PREVENAR13(REGISTRIED) SUSPENSION LIQUID FOR INJECTION DRUG USE INVESTIGATION - ADULTS AGED 65 YEARS OR OLDER
Conditions: Adult Not Younger Than 65 Years
Sponsor: Pfizer

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Prevenar 13® Suspension Liquid for Injection Drug Use Investigation
- Investigation in Adults Aged 65 Years or Older -
Protocol
This protocol contains confidential information belonging to Pfizer Japan Inc. By receiving or confirming 
the protocol, any person has consented to keep this document as secret (except for the case where it is 
required by applicable laws), not to copy or disclose it to third parties, or use it for non-authorized 
purposes without separate written consent of Pfizer Japan Inc. If this obligation is violated or suspected 
to be violated, immediately report it to Pfizer Japan Inc.

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Information on the Investigation
Title
Prevenar 13® Suspension Liquid for 
Injection
Drug Use Investigation
- Investigation in Adults Aged 65 Years or
Older -
Protocol number
B1851121
Protocol version identifier
Revised version No. 2
Date of last version of protocol
25 March 2015
Nonproprietary name of the 
investigational drug
13-valent pneumococcal conjugated vaccine 
(non-toxic mutant of diphtheria toxin)
Brand name of the investigational drug
Prevenar 13® Suspension Liquid for 
Injection
Objectives
To understand the following matters under 
the actual use conditions after marketing 
concerning the safety of Prevenar 13®
Suspension Liquid for Injection given as a 
single vaccination to elderly people (adults 
aged 65 years or older):
1) Understanding of actual use conditions
2) Understanding of the occurrence of 
adverse events (AEs)
Author
 and 
PMS Planning & Operation Group 3, Post
Marketing Study Strategy and Management
PPD
PPD

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TABLE OF CONTENTS
TABLE OF CONTENTS.................................................................................................................3
1. LIST OF ABBREVIATIONS......................................................................................................6
2. PERSON RESPONSIBLE FOR THE INVESTIGATION .........................................................7
3. AMENDMENTS AND UPDATE...............................................................................................8
4. PLANNED PERIOD OF INVESTIGATION .............................................................................8
5. RATIONALE AND BACKGROUND........................................................................................8
6. RESEARCH QUESTION AND OBJECTIVES .........................................................................9
6.1. Safety Specifications............................................................................................................9
7. METHOD ....................................................................................................................................9
7.1. Design ..................................................................................................................................9
7.2. Subjects ................................................................................................................................9
7.2.1 Inclusion criteria ..............................................................................................................9
7.2.2 Exclusion criteria...........................................................................................................10
7.2.3
Investigation sites .......................................................................................................10
7.2.4
Planned period of the investigation ............................................................................10
7.2.5
Investigation method ..................................................................................................10
7.2.6
Observation period......................................................................................................10
7.3. Investigation Items.............................................................................................................11
7.3.1
Vaccinee background..................................................................................................12
7.3.2
Record of vaccination with Prevenar 13.....................................................................12
7.3.3
Concomitant therapies ................................................................................................12
7.3.4
Test .............................................................................................................................13
7.3.5
End date of observation and discontinuation record...................................................13
7.3.6
Efficacy evaluation.....................................................................................................13
7.3.7
AEs .............................................................................................................................13
7.3.8
Priority investigation items.........................................................................................14
7.4
Data Source...............................................................................................................14
7.5
Target Sample Size...................................................................................................14
7.5.1
Planned sample size of the investigation....................................................................14
7.5.2
Rationale.....................................................................................................................14
7.6
Data Management.....................................................................................................15
7.6.1
Data collection method...............................................................................................15

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7.6.2
Case registration .........................................................................................................15
7.6.2.1 Case registration procedures.....................................................................................15
7.6.2.2 Confirmation of registered cases ..............................................................................15
7.6.3
Points to consider for completing, correcting and submitting the CRF .....................15
7.6.3.1 Data entry method ....................................................................................................15
7.6.3.2 Correction method ....................................................................................................16
7.6.3.3 Submission method...................................................................................................16
7.7
Data Analyses...........................................................................................................16
7.8
Quality Control.........................................................................................................16
7.9
Limitation of Study Methods....................................................................................16
7.10
Other Necessary Matters ..........................................................................................17
8PROTECTION OF VACCINEES TO BE INCLUDED IN THE INVESTIGATION........17
8.1
Information and Consent of Vaccinees to Be Included in the Investigation............17
8.2
Criteria and Procedures for Discontinuation of the Investigation in the Vaccinees 
to Be Included in the Investigation...........................................................................17
8.3
Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)...............18
8.4
Ethical Conduct of the Investigation ........................................................................18
9MANAGEMENT AND REPORTING OF AES/ADVERSE DRUG REACTIONS 
(ADRS).....................................................................................................................18
9.1
Report Requirements ................................................................................................18
9.2
Reporting Period.......................................................................................................19
9.3
Assessment of the Causal Relationship....................................................................19
9.4
Definition of Safety Events ......................................................................................20
9.4.1
AEs .............................................................................................................................20
9.4.2
SAEs ...........................................................................................................................21
9.4.3
Scenarios of events that shall be reported within 24 hours to the Safety Department, 
Pfizer.........................................................................................................................22
9.5
Single Reference Safety Document..........................................................................24
10
PLAN FOR THROUGH NOTIFICATION OF RESULTS AND PUBLICATION25
11
ORGANIZATION SYSTEM FOR THE IMPLEMENTATION OF THE 
INVESTIGATION ...................................................................................................25
12
NAME AND ADDRESS OF THE PERSON TO WHOM THE ACTIVITIES 
ARE OUTSOURCED, AND OUTSOURCED ACTIVITIES.................................25
13
POSSIBLE ADDITIONAL MEASURES TO BE TAKEN BASED ON THE 
RESULTS FROM THE INVESTIGATION AND CRITERIA FOR DECIDING
THEIR INITIATION................................................................................................25

