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Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521897
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Pneumococcal Vaccine
Streptococcus Pneumoniae
Intervention Biological: 7-valent vaccine injection
Enrollment 1143
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Period Title: Overall Study
Started 1143
Completed 1120
Not Completed 23
Reason Not Completed
Protocol Violation             18
Lost to Follow-up             5
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Baseline Participants 1120
Hide Baseline Analysis Population Description
In total, 1143 participants were enrolled in this study. Of the 1143 participants, 23 participants were excluded from the baseline analysis for the reasons of protocol violation and lost to follow-up.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1120 participants
2 to 4 < Months 528
4 to 6 < Months 516
6 to 7 < Months 76
[1]
Measure Description: Participants were vaccinated with Prevenar™ (7-valent) according to the Japanese package insert (age in months at the first vaccination).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1120 participants
Female
550
  49.1%
Male
570
  50.9%
[1]
Measure Description: Participants were vaccinated with Prevenar™ (7-valent) according to the Japanese package insert.
1.Primary Outcome
Title Number of Participants With Adverse Reactions
Hide Description An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: participants
126
2.Secondary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description A serious adverse event 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 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: participants
20
3.Secondary Outcome
Title Number of Participants With Injection Site Reactions
Hide Description Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for “injection site erythema”; induration for “injection site erythema” and “injection site swelling”; tenderness for ”injection site pain”; and warmth for “injection site warmth”.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: Participants
Erythema 46
Induration 59
Tenderness 0
Warmth 1
4.Secondary Outcome
Title Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hide Description Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: Participants
No CVs: 1st (n =184) 1
No CVs: 2nd (n =166) 1
No CVs: 3rd (n =203) 1
No CVs: 4th (n =450) 0
Hib: 1st (n =327) 3
Hib: 2nd (n =207) 0
Hib: 3rd (n =303) 0
Hib: 4th (n =39) 0
DPT: 1st (n =176) 1
DPT: 2nd (n =138) 1
DPT: 3rd (n =72) 0
DPT: 4th (n =8) 0
MR: 1st (n =0) 0
MR: 2nd (n =0) 0
MR: 3rd (n =1) 0
MR: 4th (n =179) 0
Flu: 1st (n =0) 0
Flu: 2nd (n =0) 0
Flu: 3rd (n =3) 0
Flu: 4th (n =29) 0
BCG: 1st (n =10) 0
BCG: 2nd (n =6) 0
BCG: 3rd (n =3) 0
BCG: 4th (n =0) 0
VSV: 1st (n =0) 0
VSV: 2nd (n =0) 0
VSV: 3rd (n =0) 0
VSV: 4th (n =10) 0
Mumps: 1st (n =0) 0
Mumps: 2nd (n =0) 0
Mumps: 3rd (n =0) 0
Mumps: 4th (n =3) 0
HB: 1st (n =0) 0
HB: 2nd (n =1) 0
