A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SINGLE DOSE OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN JAPANESE SUBJECTS AGED 6 TO 64 YEARS WHO ARE CONSIDERED TO BE AT INCREASED RISK OF PNEUMOCOCCAL DISEASE AND WHO ARE NAIVE TO PNEUMOCOCCAL VACCINES
Phase: PHASE3
Conditions: Pneumococcal Infections
Sponsor: Pfizer

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A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS 
THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SINGLE DOSE 
OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN JAPANESE 
SUBJECTS AGED 6 TO 64 YEARS WHO ARE CONSIDERED TO BE AT 
INCREASED RISK OF PNEUMOCOCCAL DISEASE AND WHO ARE NAIVE TO 
PNEUMOCOCCAL VACCINES 
Investigational Product Number:
PF-05208760
Investigational Product Name:
13-valent Pneumococcal Conjugate Vaccine
United States (US) Investigational New 
Drug (IND) Number:
Not Applicable (N/A)
European Clinical Trials Database 
(EudraCT) Number:
N/A
Protocol Number:
B1851172
Phase:
3
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Document History 
Document
Version Date
Summary of Changes and 
Rationale
Original protocol
20 March 2018
Not applicable (N/A)
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TABLE OF CONTENTS 
LIST OF TABLES .....................................................................................................................6
APPENDICES ...........................................................................................................................6
PROTOCOL SUMMARY .........................................................................................................7
SCHEDULE OF ACTIVITIES................................................................................................10
1. INTRODUCTION ...............................................................................................................11
1.1. Mechanism of Action/Indication .............................................................................11
1.2. Background and Rationale ......................................................................................11
1.2.1. Unmet Medical Need ..................................................................................11
1.2.2. Development of Investigational Product ....................................................12
1.2.2.1. Clinical Studies in Japan ...........................................................13
1.2.3. Study Rationale ...........................................................................................13
2. STUDY OBJECTIVES AND ENDPOINTS .......................................................................14
3. STUDY DESIGN.................................................................................................................15
3.1. Approximate Duration of Subject Participation ......................................................15
3.2. Approximate Duration of the Study ........................................................................15
3.3. Approximate Number of Subjects ...........................................................................15
4. SUBJECT ELIGIBILITY CRITERIA .................................................................................16
4.1. Inclusion Criteria .....................................................................................................16
4.2. Exclusion Criteria ....................................................................................................17
4.3. Criteria for Temporarily Delaying Investigational Product Administration ...........19
4.4. Lifestyle Requirements ...........................................................................................19
4.4.1. Contraception ..............................................................................................19
4.5. Sponsor’s Qualified Medical Personnel ..................................................................20
5. INVESTIGATIONAL PRODUCTS ...................................................................................20
5.1. Allocation to Investigational Product ......................................................................21
5.2. Subject Compliance .................................................................................................21
5.3. Investigational Product Supplies .............................................................................21
5.3.1. Dosage Form(s) and Packaging ..................................................................21
5.3.2. Preparation and Dispensing ........................................................................21
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5.4. Administration .........................................................................................................22
5.5. Investigational Product Storage ..............................................................................22
5.6. Investigational Product Accountability ...................................................................23
5.6.1. Destruction of Investigational Product Supplies ........................................23
5.7. Concomitant Treatment(s) .......................................................................................23
5.7.1. Prohibited Prior Treatment .........................................................................23
5.7.2. Prohibited During the Study .......................................................................24
5.7.3. Permitted During the Study ........................................................................24
6. STUDY PROCEDURES .....................................................................................................24
6.1. Visit 1 - Vaccination (Day 1) ..................................................................................25
6.2. Visit 2-Follow-up Visit (28 to 42 Days After Visit 1) ............................................28
6.3. Assessment of Postvaccination Severe Reactions and Systemic Events ................28
6.3.1. Severe Local Reaction or Fever Telephone Contact and Unscheduled 
Visit ..................................................................................................................28
6.3.2. Severe Systemic Event Telephone Contact ................................................29
6.4. Subject Withdrawal .................................................................................................29
7. ASSESSMENTS ..................................................................................................................30
7.1. Pregnancy Testing ...................................................................................................30
7.2. Safety Assessments .................................................................................................30
7.2.1. Local Reactions and Systemic Events ........................................................31
7.2.1.1. Electronic Diary ........................................................................31
7.2.1.2. Grading Scales for Local Reactions and Systemic Events ........31
7.2.1.3. Local Reactions .........................................................................32
7.2.1.4. Systemic Events ........................................................................34
7.2.1.5. Fever ..........................................................................................35
7.2.1.6. Use of Antipyretic Medication and Pain Medication ................36
7.3. Immunogenicity ......................................................................................................36
7.4. Biological Samples ..................................................................................................37
8. ADVERSE EVENT REPORTING......................................................................................37
8.1. Requirements ...........................................................................................................37
8.1.1. Additional Details on Recording Adverse Events on the CRF ...................39
8.1.2. Eliciting Adverse Event Information ..........................................................39
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8.1.3. Withdrawal From the Study Due to Adverse Events (see also the 
Subject Withdrawal section) ............................................................................39
8.1.4. Time Period for Collecting AE/SAE Information ......................................39
8.1.4.1. Reporting SAEs to Pfizer Safety ...............................................39
8.1.4.2. Recording Nonserious AEs and SAEs on the CRF ...................40
8.1.5. Causality Assessment .................................................................................40
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities ..................40
8.2. Definitions ...............................................................................................................40
8.2.1. Adverse Events ...........................................................................................40
8.2.2. Abnormal Test Findings .............................................................................41
8.2.3. Serious Adverse Events ..............................................................................42
8.2.4. Hospitalization ............................................................................................43
8.3. Severity Assessment ................................................................................................44
8.4. Special Situations ....................................................................................................44
8.4.1. Protocol-Specified Serious Adverse Events ...............................................44
8.4.2. Potential Cases of Drug-Induced Liver Injury ............................................45
8.4.3. Exposure to the Investigational Product During Pregnancy or 
Breastfeeding, and Occupational Exposure .....................................................46
8.4.3.1. Exposure During Pregnancy ......................................................46
8.4.3.2. Exposure During Breastfeeding ................................................48
8.4.3.3. Occupational Exposure .............................................................48
8.4.4. Medication Errors and Lack of Efficacy ....................................................48
8.4.4.1. Medication Errors ......................................................................49
8.4.4.2. Lack of Efficacy ........................................................................49
8.5. Medical Device Complaint Reporting Requirements .............................................49
9. DATA ANALYSIS/STATISTICAL METHODS ...............................................................50
9.1. Sample Size Determination .....................................................................................50
9.2. Analysis Populations ...............................................................................................50
9.3. Immunogenicity Analysis .......................................................................................51
9.4. Safety Analysis ........................................................................................................51
9.5. Interim Analysis ......................................................................................................52
9.6. Data Monitoring Committee ...................................................................................52
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10. QUALITY CONTROL AND QUALITY ASSURANCE .................................................52
11. DATA HANDLING AND RECORD KEEPING .............................................................52
11.1. Case Report Forms/Electronic Data Record .........................................................52
11.2. Record Retention ...................................................................................................53
12. ETHICS..............................................................................................................................54
12.1. Institutional Review Board/Ethics Committee ......................................................54
12.2. Ethical Conduct of the Study ................................................................................54
12.3. Subject Information and Consent ..........................................................................54
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH 
GCP ...........................................................................................................................55
13. DEFINITION OF END OF TRIAL ...................................................................................55
13.1. End of Trial in All Participating Countries ...........................................................55
14. SPONSOR DISCONTINUATION CRITERIA ................................................................55
15. PUBLICATION OF STUDY RESULTS ..........................................................................56
15.1. Communication of Results by Pfizer ....................................................................56
15.2. Publications by Investigators ................................................................................57
16. REFERENCES ..................................................................................................................58
LIST OF TABLES 
Table 1.
Approximate Number of Subjects in Each Age Group and Minimum 
Number of Subjects for the Specified Age Categories .........................................15
Table 2.
Local Reaction Grading Scale (for Subjects Aged 6 to <12 Years) .....................33
Table 3.
Local Reaction Grading Scale (for Subjects Aged 12 to <18 Years and 18 
to <65 Years) ........................................................................................................34
Table 4.
Systemic Event Grading Scale (for All Age Groups and Categories) ..................35
Table 5.
Scale for Fever ......................................................................................................36
Table 6.
Probability of Observing at Least 1 Event by Assumed True Incidence 
Rates With Different Sample Sizes ......................................................................50
APPENDICES 
Appendix 1. Abbreviations ......................................................................................................62
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PROTOCOL SUMMARY 
Disease caused by Streptococcus pneumoniae is a major global public health concern.  While 
the burden of invasive pneumococcal disease (IPD) is predominantly borne by the very 
young, very old, and immunocompromised, manifestations of pneumococcal disease are a 
considerable cause of morbidity and mortality in all age groups. 
In Japan, 13-valent pneumococcal conjugate vaccine (13vPnC) was approved for children 
aged t2 months to <6 years in 2013 and for adults aged t65 years in 2014.  13vPnC has not 
been approved for individuals between the ages of 6 and 64 years in Japan, which is in 
contrast to the situation in the United States, countries in Europe, and many other countries 
globally where 13vPnC is approved for these ages.  This situation is despite the fact that the 
6- to 64-year age group has a not-insignificant proportion of individuals with underlying 
medical conditions who are considered to be at increased risk for developing pneumococcal 
disease (PD) based on the epidemiological data in Japan. Furthermore, the 5- to 64-year age 
group represented 27% of reported IPD cases in Japan in 2013, and many IPD patients are 
individuals with underlying medical conditions. 
Pfizer-sponsored clinical studies conducted outside Japan in healthy individuals and in 
immunocompetent individuals with underlying stable medical conditions aged 6 years and 
older demonstrated that a single dose of 13vPnC was safe and well tolerated.  In addition, the 
safety and immunogenicity of 13vPnC have been confirmed in overseas clinical studies 
involving immunocompromised populations, ie, subjects with sickle-cell disease (SCD), 
human immunodeficiency virus (HIV)-infected subjects, and recipients of hematopoietic 
stem cell transplant (HSCT). Furthermore, more than 642 million doses of 
Prevenar 13/Prevnar 13 (13vPnC) have been administered to individuals across the age 
spectrum globally and more than 15 million doses have been administered in Japan to 
children aged <6 years and adults aged t65 years, without specific safety concerns.
Therefore, the unmet medical need for protection against PD that could be provided by 
13vPnC, the large database of safety data from clinical studies in Japan and globally, and the 
extensive postmarketing experience support the conduct of the present study, Phase 3 
Study B1851172, in Japan.  This study will assess the safety, tolerability, and 
immunogenicity of a single dose of 13vPnC in Japanese individuals aged 6 to 64 years who
are considered to be at increased risk of pneumococcal disease and who are naive to 
pneumococcal vaccine.
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STUDY OBJECTIVES AND ENDPOINTS 
Primary Objective:
Primary Endpoints:
x
To assess the safety and tolerability of a single dose of 
13vPnC as measured by the incidence of local reactions, 
systemic events, adverse events (AEs), and serious 
adverse events (SAEs).
x
Number and proportion of subjects reporting local 
reactions (redness, swelling, pain at injection site) and 
severity of the local reactions occurring within the 
7-day period following study vaccination in the 6- to 
<18-year age group.
x
Number and proportion of subjects reporting local 
reactions (redness, swelling, pain at injection site) and 
severity of the local reactions occurring within the 
14-day period following study vaccination in the 18- to 
<65-year age group.
x
Number and proportion of subjects reporting systemic 
events (fever, fatigue, headache, vomiting, diarrhea,
muscle pain, joint pain) and severity of the systemic 
events occurring within the 7-day period following 
study vaccination in the 6- to <18-year age group.
x
Number and proportion of subjects reporting systemic 
events (fever, fatigue, headache, vomiting, diarrhea, 
muscle pain, joint pain) and severity of the systemic 
events occurring within the 14-day period following 
study vaccination in the 18- to <65-year age group.
x
Number and proportion of subjects reporting AEs and 
SAEs until Visit 2 categorized according to the Medical 
Dictionary for Regulatory Activities (MedDRA) in all 
age groups.
Secondary Objective:
Secondary Endpoints:
x
To describe the immune responses elicited by a single
dose of 13vPnC.
x
Serotype-specific opsonophagocytic activity (OPA) 
geometric mean titers (GMTs) 1 month after 
vaccination in all age groups.
x
Geometric mean fold rises (GMFRs) in 
serotype-specific OPA titers from before vaccination to 
1 month after vaccination in all age groups.
x
Serotype-specific immunoglobulin G (IgG) geometric 
mean concentrations (GMCs) 1 month after vaccination
in all age groups.
x
GMFRs in serotype-specific IgG from before 
vaccination to 1 month after vaccination in all age 
groups.
STUDY DESIGN 
This is a Phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, 
and immunogenicity of single dose of 13vPnC in Japanese subjects aged 6 to 64 years who 
are considered to be at increased risk of pneumococcal disease and who are naive to 
pneumococcal vaccines. 