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14
IMPLEMENTATION STATUS OF THE INVESTIGATION AND 
EVALUATION OF OBTAINED RESULTS, OR PLANNED MILESTONES 
FOR MAKING REPORTS TO THE PMDA AND THEIR RATIONALES ..........26
15
OTHER NECESSARY MATTERS.........................................................................26
16
CONTACT INFORMATION ..................................................................................26
16.1
Where to Contact for the Contents of Investigation.................................................26
16.2
Where to Contact for the EDC System.....................................................................26
17
REFERENCES.........................................................................................................27
18
LIST OF TABLES....................................................................................................27
19
LIST OF FIGURES..................................................................................................27
Table of contents of independent documents .........................................................................27
Follow-up information............................................................................................................27

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1. LIST OF ABBREVIATIONS
Abbreviation
Term
23vPS
23-valent pneumococcal polysaccharide vaccine 
AE
adverse event
EDP
exposure during pregnancy
IEC
Independent Ethics Committee
IRB
institutional review board
NIS
Non interventional study
SRSD
Single Reference Safety Document

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2. PERSON RESPONSIBLE FOR THE INVESTIGATION
Postmarketing surveillance control manager
Investigator
Not applicable

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3. AMENDMENTS AND UPDATE
Amendment 
number
Date
Amendment to 
the protocol 
contents/ 
others
Amended section
Summary of 
amendment
Reason
Revised 
version 1
25 February 
2016
Additions
Section 12
Additions
Inadequate 
description
Version 2
25 March 2015
Other
Cover page,
Sections 3, 7, 9, 11, 16, 
17, 20 and 21
Description 
reorganization
Error 
entries and 
inadequate 
description
First version
3 February 2015
N/A
N/A
N/A
N/A
4. PLANNED PERIOD OF INVESTIGATION
Item
Planned date
Start date of the investigation
April 2015
End date of the investigation
October 2016
Date of preparation of the final report
Undecided
5. RATIONALE AND BACKGROUND
Prevenar 13® Suspension Liquid for Injection (hereinafter referred to as Prevenar 13) is a 
pneumococcal conjugated vaccine containing an active ingredient that is pneumococcal 
capsular polysaccharides of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 
23F), conjugated to non-toxic mutant of diphtheria toxin (CRM197) as a protein carrier, and 
aluminium phosphate as an adjuvant and polysorbate 80 as an additive. In Japan, marketing 
approval for Prevenar 13 was granted in June 2013 for the indication: “Prevention of invasive 
infections due to Streptococcus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 
19A, 19F, and 23F) by assuming administration to infants at the age of 2 months, inclusive, to 
6 years, exclusive. Furthermore, Prevenar 13 received additional approval in June 2014 for 
“prevention of infections due to Streptococcus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 
9V, 14, 18C, 19A, 19F and 23F) in the elderly.
A drug use investigation - investigation in adults aged 65 years or older - (hereinafter referred 
to as the investigation) of Prevenar 13® Suspension Liquid for Injection will be implemented to 
understand the below mentioned matters under the actual use conditions after marketing 
concerning the safety of Prevenar 13 given as a single vaccination to elderly people (adults 
aged 65 years or older). Information collected in the investigation will be used for providing 
information on proper use and preparing application data for reexamination. Therefore, the 
investigation shall be conducted in compliance with the “Ministerial Ordinance on Good 

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Postmarketing Study Practice” (Ordinance No. 171 of the Ministry of Health, Labour and 
Welfare [MHLW] dated December 20, 2004). Case data collected in the investigation will be 
reported to the MHLW pursuant to the “Act on Securing Quality, Efficacy and Safety of 
Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy 
Products, and Cosmetics.” In that case, information such as the drug name, adverse reaction 
terms, gender, and age (age category) for applicable case data may be disclosed in a case list in 
the “Pharmaceuticals and Medical Devices Safety Information” and “Website for Provision of 
Pharmaceuticals and Medical Devices Information (http://www.info.pmda.go.jp).”
Furthermore, collected case data will be disclosed if a request for disclosure is made to the 
MHLW in accordance with the “Law Concerning Disclosure of Information Retained by 
Administrative Bodies” (Law No. 42 dated May 14, 1999). In either case, however, information 
such as the names of physicians and institutions will not be subject to reporting, and thus will 
not be posted or disclosed.
6. RESEARCH QUESTION AND OBJECTIVES
To understand the following matters under the actual use conditions after marketing 
concerning the safety of Prevenar 13® Suspension Liquid for Injection given as a single 
vaccination to elderly people (adults aged 65 years or older):
1) Understanding of actual use conditions
2) Understanding of the occurrence of adverse events (AEs)
6.1. Safety Specifications
1) Safety in persons with immunocompromised state
2) Safety of concurrent vaccination with other vaccines
3) Safety in the elderly (adults aged 65 years or older) who received multiple vaccinations 
with Prevenar 13
4) Safety of Prevenar 13 in the elderly (adults aged 65 years or older) with a history of 
immunization with polyvalent pneumococcal capsular polysaccharide vaccines
7. METHOD
7.1. Design
This is a multicenter, open-label investigation in persons who are vaccinated with Prevenar 
13. Case report forms (CRFs) will be completed based on medical records documenting data 
obtained mainly from usual routine medical examination. In order to collect accurate safety
data, the “Health Survey Diary for Pneumococcal Vaccine” will be introduced to directly 
request vaccinees for collaboration.
7.2. Subjects
The subjects of the investigation will be vaccinees who meet the inclusion criteria and 
defined as registration criteria.
7.2.1 Inclusion criteria
1) Elderly persons (adults aged 65 years or older) who received Prevenar 13