HB: 3rd (n =0) 0
HB: 4th (n =3) 0
OPV: 1st (n =1) 0
OPV: 2nd (n =1) 0
OPV: 3rd (n =0) 0
OPV: 4th (n =2) 0
IPV: 1st (n =0) 0
IPV: 2nd (n =0) 0
IPV: 3rd (n =0) 0
IPV: 4th (n =4) 0
DPT + Hib: 1st (n =412) 1
DPT + Hib: 2nd (n =556) 1
DPT + Hib: 3rd (n =420) 1
DPT + Hib: 4th (n =34) 1
Hib + MR: 1st (n =0) 0
Hib + MR: 2nd (n =1) 0
Hib + MR: 3rd (n =1) 0
Hib + MR: 4th (n =12) 0
Hib + Flu: 1st (n =0) 0
Hib + Flu: 2nd (n =2) 0
Hib + Flu: 3rd (n =1) 0
Hib + Flu: 4th (n =5) 1
Hib + HB: 1st (n =1) 0
Hib + HB: 2nd (n =1) 0
Hib + HB: 3rd (n =0) 0
Hib + HB: 4th (n =0) 0
BCG + Hib: 1st (n =8) 1
BCG + Hib: 2nd (n =2) 0
BCG + Hib: 3rd (n =3) 0
BCG + Hib: 4th (n =0) 0
OPV + Hib: 1st (n =1) 0
OPV + Hib: 2nd (n =0) 0
OPV + Hib: 3rd (n =4) 0
OPV + Hib: 4th (n =0) 0
DPT + MR: 1st (n =0) 0
DPT + MR: 2nd (n =1) 0
DPT + MR: 3rd (n =0) 0
DPT + MR: 4th (n =0) 0
DPT + Flu: 1st (n =0) 0
DPT + Flu: 2nd (n =1) 0
DPT + Flu: 3rd (n =0) 0
DPT + Flu: 4th (n =1) 0
DPT + VSV: 1st (n =0) 0
DPT + VSV: 2nd (n =0) 0
DPT + VSV: 3rd (n =0) 0
DPT + VSV: 4th (n =2) 0
DPT + Mumps: 1st (n =0) 0
DPT + Mumps: 2nd (n =0) 0
DPT + Mumps: 3rd (n =0) 0
DPT + Mumps: 4th (n =0) 0
MR + VSV: 1st (n =0) 0
MR + VSV: 2nd (n =0) 0
MR + VSV: 3rd (n =0) 0
MR + VSV: 4th (n =3) 0
MR + Mumps: 1st (n =0) 0
MR + Mumps: 2nd (n =0) 0
MR + Mumps: 3rd (n =0) 0
MR + Mumps: 4th (n =2) 0
MR + HB: 1st (n =0) 0
MR + HB: 2nd (n =0) 0
MR + HB: 3rd (n =0) 0
MR + HB: 4th (n =1) 0
Flu + MR: 1st (n =0) 0
Flu + MR: 2nd (n =0) 0
Flu + MR: 3rd (n =0) 0
Flu + MR: 4th (n =3) 0
Flu + Mumps: 1st (n =0) 0
Flu + Mumps: 2nd (n =0) 0
Flu + Mumps: 3rd (n =0) 0
Flu + Mumps: 4th (n =1) 0
VSV + Mumps: 1st (n =0) 0
VSV + Mumps: 2nd (n =0) 0
VSV + Mumps: 3rd (n =0) 0
VSV + Mumps: 4th (n =4) 0
MR + VSV + Mumps: 1st (n =0) 0
MR + VSV + Mumps: 2nd (n =0) 0
MR + VSV + Mumps: 3rd (n =0) 0
MR + VSV + Mumps: 4th (n =34) 0
DPT + Hib + MR: 1st (n =0) 0
DPT + Hib + MR: 2nd (n =0) 0
DPT + Hib + MR: 3rd (n =0) 0
DPT + Hib + MR: 4th (n =1) 0
Hib + MR + VSV: 1st (n =0) 0
Hib + MR + VSV: 2nd (n =0) 0
Hib + MR + VSV: 3rd (n =0) 0
Hib + MR + VSV: 4th (n =1) 0
DPT + Hib + Mumps: 1st (n =0) 0
DPT + Hib + Mumps: 2nd (n =0) 0
DPT + Hib + Mumps: 3rd (n =1) 0
DPT + Hib + Mumps: 4th (n =0) 0
DPT + Hib + HB: 1st (n =0) 0
DPT + Hib + HB: 2nd (n =0) 0
DPT + Hib + HB: 3rd (n =1) 0
DPT + Hib + HB: 4th (n =0) 0
DPT + Hib + IPV: 1st (n =0) 0
DPT + Hib + IPV: 2nd (n =0) 0
DPT + Hib + IPV: 3rd (n =1) 0
DPT + Hib + IPV: 4th (n =0) 0
VSV + Mumps + IPV: 1st (n =0) 0
VSV + Mumps + IPV: 2nd (n =0) 0
VSV + Mumps + IPV: 3rd (n =0) 0
VSV + Mumps + IPV: 4th (n =2) 0
Hib + MR + VSV + Mumps: 1st (n =0) 0
Hib + MR + VSV + Mumps: 2nd (n =0) 0
Hib + MR + VSV + Mumps: 3rd (n =0) 0
Hib + MR + VSV + Mumps: 4th (n =1) 0
Hib + MR + Mumps + IPV: 1st (n =0) 0
Hib + MR + Mumps + IPV: 2nd (n =0) 0
Hib + MR + Mumps + IPV: 3rd (n =0) 0
Hib + MR + Mumps + IPV: 4th (n =1) 0
MR + VSV + Mumps + HB: 1st (n =0) 0
MR + VSV + Mumps + HB: 2nd (n =0) 0
MR + VSV + Mumps + HB: 3rd (n =0) 0