Approximate Duration of Subject Participation 
Subjects will participate in the study for approximately 1 month (29 to 43 days). 
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Approximate Duration of the Study 
The study will be completed in approximately 6 months.  Study duration is from first subject 
first visit (FSFV) to last subject last visit (LSLV).
Approximate Number of Subjects 
Approximately 200 subjects will be enrolled: approximately 50 subjects in the 6- to <18-year 
age group and approximately 150 subjects in the 18- to <65-year age group. 
For the purpose of ensuring a minimum number of subjects in each of the age categories, at 
least 15 subjects aged 6 to <12 years and 15 subjects aged 12 to <18 years will be enrolled 
within the 6- to <18-year age group.  Furthermore, at least 50 subjects aged 18 to <50 years 
and 50 subjects aged 50 to <65 years will be enrolled within the 18- to <65-year age group. 
Study Vaccine 
The investigational products (13vPnC) will be provided by the sponsor to each study site.  
The study vaccines will be packed and labeled as investigational products in accordance with 
current guidelines and applicable local and legal regulatory requirements. 
13vPnC 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 cross-reactive 
material 197 (CRM197).  The vaccine is formulated to contain 2.2 μg of each saccharide, 
except for 4.4 μg of 6B, per 0.5-mL dose.  The vaccine contains 5 mM succinate buffer, 
0.85% sodium chloride, 0.02% polysorbate 80, and 0.125 mg aluminum as aluminum 
phosphate, per 0.5-mL dose.  The vaccine will be provided as a single-dose prefilled syringe. 
Statistical Methods 
An analysis of safety and immunogenicity data will be conducted when data are available 
through 1 month after vaccination.  All analyses will be descriptive.  No formal hypothesis 
tests are planned. 
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SCHEDULE OF ACTIVITIES
The schedule of activities table provides an overview of the protocol visits and procedures.  
Refer to the Study Procedures and Assessments sections of the protocol for detailed 
information on each procedure and assessment required for compliance with the protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed on the 
schedule of activities table, in order to conduct evaluations or assessments required to protect 
the well-being of the subject. 
Visit Number 
1
2
Visit ID
Vaccination
Follow-up Visit
Visit Windowa
Day 1
Day 29 to Day 43
Informed consent/assent
X
Demographics
X
Medical history
X
Smoking status
X
Prior/concomitant vaccination and/or
immunosuppressive drugs, including systemic 
corticosteroids, immune-modifying drugs, or 
monoclonal antibodies
X
X
Physical examination
X
Prevaccination axillary temperature
X
Urine pregnancy testb
X
Inclusion and exclusion criteria
X
Temporary delay criteria
X
Immunogenicity blood sampling
Xc
X
Investigational product administration
X
30-Minute postvaccination observation and 
assessment of acute reactions
X
Train subject or a legally acceptable 
representative/parent/legal guardian to use e-diary 
and set up e-diary for the subject
X
Dispense e-diary, digital thermometer, and caliper
X
Subjects to record local reactions and systemic events 
in e-diary
6- to <18-year age group: Day 1 to 
Day 7
18- to <65-year age group: Day 1 
to Day 14
Review e-diary datad
X-------------------------X
Collect e-diary
X
Serious and nonserious adverse event collection
X-------------------------X
Abbreviation: e-diary = electronic diary.
a.
Day relative to study vaccination (Day 1).
b.
For female subjects of childbearing potential. Pregnancy tests will also be done whenever 1 menstrual 
cycle is missed during the active treatment period (28 days after vaccination) (or when potential pregnancy 
is otherwise suspected).
c.
Immunogenicity blood sampling at Day 1 must occur before administration of investigational product.
d.
Investigators (or appropriately qualified designees) review the e-diary data online at frequent intervals after 
Day 1.
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1. INTRODUCTION 
1.1. Mechanism of Action/Indication 
13-valent pneumococcal conjugate vaccine (13vPnC) is indicated for the prevention of 
disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 
19A, 19F, and 23F in individuals 6 to 64 years of age who are considered to be at increased 
risk of pneumococcal disease. 
1.2. Background and Rationale 
1.2.1. Unmet Medical Need 
Disease caused by S pneumoniae is a major global public health concern.  While the burden 
of invasive pneumococcal disease (IPD) is predominantly borne by the very young, very old, 
and immunocompromised, manifestations of pneumococcal disease are a considerable cause 
of morbidity and mortality in all age groups.  Globally, pneumococcal pneumonia was 
estimated to cause 1,517,388 deaths (95% uncertainty interval [UI]: 857,940-2,183,791) in
2015 and, across all ages, accounted for 55.4% (95% UI: 31.5-79.1) of deaths due to lower 
respiratory tract infections.1
In Japan, S pneumoniae was the leading causative pathogen of community-onset pneumonia 
and was responsible for 20% to 28% of community-onset pneumonia.2 The estimated annual 
incidence of S pneumoniae–associated community-onset pneumonia in Japan was 4.7 per 
1000 persons among individuals aged 15 years and older, with the estimated annual 
incidence ranging from 0.8 to 3.8 per 1000 persons when considering the various age decades 
between 15 and <65 years old.2 S pneumoniae is also an important cause of invasive disease 
and the estimated incidence of IPD in Japan in 2013 was 1.18 per 100,000 population.3 The 
incidence (per 100,000) was higher at both ends of the age spectrum: 6.32 for the population 
under 5 years of age, 0.36 for the population 5 to 14 years of age, 0.46 for the population 
15 to 64 years of age, and 2.41 for the population 65 years of age and older.3  In 2013, the 
number of IPD cases was 1505 in total: 331 (22%) for the population under 5 years of age, 
406 (27%) for the population 5 to 64 years of age, and 768 (51%) for the population 65 years 
of age and older.  Thus, the number of IPD cases in the population 5 to 64 years of age was 
similar to that in the population under 5 years of age.3
Individuals with certain underlying medical conditions are considered to be at increased risk 
for developing pneumococcal disease (PD) and also for experiencing severe IPD and its 
complications.  Predisposing factors for pneumococcal disease include chronic medical 
conditions such as cardiovascular, pulmonary, hepatic, or renal diseases; diabetes mellitus; 
asplenia; human immunodeficiency virus (HIV) infection or other immunosuppressive 
conditions; cochlear implant; cerebrospinal fluid (CSF) leaks; smoking; alcoholism; and 
residence in certain environments, such as nursing homes. According to a research project 
conducted in 10 prefectures in Japan, in patients older than 15 years who had IPD, 72% had 
underlying diseases and the case fatality proportion for all cases was 20%.4,5,6,7
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In addition, because of an increasing prevalence of S pneumoniae strains resistant to 
antibiotics, including penicillin, other beta-lactam antibiotics, and macrolides, the treatment 
of pneumococcal infections is becoming more difficult.8,9,10,11,12
Therefore, there is a need for an effective vaccine to protect against PD across the spectrum 
of age groups, including in those individuals with underlying medical conditions that
increase the risk of contracting pneumococcal disease. 
1.2.2. Development of Investigational Product 
23-valent pneumococcal polysaccharide vaccine (PPSV23), which contains purified 
carbohydrates alone and elicits T-cell–independent immune responses, has been licensed for 
prevention against PD for individuals 2 years of age and older who are considered to be at
increased risks of PD.13,14 Effectiveness of PPSV23 to prevent IPD has been demonstrated 
but the duration of protection was reported to be short, and the vaccine has failed to show an 
impact on the burden of PD at the population level.15,16,17,18 The vaccine’s effectiveness for 
noninvasive pneumococcal pneumonia has been inconclusive, and inconsistent study results 
have been reported.18,19,20,21,22 PPSV23 did not demonstrate efficacy against IPD in the 
HIV-infected population.23
Manufacturing vaccines using glycoconjugate technology, where a carbohydrate antigen 
(bacterial polysaccharide) is chemically coupled to an immunogenic protein carrier, has 
overcome the limitation of using carbohydrates as vaccine antigens rooted in T-cell–
independent immune responses.  By conjugating the purified capsular saccharides of 
S pneumoniae to an immunogenic protein carrier, a nontoxic diphtheria toxoid, the normally 
T-cell–independent immune response is converted to a T-cell–dependent immune response, 
leading to immunological memory and boosting upon repeated vaccination and thus 
overcoming the limitation of using polysaccharides as vaccine antigens. 
13vPnC contains the same 7 pneumococcal capsular polysaccharide serotypes as the 7-valent 
pneumococcal conjugate vaccine (7vPnC; serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) plus 6 
additional serotypes (1, 3, 5, 6A, 7F, and 19A), with each polysaccharide individually 
conjugated to cross-reactive material 197 (CRM197).  The vaccine is a sterile liquid 
formulation. 13vPnC has been shown to be safe and immunogenic.  13vPnC elicits immune 
responses that are quantitatively and qualitatively distinct from those elicited by PPSV23.
Since 2009, 13vPnC has been approved for use in children 6 weeks through 5 years of age in 
the United States, Europe, and other countries under the trademarks Prevnar 13 and 
Prevenar 13 for 1 or more of the following indications: prevention of IPD, pneumonia, and 
otitis media.  The indication has been expanded, and 13vPnC is currently approved for 
children from 6 weeks of age and for adults of all ages in 75 countries, including the United 
States and countries in Europe. The US Advisory Committee on Immunization Practices 
(ACIP) has issued recommendations for the use of 13vPnC for children 6 to 18 years of age 
and for adults t19 years of age with certain medical conditions, including 
immunocompromising conditions.4
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In Japan, 13vPnC was approved for children aged t2 months to <6 years in 2013 and for 
adults aged t65 years in 2014.  Since introduction of 7vPnC to Japan in 2010, a 98% 
reduction in incidence of vaccine-type IPD was observed in children under 5 years old.24
1.2.2.1. Clinical Studies in Japan 
Two studies in Japanese infants aged 2 or 3 months to 6 months (6096A1-3003 and 
6096A1-3024) and 2 studies in Japanese adults aged 50 or 65 years and older (6115A1-3004 
and B1851088) have been conducted in Japan.  These studies supported the licensure of 
13vPnC for children aged t2 months to <6 years and for adults aged t65 years in Japan. 
In the infant studies, 376 infants received at least 1 dose of 13vPnC subcutaneously; these 
studies demonstrated that 13vPnC vaccination with a 3-dose infant series followed by a 
booster dose at 12 to 15 months of age was safe and well tolerated.25,26 Study 6096A1-3024 
demonstrated that immune responses to the pneumococcal antigens in 13vPnC were 
noninferior to those of 7vPnC for the 7 common serotypes and substantially greater for the 6 
additional serotypes.26
In the adult studies, 134 adults aged 50 to 64 years and 516 adults aged 65 years and older, 
who were naive to pneumococcal vaccine, received 1 dose of 13vPnC intramuscularly.  
Overall, a single dose of 13vPnC was safe and well tolerated.27,28 The B1851088 study 
demonstrated that 13vPnC was noninferior to PPSV23 for the 12 common serotypes, and was 
significantly more immunogenic for most of the common serotypes and for serotype 6A in 
Japanese elderly adults aged 65 years and older who were naive to pneumococcal vaccines.28
1.2.3. Study Rationale 
In Japan, 13vPnC has not been approved for individuals between the ages of 6 and 64 years.
This situation is despite the fact that this age group has a not-insignificant proportion of 
individuals with underlying medical conditions who are considered to be at increased risk for 
developing PD based on the epidemiological data in Japan.29,30 The 5- to 64-year age group 
represented 27% of reported IPD cases in Japan in 2013.3 Furthermore, many IPD patients 
have underlying medical conditions.7 In view of the epidemiology and prevalence of IPD 
cases in Japan, development of 13vPnC in Japanese children, adolescents, and adults 
between 6 years and <65 years of age has also been advocated by Japanese physicians and 
their professional associations.31
Pfizer-sponsored clinical studies conducted outside Japan in healthy individuals and in 
immunocompetent individuals with underlying stable medical conditions aged 6 years and 
older demonstrated that a single dose of 13vPnC was safe and well tolerated.  In addition, the 
safety and immunogenicity of 13vPnC have been confirmed in overseas clinical studies 
involving immunocompromised populations, ie, subjects with sickle-cell disease (SCD), 
HIV-infected subjects, and recipients of hematopoietic stem cell transplant (HSCT).
Furthermore, more than 642 million doses of Prevenar 13/Prevnar 13 (13vPnC) have been 
administered to individuals across the age spectrum globally and more than 15 million doses
have been administered in Japan to children aged <6 years and adults aged t65 years,
without specific safety concerns.
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Therefore, the unmet medical need for protection against PD that could be provided by 
13vPnC, the large database of safety data from clinical studies in Japan and globally, and the
extensive postmarketing experience support the conduct of the present study, Phase 3 
Study B1851172, in Japan.  This study will assess the safety, tolerability, and 
immunogenicity of a single dose of 13vPnC in Japanese individuals aged 6 to 64 years who
are considered to be at increased risk of pneumococcal disease and who are naive to 
pneumococcal vaccine.
Additional information for this compound may be found in the single reference safety 
document (SRSD), which for this study is the investigator’s brochure. 
