.
•
Record vaccines administered since Visit 6 as described in Section 5.7.4.
•
Review the subject's e-diary data with the subject’s legally acceptable representative;
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.
•
Collect the e-diary (if device provided).
•
Determine whether any AEs (includes nonserious AEs, SAEs, or NDCMCs) have 
occurred since the previous visit and follow up on any previously reported events to 
determine the outcome (ie, record stop dates or confirm if they are still continuing) and 
record as described in Section 8, and record concomitant medications used to treat SAEs 
and NDCMCs.
 
•
Remind the subject’s legally acceptable representative to contact the investigator or 
investigator site staff immediately if any significant illness or medical event 
(eg, emergency room visit or hospitalization) occurs.
•
The investigator or an authorized designee completes the CRF.
CCI

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6.3.8. Group 3 Visit 8 (Follow-up: 19-Month Phone Contact, 168 to 196 Days After the 
Supplemental Dose)

Contact the subject’s legally acceptable representative by telephone approximately
6 months after the Supplemental Dose; this contact should be attempted for all subjects 
who have received at least 1 dose of Prevnar 13, unless the subject’s legally acceptable
representative has withdrawn consent.

Determine whether any SAEs or NDCMCs have occurred since the previous visit and 
follow up on any previously reported events to determine the outcome (ie, record stop 
dates or confirm if they are still continuing) and record as described in Section 8, and 
record concomitant medications used to treat SAEs and NDCMCs.

The investigator or an authorized designee completes the CRF.
6.4. Unscheduled Visits
If the subject’s legally acceptable representative reports redness or swelling at the injection 
site measuring >14 measuring device units (>7 cm) or severe injection site pain or a fever 
>104.0°F (>40.0°C) during the 7-day postvaccination period of c7vPnC Doses 1 to 4 and the 
Supplemental Dose, a telephone contact must occur as soon as possible between the 
investigator or medically qualified designee and subject’s legally acceptable representative to 
assess if an unscheduled investigator site visit is required.  Note that for a fever >104.0°F 
(>40.0°C), the subject’s legally acceptable representative should be instructed not to delay 
seeking medical care, as appropriate, while arranging for an unscheduled visit.  An 
investigator site visit should be scheduled as soon as possible to assess the extent of the 
reaction unless any of the following is true:

The subject’s legally acceptable representative is unable to bring the subject to the 
unscheduled visit.

The reaction is no longer present at the time of the telephone contact.

The subject’s legally acceptable representative recorded an incorrect value in the e-diary 
(confirmation of an e-diary data entry error).

The principal investigator (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’s legally acceptable representative is unable to bring the subject to an 
unscheduled visit, or the PI or authorized designee determined it was not needed, any 
ongoing reactions must be assessed at the next study visit.
During the investigator site visit, the reactions should be assessed by the investigator or a 
medically qualified member of the study staff such as a study physician or a study nurse, as 
applicable to the investigator’s local practice, who will:

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
Measure rectal 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 in accordance with the grades provided in Section 7.1.2
(if present).

Assess for other findings associated with the reaction and record on the AE page of the 
CRF, if appropriate.
The investigator or an authorized designee will complete the unscheduled visit assessment 
page of the CRF.
The subject’s legally acceptable representative will also be instructed to contact investigator 
site staff if the subject experiences any emergency room visit or hospitalization for decreased 
appetite, drowsiness/increased sleep, irritability, or local reaction within 7 days of 
vaccination.
The subject’s legally acceptable representative will also be instructed to contact the 
investigator site to report any significant illness, medical event, or hospitalization that occurs 
during the study period.  The investigator site should determine if an unscheduled visit to 
further evaluate the event is warranted in all such cases.
Additionally, study staff may contact the subject’s legally acceptable representative to obtain 
additional information on Grade 3 events entered into the e-diary.
6.5. 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 applicable inclusion criteria, new 
information becomes available that would exclude the subject, or the subject develops a 
condition or situation that would meet exclusion criteria (eg, exclusion criteria 1, 6 to 13), the 
subject may be considered for withdrawal.
Reasons why a subject may discontinue or be withdrawn from the study by the investigator
or sponsor include, but are not limited to, failure to meet entrance criteria (screening failure), 
AE, death, protocol deviation, lost to follow-up, legally acceptable representative 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 follow-up telephone contact for the collection of safety information should be completed 
for all subjects who have been withdrawn after administration of investigational product 
unless consent for further contact has been withdrawn.