MR + VSV + Mumps + HB: 4th (n =1) 0
5.Secondary Outcome
Title Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hide Description Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: participants
No CVs: 1st (n =184) 6
No CVs: 2nd (n =166) 1
No CVs: 3rd (n =203) 3
No CVs: 4th (n =450) 1
Hib: 1st (n =327) 8
Hib: 2nd (n =207) 4
Hib: 3rd (n =303) 1
Hib: 4th (n =39) 0
DPT: 1st (n =176) 11
DPT: 2nd (n =138) 3
DPT: 3rd (n =72) 0
DPT: 4th (n =8) 0
MR: 1st (n =0) 0
MR: 2nd (n =0) 0
MR: 3rd (n =1) 0
MR: 4th (n =179) 2
Flu: 1st (n =0) 0
Flu: 2nd (n =0) 0
Flu: 3rd (n =3) 0
Flu: 4th (n =29) 0
BCG: 1st (n =10) 0
BCG: 2nd (n =6) 0
BCG: 3rd (n =3) 0
BCG: 4th (n =0) 0
VSV: 1st (n =0) 0
VSV: 2nd (n =0) 0
VSV: 3rd (n =0) 0
VSV: 4th (n =10) 0
Mumps: 1st (n =0) 0
Mumps: 2nd (n =0) 0
Mumps: 3rd (n =0) 0
Mumps: 4th (n =3) 0
HB: 1st (n =0) 0
HB: 2nd (n =1) 0
HB: 3rd (n =0) 0
HB: 4th (n =3) 0
OPV: 1st (n =1) 0
OPV: 2nd (n =1) 0
OPV: 3rd (n =0) 0
OPV: 4th (n =2) 0
IPV: 1st (n =0) 0
IPV: 2nd (n =0) 0
IPV: 3rd (n =0) 0
IPV: 4th (n =4) 0
DPT + Hib: 1st (n =412) 15
DPT + Hib: 2nd (n =556) 14
DPT + Hib: 3rd (n =420) 3
DPT + Hib: 4th (n =34) 1
Hib + MR: 1st (n =0) 0
Hib + MR: 2nd (n =1) 0
Hib + MR: 3rd (n =1) 0
Hib + MR: 4th (n =12) 0
Hib + Flu: 1st (n =0) 0
Hib + Flu: 2nd (n =2) 0
Hib + Flu: 3rd (n =1) 0
Hib + Flu: 4th (n =5) 1
Hib + HB: 1st (n =1) 0
Hib + HB: 2nd (n =1) 0
Hib + HB: 3rd (n =0) 0
Hib + HB: 4th (n =0) 0
BCG + Hib: 1st (n =8) 1
BCG + Hib: 2nd (n =2) 0
BCG + Hib: 3rd (n =3) 0
BCG + Hib: 4th (n =0) 0
OPV + Hib: 1st (n =1) 0
OPV + Hib: 2nd (n =0) 0
OPV + Hib: 3rd (n =4) 0
OPV + Hib: 4th (n =0) 0
DPT + MR: 1st (n =0) 0
DPT + MR: 2nd (n =1) 0
DPT + MR: 3rd (n =0) 0
DPT + MR: 4th (n =0) 0
DPT + Flu: 1st (n =0) 0
DPT + Flu: 2nd (n =1) 0
DPT + Flu: 3rd (n =0) 0
DPT + Flu: 4th (n =1) 0
DPT + VSV: 1st (n =0) 0
DPT + VSV: 2nd (n =0) 0
DPT + VSV: 3rd (n =0) 0
DPT + VSV: 4th (n =2) 0
DPT + Mumps: 1st (n =0) 0
DPT + Mumps: 2nd (n =0) 0
DPT + Mumps: 3rd (n =0) 0
DPT + Mumps: 4th (n =0) 0
MR + VSV: 1st (n =0) 0
MR + VSV: 2nd (n =0) 0
MR + VSV: 3rd (n =0) 0
MR + VSV: 4th (n =3) 0
MR + Mumps: 1st (n =0) 0
MR + Mumps: 2nd (n =0) 0
MR + Mumps: 3rd (n =0) 0
MR + Mumps: 4th (n =2) 0
MR + HB: 1st (n =0) 0
MR + HB: 2nd (n =0) 0
MR + HB: 3rd (n =0) 0
MR + HB: 4th (n =1) 0
Flu + MR: 1st (n =0) 0
Flu + MR: 2nd (n =0) 0
Flu + MR: 3rd (n =0) 0
Flu + MR: 4th (n =3) 1
Flu + Mumps: 1st (n =0) 0
Flu + Mumps: 2nd (n =0) 0
Flu + Mumps: 3rd (n =0) 0
Flu + Mumps: 4th (n =1) 0
VSV + Mumps: 1st (n =0) 0
VSV + Mumps: 2nd (n =0) 0
VSV + Mumps: 3rd (n =0) 0
VSV + Mumps: 4th (n =4) 0
MR + VSV + Mumps: 1st (n =0) 0
MR + VSV + Mumps: 2nd (n =0) 0
MR + VSV + Mumps: 3rd (n =0) 0
MR + VSV + Mumps: 4th (n =34) 1
DPT + Hib + MR: 1st (n =0) 0
DPT + Hib + MR: 2nd (n =0) 0
DPT + Hib + MR: 3rd (n =0) 0
DPT + Hib + MR: 4th (n =1) 0
Hib + MR + VSV: 1st (n =0) 0
Hib + MR + VSV: 2nd (n =0) 0
Hib + MR + VSV: 3rd (n =0) 0
Hib + MR + VSV: 4th (n =1) 0
DPT + Hib + Mumps: 1st (n =0) 0
DPT + Hib + Mumps: 2nd (n =0) 0