2. STUDY OBJECTIVES AND ENDPOINTS 
Primary Objective:
Primary Endpoints:
x
To assess the safety and tolerability of a single dose of 
13vPnC as measured by the incidence of local reactions, 
systemic events, adverse events (AEs), and serious 
adverse events (SAEs).
x
Number and proportion of subjects reporting local 
reactions (redness, swelling, pain at injection site) and 
severity of the local reactions occurring within the 
7-day period following study vaccination in the 6- to 
<18-year age group.
x
Number and proportion of subjects reporting local 
reactions (redness, swelling, pain at injection site) and 
severity of the local reactions occurring within the 
14-day period following study vaccination in the 18- to 
<65-year age group.
x
Number and proportion of subjects reporting systemic 
events (fever, fatigue, headache, vomiting, diarrhea, 
muscle pain, joint pain) and severity of the systemic 
events occurring within the 7-day period following 
study vaccination in the 6- to <18-year age group.
x
Number and proportion of subjects reporting systemic 
events (fever, fatigue, headache, vomiting, diarrhea, 
muscle pain, joint pain) and severity of the systemic 
events occurring within the 14-day period following 
study vaccination in the 18- to <65-year age group.
x
Number and proportion of subjects reporting AEs and 
SAEs until Visit 2 categorized according to the Medical 
Dictionary for Regulatory Activities (MedDRA) in all 
age groups.
Secondary Objective:
Secondary Endpoints:
x
To describe the immune responses elicited by a single
dose of 13vPnC.
x
Serotype-specific opsonophagocytic activity (OPA) 
geometric mean titers (GMTs) 1 month after 
vaccination in all age groups.
x
Geometric mean fold rises (GMFRs) in 
serotype-specific OPA titers from before vaccination to 
1 month after vaccination in all age groups.
x
Serotype-specific immunoglobulin G (IgG) geometric 
mean concentrations (GMCs) 1 month after vaccination
in all age groups.
x
GMFRs in serotype-specific IgG from before 
vaccination to 1 month after vaccination in all age 
groups.
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3. STUDY DESIGN 
This is a Phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, 
and immunogenicity of a single dose of 13vPnC in Japanese subjects aged 6 to 64 years who 
are considered to be at increased risk of pneumococcal disease and who are naive to 
pneumococcal vaccines. 
This study consists of 2 age groups, 6 to <18 years old and 18 to <65 years old.  Subjects will 
be enrolled in 1 of these age groups and will be assigned a container number of
investigational product by an interactive web response (IWR) system.  For the purposes of 
subject participation in the study, including data collection procedures, enrollment in the 
study is considered to occur at the time of investigational product assignment.
3.1. Approximate Duration of Subject Participation 
Subjects will participate in the study for approximately 1 month (29 to 43 days). 
3.2. Approximate Duration of the Study 
The study will be completed in approximately 6 months.  Study duration is from first subject 
first visit (FSFV) to last subject last visit (LSLV). 
3.3. Approximate Number of Subjects 
Approximately 200 subjects will be enrolled: approximately 50 subjects in the 6- to <18-year 
age group and approximately 150 subjects in the 18- to <65-year age group. 
For the purpose of ensuring a minimum number of subjects in each of the age categories, at 
least 15 subjects aged 6 to <12 years and 15 subjects aged 12 to <18 years will be enrolled 
within the 6- to <18-year age group.  Furthermore, at least 50 subjects aged 18 to <50 years 
and 50 subjects aged 50 to <65 years will be enrolled within the 18- to <65-year age group 
(Table 1).
Table 1.
Approximate Number of Subjects in Each Age Group and Minimum 
Number of Subjects for the Specified Age Categories
Age Group 6 to <18 Yearsa
Age Group 18 to <65 Yearsb
Total Subjects
50
150
200
Minimum number of subjects per age 
category
Minimum number of subjects per age 
category
6 to <12 yearsa
12 to <18 yearsa
18 to <50 yearsb
50 to <65 yearsb
15
15
50
50
a.
Approximately 50 subjects will be enrolled in the 6- to <18-year age group; at least 15 subjects will be 
enrolled in each of the 6- to <12-year and 12- to <18-year age groups.
b.
Approximately 150 subjects will be enrolled in the 18- to <65-year age group; at least 50 subjects will be 
enrolled in each of the 18- to <50-year or 50- to <65-year age groups.
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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 and/or a legally acceptable representative/parent/legal guardian for 
subjects considered to be minors in Japan (6 to <20 years old) has/have been 
informed of all pertinent aspects of the study. 
2. Availability for the entire duration of the study, and subjects (and a legally acceptable 
representative/parent/legal guardian if the subject is 6 to <18 years old) who are 
willing and able to comply with scheduled visits, vaccination plan, and other study 
procedures including completion of the electronic diary (e-diary) for 7 days (Day 1 to 
Day 7) for subjects aged 6 to <18 years or 14 days (Day 1 to Day 14) for subjects 
aged 18 to <65 years after study vaccination. 
3. Japanese males and females aged 6 to <65 years at enrollment.
4. Subjects with an increased risk of pneumococcal disease determined by documented 
medical history, physical examination, and clinical judgment of the investigator.  The 
risks may include but are not limited to stable chronic heart disease, lung disease, 
liver disease, or renal disease; diabetes mellitus; hematologic or solid organ 
malignancy; immunocompromised persons with known or suspected 
immunodeficiency due to underlying diseases or treatments; subjects with anatomic 
host defense abnormalities such as cochlear implants or CSF leaks. 
5. Subject (and/or a legally acceptable representative/parent/legal guardian if the subject 
is 6 to <18 years old) must be able to be contacted by telephone during study 
participation. 
6. Male subjects able to father children and female subjects of childbearing potential 
who are, in the opinion of the investigator, sexually active and at risk for pregnancy 
with their partner(s) must agree to use a highly effective method of contraception 
throughout the study and for at least 28 days after vaccination. 
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Female subjects of nonchildbearing potential must meet at least 1 of the following 
criteria: 
a.
Achieved postmenopausal status, defined as follows: cessation of regular menses 
for at least 12 consecutive months with no alternative pathological or 
physiological cause; status may be confirmed with a serum follicle-stimulating 
hormone (FSH) level confirming the postmenopausal state.
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy. 
c.
Have medically confirmed ovarian failure. 
d. Female subjects who are <9 years old.  If the female subject who is <9 years old 
has experienced menarche at an earlier age, the subject will be considered of 
childbearing potential. 
All other female subjects (including female subjects with tubal ligations) are 
considered to be of childbearing potential. 
4.2. Exclusion Criteria
Subjects with any of the following characteristics/conditions will not be included in the 
study: 
1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or 
planned receipt during study participation. 
2. Unstable chronic medical condition or disease requiring significant changea in
therapy or hospitalization for worsening disease within 6 weeks before investigational 
product administration. 
3. End-stage disease including but not limited to metastaticb malignancy, severe chronic 
obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage 
renal disease with or without dialysis. 
4. Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months 
before investigational product administration or history of HSCT, or potential for 
solid organ transplant or HSCT during study participation. 
                                                
a Change in dose or therapy within a category (eg, change from 1 nonsteroidal anti-inflammatory drug 
[NSAID] to another) is allowed.  Change to new therapy categories (eg, surgery, or addition of a new 
pharmacological class) is allowed only if it is not caused by worsening disease.  If change to new therapy 
categories is caused by worsening disease, this would be considered significant. 
b Subjects with lymph node and/or distant metastases. 
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5. Receipt of cytotoxic chemotherapy or blood products within 3 months before 
investigational product administration or anti–B-cell antibodies within 6 months 
before investigational product administration through completion of study 
participation. 
6. Any contraindication to vaccination or vaccine components, including previous 
anaphylactic reaction to any vaccine or vaccine-related components. 
7. Bleeding diathesis or condition associated with prolonged bleeding time that would 
contraindicate any type of injection. 
8. Vaccination with a diphtheria-containing vaccine or toxoid within 6 months before 
investigational product administration through the completion of the study 
participation. 
9. Documented S pneumoniae infection within the past 5 years before investigational 
product administration. 
10. Insufficient muscle mass, in the opinion of the investigator, to receive a vaccination 
in the deltoid muscle of the arm. 
11. Residence in a nursing home or long-term care facility, or requirement for semiskilled 
nursing care.  An ambulatory subject who is a resident of a retirement home or village 
is eligible for the trial. 
12. Severe visual impairment requiring third-party support to read. 
13. Investigator site staff members directly involved in the conduct of the study and their 
family members, site staff members otherwise supervised by the investigator, or 
subjects who are Pfizer employees, including their family members, directly involved 
in the conduct of the study. 
14. Participation in other studies involving investigational drug(s) or vaccine(s) within 
28 days prior to study entry and/or during study participation.  Participation in purely 
observational studies is acceptable. 
15. Other acute or chronic medical or psychiatric condition including recent (within the 
past year) or active suicidal ideation or behavior or laboratory abnormality that may 
increase the risk associated with study participation or investigational product 
administration or may interfere with the interpretation of study results and, in the 
judgment of the investigator, would make the subject inappropriate for entry into this 
study. 
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16. Pregnant female subjects as determined by urine pregnancy test (human chorionic 
gonadotropin [hCG]); breastfeeding females; fertile male and female subjects of 
childbearing potential who are unwilling or unable to use a highly effective method of 
contraception as outlined in this protocol for the duration of the study and for at least 
28 days after vaccination. 
4.3. Criteria for Temporarily Delaying Investigational Product Administration 
The following conditions are temporary or self-limiting and an investigational product may 
be administered to a subject in the study once the condition(s) has/have resolved and no other 
exclusion criteria are met: 
1. Current febrile illness (axillary temperature t37.5°C) or other acute illness within 
48 hours before investigational product administration. 
2. Subject has received systemic antibiotic therapy for an acute illness within 72 hours 
before investigational product administration. 
3. Subject has received any inactivated vaccine within 14 days or any live vaccine 
within 28 days before investigational product administration. 
If a subject meets any delaying criteria for investigational product administration, all study 
procedures including blood draw at Day 1 should be delayed until the day of investigational 
product administration. 
4.4. Lifestyle Requirements 
4.4.1. Contraception 
All fertile male subjects and female subjects who are of childbearing potential who are, in the 
opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) 
must agree to use a highly effective method of contraception consistently and correctly for 
the duration of the study and for at least 28 days after the last dose of investigational product.  
The investigator or his or her designee, in consultation with the subject, will confirm that the 
subject has selected an appropriate method of contraception for the individual subject from 
the permitted list of contraception methods (see below) and will confirm that the subject has 
been instructed in its consistent and correct use.  At time points indicated in the Schedule of 
Activities, the investigator or designee will inform the subject of the need to use highly 
effective contraception consistently and correctly and document the conversation and the 
subject’s affirmation in the subject’s chart (subjects need to affirm their consistent and 
correct use of at least 1 of the selected methods of contraception).  In addition, the 
investigator or designee will instruct the subject to call immediately if the selected 
contraception method is discontinued or if pregnancy is known or suspected in the subject or 
the partner. 
Highly effective methods of contraception are those that, alone or in combination, result in a 
failure rate of less than 1% per year when used consistently and correctly (ie, perfect use) and 
include the following: 
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1. Established use of hormonal methods of contraception associated with inhibition of 
ovulation (eg, oral, inserted, injected, implanted, transdermal) provided the subject or 
male subject’s female partner plans to remain on the same treatment throughout the 
entire study and has been using that hormonal contraceptive for an adequate period of 
time to ensure effectiveness. 
2. Correctly placed copper-containing intrauterine device (IUD). 
3. Male condom or female condom used WITH a separate spermicide product (ie, foam, 
gel, film, cream, or suppository).  For countries where spermicide is not available or 
condom plus spermicide is not accepted as highly effective contraception, this option 
is not appropriate. 
4. Male sterilization with absence of sperm in the postvasectomy ejaculate. 
5. Bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure 
(provided that occlusion has been confirmed in accordance with the device’s label).
NOTE: Sexual abstinence, defined as completely and persistently refraining from all 
heterosexual intercourse (including during the entire period of risk associated with the study 
treatments) may obviate the need for contraception ONLY if this is the preferred and usual 
lifestyle of the subject. 
4.5. Sponsor’s Qualified Medical Personnel 
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study documentation.
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, subjects are provided with a contact card.  The contact card contains, 
at a minimum, protocol and investigational product identifiers, subject study numbers, 
contact information for the investigator site, and contact details for a contact center in the 
event that the investigator site staff cannot be reached to provide advice on a medical 
question or problem originating from another healthcare professional not involved in the 
subject’s participation in the study. The contact number can also be used by investigator 
staff if they are seeking advice on medical questions or problems; however, it should be used 
only in the event that the established communication pathways between the investigator site 
and the study team are not available.  It is therefore intended to augment, but not replace, the 
established communication pathways between the investigator site and the study team for 
advice on medical questions or problems that may arise during the study.  The contact 
number is not intended for use by the subject directly, and if a subject calls that number, he 
or she will be directed back to the investigator site. 
