Trial Outcomes & Findings for Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan) (NCT NCT01521897)
NCT ID: NCT01521897
Last Updated: 2016-01-20
Results Overview
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.).
Recruitment status
COMPLETED
Target enrollment
1143 participants
Primary outcome timeframe
28 days
Results posted on
2016-01-20
Participant Flow
Participant milestones
| Measure |
Prevenar™ (7-valent)
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.
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|---|---|
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Overall Study
STARTED
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1143
|
|
Overall Study
COMPLETED
|
1120
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Prevenar™ (7-valent)
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.
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|---|---|
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Overall Study
Protocol Violation
|
18
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Overall Study
Lost to Follow-up
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5
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Baseline Characteristics
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Baseline characteristics by cohort
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
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|---|---|
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Age, Customized
2 to 4 < Months
|
528 Participants
n=93 Participants
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Age, Customized
4 to 6 < Months
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516 Participants
n=93 Participants
|
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Age, Customized
6 to 7 < Months
|
76 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
550 Participants
n=93 Participants
|
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Sex: Female, Male
Male
|
570 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: 28 daysPopulation: 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.
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.).
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
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|---|---|
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Number of Participants With Adverse Reactions
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126 participants
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SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
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|---|---|
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Number of Participants With Serious Adverse Events
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20 participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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".
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
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|---|---|
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Number of Participants With Injection Site Reactions
Erythema
|
46 Participants
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Number of Participants With Injection Site Reactions
Induration
|
59 Participants
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Number of Participants With Injection Site Reactions
Tenderness
|
0 Participants
|
|
Number of Participants With Injection Site Reactions
Warmth
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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).
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
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|---|---|
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Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
No CVs: 1st (n =184)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
No CVs: 2nd (n =166)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
No CVs: 3rd (n =203)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
No CVs: 4th (n =450)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib: 1st (n =327)
|
3 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib: 2nd (n =207)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib: 3rd (n =303)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib: 4th (n =39)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT: 1st (n =176)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT: 2nd (n =138)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT: 3rd (n =72)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT: 4th (n =8)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR: 3rd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR: 4th (n =179)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu: 3rd (n =3)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu: 4th (n =29)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG: 1st (n =10)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG: 2nd (n =6)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG: 3rd (n =3)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV: 4th (n =10)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Mumps: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Mumps: 4th (n =3)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
HB: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
HB: 2nd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
HB: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
HB: 4th (n =3)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV: 1st (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV: 2nd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV: 4th (n =2)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
IPV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
IPV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
IPV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
IPV: 4th (n =4)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib: 1st (n =412)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib: 2nd (n =556)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib: 3rd (n =420)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib: 4th (n =34)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR: 2nd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR: 3rd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR: 4th (n =12)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + Flu: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + Flu: 2nd (n =2)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + Flu: 3rd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + Flu: 4th (n =5)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + HB: 1st (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + HB: 2nd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + HB: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + HB: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG + Hib: 1st (n =8)
|
1 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG + Hib: 2nd (n =2)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG + Hib: 3rd (n =3)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
BCG + Hib: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV + Hib: 1st (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV + Hib: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV + Hib: 3rd (n =4)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
OPV + Hib: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + MR: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + MR: 2nd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + MR: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + MR: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Flu: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Flu: 2nd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Flu: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Flu: 4th (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + VSV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + VSV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + VSV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + VSV: 4th (n =2)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Mumps: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Mumps: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV: 4th (n =3)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + Mumps: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + Mumps: 4th (n =2)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + HB: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + HB: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + HB: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + HB: 4th (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + MR: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + MR: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + MR: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + MR: 4th (n =3)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + Mumps: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Flu + Mumps: 4th (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps: 4th (n =4)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 4th (n =34)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 4th (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 4th (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 3rd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 3rd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 3rd (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 4th (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 4th (n =2)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 4th (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 4th (n =1)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 1st (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 2nd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 3rd (n =0)
|
0 Participants
|
|
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 4th (n =1)
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: 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.
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).