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2) Consent of vaccinees (that written informed consent showing that appropriate information 
on the investigation has been notified is signed and dated personally by the vaccinees to be 
included in the investigation [or their legal proxies])
The indication, and dosage and administration of Prevenar 13 are as follows. For 
administration of Prevenar 13, see the latest package insert:
[Indication]
Prevention of infections due to Streptococcus pneumonia (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 
9V, 14, 18C, 19A, 19F and 23F)
[Dosage and administration]
Prevenar 13 should be intramuscular injected at a dose of 0.5 mL.
7.2.2 Exclusion criteria
No exclusion criteria are specified in the investigation.
7.2.3
Investigation sites
This investigation will be implemented at approximately 100 sites mainly the department of 
internal medicine.
7.2.4
Planned period of the investigation
The planned period of the investigation is as follows:
Period of the investigation: April 2015 to October 2016
Registration period: April 2015 to September 2016
7.2.5
Investigation method
The investigation will be conducted using the continuous investigation method, with which 
vaccinees who meet the inclusion criteria will be continuously registered until the number of 
contracted cases is reached.
7.2.6
Observation period
The observation period will be a period up to 28 days after vaccination with Prevenar 13 (The 
day of vaccination will be defined as Day 0).
The investigator should evaluate AEs on or after Day 28 from the date of vaccination, by 
defining the day when the vaccinee first visits the hospital as the end day of observation. If 
the vaccinee does not visit the hospital, the investigator should make an inquiry to the 
vaccinee by phone and assess AEs. For the timing of confirmation by phone, see Table 2.
If the observation period does not meet the requirement of up to Day 28 after vaccination 
despite the use of the abovementioned method, and confirmation by phone cannot be made, 

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AEs should be evaluated with the period up to the date on which the investigator was able to 
confirm the information of the vaccinee for the last time regarded as the observation period.
In addition, the investigator should distribute the “Health Survey Diary for Pneumococcal 
Vaccine” to request vaccinees to record the results of observation during a period from the 
date of vaccination to Day 13 (The day of vaccination will be defined as Day 0). The diary
should be retrieved at hospital visits on or after Day 13, and the investigator should interview 
the vaccinees to collect AEs.
Table 1. Method and timing of AE evaluation
Standard 
AE 
evaluation (at a visit)
AEs will be evaluated on or after Day 28 from the vaccination, 
whenever the vaccinee first visits the hospital.
Timing 
of 
AE 
evaluation by phone
Information on a vaccinee will be confirmed by phone if the 
vaccinee does not make a visit after the abovementioned 
period.
In the case where the 
observation 
period 
does not meet the 
requirement 
of 
28 
days after vaccination
If the observation period does not meet the requirement of up 
to Day 28 after the vaccination despite the use of the 
abovementioned method, and confirmation by phone cannot 
be made, AEs will be evaluated with the period up to the date 
on which the investigator was able to confirm the information 
of the vaccinee for the last time regarded as the observation 
period.
7.3. Investigation Items
Table 2 List of investigation items
Registration form
CRF
   Time point
Investigation items
At registration
Observation period
(from day of 
vaccination to Day 
28)
Registration
items
Information to identify the 
vaccinee
●
●
Date of the vaccination with 
Prevenar 13
●
●
Whether the registration
criteria are met
●
Investigation items
Body weight
●
Inpatient/outpatient status
●
Medical history (past history 
and complications)
●
Details of treatment of 
immunodeficiency disorder
●
History of immunization with 
23vPS
●
History of immunization with 
other vaccines
●
Record of vaccination with 
Prevenar 13
●
Body temperature at 
●

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vaccination with Prevenar 13
Concurrently used vaccines
●
Status of immunization with 
other vaccines
●
End date of observation and 
discontinuation record
●
AEs
●
7.3.1
Vaccinee background
1) The following information at vaccination with Prevenar 13 should be entered in the 
registration form:
(1) Identification number (other than the medical record number)
(2) Gender
(3) Age (as of the day of vaccination with Prevenar 13)
(4) Date of vaccination with Prevenar 13
(5) Whether the registration criteria are met
2) The following information at vaccination with Prevenar 13 should be recorded in the CRF:
(1) Body weight
(2) Inpatient/outpatient status
(3) Medical history (past history and complications)
For vaccinees suffering from a disease*, the status of morbidity at vaccination with 
Prevenar 13 and the name of the disease will be entered.
As for the status of morbidity, it will be entered as “past history” in the case where the 
vaccinee had the disease before vaccination with Prevenar 13 but the disease has been 
cured at the time of the first vaccination, and as a “complication” in the case where the 
vaccinee is suffering from the disease at the time of vaccination with Prevenar 13.
* Disease: Chronic disease (including allergy), disease requiring treatment, disease or 
disorder associated with surgery, hospitalization, and sequela, or any other disease (or 
syndrome) considered to be a problem.
(4) Details of treatment of immunodeficiency disorder
(5) History of immunization with 23vPS
(6) History of immunization with other vaccines
7.3.2
Record of vaccination with Prevenar 13
The following information should be entered for the status of vaccination with Prevenar 13:
1) Date of vaccination
2) Dose
3) Administration site
4) Route of administration
5) Serial number (lot number)
7.3.3
Concomitant therapies
Information on vaccines falling into the following should be entered:
1) Vaccines concurrently administered with Prevenar 13

