Prevenar13 Post Market Surveillance

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01509105
• Collaborator: (none)
• Enrollment: 649
• Locations: 18
• Duration (Months): 52
• Patients Per Site: 36.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: 13-valent pneumococcal vaccine

Detailed Description

non-randomization, non-probability sampling

Study Design

• Study Type: Observational
• Actual Enrollment: 649 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance To Observe Safety Of Prevenar 13
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Group1	Biological: 13-valent pneumococcal vaccine; 0.5mL IM (Intramuscular administration) as per recommended schedule; Other Names: Prevenar 13

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 [Within 7 days after Vaccination 1]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

2. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 [Within 7 days after Vaccination 2]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

3. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 [Within 7 days after Vaccination 3]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

4. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 [Within 28 days after Vaccination 4]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

5. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 [Within 7 days after Vaccination 1]

   An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

6. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 [Within 7 days after Vaccination 2]

   An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

7. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 [Within 7 days after Vaccination 3]

   An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

8. Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 [Within 28 days after Vaccination 4]

   An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary Outcome Measures

1. Duration of Adverse Events (AEs) [Baseline up to 28 days after last dose of study vaccination (13 Months)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.

2. Number of Participants With Adverse Events (AEs) by Severity [Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).

3. Number of Participants With Outcome in Response to Adverse Events (AEs) [Baseline up to 28 days after last dose of study vaccination (13 Months)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.

4. Number of Participants Discontinued Due to Adverse Events [Baseline up to 28 days after last dose of study vaccination (13 Months)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion Criteria:

• Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Choi's Pediatric Clinic	Wonju-si	Gangwon-do	Korea, Republic of	220-956
2	Seoul Children's Hospital	Osan	Gyeonggi-do	Korea, Republic of	447-804
3	Bundang Pediatric Clinic	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-821
4	Teun Teun Pediatric clinic	Suwon-si	Gyeonggi-do	Korea, Republic of	443-471
5	Namujungwon Women's Hospital	Yangju	Gyeonggi-do	Korea, Republic of	482-050
6	Yonsei Pediatric Clinic	Yongin-si	Gyeonggi-do	Korea, Republic of	448-508
7	Busan National University Hospital	Busan		Korea, Republic of	602-739
8	Jaeil Alliance Pediatrics Clinic	Daegu		Korea, Republic of	701847
9	Teun Teun Pediatric Clinic	Daegu		Korea, Republic of	702886
10	Eulji University Hospital	Daejeon		Korea, Republic of	302-799
11	Korea University Ansan Hospital	Gyeonggi-do		Korea, Republic of	425-707
12	Cha Bundang Medical Center, Cha University	Gyeonggi-do		Korea, Republic of	463-712
13	Inha University Hospital	Incheon		Korea, Republic of	400-711
14	Lee Ha Young Pediatrics	Incheon		Korea, Republic of	402-852
15	Asan Medical Center	Seoul		Korea, Republic of	138-736
16	Eulji Medical Center	Seoul		Korea, Republic of	139-711
17	JaMo Women's Hospital	Suyeong-gu		Korea, Republic of	613-806
18	Ulsan University Hospital	Ulsan		Korea, Republic of	682-714

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01509105
• Other Study ID Numbers: 6096A1-4029; B1851057
• First Posted: Jan 12, 2012
• Last Update Posted: Feb 13, 2017
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Period Title: Overall Study
STARTED	649
COMPLETED	649
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Overall Participants	649
Age (months) [Mean (Standard Deviation) ]
Mean Age	4.26 (12.86)
Gender (Count of Participants)
Female	321 49.5%
Male	328 50.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame	Within 7 days after Vaccination 1

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	640
Adverse Events	68 10.5%
Serious Adverse Events	1 0.2%

2. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame	Within 7 days after Vaccination 2

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	536
Adverse Events	67 10.3%
Serious Adverse Events	0 0%

3. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame	Within 7 days after Vaccination 3

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	489
Adverse Events	52 8%
Serious Adverse Events	2 0.3%

4. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame	Within 28 days after Vaccination 4

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	342
Adverse Events	43 6.6%
Serious Adverse Events	0 0%

5. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Description	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 7 days after Vaccination 1

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	640
Adverse Events	37 5.7%
Serious Adverse Events	0 0%

6. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Description	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 7 days after Vaccination 2

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	536
Adverse Events	30 4.6%
Serious Adverse Events	0 0%

7. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Description	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 7 days after Vaccination 3

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	489
Adverse Events	13 2%
Serious Adverse Events	0 0%

8. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Description	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Within 28 days after Vaccination 4

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	342
Adverse Events	17 2.6%
Serious Adverse Events	0 0%