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The subject’s legally acceptable representative may withdraw the study subject from the 
study at any time at the representative’s own request, or the subject may be withdrawn at any 
time at the discretion of the investigator or sponsor for safety (see also the Withdrawal From 
the Study Due to Adverse Events, Section 8.1.3) or behavioral reasons, or the inability of the
subject or the subject’s legally acceptable representative 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’s legally acceptable representative.  All attempts to contact the subject’s legally 
acceptable representative 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’s legally acceptable representative withdraws the subject from the study, and 
also withdraws consent for disclosure of future information, no further evaluations should be 
performed, and no additional data should be collected.  The sponsor may retain and continue 
to use any data collected before such withdrawal of consent.
Withdrawal of consent:
Subjects whose legally acceptable representative requests the subject to discontinue receipt 
of investigational product will remain in the study and must continue to be followed for 
protocol-specified safety procedures through 6 months after the last dose of c7vPnC for
Groups 1 and 2 and the c7vPnC Supplemental Dose for Group 3.  The only exception to this 
is when the subject’s legally acceptable representative specifically withdraws consent for any 
further contact with the subject.  The subject’s legally acceptable representative should notify 
the investigator in writing of the decision to withdraw consent from future follow-up, 
whenever possible.  The withdrawal of consent should be explained in detail in the medical
records by the investigator, as to whether the withdrawal is only from further receipt of 
investigational product or also from study procedures and/or posttreatment study follow-up, 
and entered on the appropriate CRF page.
Lost to follow-up:
All reasonable efforts must be made to locate the subject and/or the subject’s legally 
acceptable representative 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’s legally acceptable representative after a 
minimum of 2 documented phone calls, faxes, or emails as well as lack of response by the 
subject’s legally acceptable representative 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 

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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 publicly available sources, 
such as public health registries and databases, in order to obtain updated contact information.  
If, after all attempts, the subject remains lost to follow-up, then the last-known-alive date as 
determined by the investigator should be reported and documented in the subject’s medical 
records.
7. ASSESSMENTS
Every effort should be made to ensure that the protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside of the control of the investigator that may make it unfeasible to 
perform the test. In these cases the investigator will take all steps necessary to ensure the 
safety and well-being of the subject. When a protocol-required test cannot be performed, the 
investigator will document the reason for this and any corrective and preventive actions that 
he or she has taken to ensure that normal processes are adhered to as soon as possible. The 
study team will be informed of these incidents in a timely manner.
7.1. Safety Parameters
Safety parameters will be assessed as described in the Schedule of Activities, Section 8, and 
below.
A medical history, physical examination, and measurement of rectal temperature will be 
performed on all subjects prior to Dose 1 of c7vPnC in Groups 1 and 2 and the first dose of 
Prevnar 13 in Group 3 to determine subject eligibility and to establish a clinical baseline. 
Significant medical history and clinically significant observations from the physical 
examination and temperature measurement will be documented and recorded in the CRF.
Acute reactions within the first 30 minutes after Doses 1 to 4, the c7vPnC Supplemental 
Dose (Group 3), and concomitant vaccine administration (Groups 1 and 3) will be assessed 
and documented as an AE or SAE in the CRF, as appropriate.  Prompted e-diary events, 
including local reactions (pain, redness, and swelling) and systemic events (fever, decreased 
appetite, drowsiness/increased sleep, and irritability) that occur in the 7 days after Doses 1 to 
4 and the Supplemental Dose, are graded as described in Section 7.1.2.
7.1.1. Subject Electronic Diary
The subject’s legally acceptable representative will be asked to monitor and record local 
reactions, specific systemic events, and antipyretic/pain medication taken for 7 days, each 
evening following Doses 1 to 4 and the Supplemental Dose using an e-diary (in a provisioned 
device or an application on a personal device), which 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, specific systemic events, and
antipyretic/pain medication reported in the e-diary will be transferred electronically to the 
e-diary vendor, where they will be available for review by investigators, their qualified 
designees, and sponsor staff at all times via an internet-based portal.  At intervals agreed to 