DPT + Hib + Mumps: 3rd (n =1) 0
DPT + Hib + Mumps: 4th (n =0) 0
DPT + Hib + HB: 1st (n =0) 0
DPT + Hib + HB: 2nd (n =0) 0
DPT + Hib + HB: 3rd (n =1) 0
DPT + Hib + HB: 4th (n =0) 0
DPT + Hib + IPV: 1st (n =0) 0
DPT + Hib + IPV: 2nd (n =0) 0
DPT + Hib + IPV: 3rd (n =1) 0
DPT + Hib + IPV: 4th (n =0) 0
VSV + Mumps + IPV: 1st (n =0) 0
VSV + Mumps + IPV: 2nd (n =0) 0
VSV + Mumps + IPV: 3rd (n =0) 0
VSV + Mumps + IPV: 4th (n =2) 0
Hib + MR + VSV + Mumps: 1st (n =0) 0
Hib + MR + VSV + Mumps: 2nd (n =0) 0
Hib + MR + VSV + Mumps: 3rd (n =0) 0
Hib + MR + VSV + Mumps: 4th (n =1) 0
Hib + MR + Mumps + IPV: 1st (n =0) 0
Hib + MR + Mumps + IPV: 2nd (n =0) 0
Hib + MR + Mumps + IPV: 3rd (n =0) 0
Hib + MR + Mumps + IPV: 4th (n =1) 0
MR + VSV + Mumps + HB: 1st (n =0) 0
MR + VSV + Mumps + HB: 2nd (n =0) 0
MR + VSV + Mumps + HB: 3rd (n =0) 0
MR + VSV + Mumps + HB: 4th (n =1) 0
6.Other Pre-specified Outcome
Title Number of Participants by Month of Age at Each Vaccination Time
Hide Description Number of participants was counted by month of age at each vaccination time (first to fourth).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: Participants
2 to less than 3 months: 1st (n =1120) 248
2 to less than 3 months: 2nd (n =1083) 5
2 to less than 3 months: 3rd (n =1017) 0
2 to less than 3 months: 4th (n =836) 0
3 to less than 4 months: 1st (n =1120) 280
3 to less than 4 months: 2nd (n =1083) 193
3 to less than 4 months: 3rd (n =1017) 7
3 to less than 4 months: 4th (n =836) 0
4 to less than 5 months: 1st (n =1120) 297
4 to less than 5 months: 2nd (n =1083) 235
4 to less than 5 months: 3rd (n =1017) 97
4 to less than 5 months: 4th (n =836) 0
5 to less than 6 months: 1st (n =1120) 219
5 to less than 6 months: 2nd (n =1083) 276
5 to less than 6 months: 3rd (n =1017) 207
5 to less than 6 months: 4th (n =836) 0
6 to less than 7 months: 1st (n =1120) 76
6 to less than 7 months: 2nd (n =1083) 213
6 to less than 7 months: 3rd (n =1017) 241
6 to less than 7 months: 4th (n =836) 0
7 to less than 8 months: 1st (n =1120) 0
7 to less than 8 months: 2nd (n =1083) 93
7 to less than 8 months: 3rd (n =1017) 229
7 to less than 8 months: 4th (n =836) 1
8 to less than 9 months: 1st (n =1120) 0
8 to less than 9 months: 2nd (n =1083) 20
8 to less than 9 months: 3rd (n =1017) 108
8 to less than 9 months: 4th (n =836) 1
9 to less than 10 months: 1st (n =1120) 0
9 to less than 10 months: 2nd (n =1083) 7
9 to less than 10 months: 3rd (n =1017) 45
9 to less than 10 months: 4th (n =836) 2
10 to less than 11 months: 1st (n =1120) 0
10 to less than 11 months: 2nd (n =1083) 3
10 to less than 11 months: 3rd (n =1017) 18
10 to less than 11 months: 4th (n =836) 1
11 to less than 12 months: 1st (n =1120) 0
11 to less than 12 months: 2nd (n =1083) 4
11 to less than 12 months: 3rd (n =1017) 11
11 to less than 12 months: 4th (n =836) 7
12 to less than 16 months: 1st (n =1120) 0
12 to less than 16 months: 2nd (n =1083) 2
12 to less than 16 months: 3rd (n =1017) 16