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(1) Name of concurrently administered vaccine
(2) Administration site
2) Vaccines administered before Day 28 after vaccination with Prevenar 13 (The day of 
vaccination will be defined as Day 0.)
(1) Name of vaccine
(2) Date of vaccination
7.3.4
Test
1) Body temperature
Body temperature at vaccination with Prevenar 13 should be entered.
7.3.5
End date of observation and discontinuation record
The investigator should enter Day 28 from the vaccination or any day after Day 28 (The day 
of vaccination will be defined as Day 0), whenever the vaccinee first visits the hospital (the 
date on which the investigator was able to confirm the information of the vaccinee), as the 
end date of observation. If the end day of observation does not meet the requirement of up to 
Day 28 from vaccination, the reason for discontinuation should be input.
7.3.6
Efficacy evaluation
No efficacy evaluation will be performed in the investigation.
7.3.7
AEs
The investigator should record the below mentioned information after checking the 
occurrence of AEs during the AE collection period. Particularly, the vaccinees should be 
explained to notify local and systemic reactions, if occurred, to the investigator. If AEs are 
identified, the investigator should take appropriate therapeutic actions, immediately inform
the sponsor, and monitor the outcome and course until symptoms resolve, as a rule.
If the sponsor determines it necessary in vaccinees with serious adverse reactions, adverse 
reactions such as local and systemic reactions in the investigation, adverse reactions not 
specified in the package insert, etc., a detailed investigation should be separately performed.
(1) Whether or not AEs occurred
(2) AE term
(3) Date of onset
(4) Severity
(5) Therapeutic action taken or not taken (if taken, its detail)
(6) Seriousness
(7) Outcome
(8) Causal relationship with Prevenar 13
[Assessment of severity]
The investigator should record the maximum severity during the period from the onset of the 
AE to the confirmation of its outcome using mild, moderate, or severe (for pyrexia, mild, 
moderate, severe or possibly life-threatening). The severity will be defined as follows (Table 
3):

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Table 3 Definition of severity
Absent
Mild
Moderate
Severity
Possibly 
life-
threatening
Injection 
site 
erythema and 
swelling
< 2.5 cm
2.5 cm,
5.0 cm
> 5.0 cm,
10.0 cm
> 10.0 cm
-
Pyrexia
< 37.5C
37.5C,
38.4C
38.5C,
38.9C
39.0C,
40.0C
> 40.0C
Other AEs
-
Not 
interfering 
with the normal 
function of the 
vaccinee
Interfering with 
the 
normal 
function of the 
vaccinee 
to 
some degree
Significantly 
interfering with 
the 
normal 
function of the 
vaccinee
-
[If an AE of pyrexia occurs, the following information should be additionally entered:]
(1) Date of measurement
(2) Body temperature
Be sure to record the maximum body temperature during the period from the onset of pyrexia 
to its resolution.
[In the case of AEs related to laboratory tests, etc. and abnormal changes in test values, the 
following should be additionally entered:]
(1) Name of test
(2) Site reference value
(3) Unit
(4) Date of measurement
(5) Results
7.3.8 Priority investigation items
No priority investigation item is specified in the investigation.
7.4 Data Source
In the investigation, the investigator will extract necessary information in accordance with the 
protocol using information in medical records and the “Health Survey Diary for 
Pneumococcal Vaccine.”
7.5 Target Sample Size
7.5.1
Planned sample size of the investigation
600 persons (number of persons to be registered)
7.5.2
Rationale
In the age group of 65 years or older in a clinical study, B1851088 (noninferiority study) 
involving elderly subjects (adults aged 65 years or older) without history of immunization 
with pneumococcal vaccines and a clinical study, 6115A1-3004 (open-label study) involving

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adults aged 50 years or older conducted in Japan, the incidence of local reactions reported by 
the subjects using an electronic diary during 14 days after vaccination with Prevenar 13 was 
55.8% and 63.6%, respectively, and the incidence of systemic reactions was 37.9% and 
52.6%, respectively. In the two studies, the incidence of AEs (adverse reactions) related to 
Prevenar 13 reported by the investigators during approximately one month after vaccination 
with Prevenar 13 was 3.9% (13/333) and 6.6% (9/136), respectively. The results of 
comparison between Japanese and overseas clinical study data revealed no new risk factor 
requiring attention in the Japanese subjects aged 65 years or older. In the Japanese clinical 
studies, 518 elderly subjects aged 65 years or older (B1851088, n = 382; and 6115A1-3004, n 
= 136) received Prevenar 13, and 469 subjects included in the safety set (B1851088, n = 333; 
and 6115A1-3004, n = 136) were evaluated for safety. Consequently, for the safety of 
Prevenar 13 under actual use conditions after marketing, a planned sample size of the 
investigation was set to 600 persons to collect and examine safety information from a subject 
scale equivalent to those of the Japanese clinical studies.
7.6 Data Management
7.6.1
Data collection method
In the investigation, data entry and verification will be carried out using the drug 
postmarketing surveillance data collection system (EDC; hereinafter referred to as the 
system) on the internet.
7.6.2 Case registration
7.6.2.1 Case registration procedures
After receiving individual user ID and password for the investigator, he/she will register 
persons on the vaccinee registration screen of the system. In addition, the investigator will 
explain the vaccinees to use the “Health Survey Diary for Pneumococcal Vaccine” and 
receive their consent before case registration. Case registration shall be carried out as soon as 
Prevenar 13 is given to the vaccinees.
7.6.2.2 Confirmation of registered cases
After the number of registered cases reaches the number of contracted cases, the investigator 
should check the contents of the “Continuous Investigation Confirmation Form” provided by 
the sponsor and affix his/her name and seal on or sign the confirmation form.
7.6.3 Points to consider for completing, correcting and submitting the CRF
7.6.3.1 Data entry method
The investigator should enter data to the system based on medical records upon confirming 
the investigation items and send the data after digital signing.