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by the vendor and Pfizer, these data will be transferred electronically to Pfizer for analysis 
and reporting. 
The daily e-diary data will not be captured 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.
The investigator or designee must obtain stop dates for any reactions ongoing on the last day 
that the e-diary was completed.  The stop dates should be entered in the CRF.
Investigators (or an appropriately qualified designee) are required to review the e-diary data 
online at frequent intervals (daily is optimal) to evaluate subject compliance and reported 
events as part of the ongoing safety review.
7.1.2. Grading Scale for Prompted Events
The grading scales used in this study to assess prompted events 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 adults and 
adolescent volunteers enrolled in preventive vaccine clinical trials, but have been adapted for 
applicability to healthy infants.69
7.1.2.1. Local Reactions
For the first 7 days following Doses 1 to 4 and the Supplemental Dose, the subject’s legally 
acceptable representative 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 >14; an entry in the e-diary of 
15 will denote >14), and then categorized during analysis as mild, moderate, or severe based 
on the grading scale in Table 2 below.  Measuring device units can be converted to 
centimeters according to the following scale: 1 measuring device unit = 0.5 cm.  Pain at the 
vaccine injection site will be assessed by the subject’s legally acceptable representative as 
mild, moderate, or severe according to the grading scale in Table 2 below.  The subject’s 
legally acceptable representative will be prompted to contact the investigator if the subject 
experiences a severe (Grade 3 or above) local reaction to assess the reaction and perform an 
unscheduled assessment or visit as appropriate. 
Only an investigator is able to classify a subject’s local reaction as Grade 4, after physical 
examination of the subject or documentation from another medically qualified source 
(eg, emergency room or hospital record).  If a subject experiences a Grade 4 local reaction, 
the investigator must immediately notify the sponsor. Site staff will educate the subject’s 
legally acceptable representative regarding signs and symptoms that would prompt site 
contact. 
The procedure for notification of the sponsor is provided in the study reference manual 
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Table 2.
Grading Scales for Local Reactions
Mild
Grade 1
Moderate 
Grade 2
Severe 
Grade 3a
Grade 4b
Redness
(synonymous with 
erythema)
1 to 4 caliper units (or 
measuring device 
units)
=
0.5 to 2.0 cm
5 to 14 caliper units (or 
measuring device
units)
=
>2.0 to 7.0 cm
>14 caliper units (or 
measuring device 
units)
=
>7 cm
Necrosis or exfoliative 
dermatitis
Swelling
(synonymous with 
edema)
1 to 4 caliper units (or 
measuring device 
units)
=
0.5 to 2.0 cm
5 to 14 caliper units (or 
measuring device
units)
=
>2.0 to 7.0 cm
>14 caliper units (or 
measuring device 
units)
=
>7 cm
Necrosis
Pain at injection site 
(tenderness)
Hurts if gently touched
(eg, whimpers, winces, 
protests, or withdraws)
Hurts if gently 
touched, with crying
Causes limitation of 
limb movement
Emergency room visit 
or hospitalization for 
severe pain 
(tenderness) at 
injection site
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.
Legally acceptable representatives of the subjects experiencing local reactions >14 caliper units 
(>7.0 cm) are to be contacted by the study site.  An unscheduled visit may be required.
b.
Grade 4 assessment should be made by the investigator.  Grade 4 will not be collected in the e-diary but as an AE on
the CRF.  The severity of the local reaction should be graded using the AE severity grading scale in Section 8.3.
7.1.2.2. Systemic Event Symptoms and Fever
7.1.2.2.1. Systemic Event Symptoms
For the first 7 days following Doses 1 to 4 and the Supplemental Dose, the subject’s legally 
acceptable representative will be asked to assess decreased appetite, drowsiness/increased 
sleep, and irritability and to record the symptoms in the e-diary in the evening.  The 
symptoms will be assessed by the subject’s legally acceptable representative as mild, 
moderate, or severe according to the grading scale in Table 3 below.  The subject’s legally 
acceptable representative will also be instructed to contact site staff if the subject experiences
any possible Grade 4 prompted systemic event (ie, emergency room visit or hospitalization 
for severe decreased appetite, severe drowsiness/increased sleep, or severe irritability) within
7 days after vaccination.  Study staff may also contact the subject’s legally acceptable 
representative 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 
examination of the subject or documentation from another medically qualified source 
(eg, emergency room or hospital record) or telephone contact with the subject’s legally 
acceptable representative.  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.