5. INVESTIGATIONAL PRODUCTS 
For the purposes of this study, and per International Council for Harmonisation (ICH) 
guidelines, investigational product is defined as a pharmaceutical form of an active 
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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 product is 13vPnC. 
5.1. Allocation to Investigational Product 
Subjects will be assigned container number by 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 container number when investigational product 
is being supplied via the IWR system.  The IWR system will provide a confirmation report 
containing the container number assigned. The confirmation report must be stored in the 
site’s files.
The study-specific IWR reference manual will provide the help desk’s contact information 
and further details on the use of the IWR. 
5.2. Subject Compliance 
All doses of investigational product will be administered by the appropriately designated 
study staff at the investigator site. 
5.3. Investigational Product Supplies 
5.3.1. Dosage Form(s) and Packaging 
The investigational products (13vPnC) will be provided by the sponsor to each study site.  
The study vaccines will be packed and labeled as investigational products in accordance with 
current guidelines and applicable local and legal regulatory requirements. 
13vPnC 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 formulated to contain 2.2 μg of each saccharide, except for 4.4 μg of 6B, per 
0.5-mL dose.  The vaccine contains 5 mM succinate buffer, 0.85% sodium chloride, 0.02% 
polysorbate 80, and 0.125 mg aluminum as aluminum phosphate, per 0.5-mL dose.  The 
vaccine will be provided as a single-dose prefilled syringe. 
5.3.2. Preparation and Dispensing 
Only appropriately qualified personnel must dispense the investigational product. 
Preparation and dispensing information will be provided in the study reference manual 
(SRM).
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5.4. Administration 
All subjects will receive a single dose (0.5 mL) of 13vPnC intramuscularly into the deltoid 
muscle of the nondominant arm, unless medically contraindicated, in which case the injection 
may be administered in the dominant arm, at Visit 1.
Standard vaccination practices must be observed and vaccine must not be injected into blood 
vessels.  Appropriate medication and other supportive measures for management of an acute 
hypersensitivity reaction should be available in accordance with local guidelines for standard 
immunization practices.
Administration of investigational products should be performed by an appropriately 
qualified, Good Clinical Practice (GCP)-trained, and vaccine-experienced member of the 
study staff (eg, physician, nurse, physician’s assistant, nurse practitioner, pharmacist, or 
medical assistant) as allowed by local, state, and institutional guidance. 
Investigational product administration details will be recorded on the case report form (CRF). 
5.5. Investigational Product Storage 
13vPnC will be shipped at +2°C to +8°C to each study site after required regulatory and legal 
documents have been received by the sponsor.  Upon receipt at the study site, the vaccines
should be immediately transferred to a +2°C to +8°C temperature-monitored refrigerator for 
storage. 
The investigator or an approved representative, eg, pharmacist, will ensure that all 
investigational products are stored in a secured area with controlled access under required 
storage conditions and in accordance with applicable regulatory requirements.
Investigational products should be stored in their original containers and in accordance with 
the labels.
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. 
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Any excursions from the product label storage conditions should be reported to Pfizer upon 
discovery.  The site should actively pursue options for returning the product to the storage 
conditions described in the labeling, as soon as possible.  Deviations from the storage 
requirements, including any actions taken, must be documented and reported to Pfizer.
Once an excursion is identified, the investigational product must be quarantined and not used 
until Pfizer provides permission to use the investigational product.  It will not be considered a 
protocol deviation if Pfizer approves the use of the investigational product after the 
temperature excursion. Use of the investigational product prior to Pfizer approval will be 
considered a protocol deviation.  Specific details regarding information the site should report
for each excursion will be provided to the site. 
Receipt of materials, door opening and closing, and other routine handling operations where 
the products are briefly out of the temperature range described in the labeling are not 
considered excursions. 
5.6. 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.
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 Treatment(s) 
The following concomitant medications and vaccinations will be recorded in the CRF: 
x
Immunosuppressive drugs, including systemic corticosteroids; immune-modifying drugs, 
including, but not limited to, disease-modifying antirheumatic drugs (DMARDs) such as 
methotrexate and the tumor necrosis factor antagonists; or monoclonal antibodies from 
6 months prior to study enrollment until completion of study participation, and their start 
and stop dates, medication name, dose, and units. 
x
Nonstudy vaccines administered from 6 months prior to study enrollment until 
completion of study participation, including name of vaccine and date administered. 
5.7.1. Prohibited Prior Treatment 
x
Previous vaccination with any licensed or experimental pneumococcal vaccine 
(see Section 4.2). 
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x
Diphtheria-containing vaccine or toxoid within 6 months before investigational product 
administration (see Section 4.2).
x
Cytotoxic chemotherapy or blood products within 3 months before investigational 
product administration or anti–B-cell antibodies within 6 months before investigational 
product administration (see Section 4.2). 
x
Investigational product within 28 days before study participation (see Section 4.2).
x
Systemic antibiotic therapy for an acute illness within 72 hours before investigational 
product administration (see Section 4.3). 
x
Any inactivated vaccine within 14 days or any live vaccine within 28 days before 
investigational product administration (see Section 4.3).
5.7.2. Prohibited During the Study 
x
Any licensed vaccine other than pneumococcal vaccine administered concomitantly with 
the investigational product.
x
Any other licensed and/or experimental pneumococcal vaccine (other than the study 
vaccine administered at Visit 1).
x
Diphtheria-containing vaccine or toxoid. 
x
Cytotoxic chemotherapy, blood products, or anti–B-cell antibodies.
x
Any other investigational product other than the study vaccine administered at Visit 1. 
x
Prophylactic antipyretics or other pain medication to prevent symptoms such as fever or 
pain associated with investigational product administration.
5.7.3. Permitted During the Study 
x
The use of antipyretics and pain medications to treat symptoms. 
x
Medications, other than those described in Section 5.7.2.
x
Any licensed vaccine other than pneumococcal vaccine is permitted but may not be 
administered concomitantly with the investigational product.  Whenever possible, any 
licensed vaccine should be administered at least 14 days for inactivated vaccines, or at 
least 28 days for live vaccines, before or after study vaccination. 
6. STUDY PROCEDURES 
The schedule of procedures is presented in the Schedule of Activities.  In order that the study 
visits are scheduled within the correct time frames, the day of vaccination should be 
considered Day 1. 
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6.1. Visit 1 - Vaccination (Day 1) 
x
Obtain written informed consent and, if applicable, assent (age dependent on local 
requirement) before performing any study-specific procedures. 
x
Obtain a subject number from IWR. 
x
Obtain and record the subject demography including date of birth, sex, race, and 
ethnicity. 
x
Obtain and record medical history and current medical conditions, including the presence 
of chronic conditions, medical history of significance such as cardiac, pulmonary, renal, 
hepatic, hematologic, neurological, and/or endocrinologic medical history, relevant 
surgical procedures and/or allergies (drug or nondrug), and their start and stop dates.
x
Obtain and record vaccination history within 6 months before the study participation as 
described in Section 5.7. For diphtheria vaccine, obtain and record the date of last 
booster vaccination (the date may be beyond 6 months before study participation). 
x
Obtain and record any immunosuppressive drugs, including systemic corticosteroids, 
immune-modifying drugs, or monoclonal antibodies, received within 6 months before the 
study participation as described in Section 5.7. 
x
Assess and record smoking status as either smoker, ex-smoker, or never smoked during 
the 6 months prior to the study participation.
x
Perform a physical examination evaluating any clinically significant abnormalities within 
the following body systems: general appearance, skin, head, eyes, ears, nose, throat, 
heart, lungs, abdomen, musculoskeletal, neurological, and lymph nodes, including 
worsening of medical history conditions.  Record findings of physical examination on the 
physical examination record and, if appropriate, on the medical history CRF.  If the 
condition started after informed consent was given, the condition should be recorded on 
the AE CRF. 
x
Perform a urine pregnancy test on female subjects of childbearing potential.  A negative 
pregnancy test result is required before female subjects of childbearing potential may 
receive the investigational product. 
x
On the day of investigational product administration, measure the subject’s axillary 
temperature (qC) using the digital thermometer prior to investigational product 
administration and record the temperature on the vital signs CRF.  When multiple 
measurements are taken for the same time point, the most out-of-range (eg, highest) value 
must be reported. 
x
Ensure that all of the inclusion criteria, none of the exclusion criteria, and none of the 
criteria for temporarily delaying vaccine administration are met.  If a subject meets any 
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delay criteria for vaccination, all study procedures including the blood draw at Day 1 
should be delayed until the day of vaccination. 
x
After all eligibility criteria are confirmed, obtain the investigational product assignment 
from IWR.  Refer to the SRM for further instructions and requirements for recording 
screen failure subjects. 
x
Prior to vaccination, collect a blood sample (approximately 10 mL) for immunogenicity 
assessments and record sample tracking information on the CRF. 
x
Administer a single 0.5-mL injection of the investigational product into the deltoid 
muscle of the nondominant arm, unless medically contraindicated, in which case the 
injection may be administered in the dominant arm.
x
Observe the subject for at least 30 minutes after the investigational product 
administration for any acute reactions.  Record any AEs in the subject’s source 
documents and on the AE CRFs.
x
Provide training in the use of the e-diary device. 
x
For subjects aged 6 to <18 years: 
x
Train the subject’s legally acceptable representative/parent/legal guardian to use 
the e-diary and set up the e-diary for the subject.  Specific instructions for the site 
user and the subject’s legally acceptable representative/parent/legal guardian to
use the e-diary will be provided under separate cover. 
x
Issue an e-diary, measuring device (caliper [range: 1 to 14+ for subjects aged 6 to 
<12 years or caliper [range: 1 to 21+] for subjects aged 12 to <18 years), and 
digital thermometer and provide instructions for usage. 
x
Ask the subject’s legally acceptable representative/parent/legal guardian to
complete the e-diary from Days 1 to 7 after investigational product 
administration, where Day 1 is the day of investigational product administration.
x
Ask the subject’s legally acceptable representative/parent/legal guardian to 
contact the investigator immediately if the subject experiences a severe local 
reaction (redness or swelling) at the injection site measuring >14 caliper units 
(greater than 7 cm) for subjects aged 6 to <12 years or >20 caliper units (greater 
than 10 cm) for subjects aged 12 to <18 years to arrange an unscheduled visit as
specified in Section 6.3. 
x
Ask the subject’s legally acceptable representative/parent/legal guardian to 
contact the investigator immediately if the subject experiences a severe systemic 
event or fever t39.0qC.
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x
Ask the subject’s legally acceptable representative/parent/legal guardian to make 
a note of the stop date for any local reactions and systemic events, including the 
use of antipyretics and pain medication to treat symptoms, ongoing on the last day 
that the e-diary was completed and to report that to the investigator at the next 
visit. 
x
Ask the subject’s legally acceptable representative/parent/legal guardian to
contact the investigator immediately if any significant illness or hospitalization 
occurs during the study period. 
x
Ask the subject’s legally acceptable representative/parent/legal guardian to return 
the completed e-diary at Visit 2 approximately 1 month (28 to 42 days) after 
vaccination. 
x
For subjects aged 18 to <65 years: 
x
Train the subject to use the e-diary and set up the e-diary for the subject.  Specific 
instructions for the site user and the subject to use the e-diary will be provided 
under separate cover. 
x
Issue an e-diary, measuring device (caliper [range: 1 to 21+]), and digital 
thermometer and provide instructions for usage. 
x
Ask the subject to complete the e-diary from Days 1 to 14 after investigational 
product administration, where Day 1 is the day of investigational product 
administration.
x
Ask the subject to contact the investigator immediately if he or she experiences a 
severe local reaction (redness or swelling) at the injection site measuring >20 
caliper units (greater than 10 cm) to arrange an unscheduled visit as specified in 
Section 6.3.
x
Ask the subject to contact the investigator immediately if the subject experiences 
a severe systemic event or fever t39.0qC.
x
Ask the subject to make a note of the stop date for any local reactions and 
systemic events, including the use of antipyretics and pain medication to treat 
symptoms, ongoing on the last day that the e-diary was completed and to report 
that to the investigator at the next visit. 
x
Ask the subject to contact the investigator immediately if any significant illness or 
hospitalization occurs during the study period. 
x
Ask the subject to return the completed e-diary at Visit 2 approximately 1 month 
(28 to 42 days) after vaccination. 
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x
Schedule an appointment for the next study visit. 
x
Obtain and record AEs and SAEs as described in Section 8 and the Schedule of Activities.
x
Complete the source documents and the CRF.
x
Update the investigational product accountability records. 
x
Investigators or appropriately qualified designee reviews the e-diary data online at 
frequent intervals during the e-dairy entry period from Day 1. 
6.2. Visit 2-Follow-up Visit (28 to 42 Days After Visit 1) 
x
Collect the subject’s e-diary. 
x
Review the subject’s e-diary and follow up on any ongoing symptoms. Record their stop 
date or confirm that they are still continuing on the CRF. 
x
Obtain and record AEs and SAEs as described in Section 8 and the Schedule of Activities.
x
Obtain and record any nonstudy vaccinations, and/or immunosuppressive drugs,
including systemic corticosteroid, immune-modifying drugs, or monoclonal antibodies,
received since the last study visit.
x
Collect a blood sample (approximately 10 mL) for immunogenicity assessments and 
record sample tracking information on the CRF. 
x
Complete the source documents and the CRF.