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7.6.3.2 Correction method
If an inquiry (reinvestigation) concerning the entered data is made by the sponsor, the 
investigator will confirm the medical records again, and as necessary, correct the entered data 
and send it.
7.6.3.3 Submission method
The CRFs should be sent as soon as data are entered in accordance with procedures specified 
by the sponsor.
7.7 Data Analyses
1) Safety analysis set
The safety analysis set will include persons who meet the registration criteria for vaccinees 
and whose safety data are obtained after vaccination with Prevenar 13.
2) Method of safety analysis
The incidence (the number of vaccinees with adverse reactions/the number of vaccinees in 
the safety analysis set) of adverse reactions (vaccination-related AEs) will be the primary 
analysis endpoint, which will be tabulated. In addition, the incidence of adverse reactions will 
be tabulated by variable of vaccinee background, etc. to examine factors affecting the onset 
of adverse reactions.
The details of analysis methods should be as specified in a separately prepared statistical 
analysis plan.
The detailed methods for statistical analyses of data collected in the investigation will be 
presented in the statistical analysis plan for the investigation which will be retained by Pfizer. 
In the statistical analysis plan, the plan summarized in the protocol may be changed, but the 
definition of the primary endpoint and/or important changes in its analysis will be reflected in 
a protocol revision.
7.8 Quality Control
Prior to the implementation of the investigation, the person in charge of the site will explain 
details such as the protocol to the investigator and request him/her to prepare CRFs based on 
medical records.
7.9 Limitation of Study Methods
The following matters may be assumed for the investigation:
1) Because no control group is established, there is a limitation in determining whether or not 
vaccination with Prevenar 13 increases the risk of AEs or adverse reactions.
2) Background information may not be adequately collected so that confounders may not be 
fully taken into account.
3) Since this is an investigation to collect data from medical records, specified data may not 
be collected or lack.

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7.10 Other Necessary Matters
Not applicable
8 PROTECTION OF VACCINEES TO BE INCLUDED IN THE INVESTIGATION
8.1 Information and Consent of Vaccinees to Be Included in the Investigation
Any personnel who is involved in the investigation shall guarantee the protection of the 
personal information of vaccinees to be included in the investigation and prevent that the 
names of vaccinees to be included in the investigation are not mentioned in forms to be 
completed provided by Pfizer, reports, publications or other documents possibly disclosed, 
except for the case where such is required by laws. Pfizer shall maintain high level 
confidentiality to protect personal information when transferring data.
The informed consent form shall be in compliance with regulatory and legal requirements of 
the countries where the investigation is conducted.
The informed consent form to be used for the investigation and any change made during the 
investigation period shall be approved by Pfizer. The informed consent form shall be 
approved by the Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)
before its use at necessary sites.
The investigator shall adequately explain the vaccinees to be included in the investigation or 
their legal proxies about the contents and objectives of the investigation and potential risks 
associated with participation in it. The investigator or person designated by the investigator
should receive written consent of the vaccinees to be included in the investigation or their 
legal proxies prior to implementing investigation-related activities. The investigator should 
retain the original of the informed consent form signed by the vaccinees to be included in the 
investigation.
8.2 Criteria and Procedures for Discontinuation of the Investigation in the Vaccinees to
Be Included in the Investigation
The vaccinees to be included in the investigation may terminate their participation in the 
investigation at any time if they wish to do so. Also, the investigator or Pfizer may 
discontinue their participation in the investigation at their discretion at any time because of 
safety, behaviors of the vaccinees to be included in the investigation, or management reasons. 
In any event, the outcome of the vaccinees to be included in the investigation should be 
recorded whenever possible. The investigator shall confirm the reason for discontinuation, 
and follow up the course of the vaccinees to be included in the investigation if there are AEs
not resolved.
In the case where the participation of the vaccinees to be included in the investigation is 
terminated and their consent for information disclosure in the future is withdrawn, no 
evaluation or collection of additional data thereafter shall be carried out. Pfizer may retain 
and continue using data collected before withdrawal of consent.

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8.3 Institutional Review Board (IRB)/ Independent Ethics Committee (IEC)
No review of the investigation by the Institutional Review Board (IRB)/ Independent Ethics 
Committee (IEC) is mandatory.
8.4 Ethical Conduct of the Investigation
This section is not applicable to the investigation because it is within the scope of application 
of the “Ministerial Ordinance on Good Postmarketing Study Practice” (Ordinance No. 171 of 
the MHLW dated December 20, 2004).
9 MANAGEMENT AND REPORTING OF AES/ADVERSE DRUG REACTIONS 
(ADRS)
The handling of each event when the investigator learned events related to safety information 
is specified below.
Events required to be reported to the sponsor within 24 hours should be notified using a given 
AEs report form (NIS AE Report Form).
The person in charge of the site should request the investigator to report events, which are 
required to be reported within 24 hours by him/her, at the start of the investigation, and 
periodically visit the investigator to request for reporting during the investigation period.
The AE report form (NIS AE Report Form) should be handled as part of the CRF.
9.1 Report Requirements
The following table summarizes requirements for recording of safety events in the CRF and 
reporting of safety events to Pfizer Safety Division using the NIS AE Report Form (Non-
Interventional Study Adverse Event Report Form). These requirements are described for the 
following three types of events: (1) serious adverse events (SAEs), (2) non-serious AEs (if 
applicable), and (3) drug exposure-related scenario including exposure during pregnancy, 
exposure during breastfeeding, misdosing, overdosing, drug misuse, extravasation, and 
occupational exposure. These events are defined in the Section “Definition of Safety Events.”
Safety events
To record in the CRF
To report within 24 hours after 
learning the event to Pfizer 
Safety Division using the NIS 
AE Report Form
SAEs
All
All
Non-serious AEs
All
None
Prevenar 13 exposure-related 
scenario including exposure during 
pregnancy, exposure during 
breastfeeding, misdosing, 
overdosing, drug misuse, 
extravasation, lack of 
pharmacological effect, and 
occupational exposure
(Regardless of accompanying 
AEs) all, excluding 
occupational exposure
(Regardless of accompanying AEs) 
all