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
|
|---|---|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Mumps: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Mumps: 4th (n =3)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
HB: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
HB: 2nd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
No CVs: 1st (n =184)
|
6 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
No CVs: 2nd (n =166)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
No CVs: 3rd (n =203)
|
3 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
No CVs: 4th (n =450)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib: 1st (n =327)
|
8 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib: 2nd (n =207)
|
4 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib: 3rd (n =303)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib: 4th (n =39)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT: 1st (n =176)
|
11 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT: 2nd (n =138)
|
3 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT: 3rd (n =72)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT: 4th (n =8)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR: 3rd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR: 4th (n =179)
|
2 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu: 3rd (n =3)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu: 4th (n =29)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG: 1st (n =10)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG: 2nd (n =6)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG: 3rd (n =3)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV: 4th (n =10)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
HB: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
HB: 4th (n =3)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV: 1st (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV: 2nd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV: 4th (n =2)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
IPV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
IPV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
IPV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
IPV: 4th (n =4)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib: 1st (n =412)
|
15 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib: 2nd (n =556)
|
14 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib: 3rd (n =420)
|
3 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib: 4th (n =34)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR: 2nd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR: 3rd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR: 4th (n =12)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + Flu: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + Flu: 2nd (n =2)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + Flu: 3rd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + Flu: 4th (n =5)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + HB: 1st (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + HB: 2nd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + HB: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + HB: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG + Hib: 1st (n =8)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG + Hib: 2nd (n =2)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG + Hib: 3rd (n =3)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
BCG + Hib: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV + Hib: 1st (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV + Hib: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV + Hib: 3rd (n =4)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
OPV + Hib: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + MR: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + MR: 2nd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + MR: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + MR: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Flu: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Flu: 2nd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Flu: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Flu: 4th (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + VSV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + VSV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + VSV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + VSV: 4th (n =2)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Mumps: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Mumps: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV: 4th (n =3)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + Mumps: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + Mumps: 4th (n =2)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + HB: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + HB: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + HB: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + HB: 4th (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + MR: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + MR: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + MR: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + MR: 4th (n =3)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + Mumps: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Flu + Mumps: 4th (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps: 4th (n =4)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps: 4th (n =34)
|
1 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + MR: 4th (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV: 4th (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 3rd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + Mumps: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 3rd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + HB: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 3rd (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
DPT + Hib + IPV: 4th (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
VSV + Mumps + IPV: 4th (n =2)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + VSV + Mumps: 4th (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Hib + MR + Mumps + IPV: 4th (n =1)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 1st (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 2nd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 3rd (n =0)
|
0 participants
|
|
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
MR + VSV + Mumps + HB: 4th (n =1)
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
Number of participants was counted by month of age at each vaccination time (first to fourth).
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
|
|---|---|
|
Number of Participants by Month of Age at Each Vaccination Time
16 to less than 18 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
16 to less than 18 months: 2nd (n =1083)
|
1 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
2 to less than 3 months: 1st (n =1120)
|
248 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
2 to less than 3 months: 2nd (n =1083)
|
5 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
2 to less than 3 months: 3rd (n =1017)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
2 to less than 3 months: 4th (n =836)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
3 to less than 4 months: 1st (n =1120)
|
280 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
3 to less than 4 months: 2nd (n =1083)
|
193 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
3 to less than 4 months: 3rd (n =1017)
|
7 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
3 to less than 4 months: 4th (n =836)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
4 to less than 5 months: 1st (n =1120)
|
297 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
4 to less than 5 months: 2nd (n =1083)
|
235 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
4 to less than 5 months: 3rd (n =1017)
|
97 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
4 to less than 5 months: 4th (n =836)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
5 to less than 6 months: 1st (n =1120)
|
219 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
5 to less than 6 months: 2nd (n =1083)
|
276 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
5 to less than 6 months: 3rd (n =1017)
|
207 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
5 to less than 6 months: 4th (n =836)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
6 to less than 7 months: 1st (n =1120)
|
76 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
6 to less than 7 months: 2nd (n =1083)
|
213 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
6 to less than 7 months: 3rd (n =1017)
|
241 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
6 to less than 7 months: 4th (n =836)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
7 to less than 8 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
7 to less than 8 months: 2nd (n =1083)
|
93 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
7 to less than 8 months: 3rd (n =1017)
|
229 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
7 to less than 8 months: 4th (n =836)
|
1 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
8 to less than 9 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
8 to less than 9 months: 2nd (n =1083)
|
20 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
8 to less than 9 months: 3rd (n =1017)
|
108 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
8 to less than 9 months: 4th (n =836)
|
1 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
9 to less than 10 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
9 to less than 10 months: 2nd (n =1083)
|
7 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
9 to less than 10 months: 3rd (n =1017)
|
45 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
9 to less than 10 months: 4th (n =836)
|
2 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
10 to less than 11 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
10 to less than 11 months: 2nd (n =1083)
|
3 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
10 to less than 11 months: 3rd (n =1017)
|
18 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
10 to less than 11 months: 4th (n =836)
|
1 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
11 to less than 12 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
11 to less than 12 months: 2nd (n =1083)
|
4 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
11 to less than 12 months: 3rd (n =1017)
|
11 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
11 to less than 12 months: 4th (n =836)
|
7 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
12 to less than 16 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
12 to less than 16 months: 2nd (n =1083)
|
2 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
12 to less than 16 months: 3rd (n =1017)
|
16 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
12 to less than 16 months: 4th (n =836)
|
650 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
16 to less than 18 months: 3rd (n =1017)
|
2 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
16 to less than 18 months: 4th (n =836)
|
57 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
18 to less than 24 months: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
18 to less than 24 months: 2nd (n =1083)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
18 to less than 24 months: 3rd (n =1017)
|
4 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
18 to less than 24 months: 4th (n =836)
|
88 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
24 months and order: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
24 months and order: 2nd (n =1083)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
24 months and order: 3rd (n =1017)
|
1 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
24 months and order: 4th (n =836)
|
6 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
Unknown: 1st (n =1120)
|
0 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
Unknown: 2nd (n =1083)
|
31 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
Unknown: 3rd (n =1017)
|
31 Participants
|
|
Number of Participants by Month of Age at Each Vaccination Time
Unknown: 4th (n =836)
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
Number of participants was counted by vaccination sites at each vaccination time (first to fourth).