12 to less than 16 months: 4th (n =836) 650
16 to less than 18 months: 1st (n =1120) 0
16 to less than 18 months: 2nd (n =1083) 1
16 to less than 18 months: 3rd (n =1017) 2
16 to less than 18 months: 4th (n =836) 57
18 to less than 24 months: 1st (n =1120) 0
18 to less than 24 months: 2nd (n =1083) 0
18 to less than 24 months: 3rd (n =1017) 4
18 to less than 24 months: 4th (n =836) 88
24 months and order: 1st (n =1120) 0
24 months and order: 2nd (n =1083) 0
24 months and order: 3rd (n =1017) 1
24 months and order: 4th (n =836) 6
Unknown: 1st (n =1120) 0
Unknown: 2nd (n =1083) 31
Unknown: 3rd (n =1017) 31
Unknown: 4th (n =836) 23
7.Other Pre-specified Outcome
Title Number of Participants by Vaccination Sites at Each Vaccination Time
Hide Description Number of participants was counted by vaccination sites at each vaccination time (first to fourth).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: Participants
Upper Arm: 1st (n =1120) 1110
Upper Arm: 2nd (n =1083) 1074
Upper Arm: 3rd (n =1017) 1013
Upper Arm: 4th (n =836) 836
Other: 1st (n =1120) 10
Other: 2nd (n =1083) 9
Other: 3rd (n =1017) 4
Other: 4th (n= 836) 0
8.Other Pre-specified Outcome
Title Number of Participants by Pattern of Concomitant Vaccines
Hide Description Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: participants
No CVs: 1st (n =1120) 184
No CVs: 2nd (n =1083) 166
No CVs: 3rd (n =1017) 203
No CVs: 4th (n =836) 450
Hib: 1st (n =1120) 327
Hib: 2nd (n =1083) 207
Hib: 3rd (n =1017) 303
Hib: 4th (n =836) 39
DPT: 1st (n =1120) 176
DPT: 2nd (n =1083) 138
DPT: 3rd (n =1017) 72
DPT: 4th (n =836) 8
MR: 1st (n =1120) 0
MR: 2nd (n =1083) 0
MR: 3rd (n =1017) 1
MR: 4th (n =836) 179
Flu: 1st (n =1120) 0
Flu: 2nd (n =1083) 0
Flu: 3rd (n =1017) 3
Flu: 4th (n =836) 29
BCG: 1st (n =1120) 10
BCG: 2nd (n =1083) 6
BCG: 3rd (n =1017) 3
BCG: 4th (n =836) 0
VSV: 1st (n =1120) 0
VSV: 2nd (n =1083) 0
VSV: 3rd (n =1017) 0
VSV: 4th (n =836) 10
Mumps: 1st (n =1120) 0
Mumps: 2nd (n =1083) 0
Mumps: 3rd (n =1017) 0
Mumps: 4th (n =836) 3
HB: 1st (n =1120) 0
HB: 2nd (n =1083) 1
HB: 3rd (n =1017) 0
HB: 4th (n =836) 3
OPV: 1st (n =1120) 1
OPV: 2nd (n =1083) 1
OPV: 3rd (n =1017) 0
OPV: 4th (n =836) 2
IPV: 1st (n =1120) 0
IPV: 2nd (n =1083) 0
IPV: 3rd (n =1017) 0
IPV: 4th (n =836) 4
DPT + Hib: 1st (n =1120) 412
DPT + Hib: 2nd (n =1083) 556
DPT + Hib: 3rd (n =1017) 420
DPT + Hib: 4th (n =836) 34
Hib + MR: 1st (n =1120) 0
Hib + MR: 2nd (n =1083) 1
Hib + MR: 3rd (n =1017) 1
Hib + MR: 4th (n =836) 12
Hib + Flu: 1st (n =1120) 0
Hib + Flu: 2nd (n =1083) 2
Hib + Flu: 3rd (n =1017) 1
Hib + Flu: 4th (n =836) 5
Hib + HB: 1st (n =1120) 1
Hib + HB: 2nd (n =1083) 1
Hib + HB: 3rd (n =1017) 0
Hib + HB: 4th (n =836) 0
BCG + Hib: 1st (n =1120) 8
BCG + Hib: 2nd (n =1083) 2
BCG + Hib: 3rd (n =1017) 3
BCG + Hib: 4th (n =836) 0
OPV + Hib: 1st (n =1120) 1
OPV + Hib: 2nd (n =1083) 0
OPV + Hib: 3rd (n =1017) 4
OPV + Hib: 4th (n =836) 0
DPT + MR: 1st (n =1120) 0
DPT + MR: 2nd (n =1083) 1
DPT + MR: 3rd (n =1017) 0
DPT + MR: 4th (n =836) 0