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The investigator shall confirm the outcome of each AE and obtain adequate information to 
determine whether or not the event corresponds to the criteria for SAEs (see the Section 
“SAEs” below).
The safety events listed in the above table shall be reported to Pfizer within 24 hours after the 
investigator is aware of it whether or not the investigator judges that the event is related to 
Prevenar 13. Particularly, SAEs resulting in death or being life-threatening shall be promptly
notified to Pfizer regardless of the degree of their information obtained. This reporting period 
is also applicable to the case where new additional (follow-up investigation) information for a 
submitted safety event report is obtained. In a rare case where the investigator is not promptly
aware of the onset of safety events, the investigator shall report the event within 24 hours 
after learning it and record the first date and time when he/she is aware of the event.
For safety events deemed as serious and safety events specified in the right column of the 
above table that shall be reported to Pfizer within 24 hours after learning the events, the 
investigator shall perform a follow-up investigation and report follow-up information if any 
to Pfizer in accordance with the reporting period of within 24 hours. Furthermore, the 
investigator may be requested from Pfizer to urgently obtain specific follow-up information. 
Such information is required to be more detailed information than that to be recorded in the 
CRF. In general, this information includes complete medical evaluation on the AE and 
adequately detailed information enabling to independently assess the causal relationship. 
Information (e.g., concomitant medications and complications) on the event shall be also 
provided. If the vaccinees died, a summary of available autopsy findings shall be promptly 
submitted to Pfizer or the person to whom Pfizer has outsourced the activity.
9.2 Reporting Period
The reporting period of safety events in each vaccinee shall be at least 28 days (calendar
days) after administration of Prevenar 13 starting from the first administration of Prevenar 13 
to the vaccinee or if the vaccinee has already received Prevenar 13, from the time of 
obtaining his/her consent to the end of the observation period in the investigation. If the types 
of safety events listed in the above table occurred during the said period, a report shall be 
submitted to Pfizer Safety Division (or the person to whom Pfizer has outsourced the activity). 
If the vaccinees have received Prevenar 13 on the end day of the observation period, the 
reporting period will be prolonged for 28 days (calendar days) after the end of observation. In 
the majority of cases, the date of informed consent is the same as the date of registration. 
Under some circumstances, there may be a time difference between the date of informed 
consent and the date of registration. In such a situation, when consent is received from 
vaccinees, but they are not registered in the investigation (e.g., the vaccinees changed their 
mind about taking part in the investigation), the reporting period is terminated on the day 
when a decision not to register the vaccinees is made.
In the case where the investigator learned that SAEs occurred at any time after the 
completion of the investigation, if the SAEs are determined to be related to Prevenar 13, the 
SAEs shall be also reported to Pfizer Safety Division.
9.3 Assessment of the Causal Relationship
The investigator will be required to assess and record the causal relationship. Furthermore, 
he/she shall obtain adequate information for assessing the causal relationship for each AE. 

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For AEs related to Prevenar 13, the investigator will be required to carry out a follow-up 
investigation until the event or its associated sequela resolves, or becomes stable to the extent 
it can be accepted by the investigator, and Pfizer agrees with the judgement.
The assessment of the causal relationship by the investigator should be made based on 
whether or not Prevenar 13 may have reasonably caused the AE or be of its cause. When the 
final assessment of the causal relationship by the investigator is “unknown” and whether or 
not Prevenar 13 has caused the event cannot be determined, the safety event shall be reported 
within 24 hours.
When the investigator cannot identify the cause of the event but judges that Prevenar 13 has 
not caused the event, such a fact should be specified in the CRF and NIS AE Report Form.
9.4 Definition of Safety Events
9.4.1
AEs
An AE is any untoward medical occurrence in a vaccinee administered a pharmaceutical 
product and which does not necessarily have to have a causal relationship with this treatment. 
Example AEs are listed below but are not limited to the following:
Abnormal test findings (for criteria for abnormal test findings to correspond to AEs, see 
below)
•
Clinically significant symptoms and signs
•
Changes in physiological test findings
•
Hypersensitivity
•
Progression/ worsening of the primary disease
•
Lack of pharmacological effect
•
Drug abuse
•
Drug dependency
Furthermore, signs and symptoms due to the following causes may be included:
•
Drug overdosing
•
Treatment discontinuation
•
Drug misuse
•
Off-label use
•
Drug interactions
•
Extravasation
•
Exposure during pregnancy
•
Exposure during breastfeeding
•
Misdosing
•
Occupational exposure
Abnormal test findings

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Criteria for determining abnormal test findings that should be reported as AEs are as follows:
•
When symptoms related to tests results are present
•
When an additional diagnostic test or medical/surgical treatment is required
•
When a change of the dose of Prevenar 13, treatment discontinuation, or addition of 
treatment with concomitant medications or other treatment is made based on test results
•
When the investigator or Pfizer judged abnormal test findings to be AEs.
The persistence of simple abnormal values not falling into any of the above criteria is not an 
AE. Also, it is unnecessary to report abnormal values due to test errors as AEs.
9.4.2
SAEs
An SAE is any untoward medical occurrence in a vaccinee administered a pharmaceutical or 
nutrition product (including products for children) at any dose that corresponds to the 
following events that:
•
results in death;
•
is life-threatening;
•
requires hospitalization or prolongation of existing hospitalization (For conditions not 
corresponding to AEs, see below);
•
results in persistent or significant disability/incapacity (that significantly interferes with 
the ability to execute usual living function); or
•
results in congenital anomaly/birth defect.
Medical and scientific judgement should be exercised in deciding whether or not the event is 
medically important. Medically important events may not be immediately life-threatening or 
result in death but may jeopardize the vaccinee or may require intervention to prevent one of 
the other outcomes listed in the definition above. These should be reported as SAEs.
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.
Furthermore, when transmission of infectious substance via Pfizer products is suspected, it is 
deemed as serious whether it is pathogenic or non-pathogenic. Such events may be suspected 
from clinical signs or laboratory findings suggesting infection in vaccinees exposed to Pfizer
products. The term “suspected infection transmission” is considered to be a synonym of 
“infection transmission.” These cases are deemed as unexpected events and handled by the 
Safety Department to be a serious emergency priority case. In addition, for such a case, 
reporting of a product defect, if appropriate, shall be also considered.
Hospitalization
Hospitalization is defined as new admission to the hospital or medical institution equivalent 
to this (even if the hospital stay is less than 24 hours) or the prolongation of an existing 
hospitalization period. Transfer to another department or emergency/intensive care unit in the 
hospital (e.g., transfer from the psychiatric ward to the internal medicine ward, from the 