6.3. Assessment of Postvaccination Severe Reactions and Systemic Events 
6.3.1. Severe Local Reaction or Fever Telephone Contact and Unscheduled Visit 
Severe redness and/or swelling at the injection site is defined as: 
x
>14 caliper units (greater than 7 cm) for subjects aged 6 to <12 years. 
x
>20 caliper units (greater than 10 cm) for subjects aged 12 to <65 years. 
If a severe local reaction (redness, swelling, or pain at the injection site) or fever t39.0qC is
reported in the e-diary, a contact must occur as soon as possible between the investigator and 
the subject to assess whether an unscheduled site visit is required.  A site visit must be 
scheduled as soon as possible to assess the extent of the reaction unless: 
x
The subject is unable to attend the unscheduled visit, or 
x
The reaction is no longer present at the time of the contact, or 
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x
The investigator confirms that the data were entered into the e-diary in error by the 
subject. 
The subject contact will be recorded on the CRF.  If the subject is unable to attend the 
unscheduled visit, a reason must be given why the subject did not attend the unscheduled 
visit.  The investigator must contact the subject by telephone to determine whether the local 
reaction meets Grade 4 and/or SAE reporting criteria (refer to Table 2, Table 3, and 
Section 8.2.3).
At the severe local reaction or fever assessment visit, the following procedures will be 
conducted by the investigator or medically qualified member of the study staff.  For the 
purpose of severe reaction assessment, a medically qualified member of the study staff is a 
study physician or study nurse, as applicable to the investigator’s local practice.
The following study procedures will be performed during an unscheduled visit: 
x
Measure the subject’s axillary temperature (qC). 
x
Measure the minimum and maximum diameter (cm) of any redness and the swelling at 
the site of vaccination.
x
Assess pain in accordance with the criteria provided in Section 7.2.1.3.
x
Complete the source documents with any new or updated information. 
x
Complete the CRF. 
x
If applicable, remind the subject to make a note of a stop date of the reaction ongoing on 
the last day that the e-diary was completed and to report that to the investigator at the 
next visit. 
6.3.2. Severe Systemic Event Telephone Contact 
If a severe systemic event (fatigue, headache, vomiting, diarrhea, muscle pain, or joint pain) 
is reported in the e-diary, the investigator must contact the subject by telephone as soon as 
possible to determine whether the systemic event meets Grade 4 and/or SAE reporting 
criteria (refer to Table 4 and Section 8.2.3).
This telephone contact will be recorded in the source documents. 
6.4. Subject Withdrawal 
Subjects may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety (see also the 
Withdrawal From the Study Due to Adverse Events section) or behavioral reasons, or the 
inability of the subject to comply with the protocol-required schedule of study visits or 
procedures at a given study site. 
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If a subject does not return for a scheduled visit, every effort should be made to contact the 
subject.  All attempts to contact the subject and information received during contact attempts 
must be documented in the subject’s medical record.  In any circumstance, every effort 
should be made to document subject outcome, if possible.  The investigator should inquire 
about the reason for withdrawal, request that the subject return all e-diary supplies, request 
that the subject return for a final visit, if applicable, and follow up with the subject regarding 
any unresolved AEs. 
Any vaccinated subject who withdraws from the study, provided the subject is agreeable, will 
receive safety follow-up for at least 28 days after study vaccination.  If the subject withdraws 
from the study, and also withdraws consent for disclosure of future information, no further 
evaluations should be performed, and no additional data should be collected.  The sponsor 
may retain and continue to use any data collected before such withdrawal of consent. 
7. ASSESSMENTS 
Every effort should be made to ensure that the protocol-required tests and procedures are 
completed as described.  However, it is anticipated that from time to time there may be 
circumstances outside of the control of the investigator that may make it unfeasible to 
perform the test.  In these cases the investigator will take all steps necessary to ensure the 
safety and well-being of the subject.  When a protocol-required test cannot be performed, the
investigator will document the reason for this and any corrective and preventive actions that
he or she has taken to ensure that normal processes are adhered to as soon as possible. The 
study team will be informed of these incidents in a timely manner. 
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study. 
7.1. Pregnancy Testing 
For female subjects of childbearing potential, a urine pregnancy test, with hCG sensitivity of 
at least 25 mIU/mL, will be performed immediately before investigational product 
administration. 
A negative pregnancy test result is required before female subjects of childbearing potential 
may receive the investigational product.  Pregnancy tests will also be done whenever 
1 menstrual cycle is missed during the active treatment period (or when potential pregnancy 
is otherwise suspected).  Pregnancy tests may also be repeated if requested by institutional 
review boards (IRBs)/ethics committees (ECs) or if required by local regulations.
In the case of a positive confirmed pregnancy, the subject will be withdrawn from 
administration of investigational product. 
7.2. Safety Assessments 
Safety parameters will be assessed as described in the Schedule of Activities and below. 
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A medical history, physical examination, and measurement of temperature will be performed 
on all subjects prior to vaccination to determine subject eligibility and to establish a clinical 
baseline.  Significant medical history and observations from the physical examination and 
temperature measurement will be documented and recorded in the CRF. 
The postvaccination safety parameters include assessments of local reactions and systemic 
events occurring within 7 days for subjects aged 6 to <18 years or 14 days for subjects aged 
18 to <65 years following investigational product administration.  The reactogenicity will be 
graded as described in Section 7.2.1.3 and Section 7.2.1.4.
Reactions occurring within 30 minutes after investigational product administration will be 
documented and recorded in the AE CRF. 
AEs and SAEs will be collected and reported as described in Section 8. 
7.2.1. Local Reactions and Systemic Events 
7.2.1.1. Electronic Diary 
The subject will be issued an e-diary, based on a smartphone or equivalent technology.  
Starting on the day of vaccination, local reactions, systemic events, and any antipyretics or 
pain medication used to treat symptoms will be monitored by the subject’s legally acceptable 
representative/parent/legal guardian for 7 days for subjects aged 6 to <18 years or by the 
subject for 14 days for subjects aged 18 to <65 years.  The e-diary allows recording of these 
assessments only within a fixed time window, thus providing the accurate representation of 
the subject’s experience at that time.  Data on local reactions, systemic events, and 
antipyretics/pain medication used to treat symptoms reported in the e-diary will be 
transferred electronically to the e-diary vendor, where they will be available for review by 
investigators via an internet-based portal.  At intervals agreed to by the vendor and Pfizer, the 
data will be transferred electronically into Pfizer's event database for analysis and reporting. 
Investigators (or appropriately qualified designee) are required to review the e-diary data 
online at frequent intervals during e-diary periods, as part of the ongoing safety review. 
The investigator or designee will obtain from the subject stop dates for any symptoms 
ongoing on the last day that the e-diary was completed.  The stop dates will be documented 
in the source documents and the information entered in the CRF. 
7.2.1.2. Grading Scales for Local Reactions and Systemic Events 
The grading scales used in this study to assess local reactions and systemic events as 
described below are derived from the Food and Drug Administration (FDA) Center for 
Biologics Evaluation and Research (CBER) guidelines on toxicity grading scales for healthy 
adult volunteers enrolled in preventive vaccine clinical trials.32
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7.2.1.3. Local Reactions 
For subjects aged 6 to <18 years, the subject’s legally acceptable representative/parent/legal 
guardian will be asked to assess redness, swelling, and pain at the injection site and to record 
the symptoms in the e-diary for 7 consecutive days starting on the day of vaccination. 
For subjects aged 18 to <65 years, subjects will be asked to assess redness, swelling, and pain 
at the injection site and to record the symptoms in the e-diary for 14 consecutive days starting 
on the day of vaccination. 
Redness and swelling will be measured and recorded in caliper units (range: 1 to 14+) by the 
subject’s legally acceptable representative/parent/legal guardian, and then categorized as 
mild, moderate, or severe based on the grading scale in Table 2 for subjects aged 6 to 
<12 years. 
Redness and swelling will be measured and recorded in caliper units (range: 1 to 21+) by the 
subject’s legally acceptable representative/parent/legal guardian, and then categorized as 
mild, moderate, or severe based on the grading scale in Table 3 for subjects aged 12 to 
<18 years. 
Redness and swelling will be measured and recorded in caliper units (range: 1 to 21+) by the 
subject, and then categorized as mild, moderate, or severe based on the grading scale in 
Table 3 for subjects aged 18 to <65 years. 
Caliper units can be converted to centimeters according to the following formula: 
1 caliper  unit = 0.5 cm. 
Pain at the injection site will be assessed by the subject or the subject’s legally acceptable 
representative/parent/legal guardian as mild, moderate, or severe according to the grading 
scales in Table 2 and Table 3.
When a severe/Grade 3 local reaction is recorded, the subject/legally acceptable 
representative/parent/legal guardian will contact the investigator, who will assess the reaction 
and perform a severe local reaction or fever assessment visit as appropriate.  In the event that 
the subject/legally acceptable representative/parent/legal guardian does not call, the 
investigator will call the subject/legally acceptable representative/parent/legal guardian. 
7.2.1.3.1. Management of Grade 4 Local Reactions 
Only an investigator is able to classify a subject’s local reaction as Grade 4, after physical 
examination of the subject or telephone contact with the subject/legally acceptable 
representative/parent/legal guardian.  Confirmed Grade 4 local reactions require immediate 
notification to the sponsor and include: 
x
Skin necrosis or exfoliative dermatitis (for redness) or skin necrosis (for swelling): 
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Consider whether the reaction is an important medical event (Section 8.2.3).  If yes, 
report the reaction as an SAE; if no, report it as an AE. Grade the severity of the necrosis 
or exfoliative dermatitis using the AE severity grading scale in Section 8.3.
x
An emergency room visit for management of pain at the injection site:  
Consider whether the reaction is an important medical event (Section 8.2.3).  If yes, 
report the reaction as an SAE; if no, report it as an AE.  Grade the severity of the 
injection site pain using the AE severity grading scale in Section 8.3. 
x
Hospitalization for management of pain at the injection site:  
Report the hospitalization for injection site pain management as an SAE and grade the 
severity of the injection site pain using the AE severity grading scale in Section 8.3.
Table 2.
Local Reaction Grading Scale (for Subjects Aged 6 to <12 Years)
GRADE 1
mild
GRADE 2
moderate
GRADE 3a
severe
GRADE 4b
Redness
1 to 4 caliper units
(or measuring device 
units) 
0.5 to 2.0 cm
>4 to 14 caliper units
(or measuring device 
units) 
>2.0 to 7.0 cm
>14 caliper units
(or measuring device 
units) 
>7.0 cm
Necrosis
or exfoliative
dermatitisb
Swelling
1 to 4 caliper units
(or measuring device 
units) 
0.5 to 2.0 cm
>4 to 14 caliper units
(or measuring device 
units) 
>2.0 to 7.0 cm
>14 caliper units
(or measuring device 
units) 
>7.0 cm
Necrosisb
Pain
(tenderness)
at the 
injection site
Does not interfere with 
activity
Interferes with activity
Prevents daily activity
Emergency room visit 
or hospitalization for 
severe pain 
(tenderness) at the 
injection site
Abbreviations: CRF = case report form; e-diary = electronic diary.
Note: If the size of the redness and/or swelling falls between 2 caliper units, the higher caliper unit number will 
be recorded in the e-diary.
a.
When subjects experience local reactions >14 caliper units (>7.0 cm) or severe pain (tenderness) at the 
injection site, the subject/legally acceptable representative/parent/legal guardian will telephone the study 
site. In the event that the subject/legally acceptable representative/parent/legal guardian does not call, the 
investigator will call the subject/legally acceptable representative/parent/legal guardian.
b.
Grade 4 assessment should be made by the investigator and recorded as an AE on the CRF.  Manage as 
shown in Section 7.2.1.3.1 and Section 8.3.
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Table 3.
Local Reaction Grading Scale (for Subjects Aged 12 to <18 Years and 18 to 
<65 Years)
GRADE 1
mild
GRADE 2
moderate
GRADE 3a
severe
GRADE 4b
Redness
5 to 10 caliper units
(or measuring device 
units) 
2.5 to 5.0 cm
>10 to 20 caliper units
(or measuring device 
units) 
>5.0 to 10.0 cm
>20 caliper units
(or measuring device 
units) 
>10.0 cm
Necrosis
or exfoliative
dermatitisb
Swelling
5 to 10 caliper units
(or measuring device 
units) 
2.5 to 5.0 cm
>10 to 20 caliper units
(or measuring device 
units) 
>5.0 to 10.0 cm
>20 caliper units
(or measuring device 
units) 
>10.0 cm
Necrosisb
Pain at the 
injection 
site
Does not interfere with 
activity
Interferes with activity
Prevents daily activity
Emergency room visit 
or hospitalization for 
severe pain at the 
injection site
Abbreviations: CRF = case report form; e-diary = electronic diary.
Note: If the size of the redness and/or swelling falls between 2 caliper units, the higher caliper unit number will 
be recorded in the e-diary.
a.