DPT + Flu: 1st (n =1120) 0
DPT + Flu: 2nd (n =1083) 1
DPT + Flu: 3rd (n =1017) 0
DPT + Flu: 4th (n =836) 1
DPT + VSV: 1st (n =1120) 0
DPT + VSV: 2nd (n =1083) 0
DPT + VSV: 3rd (n =1017) 0
DPT + VSV: 4th (n =836) 2
DPT + Mumps: 1st (n =1120) 0
DPT + Mumps: 2nd (n =1083) 0
DPT + Mumps: 3rd (n =1017) 0
DPT + Mumps: 4th (n =836) 0
MR + VSV: 1st (n =1120) 0
MR + VSV: 2nd (n =1083) 0
MR + VSV: 3rd (n =1017) 0
MR + VSV: 4th (n =836) 3
MR + Mumps: 1st (n =1120) 0
MR + Mumps: 2nd (n =1083) 0
MR + Mumps: 3rd (n =1017) 0
MR + Mumps: 4th (n =836) 2
MR + HB: 1st (n =1120) 0
MR + HB: 2nd (n =1083) 0
MR + HB: 3rd (n =1017) 0
MR + HB: 4th (n =836) 1
Flu + MR: 1st (n =1120) 0
Flu + MR: 2nd (n =1083) 0
Flu + MR: 3rd (n =1017) 0
Flu + MR: 4th (n =836) 3
Flu + Mumps: 1st (n =1120) 0
Flu + Mumps: 2nd (n =1083) 0
Flu + Mumps: 3rd (n =1017) 0
Flu + Mumps: 4th (n =836) 1
VSV + Mumps: 1st (n =1120) 0
VSV + Mumps: 2nd (n =1083) 0
VSV + Mumps: 3rd (n =1017) 0
VSV + Mumps: 4th (n =836) 4
MR + VSV + Mumps: 1st (n =1120) 0
MR + VSV + Mumps: 2nd (n =1083) 0
MR + VSV + Mumps: 3rd (n =1017) 0
MR + VSV + Mumps: 4th (n =836) 34
DPT + Hib + MR: 1st (n =1120) 0
DPT + Hib + MR: 2nd (n =1083) 0
DPT + Hib + MR: 3rd (n =1017) 0
DPT + Hib + MR: 4th (n =836) 1
Hib + MR + VSV: 1st (n =1120) 0
Hib + MR + VSV: 2nd (n =1083) 0
Hib + MR + VSV: 3rd (n =1017) 0
Hib + MR + VSV: 4th (n =836) 1
DPT + Hib + Mumps: 1st (n =1120) 0
DPT + Hib + Mumps: 2nd (n =1083) 0
DPT + Hib + Mumps: 3rd (n =1017) 1
DPT + Hib + Mumps: 4th (n =836) 0
DPT + Hib + HB: 1st (n =1120) 0
DPT + Hib + HB: 2nd (n =1083) 0
DPT + Hib + HB: 3rd (n =1017) 1
DPT + Hib + HB: 4th (n =836) 0
DPT + Hib + IPV: 1st (n =1120) 0
DPT + Hib + IPV: 2nd (n =1083) 0
DPT + Hib + IPV: 3rd (n =1017) 1
DPT + Hib + IPV: 4th (n =836) 0
VSV + Mumps + IPV: 1st (n =1120) 0
VSV + Mumps + IPV: 2nd (n =1083) 0
VSV + Mumps + IPV: 3rd (n =1017) 0
VSV + Mumps + IPV: 4th (n =836) 2
Hib + MR + VSV + Mumps: 1st (n =1120) 0
Hib + MR + VSV + Mumps: 2nd (n =1083) 0
Hib + MR + VSV + Mumps: 3rd (n =1017) 0
Hib + MR + VSV + Mumps: 4th (n =836) 1
Hib + MR + Mumps + IPV: 1st (n =1120) 0
HIb + MR + Mumps + IPV: 2nd (n =1083) 0
Hib + MR + Mumps + IPV: 3rd (n =1017) 0
Hib + MR + Mumps + IPV: 4th (n =836) 1
MR + VSV + Mumps + HB: 1st (n =1120) 0
MR + VSV + Mumps + HB: 2nd (n =1083) 0
MR + VSV + Mumps + HB: 3rd (n =1017) 0
MR + VSV + Mumps + HB: 4th (n =836) 1
9.Other Pre-specified Outcome
Title Number of Participants by Pattern of Concomitant Vaccination Sites
Hide Description Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description:
Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Number of Participants Analyzed 1120
Measure Type: Number
Unit of Measure: participants
No CVs: 1st (n =1120) 184
No CVs: 2nd (n =1083) 166
No CVs: 3rd (n =1017) 203
No CVs: 4th (n =836) 450
CV, same UA: 1st (n =1120) 5
CV, same UA: 2nd (n =1083) 1
CV, same UA: 3rd (n =1017) 5
CV, same UA: 4th (n =836) 2
CV, other UA: 1st (n =1120) 508
CV, other UA: 2nd (n =1083) 351