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
|
|---|---|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Upper Arm: 1st (n =1120)
|
1110 Participants
|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Upper Arm: 2nd (n =1083)
|
1074 Participants
|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Upper Arm: 3rd (n =1017)
|
1013 Participants
|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Upper Arm: 4th (n =836)
|
836 Participants
|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Other: 1st (n =1120)
|
10 Participants
|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Other: 2nd (n =1083)
|
9 Participants
|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Other: 3rd (n =1017)
|
4 Participants
|
|
Number of Participants by Vaccination Sites at Each Vaccination Time
Other: 4th (n= 836)
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
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).
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
|
|---|---|
|
Number of Participants by Pattern of Concomitant Vaccines
No CVs: 1st (n =1120)
|
184 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
No CVs: 2nd (n =1083)
|
166 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
No CVs: 3rd (n =1017)
|
203 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
No CVs: 4th (n =836)
|
450 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib: 1st (n =1120)
|
327 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib: 2nd (n =1083)
|
207 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib: 3rd (n =1017)
|
303 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib: 4th (n =836)
|
39 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT: 1st (n =1120)
|
176 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT: 2nd (n =1083)
|
138 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT: 3rd (n =1017)
|
72 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT: 4th (n =836)
|
8 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR: 4th (n =836)
|
179 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu: 3rd (n =1017)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu: 4th (n =836)
|
29 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG: 1st (n =1120)
|
10 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG: 2nd (n =1083)
|
6 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG: 3rd (n =1017)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV: 4th (n =836)
|
10 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Mumps: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Mumps: 4th (n =836)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
HB: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
HB: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
HB: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
HB: 4th (n =836)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV: 1st (n =1120)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV: 4th (n =836)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
IPV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
IPV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
IPV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
IPV: 4th (n =836)
|
4 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib: 1st (n =1120)
|
412 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib: 2nd (n =1083)
|
556 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib: 3rd (n =1017)
|
420 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib: 4th (n =836)
|
34 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR: 4th (n =836)
|
12 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + Flu: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + Flu: 2nd (n =1083)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + Flu: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + Flu: 4th (n =836)
|
5 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + HB: 1st (n =1120)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + HB: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + HB: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + HB: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG + Hib: 1st (n =1120)
|
8 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG + Hib: 2nd (n =1083)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG + Hib: 3rd (n =1017)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
BCG + Hib: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV + Hib: 1st (n =1120)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV + Hib: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV + Hib: 3rd (n =1017)
|
4 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
OPV + Hib: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + MR: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + MR: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + MR: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + MR: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Flu: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Flu: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Flu: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Flu: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + VSV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + VSV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + VSV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + VSV: 4th (n =836)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Mumps: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Mumps: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV: 4th (n =836)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + Mumps: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + Mumps: 4th (n =836)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + HB: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + HB: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + HB: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + HB: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + MR: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + MR: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + MR: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + MR: 4th (n =836)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + Mumps: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Flu + Mumps: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps: 4th (n =836)
|
4 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps: 4th (n =836)
|
34 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + MR: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + MR: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + MR: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + MR: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + Mumps: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + Mumps: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + HB: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + HB: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + HB: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + HB: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + IPV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + IPV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + IPV: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
DPT + Hib + IPV: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps + IPV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps + IPV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps + IPV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
VSV + Mumps + IPV: 4th (n =836)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV + Mumps: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV + Mumps: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV + Mumps: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + VSV + Mumps: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + Mumps + IPV: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
HIb + MR + Mumps + IPV: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + Mumps + IPV: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
Hib + MR + Mumps + IPV: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps + HB: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps + HB: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps + HB: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccines
MR + VSV + Mumps + HB: 4th (n =836)
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
Prevenar™ (7-valent)
n=1120 Participants
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.