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Table 3.
Grading Scales for Systemic Events
Systemic Event
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
Decreased appetite 
(loss of appetite)
Decreased interest in
eating
Decreased oral 
intake
Refusal to feed
Emergency room 
visit or 
hospitalization for 
severe decreased 
appetite (loss of 
appetite)
Drowsiness
(increased sleep)
Increased or 
prolonged sleeping 
bouts
Slightly subdued, 
interfering with daily 
activity
Disabling, not 
interested in usual 
daily activity
Emergency room 
visit or 
hospitalization for 
severe drowsiness 
(increased sleep)
Irritability
(fussiness)
(synonymous with 
restless sleep; 
decreased sleep)
Easily consolable
Requiring increased 
attention
Inconsolable; crying 
cannot be comforted
Emergency room 
visit or 
hospitalization for 
severe irritability
(fussiness)
Abbreviations: CRF = case report form; e-diary = electronic diary.
a.
Grade 4 assessment should be made by the investigator; Grade 4 will not be collected in the e-diary but will 
be collected as an AE on the CRF. The severity of the systemic event should be graded using the AE 
severity grading scale in Section 8.3.
7.1.2.2.2. Fever
In order to record information on fever, a digital thermometer will be given to the subject’s 
legally acceptable representative with instructions on how to measure rectal temperature at
home.  Temperature will be collected in the evening daily for 7 days following Doses 1 to 4 
and the Supplemental Dose (Days 1 to 7, where Day 1 is the day of vaccination) and at any 
time during the 7 days that fever is suspected.  Fever is defined as a rectal temperature of 
100.4F (38.0C).  The highest temperature for each day will be recorded in the e-diary.  
In the event of a fever on Day 7, temperature will be collected daily until fever has resolved 
(1 day of temperature less than 100.4F [38.0C]) in order to collect a stop date in the CRF. 
A subject’s legally acceptable representative will be prompted to contact the investigator if 
the subject experiences a fever >104.0F (>40.0C) to assess the fever and perform an 
unscheduled assessment.  Study staff may also contact the subject’s legally acceptable 
representative 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; see Table 4 below. 

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Table 4.
Ranges for Fever
100.4°F to 101.1°F (38.0°C to 38.4°C)
101.2°F to 102.0°F (38.5°C to 38.9°C)
102.1°F to 104.0°F (39.0°C to 40.0°C)
>104.0°F (>40.0°C)
 
 
7.2. Immunogenicity
Blood samples (approximately 5 mL/visit) for immunogenicity assessments will be collected 
from all subjects 1 month after Dose 3, prior to Dose 4, and 1 month after Dose 4, 
 
.  In Group 2, blood will also be collected 
prior to Dose 3.  Sample collection, processing, storage, and shipping information can be 
found in the SRM or equivalent manual.
Concentrations of anticapsular polysaccharide IgG antibodies for the 7 vaccine serotypes 
 
will be determined on sera collected at each blood draw in all 
subjects. The serotype-specific IgG concentrations will be measured by Pfizer’s Luminex-
based assay.
 
 
 
 
 
 
 
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.  Serum samples should be processed and stored as indicated in the 
SRM or equivalent document.
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Immunogenicity assays will be performed at the Pfizer Vaccine Research & Development 
laboratory located at 401 North Middletown Road, Pearl River, New York 10965 and/or at an 
external laboratory designated by Pfizer.
7.3. Biological Samples
Blood samples will be used only for scientific research.  Each sample will be labeled with a 
code so that the laboratory personnel testing the samples will not know the subject’s identity.
Samples that remain after performing assays outlined in the protocol may be stored by Pfizer. 
Unless a time limitation is required by local regulations or ethical requirements, the samples 
will be stored for up to 15 years after the end of the study and then destroyed.  
 
 
 No testing of the subject’s genetic material will be performed.
The subject’s legally acceptable representative may request that his or her child’s samples, if 
still identifiable, be destroyed at any time; however, any data already collected from those 
samples will still be used for this research.  The biological samples may be shared with other 
researchers as long as confidentiality is maintained and no testing of the subject’s genetic 
material is performed.
 