CV, other UA: 3rd (n =1017) 375
CV, other UA: 4th (n =836) 270
CV, same F: 1st (n =1120) 0
CV, same F: 2nd (n =1083) 0
CV, same F: 3rd (n =1017) 2
CV, same F: 4th (n =836) 3
CV, O: 1st (n =1120) 1
CV, O: 2nd (n =1083) 1
CV, O: 3rd (n =1017) 0
CV, O: 4th (n =836) 2
CVs, same UA X2: 1st (n =1120) 0
CVs, same UA X2: 2nd (n =1083) 0
CVs, same UA X2: 3rd (n =1017) 1
CVs, same UA X2: 4th (n =836) 0
CVs, same UA + other UA: 1st (n =1120) 214
CVs, same UA + other UA: 2nd (n =1083) 301
CVs, same UA + other UA: 3rd (n =1017) 236
CVs, same UA + other UA: 4th (n =836) 39
CVs, other UA X2: 1st (n =1120) 181
CVs, other UA X2: 2nd (n =1083) 234
CVs, other UA X2: 3rd (n =1017) 167
CVs, other UA X2: 4th (n =836) 24
CVs, other UA + same F: 1st (n =1120) 11
CVs, other UA + same F: 2nd (n =1083) 12
CVs, other UA + same F: 3rd (n =1017) 7
CVs, other UA + same F: 4th (n =836) 5
CVs, other UA + other F: 1st (n =1120) 0
CVs, other UA + other F: 2nd (n =1083) 1
CVs, other UA + other F: 3rd (n =1017) 4
CVs, other UA + other F: 4th (n =836) 0
CVs, other UA + O: 1st (n =1120) 1
CVs, other UA + O: 2nd (n =1083) 0
CVs, other UA + O: 3rd (n =1017) 4
CVs, other UA + O: 4th (n =836) 0
CVs, other UA + other UB: 1st (n =1120) 2
CVs, other UA + other UB: 2nd (n =1083) 5
CVs, other UA + other UB: 3rd (n =1017) 3
CVs, other UA + other UB: 4th (n =836) 0
CVs, other UA + same UB: 1st (n =1120) 2
CVs, other UA + same UB: 2nd (n =1083) 2
CVs, other UA + same UB: 3rd (n =1017) 3
CVs, other UA + same UB: 4th (n =836) 0
CVs, unknown X2: 1st (n =1120) 1
CVs, unknown X2: 2nd (n =1083) 0
CVs, unknown X2: 3rd (n =1017) 0
CVs, unknown X2: 4th (n =836) 0
CVs, same UA + other UA X2: 1st (n =1120) 0
CVs, same UA + other UA X2: 2nd (n=1083) 0
CVs, same UA + other UA X2: 3rd (n =1017) 2
CVs, same UA + other UA X2: 4th (n =836) 36
CVs, other UA + same UA X2: 1st (n =1120) 0
CVs, other UA + same UA X2: 2nd (n =1083) 0
CVs, other UA + same UA X2: 3rd (n =1017) 1
CVs, other UA + same UA X2: 4th (n =836) 1
CVs, other UA X2 + same F: 1st (n =1120) 0
CVs, other UA X2 + same F: 2nd (n =1083) 0
CVs, other UA X2 + same F: 3rd (n =1017) 0
CVs, other UA X2 + same F: 4th (n =836) 1
CVs, same UA X2 + other UA X2: 1st (n =1120) 0
CVs, same UA X2 + other UA X2: 2nd (n =1083) 0
CVs, same UA X2 + other UA X2: 3rd (n =1017) 0
CVs, same UA X2 + other UA X2: 4th (n=836) 2
CVs, other UA + same UA + other F X2: 1st (n=1120) 0
CVs, other UA + same UA + other F X2: 2nd (n=1083) 0
CVs, other UA + same UA + other F X2: 3rd (n=1017) 0
CVs, other UA + same UA + other F X2: 4th (n=836) 1
PVN7, R F; CVs, R UA + L UA: 1st (n =1120) 0
PVN7, R F; CVs, R UA + L UA: 2nd (n =1083) 1
PVN7, R F; CVs, R UA + L UA: 3rd (n =1017) 3
PVN7, R F; CVs, R UA + L UA: 4th (n =836) 0
PVN7, L F; CVs, L UA + R UA: 1st (n =1120) 4
PVN7, L F; CVs, L UA + R UA: 2nd (n =1083) 8
PVN7, L F; CVs, L UA + R UA: 3rd (n =1017) 0
PVN7, L F; CVs, L UA + R UA: 4th (n =836) 0
PVN7, F; CVs, same UA + other UA: 1st (n =1120) 5