9. Secondary Outcome

Title	Duration of Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.
Time Frame	Baseline up to 28 days after last dose of study vaccination (13 Months)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who had at least 1 adverse event.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	166
Mean (Standard Deviation) [days]	7.21 (6.92)

10. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) by Severity
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Time Frame	Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "n" signifies those participants who were evaluable at specified time points.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	649
After Vaccination 1: Mild (n =640)	66 10.2%
After Vaccination 1: Moderate (n =640)	4 0.6%
After Vaccination 1: Severe (n =640)	0 0%
After Vaccination 2: Mild (n =536)	64 9.9%
After Vaccination 2: Moderate (n =536)	4 0.6%
After Vaccination 2: Severe (n =536)	0 0%
After Vaccination 3: Mild (n =489)	50 7.7%
After Vaccination 3: Moderate (n =489)	7 1.1%
After Vaccination 3: Severe (n =489)	0 0%
After Vaccination 4: Mild (n =342)	41 6.3%
After Vaccination 4: Moderate (n =342)	2 0.3%
After Vaccination 4: Severe (n =342)	0 0%

11. Secondary Outcome

Title	Number of Participants With Outcome in Response to Adverse Events (AEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.
Time Frame	Baseline up to 28 days after last dose of study vaccination (13 Months)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who had at least 1 adverse event.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	166
Yes	1 0.2%
Unknown	1 0.2%
No-resolved	164 25.3%

12. Secondary Outcome

Title	Number of Participants Discontinued Due to Adverse Events
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame	Baseline up to 28 days after last dose of study vaccination (13 Months)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.

Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
Measure Participants	649
Number [participants]	0 0%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Arm/Group Title	Prevenar 13
Arm/Group Description	Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
All Cause Mortality
	Prevenar 13
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Prevenar 13
	Affected / at Risk (%)	# Events
Total	3/649 (0.5%)
General disorders
MEDICINE INEFFECTIVE	1/649 (0.2%)
Infections and infestations
PHARYNGITIS	1/649 (0.2%)
PNEUMONIA	3/649 (0.5%)
Other (Not Including Serious) Adverse Events
	Prevenar 13
	Affected / at Risk (%)	# Events
Total	165/649 (25.4%)
Blood and lymphatic system disorders
ANAEMIA HYPOCHROMIC	1/649 (0.2%)
Ear and labyrinth disorders
EAR ACHE	1/649 (0.2%)
Eye disorders
CONJUNCTIVITIS	1/649 (0.2%)
HETEROPHORIA	1/649 (0.2%)
LACRIMAL DUCT OBSTRUCTION	1/649 (0.2%)
Gastrointestinal disorders
ANOREXIA	1/649 (0.2%)
CONSTIPATION	1/649 (0.2%)
DIARRHOEA	3/649 (0.5%)
ENTERITIS	12/649 (1.8%)
GASTRO-INTESTINAL DISORDER NOS	2/649 (0.3%)
GASTROENTERITIS	5/649 (0.8%)
VOMITING	1/649 (0.2%)
General disorders
CRYING ABNORMAL	1/649 (0.2%)
FEVER	40/649 (6.2%)
Infections and infestations
BRONCHITIS	15/649 (2.3%)
CYSTITIS	1/649 (0.2%)
FURUNCULOSIS	1/649 (0.2%)
INFECTION VIRAL	1/649 (0.2%)
OTITIS MEDIA	7/649 (1.1%)
PHARYNGITIS	33/649 (5.1%)
PNEUMONIA	11/649 (1.7%)
PYELONEPHRITIS	2/649 (0.3%)
RHINITIS	19/649 (2.9%)
SINUSITIS	1/649 (0.2%)
UPPER RESPIRATORY TRACT INFECTION	38/649 (5.9%)
Injury, poisoning and procedural complications
INJECTION SITE RASH	3/649 (0.5%)
INJECTION SITE REACTION	7/649 (1.1%)
Musculoskeletal and connective tissue disorders
LIGAMENT DISORDER	1/649 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NAEVUS	1/649 (0.2%)
Psychiatric disorders
INSOMNIA	1/649 (0.2%)
NERVOUSNESS	3/649 (0.5%)
Respiratory, thoracic and mediastinal disorders
COUGHING	11/649 (1.7%)
SPUTUM DISORDER	3/649 (0.5%)
Skin and subcutaneous tissue disorders
DERMATITIS	7/649 (1.1%)
DERMATITIS CONTACT	2/649 (0.3%)
ECZEMA	6/649 (0.9%)
PRURITUS	1/649 (0.2%)
RASH	3/649 (0.5%)
SEBORRHOEA	1/649 (0.2%)
SKIN DISORDER	4/649 (0.6%)
URTICARIA	3/649 (0.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.