 
 
 
 
 
 
 
 
 
 
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8. ADVERSE EVENT REPORTING
8.1. Requirements
The table below summarizes the requirements for recording safety events on the CRF and for 
reporting safety events on the Clinical Trial (CT) 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 1 month 
after Dose 3 and from Dose 4 to 1 month after Dose 4/Supplemental Dose.  Newly diagnosed chronic 
medical conditions (can be nonserious) and SAEs will be reported from the time the subject provides 
informed consent through 6 months after Dose 4/Supplemental Dose.
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 
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(see the SAE 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.
8.1.1. Additional Details on Recording Adverse Events on the CRF
All events detailed in the table above will be recorded on the AE page(s) of the CRF.  It 
should be noted that the CT SAE Report Form for reporting of SAE information is not the 
same as the AE page of the CRF.  When the same data are collected, the forms must be 
completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE Report 
Form for reporting of SAE information.
8.1.2. Eliciting Adverse Event Information
The investigator is to record on the CRF all directly observed AEs and all AEs spontaneously 
reported by the study subject’s legally acceptable representative.  In addition, each study 
subject’s legally acceptable representative 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/NDCMC 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’s legally acceptable 
representative provides informed consent, which is obtained before the subject’s participation 
in the study (ie, before undergoing any study-related procedure and/or receiving 

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investigational product).  AEs will be collected through 1 month after Dose 3 and from 
Dose 4 through 1 month after Dose 4 or 1 month after the Supplemental Dose in Group 3.  
NDCMCs and SAEs will be collected from signing of informed consent through 6 months 
after Dose 4 or the Supplemental Dose.  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.
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.

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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;

Drug withdrawal;

Drug misuse;

Drug interactions;

Extravasation;

Exposure during pregnancy (EDP);

Exposure via breastfeeding;

Medication error;

Occupational exposure.
Events that, in the clinical judgment of the investigator, are 1) consistent with normal growth
and development and 2) do not differ significantly in frequency or severity from expected,

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are not generally to be considered AEs. Examples may include, but are not limited to, 
teething, contact diaper rash, spitting up, colic, or typical fussiness/crying in infants and 
children.
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
A serious adverse event is any untoward medical occurrence at any dose that:

Results in death;

Is life-threatening (immediate risk of death);

Requires inpatient hospitalization or prolongation of existing hospitalization;

Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions);

Results in congenital anomaly/birth defect.
Or that is considered to be:

An important medical event.
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event.  An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization.  However, if it is determined that the event may jeopardize 
the subject or may require intervention to prevent one of the other AE outcomes, the 
important medical event should be reported as serious.

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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;
Examples: clinically relevant increase in the duration of a surgical procedure; a 
condition that requires hospitalization or significant prolongation of existing 
hospitalization;

Any indirect harm as a consequence of an incorrect diagnostic or in vitro diagnostic 
device test results when used within the manufacturer’s instructions for use;

Fetal distress, fetal death, or any congenital abnormality or birth defects.
8.2.4. Hospitalization
Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or 
equivalent healthcare facility, or any prolongation of an existing admission.  Admission also 
includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a
tuberculosis unit).  An emergency room visit does not necessarily constitute a hospitalization; 
however, the event leading to the emergency room visit is assessed for medical importance.
Hospitalization does not include the following:

Rehabilitation facilities;

Hospice facilities;

Respite care (eg, caregiver relief);

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
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.
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.

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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 this 
study. However, should an investigator deem it necessary to assess LFTs because a subject 
presents with clinical signs/symptoms, such LFT results should be managed and followed as 
described below.
In the majority of DILI cases, elevations in aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) precede total bilirubin (TBili) elevations (>2 × ULN) by several 
days or weeks.  The increase in TBili typically occurs while AST/ALT is/are still elevated 
above 3 × ULN (ie, AST/ALT and TBili values will be elevated within the same laboratory
sample).  In rare instances, by the time TBili elevations are detected, AST/ALT values might 
have decreased.  This occurrence is still regarded as a potential DILI.  Therefore, abnormal 
elevations in either AST OR ALT in addition to TBili that meet the criteria outlined below 
are considered potential DILI (assessed per Hy’s law criteria) cases and should always be 
considered important medical events, even before all other possible causes of liver injury 
have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the subject’s 
individual baseline values and underlying conditions.  Subjects who present with the
following laboratory abnormalities should be evaluated further as potential DILI (Hy’s law) 
cases to definitively determine the etiology of the abnormal laboratory values:

Subjects with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 

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>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) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.

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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 exposure during 
pregnancy (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).
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 
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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.
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 and Lack of Efficacy
Other exposures to the investigational product under study may occur in clinical trial settings, 
such as medication errors and lack of efficacy.