When subjects experience local reactions >20 caliper units (>10.0 cm) or severe pain at the injection site,
the subject/legally acceptable representative/parent/legal guardian will telephone the study site. In the 
event that the subject/legally acceptable representative/parent/legal guardian does not call, the investigator 
will call the subject/legally acceptable representative/parent/legal guardian.
b.
Grade 4 assessment for local reactions should be made by the investigator and recorded as an AE on the 
CRF.  Manage as shown in Section 7.2.1.3.1 and Section 8.3.
7.2.1.4. Systemic Events 
Starting on the day of vaccination, and for 7 consecutive days, postvaccination systemic 
events will be assessed by the subject’s legally acceptable representative/parent/legal 
guardian each day for subjects aged 6 to <18 years, and if present, they will be graded as 
mild, moderate, or severe and recorded in the e-diary, using the grading scale in Table 4. 
Starting on the day of vaccination, and for 14 consecutive days, postvaccination systemic 
events will be assessed by the subject each day for subjects aged 18 to <65 years, and if 
present, they will be graded as mild, moderate, or severe and recorded in the e-diary, using 
the grading scale in Table 4.
When a severe/Grade 3 systemic event is recorded, the subject/legally acceptable 
representative/parent/legal guardian will contact the investigator, who will assess the reaction.  
In the event that the subject/legally acceptable representative/parent/legal guardian does not 
call, the investigator will call the subject/legally acceptable representative/parent/legal 
guardian. 
7.2.1.4.1. Management of Grade 4 Systemic Events 
Only an investigator is able to classify a subject’s systemic event as Grade 4, after physical 
examination of the subject or telephone contact with the subject/legally acceptable 
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representative/parent/legal guardian.  Confirmed Grade 4 systemic events require immediate 
notification to the sponsor and include: 
x
An emergency room visit for management of a systemic event: 
Consider whether the systemic event is an important medical event (Section 8.2.3).  If 
yes, report the event as an SAE; if no, report it as an AE.  Grade the severity of the 
systemic event using the AE severity grading scale in Section 8.3.
x
Hospitalization for management of a systemic event: 
Report hospitalization for management of a systemic event as an SAE and grade the 
severity of the systemic event according to the AE severity grading scale in Section 8.3.
Table 4.
Systemic Event Grading Scale (for All Age Groups and Categories)
GRADE 1
mild
GRADE 2
moderate
GRADE 3a
severe
GRADE 4b
Fatigue
(tiredness)
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Headache
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Vomiting
1 to 2 times in 
24 hours
>2 times in 24 hours
Requires intravenous 
hydration
Emergency room visit 
or hospitalization
Diarrhea
2 to 3 loose stools in 
24 hours
4 to 5 loose stools in 
24 hours
6 or more loose stools 
in 24 hours
Emergency room visit 
or hospitalization
Muscle pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Joint pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization
Abbreviation: CRF = case report form.
a.
When subjects experience severe systemic events, the subject/legally acceptable representative/parent/legal 
guardian will telephone the study site.  In the event that the subject/legally acceptable 
representative/parent/legal guardian does not call, the investigator will call the subject/legally acceptable 
representative/parent/legal guardian.
b.
Grade 4 assessment for systemic events should be made by the investigator and recorded as an AE on the 
CRF.  Manage as shown in Section 7.2.1.4.1 and Section 8.3.
7.2.1.5. Fever 
Starting on the day of vaccination, temperature will be measured by the subject’s legally 
acceptable representative/parent/legal guardian each evening for 7 consecutive days and at 
any time during these periods that fever is suspected for subjects aged 6 to <18 years.  
A digital thermometer will be given to the subject’s legally acceptable 
representative/parent/legal guardian with instructions on how to measure the subject’s 
axillary temperature. 
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Starting on the day of vaccination, temperature will be measured by the subject each evening 
for 14 consecutive days and at any time during these periods that fever is suspected for 
subjects aged 18 to <65 years.  A digital thermometer will be given to the subject with 
instructions on how to measure his/her axillary temperature. 
Fever is defined as an axillary temperature of t37.5qC.  The highest temperature for each day 
will be recorded in the e-diary.  In the event of a fever, temperature will be collected daily 
until fever has resolved (1 day with a temperature less than 37.5qC).  Temperature will be 
measured and recorded to 1 decimal place by the subject/legally acceptable 
representative/parent/legal guardian and then categorized during analysis according to the 
scale shown in Table 5. 
Where a fever t39.0qC is recorded, the subject/legally acceptable representative/parent/legal 
guardian will contact the investigator by telephone and the investigator will assess whether a 
severe local reaction or fever assessment visit is required (refer to Section 6.3).  If the 
subject/legally acceptable representative/parent/legal guardian does not call the investigator, 
the investigator will contact the subject/legally acceptable representative/parent/legal 
guardian. 
Table 5.
Scale for Fever
37.5 to 38.4qC
38.5 to 38.9qC
39.0 to 40.0qC
>40.0qC
7.2.1.6. Use of Antipyretic Medication and Pain Medication 
Starting on the day of vaccination and for 7 consecutive days for subjects aged 6 to <18 years 
or for 14 consecutive days for subjects aged 18 to <65 years, the use of antipyretic 
medication and pain medication for treatment of symptoms will be recorded in the e-diary. 
7.3. Immunogenicity 
In total, 2 blood samples will be collected for assessment of the immune responses.  
Approximately 10 mL of blood will be collected at Day 1 prior to receipt of investigational 
product and 1 month later (28 to 42 days after Visit 1).  A total volume of approximately 
20 mL of blood will collected during the study to allow adequate volume required for repeat 
testing or additional antigen-specific immunogenicity testing to be performed.
In case of difficulty in obtaining a blood sample, it is possible to reschedule the sampling 
provided that the date remains within the authorized protocol window.  Refer to the Schedule 
of Activities for the time points. 
Serum samples will be obtained at the study site and be shipped for analysis.  Sample 
collection, storage, and shipping instructions will be provided in the SRM. 
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Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 
6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) will be measured centrally using a quantitative 
functional OPA assay.  Results will be expressed as titers for each serotype. 
Serum concentrations of anticapsular IgG antibodies for each of the 13 pneumococcal 
serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) will be determined in all 
subjects for each blood sample and expressed as micrograms per milliliter (μg/mL). The 
Luminex-based assay will employ 2 pneumococcal cell wall polysaccharide-containing 
extracts, as absorbents in the serum dilution buffer. 
7.4. Biological Samples 
Serum samples will be used only for scientific research.  Each sample will be labeled with a 
code so that the laboratory personnel testing the samples will not know the subject’s identity.  
Samples that remain after performing assays outlined in the protocol may be stored by Pfizer.  
Unless a time limitation is required by local regulations or ethical requirements, the samples 
will be stored for up to 15 years after the end of the study and then destroyed.  If allowed by 
the informed consent document, stored samples may be used for additional testing to better 
understand the immune responses to the vaccine(s) under study in this protocol, to inform the 
development of other products, and/or for vaccine-related assay work supporting vaccine 
programs.  No testing of the subject’s genetic material will be performed. 
The subject or subject’s legally acceptable representative/parent/legal guardian may request 
that the subject’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.
8. ADVERSE EVENT REPORTING 
8.1. Requirements 
The table below summarizes the requirements for recording safety events on the CRF and for 
reporting safety events on the Clinical Trial (CT) Serious Adverse Event (SAE) Report Form 
to Pfizer Safety.  These requirements are delineated for 3 types of events: (1) SAEs; (2) 
nonserious AEs; and (3) exposure to the investigational product under study during 
pregnancy or breastfeeding, and occupational exposure. 
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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
SAE
All
All
Nonserious AE
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)
All observed or volunteered events regardless of vaccine group or suspected causal 
relationship to the investigational product(s) will be reported as described in the following 
paragraphs. 
Events listed in the table above that require reporting to Pfizer Safety on the CT SAE Report 
Form within 24 hours of awareness of the event by the investigator are to be reported 
regardless of whether the event is determined by the investigator to be related to an 
investigational product under study.  In particular, if the SAE is fatal or life-threatening, 
notification to Pfizer Safety must be made immediately, irrespective of the extent of available 
event information.  This time frame also applies to additional new (follow-up) information on 
previously forwarded reports.  In the rare situation that the investigator does not become 
immediately aware of the occurrence of an event, the investigator must report the event 
within 24 hours after learning of it and document the time of his/her first awareness of the 
event. 
For each event, the investigator must pursue and obtain adequate information both to 
determine the outcome and to assess whether it meets the criteria for classification as an SAE 
(see the Serious Adverse Events section below).  In addition, the investigator may be 
requested by Pfizer Safety to obtain specific follow-up information in an expedited fashion.  
This information is more detailed than that recorded on the CRF. In general, this will include 
a description of the event in sufficient detail to allow for a complete medical assessment of 
the case and independent determination of possible causality.  Any information relevant to 
the event, such as concomitant medications and illnesses, must be provided.  In the case of a 
subject death, a summary of available autopsy findings must be submitted as soon as possible 
to Pfizer Safety.  Any pertinent additional information must be reported on the CT SAE 
Report Form; additional source documents (eg, medical records, CRF, laboratory data) are to 
be sent to Pfizer Safety ONLY upon request. 
As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE.  To assist 
in the determination of case seriousness, further information may be requested from the 
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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/legally acceptable representative/parent/legal guardian.  In 
addition, each study subject/legally acceptable representative/parent/legal guardian will be 
questioned about the occurrence of AEs in a nonleading manner. 
8.1.3. Withdrawal From the Study Due to Adverse Events (see also the Subject 
Withdrawal section) 
Withdrawal due to AEs should be distinguished from withdrawal due to other causes, 
according to the definition of AE noted below, and recorded on the CRF. 
When a subject withdraws from the study because of an SAE, the SAE must be recorded on 
the CRF and reported, as appropriate, on the CT SAE Report Form, in accordance with the 
Requirements section above. 
8.1.4. Time Period for Collecting AE/SAE Information 
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each subject begins from the time the subject/legally acceptable 
representative/parent/legal guardian provides informed consent, which is obtained before the 
subject’s participation in the study (ie, before undergoing any study-related procedure and/or 
receiving investigational product), through and including Visit 2.
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. 
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Follow-up by the investigator continues throughout and after the active collection period and 
until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and 
Pfizer concurs with that assessment. 
8.1.4.2. Recording Nonserious AEs and SAEs on the CRF 
During the active collection period, both nonserious AEs and SAEs are recorded on the CRF. 
Follow-up by the investigator may be required until the event or its sequelae resolve or 
stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment. 
8.1.5. Causality Assessment 
The investigator’s assessment of causality must be provided for all AEs (serious and 
nonserious); the investigator must record the causal relationship on the CRF, and report such 
an assessment in accordance with the SAE reporting requirements, if applicable.  An 
investigator’s causality assessment is the determination of whether there exists a reasonable 
possibility that the investigational product caused or contributed to an AE; generally the facts 
(evidence) or arguments to suggest a causal relationship should be provided.  If the 
investigator does not know whether or not the investigational product caused the event, then 
the event will be handled as “related to investigational product” for reporting purposes, as 
defined by the sponsor.  If the investigator's causality assessment is “unknown but not 
related” to investigational product, this should be clearly documented on study records. 
In addition, if the investigator determines that an SAE is associated with study procedures, 
the investigator must record this causal relationship in the source documents and CRF, and 
report such an assessment in the dedicated section of the CT SAE Report Form and in 
accordance with the SAE reporting requirements. 
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities
AE reporting, including suspected unexpected serious adverse reactions (SUSARs), 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:  
x
Abnormal test findings; 
x
Clinically significant signs and symptoms; 
x
Changes in physical examination findings; 
x
Hypersensitivity; 
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x
Progression/worsening of underlying disease; 
x
Drug abuse; 
x
Drug dependency. 
Additionally, AEs may include signs and symptoms resulting from: 
x
Drug overdose; 
x
Drug withdrawal; 
x
Drug misuse;  
x
Drug interactions; 
x
Extravasation; 
x
Exposure during pregnancy (EDP); 
x
Exposure via breastfeeding; 
x
Medication error; 
x
Occupational exposure. 
8.2.2. Abnormal Test Findings 
Abnormal objective test findings should be recorded as AEs when any of the following 
conditions are met:  
x
Test result is associated with accompanying symptoms; and/or 
x
Test result requires additional diagnostic testing or medical/surgical intervention; 
and/or 
x
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 
x
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. 
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8.2.3. Serious Adverse Events 
An SAE is any untoward medical occurrence at any dose that: 
x
Results in death; 
x
Is life-threatening (immediate risk of death); 
x
Requires inpatient hospitalization or prolongation of existing hospitalization; 
x
Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions); 
x
Results in congenital anomaly/birth defect. 
Or that is considered to be: 
x
An important medical event. 
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event.  An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization.  However, if it is determined that the event may jeopardize 
the subject or may require intervention to prevent one of the other AE outcomes, the 
important medical event should be reported as serious. 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; 
or development of drug dependency or drug abuse. 