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internal medicine ward to the intensive care unit for coronary diseases, and from the 
neurological ward to the tuberculosis ward) is also included in hospitalization. Treatment in 
the emergency unit is not always included in hospitalization, but events resulting in treatment 
in the emergency unit should be assessed for medical importance.
Hospitalization not accompanying a medical AE is not an AE and thus not subject to 
reporting. For example, it is not necessary to report the following hospitalization not 
accompanying a medical AE:
•
Hospitalization due to social reasons (e.g., The patient/subject has no accommodation.)
•
Management hospitalization (e.g., for once-yearly health check-up)
•
Voluntary hospitalization not due to acute changes in clinical conditions (e.g., voluntary 
plastic surgery)
•
Hospitalization for follow-up not accompanying medical AEs
•
Hospitalization for the treatment of disease existing since before the start of the 
investigation that is not related to the onset of new AEs or worsening of the pre-existing 
disease (e.g., detailed examination for abnormal laboratory values that have been noted 
since before treatment initiation)
•   Protocol-specified hospitalization during the investigation period (e.g., tests and treatment 
stipulated in the protocol)
9.4.3
Scenarios of events that shall be reported within 24 hours to the Safety 
Department, Pfizer
Scenarios concerning exposure during pregnancy, exposure during breastfeeding, misdosing, 
overdosing, drug misuse, extravasation, lack of pharmacological effect and occupational 
exposure are described below.
Exposure during pregnancy
Exposure during pregnancy (EDP) occurs in the following cases:
•
where a women became pregnant or aware of being pregnant while she is on or directly 
exposed to Prevenar 13 (e.g., environmental exposure); or where a women became pregnant 
or aware of being pregnant after discontinuation or direct exposure to Prevenar 13 (maternal 
exposure).
Examples of environmental exposure include direct contact with Pfizer products by pregnant 
women (e.g., A nurse reports that she became pregnant, and she has been exposed to 
chemotherapeutics until that time.);
•
where a man was exposed to Prevenar 13 through treatment or environmental exposure 
before or around conception; or where a man was exposed while his partner is pregnant 
(paternal exposure).
In principle, prospective and retrospective EDP reports from any information source shall be 
notified whether or not they are AEs. At that time, the procedures for SAE reporting shall be 
followed.

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In the case where the vaccinees or their partners are found to have become or be pregnant 
during the Prevenar 13 treatment period, this information shall be submitted to Pfizer using 
the NIS AE Report Form and EDP Supplemental Form whether or not it is an AE.
Furthermore, information on environmental exposure of pregnant women to Prevenar 13 (e.g., 
a pregnant subject mistakenly inhaled a cytotoxic drug or touched a spilled drug) shall be also 
handed in using the NIS AE Report Form and EDP Supplemental Form. These reports shall 
be made whether or not it is an AE.
Information to be submitted shall include the expected date of delivery (for information on 
abortion, see below).
A follow-up investigation on general pregnancy information should be carried out. 
Furthermore, a follow-up investigation on information on the outcome of EDP should be 
performed for all EDP reports in which the outcome of pregnancy is unknown. A follow-up 
investigation on pregnancy should be implemented until delivery or the termination of 
pregnancy (e.g., artificial abortion), and the outcome should be reported to Pfizer. This 
information should be submitted as a follow-up investigation on an early EDP report. If a 
newborn was born, whether or not the newborn has external malformation should be assessed. 
If an abortion is carried out, the reason should be clarified, and if clinically possible (unless 
congenital anomaly is confirmed by tests and reported), whether or not the aborted child has 
external malformation should be evaluated by gross observation.
If the outcome of pregnancy meets the criteria for SAEs [i.e., ectopic pregnancy, spontaneous 
abortion, intrauterine fetal death, neonatal death, and congenital anomaly (in the case of live-
born infant, aborted fetus, intrauterine fetal death and neonatal death)], the procedures for 
SAE reporting shall be followed.
Follow-up information on the outcome of pregnancy to be reported as an SAE is as follows:
•
Spontaneous abortion includes miscarriage and missed abortion.
•  Neonatal death within one month after birth should be reported as an SAE regardless of the 
causal relationship. Furthermore, the death of an infant after one month after birth, which 
is determined by the investigator to be related or probably related to drug exposure, should 
be reported as an SAE.
Follow-up information on EDP may be required. A detailed follow-up investigation on the 
outcome of delivery (e.g., Follow-up investigation on the presence or absence of 
developmental delay of a premature baby) should be handled for individual subjects.
In the case of paternal exposure, the subjects will receive the “Disclosure of information on 
partners during pregnancy” that should be given to their partners. The fact that this document 
to be given to the partners has been provided to the subjects shall be recorded.
Exposure during breastfeeding
A scenario of exposure during breastfeeding shall be reported whether or not it is an AE. 
Particularly, if Pfizer products (e.g., vitamins) approved to be used in breastfeeding women 
are administered in accordance with the approved dosage regimens, no report of exposure 
during breastfeeding will be prepared. However, if AEs related to administration of these 
drugs occurred in infants, the AEs should be reported with exposure during breastfeeding.
Misdosing