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Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
Medication errors and lack of 
efficacy
All (regardless of whether 
associated with an AE)
Only if associated with an 
SAE
8.4.4.1. Medication Errors
Medication errors may result from the administration or consumption of the investigational 
product by the wrong subject, or at the wrong time, or at the wrong dosage strength.
Medication errors include:

Medication errors involving subject exposure to the investigational product;

Potential medication errors or uses outside of what is foreseen in the protocol that do or 
do not involve the participating subject;

The administration of expired investigational product;

The administration of an incorrect investigational product;

The administration of an incorrect dosage;

The administration of investigational product that has undergone temperature excursion 
from the specified storage range, unless it is determined by the sponsor that the 
investigational product under question is acceptable for use.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified immediately.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on an AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
8.4.4.2. Lack of Efficacy 
Lack of efficacy in an approved indication (approved Prevnar 13 indication in this age group) 
should be reported as an SAE to Pfizer Safety.

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8.5. Medical Device Complaint Reporting Requirements
All medical device complaints, regardless of whether the medical device complaint is 
associated with an AE, will be recorded on the applicable pages within the CRF.  This 
includes potential incidents or malfunctions associated with the use of a medical device 
product.  An incident or malfunction is an event that might have led to death or serious 
deterioration in health, or if it occurred again might lead to death or serious deterioration in 
health.
Pfizer is to be notified of all medical device complaints within 24 hours of the investigator’s 
awareness of the event.
9. DATA ANALYSIS/STATISTICAL METHODS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a statistical analysis plan (SAP), which will be 
maintained by the sponsor.  The SAP may modify what is outlined in the protocol where 
appropriate; however, any major modifications of the primary endpoint definitions or their 
analyses will also be reflected in a protocol amendment.
9.1. Sample Size Determination
The study size is not based on any formal statistical hypothesis test.  Approximately 
188 infants per vaccine group are planned to be randomized.  No hypothesis tests between 
vaccine groups are planned; therefore, no power calculations for comparison of vaccine 
groups are included.
With 188 subjects per arm, the probabilities of observing at least 1 AE, local reaction, or 
systemic event where the true rate is 0.5%, 1%, and 5% are presented in Table 5.
Table 5.
Probability of Observing at Least 1 AE, Local Reaction, or Systemic Event 
by Assumed True Event Rates
Sample Size
Assumed True Event Rate of at Least 1 AE, Local Reaction, or Systemic Event
0.5%
1%
5%
N = 188
0.610
0.849
>0.999
9.2. Analysis Populations
The safety population will include all Group 1 and Group 2 subjects who receive at least 
1 dose of c7vPnC and all Group 3 subjects who receive at least 1 dose of Prevnar 13.  
Subjects will be assigned to vaccine groups corresponding to the vaccine series actually 
received.  The safety population will be the only analysis population for the primary 
endpoints.
The Dose 3 evaluable immunogenicity population will include any subject:
1. Who was eligible for the study.

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2. Who was randomized and met the SAP-specified age window on the first day of 
vaccination for the randomized group (age windows will be same for Groups 1 and 3, but 
different for Group 2).
3. Who received c7vPnC and/or Prevnar 13, as randomly assigned, through Dose 3.
4. Who had an IgG concentration for at least 1 serotype 1 month after Dose 3.
5. Whose blood collection was within the SAP-specified window after Dose 3.
6. Who had no other major protocol deviations as determined by the clinician or medical 
monitor.
Additional criteria may be described in the SAP.  The Dose 3 evaluable immunogenicity 
population will be the primary analysis population for immunogenicity results from the blood 
collected 1 month after Dose 3.
 
 
 
The Dose 4 evaluable immunogenicity population will include any subject:
1. Who was eligible for the study.
2. Who was randomized and met the SAP-specified age window on first day of vaccination 
for the randomized group (age windows will be same for Groups 1 and 3, but different 
for Group 2).
3. Who received the assigned vaccine, as randomized, within the defined window for 
Dose 4 as specified in the SAP.
4. Who received the vaccine to which he or she was randomly assigned at all 4 doses.
5. Who had an IgG concentration for at least 1 serotype 1 month after Dose 4.
6. Whose blood collection was within the SAP-specified window after Dose 4.
7. Who had no other major protocol deviations as determined by the clinician or medical 
monitor.
Additional criteria are described in the SAP.  The Dose 4 evaluable immunogenicity 
population will be the primary analysis population for immunogenicity results after Dose 4.
 