Medical device complaints may meet the SAE reporting requirement criteria (see the Medical 
Device Complaint Reporting Requirements section).  An incident is any malfunction (ie, the 
failure of a device to meet its performance specifications or to perform as intended; 
performance specifications include all claims made in the labeling for the device) that, 
directly or indirectly, might lead to or might have led to the death of a subject, or user, or of 
other persons, or to a serious deterioration in their state of health. 
A serious injury that can cause a serious deterioration in state of health can include: 
x
A life-threatening illness, even if temporary in nature; 
x
A permanent impairment of a body function or permanent damage to a body 
structure;  
x
A condition necessitating medical or surgical intervention to prevent the above 
2 bulleted items; 
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Examples: clinically relevant increase in the duration of a surgical procedure; a 
condition that requires hospitalization or significant prolongation of existing 
hospitalization; 
x
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;
x
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: 
x
Rehabilitation facilities; 
x
Hospice facilities; 
x
Respite care (eg, caregiver relief); 
x
Skilled nursing facilities; 
x
Nursing homes; 
x
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: 
x
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); 
x
Social admission (eg, subject has no place to sleep); 
x
Administrative admission (eg, for yearly physical examination); 
x
Protocol-specified admission during a study (eg, for a procedure required by the study 
protocol); 
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x
Optional admission not associated with a precipitating clinical AE (eg, for elective 
cosmetic surgery); 
x
Hospitalization for observation without a medical AE; 
x
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, SEVERE, or LIFE-THREATENING 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.
4
LIFE-
THREATENING
Life-threatening consequences; urgent intervention indicated.
The severity grading scale shown above should be used when assessing the severity of any 
AE/SAE, and Grade 4 postvaccination local reactions and systemic events as described in 
Section 7.2.1.3 and Section 7.2.1.4.
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. 
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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: 
x
Subjects with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available; 
x
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). 
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o
Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches >3 × 
ULN (whichever is smaller). 
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor.
The subject should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results.  This evaluation should 
include laboratory tests, detailed history, and physical assessment. 
In addition to repeating measurements of AST and ALT and TBili, laboratory tests should 
include albumin, creatine kinase (CK), direct and indirect bilirubin, gamma-glutamyl 
transferase (GGT), prothrombin time (PT)/international normalized ratio (INR), total bile 
acids, alkaline phosphatase, and acetaminophen drug and/or protein adduct levels.  
Consideration should also be given to drawing a separate tube of clotted blood and an 
anticoagulated tube of blood for further testing, as needed, for further contemporaneous 
analyses at the time of the recognized initial abnormalities to determine etiology.  A detailed 
history, including relevant information, such as review of ethanol, acetaminophen (either by 
itself or as a coformulated product in prescription or over-the-counter medications), 
recreational drug, supplement (herbal) use and consumption, family history, sexual history, 
travel history, history of contact with a jaundiced person, surgery, blood transfusion, history 
of liver or allergic disease, and potential occupational exposure to chemicals, should be 
collected.  Further testing for acute hepatitis A, B, C, D, and E infection and liver imaging 
(eg, biliary tract) may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found.  Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology. 
8.4.3. Exposure to the Investigational Product During Pregnancy or Breastfeeding, and 
Occupational Exposure 
Exposure to the investigational product under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness. 
8.4.3.1. Exposure During Pregnancy 
For both unapproved/unlicensed products and for marketed products, an exposure during 
pregnancy (EDP) occurs if: 
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x
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; 
x
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). 
x
A male has been exposed (eg, because of treatment or environmental exposure) to the
investigational product prior to or around the time of conception and/or is exposed 
during his partner’s pregnancy.
If a subject or subject’s partner becomes or is found to be pregnant during the subject’s 
treatment with the investigational product, the investigator must report this information to 
Pfizer Safety on the CT SAE Report Form and an EDP supplemental form, regardless of 
whether an SAE has occurred. In addition, the investigator must submit information 
regarding environmental exposure to a Pfizer product in a pregnant woman (eg, a subject 
reports that she is pregnant and has been exposed to a cytotoxic product by inhalation or 
spillage) to Pfizer Safety using the EDP supplemental form.  This must be done irrespective 
of whether an AE has occurred and within 24 hours of awareness of the exposure.  The 
information submitted should include the anticipated date of delivery (see below for 
information related to termination of pregnancy).
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP supplemental form.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a 
live-born baby, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
investigator should follow the procedures for reporting SAEs. 
Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs 
follows:  
x
Spontaneous abortion includes miscarriage and missed abortion; 
x
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 
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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. 
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
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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, or by 
inadvertent exposure. 
Medication errors include: 
x
Medication errors involving subject exposure to the investigational product; 
x
Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the participating subject. 
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. 
Other examples include, but are not limited to: 
x
The administration of expired investigational product; 
x
The administration of an incorrect investigational product; 
x
The administration of an incorrect dosage; 
x
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. 
8.4.4.2. Lack of Efficacy 
Lack of efficacy in an approved indication should be reported as an SAE to Pfizer Safety. 
8.5. Medical Device Complaint Reporting Requirements  
All medical device complaints, regardless of whether the medical device complaint is 
associated with an AE, will be recorded on the applicable pages within the CRF.  This 
includes potential incidents or malfunctions associated with the use of a medical device 
product.  An incident or malfunction is an event that might have led to death or serious 
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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.  All statistical analysis 
will be descriptive.  The number of subjects for each age group is defined to enroll a wide 
range of subjects within 6 to 64 years of age. The sample size for each age group and the 
total are described in Section 3.3.
The probabilities of observing at least 1 occurrence of any local reaction or systemic event 
with a true incidence rate when 13vPnC is administered to 50 subjects in the 6- to <18-year 
age group and 150 subjects in the 18- to <65-year age group, and the probabilities of 
observing at least 1 occurrence of any AE with a true incidence rate when 13vPnC is
administered to the total of 200 subjects are displayed in Table 6. 
Table 6.
Probability of Observing at Least 1 Event by Assumed True Incidence Rates 
With Different Sample Sizes
Assumed 
True Incidence Rate
N=50
N=150
N=200
1.0%
0.39
0.78
0.87
1.5%
0.53
0.90
0.95
2.0%
0.64
0.95
0.98
3.2%
0.80
0.99
>0.99
5.0%
0.92
>0.99
>0.99
9.2. Analysis Populations 
The safety population will include all subjects who receive 1 dose of study vaccine.  The 
safety population will be the only analysis population for the primary endpoints. 
For immunogenicity analyses, 2 analysis populations will be defined: the evaluable 
immunogenicity population and the all-available immunogenicity population.  The evaluable 
immunogenicity population will include any subject who was eligible, received study vaccine, 
had blood drawn within the specified time frame 1 month after vaccination, had at least 1 
valid and determinate assay result (OPA titer or IgG concentration) for at least 1 serotype 
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1 month after vaccination, and had no major protocol violations as determined by the 
sponsor’s clinician.
Additional criteria may be described in the SAP.  The evaluable immunogenicity population 
will be the primary analysis population for immunogenicity results. 
The all-available immunogenicity population will include all subjects who received study 
vaccine and had at least 1 valid and determinate OPA titer or IgG concentrations for at least 
1 serotype 1 month after vaccination.  The all-available immunogenicity population will be 
the secondary analysis population for immunogenicity results. 
9.3. Immunogenicity Analysis 
Secondary endpoints include OPA GMTs and IgG GMCs 1 month after vaccination, and 
OPA and IgG GMFRs measured from before vaccination to 1 month after vaccination.  Each 
serotype will be analyzed separately. 
OPA GMTs, IgG GMCs, and their associated 95% confidence intervals (CIs) will be 
provided before vaccination and 1 month after vaccination.  The OPA GMTs and IgG GMCs 
will be calculated as the mean of the assay results after making the logarithm transformation 
and then back transformation to its original scale.  Two (2)-sided 95% CIs will be 
constructed by back transformation of the CI for the mean of the logarithmically transformed 
assay results computed based on the Student t distribution. 
OPA GMFRs and IgG GMFRs will be calculated along with corresponding 2-sided 95% CIs. 
The CIs for GMFRs will be back transformations of a CI based on the Student t distribution 
for the mean difference of the log-transformed assay results before vaccination and 1 month 
after vaccination.
Reverse cumulative distribution curves (RCDCs) of OPA titers and IgG concentrations will
be compiled for each serotype before vaccination and 1 month after vaccination.
Immunogenicity analysis will be summarized for subjects of all ages, and for each age group 
(6 to <18 years old and 18 to <65 years old), if needed. 
9.4. Safety Analysis 
Safety is the primary objective.  The safety endpoints are local reactions, systemic events, 
and unsolicited AEs and SAEs.  The proportion of subjects with local reactions and systemic 
events reported on any day within the 7 days following vaccination for the 6- to <18-year age 
group, or within the 14-day period for the 18- to <65-year age group, will be compiled.  
These proportions, with the associated 2-sided 95% Clopper-Pearson CIs, will be 
summarized for each age group (6 to <18 years old and 18 to <65 years old). Severities of 
local reactions and systemic events will also be descriptively summarized. 
AEs will be categorized according to MedDRA and will be summarized for subjects of all 
ages.  All summaries will show the number and percentage of subjects experiencing at least 
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1 event and the number of events.  Additional summaries by AE severity or by vaccine 
relationship may be produced.  In addition, AEs and SAEs will be summarized for each age 
group (6 to <18 years old and 18 to <65 years old).
9.5. Interim Analysis 
No formal interim analysis will be conducted for this study.  However, as this is an 
open-label study, the sponsor may conduct unblinded reviews of the data during the course of 
the study for the purpose of safety assessment and/or to support clinical development.
9.6. Data Monitoring Committee 
This study will not use a data monitoring committee.
10. QUALITY CONTROL AND QUALITY ASSURANCE 
Pfizer or its agent will conduct periodic monitoring visits during study conduct to ensure that 
the protocol and GCPs are being followed.  The monitors may review source documents to 
confirm that the data recorded on CRFs are accurate.  The investigator and institution will 
allow Pfizer monitors/auditors or its agents and appropriate regulatory authorities direct 
access to source documents to perform this verification.  This verification may also occur 
after study completion. 
During study conduct and/or after study completion, the investigator site may be subject to 
review by the IRB/EC, and/or to quality assurance audits performed by Pfizer, or companies 
working with or on behalf of Pfizer, and/or to inspection by appropriate regulatory 
authorities. 
The investigator(s) will notify Pfizer or its agents immediately of any regulatory inspection 
notification in relation to the study.  Furthermore, the investigator will cooperate with Pfizer 
or its agents to prepare the investigator site for the inspection and will allow Pfizer or its 
agent, whenever feasible, to be present during the inspection.  The investigator site and 
investigator will promptly resolve any discrepancies that are identified between the study 
data and the subject's medical records.  The investigator will promptly provide copies of the 
inspection findings to Pfizer or its agent.  Before response submission to the regulatory 
authorities, the investigator will provide Pfizer or its agents with an opportunity to review 
and comment on responses to any such findings. 
It is important that the investigator(s) and their relevant personnel are available during the 
monitoring visits and possible audits or inspections and that sufficient time is devoted to the 
process. 
11. DATA HANDLING AND RECORD KEEPING 
11.1. Case Report Forms/Electronic Data Record 
As used in this protocol, the term CRF should be understood to refer to either a paper form or 
an electronic data record or both, depending on the data collection method used in this study. 
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A CRF is required and should be completed for each included subject.  The completed 
original CRFs are the sole property of Pfizer and should not be made available in any form to 
third parties, except for authorized representatives of Pfizer or appropriate regulatory 
authorities, without written permission from Pfizer. 
The investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs and any other data collection forms (source 
documents) and ensuring that they are accurate, authentic/original, attributable, complete, 
consistent, legible, timely (contemporaneous), enduring, and available when required.  The 
CRFs must be signed by the investigator or by an authorized staff member to attest that the 
data contained on the CRFs are true. Any corrections to entries made in the CRFs or source 
documents must be dated, initialed, and explained (if necessary) and should not obscure the 
original entry. 
In most cases, the source documents are the hospital or the physician subject chart.  In these 
cases, data collected on the CRFs must match the data in those charts. 
In some cases, the CRF may also serve as the source document.  In these cases, a document 
should be available at the investigator site and at Pfizer that clearly identifies those data that 
will be recorded on the CRF, and for which the CRF will stand as the source document. 
11.2. Record Retention 
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the 
investigator agrees to keep records, including the identity of all participating subjects 
(sufficient information to link records, eg, CRFs and hospital records), all original signed 
informed consent/assent 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. 
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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/assent 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 2002), ICH Guideline for Good Clinical Practice, and the Declaration of 
Helsinki.
12.3. Subject Information and Consent 
All parties will ensure protection of subject personal data and will not include subject names 
or other identifiable data in any reports, publications, or other disclosures, except where 
required by law. 
When study data are compiled for transfer to Pfizer and other authorized parties, subject 
names, addresses, and other identifiable data will be replaced by numerical codes based on a
numbering system provided by Pfizer in order to de-identify study subjects. The investigator 
site will maintain a confidential list of subjects who participated in the study, linking each 
subject’s numerical code to his or her actual identity.  In case of data transfer, Pfizer will 
maintain high standards of confidentiality and protection of subjects’ personal data consistent 
with applicable privacy laws. 