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Misdosing is an event leading to improper use of a drug under supervision of healthcare 
professionals, vaccinees or consumers, or adversely affecting vaccinees that can be prevented. 
Such an event is related to medical acts, products, treatments and systems including 
prescription, prescription notification, product labels, packages and names, combinations, 
preparation, distribution, administration, education, monitoring and use.
Examples of misdosing are as follows:
•
Prevented misdosing whether or not it directly affected vaccinees (e.g., careless/wrong 
administration mistakenly using dosage and administration not presented on a product label 
or prescription by healthcare professionals or vaccinees/consumers)
•
Mixing up of names (e.g., brand name)
The investigator shall submit the following misdosing whether or not there are related 
AEs/SAEs:
•
Misdosing related to exposure of vaccinees to the product whether or not misdosing 
accompanies AEs
•
Misdosing not directly involving vaccinees (e.g., possible misdosing or near miss 
including potential or prevented misdosing). If misdosing is not involved in exposure of 
vaccinees to the product, a misdosing report should be prepared based on the following 
minimum criteria:
•
Identifiable reporter
•
Suspected product
•
Misdosing event
Overdosing, drug misuse and extravasation
The investigator should report overdosing, drug misuse and extravasation associated with the 
use of Pfizer products to Pfizer whether or not they are AEs/SAEs.
Lack of pharmacological effect
The investigator should report a lack of pharmacological effect of Pfizer products to Pfizer 
whether or not it is an AE/SAE or for any indications of Pfizer products.
Occupational exposure
The investigator should occupational exposure to Pfizer products to Pfizer whether or not it is 
an AE/SAE.
9.5 Single Reference Safety Document
A single reference safety document (SRSD) refers to a document presenting information on a 
known safety profile and is the package insert of Prevenar 13 in the investigation. The 
sponsor should assess safety information reported by the investigator during the investigation 
period with the use of the SRSD.
In addition, the investigator should follow prescription and dosing guidance based on the
SRSD.

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10 PLAN FOR THROUGH NOTIFICATION OF RESULTS AND PUBLICATION
Investigation results may be presented at academic conferences or in papers for providing 
information on proper use.
Report of problems
In the case of new information on the prohibition of the use of Prevenar 13 or any restrictions 
(e.g., discontinuation of distribution) by regulatory agencies supervising any region in the 
world, or when the investigator learned new information affecting the benefit and risk 
assessment of Prevenar 13, such information should be promptly notified to the sponsor.
If the investigator took emergency safety measures to protect vaccinees registered in the 
investigation from immediate hazards and noticed major violation of the protocol, he/she 
should promptly notify it to the sponsor.
11 ORGANIZATION SYSTEM FOR THE IMPLEMENTATION OF THE 
INVESTIGATION
The organization system will be the same as that for postmarketing surveillance activities 
presented in the risk management plan (RMP). The person responsible for the investigation 
will be the Director of the Postmarketing Investigation Planning and Management 
Department.
12 NAME AND ADDRESS OF THE PERSON TO WHOM THE ACTIVITIES ARE 
OUTSOURCED, AND OUTSOURCED ACTIVITIES
1) Address: 24-1 Nihonbashi Hakozaki-cho, Chuo-ku, Tokyo
Name of company: CAC Exicare Corporation 
Scope of outsourced activities: Activities for registration, reception of CRFs, monitoring, 
data management, tabulations/analyses, etc.
2) Address: 2-4-32 Aomi, Koto-ku, Tokyo
Name of company: Fujitsu FIP Corporation
Scope of outsourced activities: EDC (e.g., Establishment and operation of a data collection 
system)
13 POSSIBLE ADDITIONAL MEASURES TO BE TAKEN BASED ON THE 
RESULTS FROM THE INVESTIGATION AND CRITERIA FOR DECIDING 
THEIR INITIATION
At milestones, the RMP including the following items should be reviewed:

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• To evaluate whether or not it is necessary to amend the details of risk minimization 
activities for the current safety specifications;
• To examine whether or not it is necessary to amend the details of this protocol (e.g., the 
continuation of the investigation and the implementation of an additional investigation) 
including the presence or absence of new safety specifications; and
• To consider whether or not it is necessary to establish a risk minimization plan for a new 
safety specification.
14 IMPLEMENTATION STATUS OF THE INVESTIGATION AND EVALUATION 
OF OBTAINED RESULTS, OR PLANNED MILESTONES FOR MAKING 
REPORTS TO THE PMDA AND THEIR RATIONALES
Safety will be assessed and reported at the time of submitting periodic safety reports and the 
end of the investigation.
15 OTHER NECESSARY MATTERS
1) Protocol revision
The necessity for revising the protocol should be examined in consideration of new evidence 
becoming available according to the progress of the investigation, and the protocol should be 
revised as needed. In addition, when partial changes in the dosage and administration or 
indications are approved during the reexamination period (excluding the case where a 
reexamination period is newly designated), the necessity of protocol revision should be 
reviewed, and the revision should be made as needed.
2) Actions for problems and questions if any
When the onset of serious and unexpected ADRs is suggested, the incidence of ADRs greatly 
increased, any efficacy or safety issue is identified as compared with those before approval, 
or the onset of different ADRs is suggested, a revision of the package insert and the 
implementation of a new special drug use investigation or postmarketing clinical study 
should be considered.
16 CONTACT INFORMATION
16.1
Where to Contact for the Contents of Investigation
Name
Postmarketing Investigation Planning and Management Department, Pfizer Japan Inc.
Address
Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589
E-mail address
PRV_Adult_EDC_PMS@pfizer.com
16.2
Where to Contact for the EDC System
Name
PostMaNet CSD, Fujitsu FIP Corporation
Reception hours
Monday through Friday: 9:00 to 21:00 (excluding national holidays)

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Phone number
0120-002-593
17 REFERENCES
None
18 LIST OF TABLES
Page.10 Table 1 Method and timing of AE evaluation
Page.11 Table 2 List of investigation items
Page.13 Table 3 Definition of severity
19 LIST OF FIGURES
Not applicable
Table of contents of independent documents
Not applicable
Follow-up information
Not applicable