 
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9.3. Immunogenicity Analysis
All serotypes will be analyzed in the same way.  All endpoints will be summarized by 
vaccine group.
9.3.1. Analyses of Secondary
 Endpoints
The secondary 
 endpoints will be summarized by:
1. Geometric mean concentrations (GMCs) after Dose 3,
3. GMCs after Dose 4,
4. Proportions of subjects with IgG concentrations ≥reference concentration after Dose 3,
 
Ninety-five percent confidence intervals (CIs) will also be calculated for all descriptive 
statistics.
GMCs and their CIs will be obtained by taking log transforms of concentrations, calculating 
the 95% CI with reference to the t-distribution, then exponentiating the mean and the limits. 
The Luminex assay IgG concentration of 0.35 μg/mL will be used as the predefined IgG 
reference concentration for all serotypes, with the exception of serotypes 5 (0.23 μg/mL), 6B 
(0.1 μg/mL), and 19A (0.12 μg/mL).  The 95% CIs will be obtained using the Clopper-
Pearson method.70
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9.4. Safety Analysis
All safety analyses will be performed using the safety population.
Descriptive statistics for local reactions for the c7vPnC injection site in Groups 1 and 2 and 
the Supplemental Dose in Group 3, as well as the Prevnar 13 site in Group 3, and systemic 
events from Day 1 to Day 7 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.  Local reactions will be compiled for each dose 
for each group (Doses 1, 2, 3, and 4 and the Supplemental Dose) separately and compiled 
across all 4 doses of the same group.
AEs (including nonserious AEs, SAEs, and NDCMCs) will be compiled over 2 intervals: 
from Dose 1 to 1 month following Dose 3 and from Dose 4 to 1 month following 
Dose 4/Supplemental Dose.  SAEs and NDCMCs will be summarized from Dose 1 until 
6 months after Dose 4/Supplemental Dose.  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.
 
 
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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.
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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.
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.

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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 
forwarded to Pfizer.
The only circumstance in which an amendment may be initiated prior to IRB/EC approval is 
where the change is necessary to eliminate apparent immediate hazards to the subjects.  In 
that event, the investigator must notify the IRB/EC and Pfizer in writing immediately after 
the implementation.
12.2. Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, legal and regulatory 
requirements, and the general principles set forth in the International Ethical Guidelines for 
Biomedical Research Involving Human Subjects (Council for International Organizations of 
Medical Sciences [CIOMS] 2002), ICH Guideline for Good Clinical Practice, and the 
Declaration of Helsinki.

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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's legally acceptable representative is 
fully informed about the nature and objectives of the study and possible risks associated with 
participation.
Whenever consent is obtained from a subject’s legally acceptable representative, the 
subject’s assent (affirmative agreement) must subsequently be obtained when the subject has 
the capacity to provide assent, as determined by the IRB/EC.  If the investigator determines 
that a subject’s decisional capacity is so limited he/she cannot reasonably be consulted, then, 
as permitted by the IRB/EC and consistent with local regulatory and legal requirements, the 
subject’s assent may be waived with source documentation of the reason assent was not 
obtained.  If the study subject does not provide his or her own consent, the source documents
must record why the subject did not provide consent (eg, minor, decisionally impaired adult), 
how the investigator determined that the person signing the consent was the subject’s legally 
acceptable representative, the consent signer’s relationship to the study subject (eg, parent, 
spouse), and that the subject’s assent was obtained or waived.  If assent is obtained verbally,
it must be documented in the source documents.
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each subject's legally acceptable representative 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 