The informed consent/assent 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/assent 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, or his or her legally acceptable 
representative/his or her parent/legal guardian if a minor, is fully informed about the nature 
and objectives of the study and possible risks associated with participation. 
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Whenever consent is obtained from a subject’s legally acceptable representative/parent/legal 
guardian, 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. 
If the study includes minor subjects who reach the age of majority during the study, as 
recognized under local law, they must reconsent as adults to remain in the study.  If the 
enrollment of emancipated minors is permitted by the study age criteria, the IRB/EC, and 
local law, they must provide documentation of legal status to give consent without the 
permission of a legally acceptable representative, parent, or legal guardian. 
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each subject or the subject's legally acceptable representative/parent/legal 
guardian and the subject’s assent, when applicable, before any study-specific activity is 
performed.  The investigator will retain the original of each subject's signed consent/assent 
document.
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP 
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the investigational 
product, Pfizer should be informed immediately. 
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study subjects against any immediate hazard, and of 
any serious breaches of this protocol or of ICH GCP that the investigator becomes aware of. 
13. DEFINITION OF END OF TRIAL 
13.1. End of Trial in All Participating Countries 
End of trial in all participating countries is defined as LSLV. 
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 
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discretion of Pfizer.  In addition, Pfizer retains the right to discontinue development of 
13vPnC 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) immediately.  As directed by Pfizer, all study materials must be collected and 
all CRFs completed to the greatest extent possible. 
15. PUBLICATION OF STUDY RESULTS 
15.1. Communication of Results by Pfizer 
Pfizer fulfills its commitment to publicly disclose clinical trial results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials 
Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance with 
applicable local laws/regulations. 
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted. 
www.clinicaltrials.gov 
Pfizer posts clinical trial US Basic Results on www.clinicaltrials.gov for Pfizer-sponsored 
interventional studies (conducted in patients) that evaluate the safety and/or efficacy of a 
Pfizer product, regardless of the geographical location in which the study is conducted.  US 
Basic Results are submitted for posting within 1 year of the primary completion date (PCD) 
for studies in adult populations or within 6 months of the PCD for studies in pediatric 
populations. 
PCD is defined as the date that the final subject was examined or received an intervention for 
the purposes of final collection of data for the primary outcome, whether the clinical study 
concluded according to the prespecified protocol or was terminated. 
EudraCT 
Pfizer posts European Union (EU) Basic Results on EudraCT for all Pfizer-sponsored 
interventional studies that are in scope of EU requirements.  EU Basic Results are submitted 
for posting within 1 year of the PCD for studies in adult populations or within 6 months of 
the PCD for studies in pediatric populations. 
www.pfizer.com 
Pfizer posts Public Disclosure Synopses (clinical study report synopses in which any data 
that could be used to identify individual patients has been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the US Basic Results document is 
posted to www.clinicaltrials.gov. 
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15.2. Publications by Investigators 
Pfizer supports the exercise of academic freedom and has no objection to publication by the 
principal investigator (PI) of the results of the study based on information collected or 
generated by the PI, whether or not the results are favorable to the Pfizer product.  However, 
to ensure against inadvertent disclosure of confidential information or unprotected 
inventions, the investigator will provide Pfizer an opportunity to review any proposed 
publication or other type of disclosure of the results of the study (collectively, “publication”) 
before it is submitted or otherwise disclosed. 
The investigator will provide any publication to Pfizer at least 30 days before it is submitted 
for publication or otherwise disclosed.  If any patent action is required to protect intellectual 
property rights, the investigator agrees to delay the disclosure for a period not to exceed an 
additional 60 days. 
The investigator will, on request, remove any previously undisclosed confidential 
information before disclosure, except for any study- or Pfizer product-related information 
necessary to the appropriate scientific presentation or understanding of the study results. 
If the study is part of a multicenter study, the investigator agrees that the first publication is 
to be a joint publication covering all investigator sites, and that any subsequent publications 
by the PI will reference that primary publication.  However, if a joint manuscript has not 
been submitted for publication within 12 months of completion or termination of the study at 
all participating sites, the investigator is free to publish separately, subject to the other 
requirements of this section. 
For all publications relating to the study, the institution will comply with recognized ethical 
standards concerning publications and authorship, including Section II - “Ethical 
Considerations in the Conduct and Reporting of Research” of the Uniform Requirements for
Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship, 
established by the International Committee of Medical Journal Editors. 
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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National Institute of Infectious Diseases. Invasive Haemophilus influenzae and 
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Centers for Disease Control and Prevention. Use of 13-valent pneumococcal conjugate 
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Parsons HK, Dockrell DH. The burden of invasive pneumococcal disease and the 
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Fukusumi M, Chang B, Tanabe Y, et al; and the Adult IPD Study Group. Invasive 
pneumococcal disease among adults in Japan, April 2013 to March 2015: disease 
characteristics and serotype distribution. BMC Infect Dis. 2017;17(1):2. 
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Bogaert D, Hermans PWM, Adrian PV, Rümke HC, de Groot R. Pneumococcal 
vaccines: an update on current strategies. Vaccine. 2004;22(17-18):2209-2220. 
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Whitney CG, Farley MM, Hadler J, et al; for the Active Bacterial Core Surveillance 
Program of the Emerging Infections Program Network. Increasing prevalence of 
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10 
Butler JC, Cetron MS. Pneumococcal drug resistance: the new "special enemy of old 
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Nuorti JP, Butler JC, Crutcher JM, et al. An outbreak of multidrug-resistant 
pneumococcal pneumonia and bacteremia among unvaccinated nursing home residents. 
N Engl J Med. 1998;338(26):1861-1868.
12 
Inoue M, Farrell DJ, Kaneko K, et al. Antimicrobial susceptibility of respiratory tract 
pathogens in Japan during PROTEKT years 1-5 (1999-2004). Microb Drug Resist.
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Pneumovax NP package insert.
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Centers for Disease Control and Prevention. Prevention of pneumococcal disease: 
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MMWR Recomm Rep. 1997;46(RR-8):1-24.
https://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf. Accessed 07 Feb 2018. 
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Austrian R, Douglas RM, Schiffman G, et al. Prevention of pneumococcal pneumonia 
by vaccination. Trans Assoc Am Physicians. 1976;89:184-194.
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World Health Organization. 23-valent pneumococcal polysaccharide vaccine: WHO 
position paper. Wkly Epidemiol Rec. 2008;83(42):373-384. 
http://www.who.int/wer/2008/wer8342.pdf. Accessed 01 Feb 2018. 
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Centers for Disease Control and Prevention. Active Bacterial Core surveillance (ABCs) 
report, Emerging Infections Program Network, Streptococcus pneumoniae, 2015. 
https://www.cdc.gov/abcs/reports-findings/survreports/spneu-types.html. Accessed 15
Mar 2018. 
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Isturiz RE, Schmoele-Thoma B, Scott DA, et al. Pneumococcal conjugate vaccine use in 
adults. Expert Rev Vaccines. 2016;15(3):279-293. 
19 
Jackson LA, Neuzil KM, Yu O, et al; for the Vaccine Safety Datalink. Effectiveness of 
pneumococcal polysaccharide vaccine in older adults. N Engl J Med.
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20 
Jackson ML, Neuzil KM, Thompson WW, et al. The burden of community-acquired 
pneumonia in seniors: results of a population-based study. Clin Infect Dis.
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Marston BJ, Plouffe JF, File TM Jr, et al; for the Community-Based Pneumonia 
Incidence Study Group. Incidence of community-acquired pneumonia requiring 
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22 
Maruyama T, Taguchi O, Niederman MS, et al. Efficacy of 23-valent pneumococcal 
vaccine in preventing pneumonia and improving survival in nursing home residents: 
double blind, randomised and placebo controlled trial. BMJ. 2010;340:c1004. 
23 
French N, Nakiyingi J, Carpenter LM, et al. 23-valent pneumococcal polysaccharide 
vaccine in HIV-1-infected Ugandan adults: double-blind, randomised and placebo 
controlled trial. Lancet. 2000;355(9221):2106-2111. 
24 
Suga S, Chang B, Asada K, et al. Nationwide population-based surveillance of invasive 
pneumococcal disease in Japanese children: effects of the seven-valent pneumococcal 
conjugate vaccine. Vaccine. 2015;33(45):6054-6060.
25 
Togashi T, Yamaji M, Thompson A, et al; on behalf of 3003 Study Group.
Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy 
infants in Japan. Pediatr Infect Dis J. 2013;32(9):984-989.
26 
Togashi T, Okada K, Yamaji M, et al. Immunogenicity and safety of a 13-valent 
pneumococcal conjugate vaccine given with DTaP vaccine in healthy infants in Japan. 
Pediatr Infect Dis J. 2015;34(10):1096-1104. 
27 
Shiramoto M, Irie S, Juergens C, et al. Immunogenicity and safety of 13-valent 
pneumococcal conjugate vaccine when administered to healthy Japanese adults aged 
t50 years: an open-label trial. Hum Vaccin Immunother. 2014;10(7):1850-1858.
28 
Shiramoto M, Hanada R, Juergens C, et al. Immunogenicity and safety of the 13-valent 
pneumococcal conjugate vaccine compared to the 23-valent pneumococcal 
polysaccharide vaccine in elderly Japanese adults. Hum Vaccin Immunother.
2015;11(9):2198-2206. 
29 
Ministry of Health, Labour and Welfare. Patient survey in 2014. Inpatient rate (per 
100000), by gender and age x disease classification.  https://www.e-stat.go.jp/stat-
search/files?page=1&layout=datalist&toukei=00450022&tstat=000001031167&cycle=7
&year=20140&tclass1=000001077497&tclass2=000001077498&second2=1. Accessed 
01 Feb 2018. 
30 
Ministry of Health, Labour and Welfare. Patient survey in 2014. Outpatient rate (per 
100000) by gender and age x disease classification.  https://www.e-stat.go.jp/stat-
search/files?page=1&layout=datalist&toukei=00450022&tstat=000001031167&cycle=7
&year=20140&tclass1=000001077497&tclass2=000001077498&second2=1. Accessed 
01 Feb 2018. 
31 
Specialist Committee on Promotion of Vaccination (SCPV) in Japan. Request for 
Expansion of Recipients of 13-Valent Pneumococcal Conjugate Vaccine (adsorbed).
08 May 2017. 
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32 
US Department of Health and Human Services, Food and Drug Administration, Center 
for Biologics Evaluation and Research. Guidance for Industry: Toxicity Grading Scale 
for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials. Rockville, MD: US Department of Health and Human Services; 2007. 
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Appendix 1. Abbreviations 
The following is a list of abbreviations that may be used in the protocol. 
Abbreviation
Term
7vPnC
7-valent pneumococcal conjugate vaccine
13vPnC
13-valent pneumococcal conjugate vaccine
ACIP
Advisory Committee on Immunization Practices
AE
adverse event
ALT
alanine aminotransferase
AST
aspartate aminotransferase
CBER
Center for Biologics Evaluation and Research
CI
confidence interval
CK
creatine kinase
COPD
chronic obstructive pulmonary disease
CRF
case report form
CRM197
cross-reactive material 197 (nontoxic variant of diphtheria toxin)
CSA
clinical study agreement
CSF
cerebrospinal fluid
CT
clinical trial
DILI
drug-induced liver injury
DMARD
disease-modifying antirheumatic drug
EC
ethics committee
e-diary
electronic diary
EDP
exposure during pregnancy
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration (United States)
FSFV
first subject first visit
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMC
geometric mean concentration
GMFR
geometric mean fold rise
GMT
geometric mean titer
GVHD
graft-versus-host disease
hCG
human chorionic gonadotropin
HIV
human immunodeficiency virus
HSCT
hematopoietic stem cell transplant
ICH
International Council for Harmonisation
ID
identification
IgG
immunoglobulin G
IND
investigational new drug application
INR
international normalized ratio
IPD
invasive pneumococcal disease
IRB
institutional review board
090177e190dcce76\Approved\Approved On: 06-May-2019 11:21 (GMT)

PF-05208760, 13-valent Pneumococcal Conjugate Vaccine 
B1851172 
Final Protocol, 20 March 2018
Page 63
Abbreviation
Term
IUD
intrauterine device
IWR
interactive web response
LFT
liver function test
LSLV
last subject last visit 
MedDRA
Medical Dictionary for Regulatory Activities
N/A
not applicable
NSAID
nonsteroidal anti-inflammatory drug
OPA
opsonophagocytic activity
PCD
primary completion date
PD
pneumococcal disease
PI
principal investigator
PPSV23
23-valent pneumococcal polysaccharide vaccine
PT
prothrombin time
RCDC
reverse cumulative distribution curves
SAE
serious adverse event
SAP
statistical analysis plan
SCD
sickle-cell disease
SRM
study reference manual
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
TBili
total bilirubin
UI
uncertainty interval
ULN
upper limit of normal
US
United States
090177e190dcce76\Approved\Approved On: 06-May-2019 11:21 (GMT)