PVN7, F; CVs, same UA + other UA: 2nd (n =1083) 0
PVN7, F; CVs, same UA + other UA: 3rd (n =1017) 1
PVN7, F; CVs, same UA + other UA: 4th (n =836) 0
PVN7, F; CVs, R UA + L UA: 1st (n =1120) 1
PVN7, F; CVs, R UA + L UA: 2nd (n =1083) 0
PVN7, F; CVs, R UA + L UA: 3rd (n =1017) 0
PVN7, F; CVs, R UA + L UA: 4th (n =836) 0
Time Frame 28 days
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Prevenar™ (7-valent)
Hide Arm/Group Description Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
All-Cause Mortality
Prevenar™ (7-valent)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prevenar™ (7-valent)
Affected / at Risk (%) # Events
Total   20/1120 (1.79%)    
Gastrointestinal disorders   
Inguinal hernia * 1  1/1120 (0.09%)  1
General disorders   
Pyrexia * 1  2/1120 (0.18%)  2
Injection site swelling * 1  1/1120 (0.09%)  1
Infections and infestations   
Cellulitis orbital * 1  1/1120 (0.09%)  1
Gastroenteritis * 1  1/1120 (0.09%)  1
Gastroenteritis adenovirus * 1  1/1120 (0.09%)  1
Gastroenteritis rotavirus * 1  1/1120 (0.09%)  1
Otitis media * 1  3/1120 (0.27%)  3
Otitis media acute * 1  4/1120 (0.36%)  4
Respiratory syncytial virus bronchiolitis * 1  1/1120 (0.09%)  1
Urinary tract infection * 1  1/1120 (0.09%)  1
Respiratory syncytial virus infection * 1  3/1120 (0.27%)  3
Metabolism and nutrition disorders   
Feeding disorder neonatal * 1  1/1120 (0.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Astrocytoma malignant * 1  1/1120 (0.09%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/1120 (0.09%)  1
Vascular disorders   
Kawasaki's disease * 1  1/1120 (0.09%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.0%
Prevenar™ (7-valent)
Affected / at Risk (%) # Events
Total   464/1120 (41.43%)    
Eye disorders   
Conjunctivitis * 1  33/1120 (2.95%)  33
Gastrointestinal disorders   
Constipation * 1  33/1120 (2.95%)  33
Diarrhoea * 1  27/1120 (2.41%)  27
General disorders   
Injection site erythema * 1  48/1120 (4.29%)  48
Injection site swelling * 1  49/1120 (4.38%)  49
Pyrexia * 1  86/1120 (7.68%)  86
Infections and infestations   
Bronchitis * 1  119/1120 (10.63%)  119
Exanthema subitum * 1  25/1120 (2.23%)  25
Gastroenteritis * 1  85/1120 (7.59%)  85
Hand-foot-and-mouth disease * 1  23/1120 (2.05%)  23
Nasopharyngitis * 1  77/1120 (6.88%)  77
Pharyngitis * 1  79/1120 (7.05%)  79
Rhinitis * 1  25/1120 (2.23%)  25
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  25/1120 (2.23%)  25
Upper respiratory tract inflammation * 1  145/1120 (12.95%)  145
Skin and subcutaneous tissue disorders   
Dermatitis diaper * 1  38/1120 (3.39%)  38
Eczema * 1  91/1120 (8.13%)  91
Asteatosis * 1  24/1120 (2.14%)  24
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01521897     History of Changes
Other Study ID Numbers: 0887X1-4447
B1841005 ( Other Identifier: Alias Study Number )
First Submitted: September 14, 2011
First Posted: January 31, 2012
Results First Submitted: December 14, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016