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information that might influence the evaluation of the benefits and risks of the investigational 
product, Pfizer should be informed immediately.
In addition, the investigator will inform Pfizer immediately of any urgent safety measures
taken by the investigator to protect the study subjects against any immediate hazard, and of 
any serious breaches of this protocol or of ICH GCP that the investigator becomes aware of.
13. DEFINITION OF END OF TRIAL
13.1. End of Trial in All Participating Countries
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 
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PCD is defined as the date that the final subject was examined or received an intervention for 
the purposes of final collection of data for the primary outcome, whether the clinical study 
concluded according to the prespecified protocol or was terminated.
EudraCT
Pfizer posts European Union (EU) Basic Results on EudraCT for all Pfizer-sponsored 
interventional studies that are in scope of EU requirements.  EU Basic Results are submitted 
for posting within 1 year of the PCD for studies in adult populations or within 6 months of
the PCD for studies in pediatric populations.
www.pfizer.com
Pfizer posts Public Disclosure Synopses (clinical study report synopses in which any data 
that could be used to identify individual patients 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
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Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship, 
established by the International Committee of Medical Journal Editors.
Publication of study results is also provided for in the CSA between Pfizer and the 
institution.  In this section entitled Publications by Investigators, the defined terms shall have 
the meanings given to them in the CSA.
If there is any conflict between the CSA and any attachments to it, the terms of the CSA 
control.  If there is any conflict between this protocol and the CSA, this protocol will control 
as to any issue regarding treatment of study subjects, and the CSA will control as to all other 
issues.

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2
O'Brien KL, Wolfson LJ, Watt JP, et al; for the Hib and Pneumococcal Global Burden 
of Disease Study Team. Burden of disease caused by Streptococcus pneumoniae in 
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Huang SS, Johnson KM, Ray GT, et al. Healthcare utilization and cost of pneumococcal
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Iyer AS, Ohtola JA, Westerink MAJ. Age-related immune response to pneumococcal 
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5
Wahl B, O’Brien KL, Greenbaum A, et al. Global burden of Streptococcus pneumoniae
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(ISPPD-10); 26-30 Jun 2016; Glasgow, Scotland.
6
Centers for Disease Control and Prevention. Active Bacterial Core surveillance. Trends 
by serotype group, 1998-2015.  http://www.cdc.gov/abcs/reports-
findings/survreports/spneu-types.html.   Accessed 27 July 2016.
7
Moore MR, Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent pneumococcal
conjugate vaccine in children on invasive pneumococcal disease in children and adults 
in the USA: analysis of multisite, population-based surveillance. Lancet Infect Dis. 
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8
Olarte L, Barson WJ, Barson RM, et al. Impact of the 13-valent pneumococcal 
conjugate vaccine on pneumococcal meningitis in US children. Clin Infect Dis. 
2015;61(5):767-775.
9
Stockmann C, Ampofo K, Byington CL, et al. Pneumococcal meningitis in children:
epidemiology, serotypes, and outcomes from 1997-2010 in Utah. Pediatrics. 
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10
Jain S, Williams DJ, Arnold SR, et al; for the CDC EPIC Study Team. Community-
acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med. 
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11
Jain S, Self WH, Wunderink RG, et al; for the CDC EPIC Study Team. Community-
acquired pneumonia requiring hospitalization among U.S. adults. N Engl J Med.
2015;373(5):415-427.
12
Marom T, Tan A, Wilkinson GS, Pierson K, Freeman JL, Chonmaitree T. Trends in
otitis media–related health care use in the United States, 2001-2011. JAMA Pediatr. 
2014;168(1):68-75.
13
Geno KA, Gilbert GL, Song JY, et al. Pneumococcal capsules and their types: past, 
present, and future. Clin Microbiol Rev. 2015;28(3):871-899.
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Appendix 1. Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
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
CRF
case report form
CRM197
cross-reactive material 197
CSA
clinical study agreement
CT
clinical trial
DILI
drug-induced liver injury
DTaP
diphtheria, tetanus, and acellular pertussis
EC
ethics committee
e-diary
electronic diary
 
ELISA
enzyme-linked immunosorbent assay
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMC
geometric mean concentration
GMT
geometric mean titer
IB
investigator’s brochure
ICH
International Council for Harmonisation
ID
identification
IgG
immunoglobulin G
IM
intramuscularly
IND
investigational new drug application
INR
international normalized ratio
IP
investigational product
IPD
invasive pneumococcal disease
IRB
institutional review board
IRT
interactive response technology
IU
international units
CCI
CCI
CCI

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Abbreviation
Term
IWR
interactive Web-based response
LFT
liver function test
LLOQ
lower limit of quantitation
LSLV
last subject last visit 
MMR
measles, mumps, and rubella
N/A
not applicable
NDCMC
newly diagnosed chronic medical condition
OPA
opsonophagocytic activity
PCD
primary completion date
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
TBili
total bilirubin
ULN
upper limit of normal
US
United States
USPI
US package insert
VT
vaccine-type
WHO
World Health Organization
CCI

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