|
|---|---|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same F: 1st (n =1120)
|
11 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same F: 2nd (n =1083)
|
12 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same F: 3rd (n =1017)
|
7 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same F: 4th (n =836)
|
5 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other F: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other F: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other F: 3rd (n =1017)
|
4 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other F: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + O: 1st (n =1120)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + O: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + O: 3rd (n =1017)
|
4 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + O: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other UB: 1st (n =1120)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other UB: 2nd (n =1083)
|
5 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other UB: 3rd (n =1017)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + other UB: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UB: 1st (n =1120)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UB: 2nd (n =1083)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UB: 3rd (n =1017)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UB: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, unknown X2: 1st (n =1120)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, unknown X2: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, unknown X2: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, unknown X2: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA X2: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA X2: 2nd (n=1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA X2: 3rd (n =1017)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA X2: 4th (n =836)
|
36 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA X2: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA X2: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA X2: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA X2: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2 + same F: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2 + same F: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2 + same F: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2 + same F: 4th (n =836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2 + other UA X2: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2 + other UA X2: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2 + other UA X2: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2 + other UA X2: 4th (n=836)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA + other F X2: 1st (n=1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA + other F X2: 2nd (n=1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA + other F X2: 3rd (n=1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA + same UA + other F X2: 4th (n=836)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, R F; CVs, R UA + L UA: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, R F; CVs, R UA + L UA: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, R F; CVs, R UA + L UA: 3rd (n =1017)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, R F; CVs, R UA + L UA: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, L F; CVs, L UA + R UA: 1st (n =1120)
|
4 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, L F; CVs, L UA + R UA: 2nd (n =1083)
|
8 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, L F; CVs, L UA + R UA: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, L F; CVs, L UA + R UA: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, same UA + other UA: 1st (n =1120)
|
5 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, same UA + other UA: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, same UA + other UA: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, same UA + other UA: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, R UA + L UA: 1st (n =1120)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, R UA + L UA: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, R UA + L UA: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
PVN7, F; CVs, R UA + L UA: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
No CVs: 1st (n =1120)
|
184 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
No CVs: 2nd (n =1083)
|
166 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
No CVs: 3rd (n =1017)
|
203 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
No CVs: 4th (n =836)
|
450 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same UA: 1st (n =1120)
|
5 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same UA: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same UA: 3rd (n =1017)
|
5 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same UA: 4th (n =836)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, other UA: 1st (n =1120)
|
508 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, other UA: 2nd (n =1083)
|
351 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, other UA: 3rd (n =1017)
|
375 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, other UA: 4th (n =836)
|
270 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same F: 1st (n =1120)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same F: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same F: 3rd (n =1017)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, same F: 4th (n =836)
|
3 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, O: 1st (n =1120)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, O: 2nd (n =1083)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, O: 3rd (n =1017)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CV, O: 4th (n =836)
|
2 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2: 2nd (n =1083)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2: 3rd (n =1017)
|
1 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA X2: 4th (n =836)
|
0 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA: 1st (n =1120)
|
214 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA: 2nd (n =1083)
|
301 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA: 3rd (n =1017)
|
236 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, same UA + other UA: 4th (n =836)
|
39 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2: 1st (n =1120)
|
181 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2: 2nd (n =1083)
|
234 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2: 3rd (n =1017)
|
167 participants
|
|
Number of Participants by Pattern of Concomitant Vaccination Sites
CVs, other UA X2: 4th (n =836)
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24 participants
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Adverse Events
Prevenar™ (7-valent)
Serious events: 20 serious events
Other events: 464 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prevenar™ (7-valent)
n=1120 participants at risk
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.
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|---|---|
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Infections and infestations
Cellulitis orbital
|
0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Infections and infestations
Otitis media
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0.27%
3/1120 • Number of events 3 • 28 days
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.
|
|
Infections and infestations
Otitis media acute
|
0.36%
4/1120 • Number of events 4 • 28 days
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.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Infections and infestations
Urinary tract infection
|
0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.27%
3/1120 • Number of events 3 • 28 days
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant
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0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
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0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Vascular disorders
Kawasaki's disease
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0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
1/1120 • Number of events 1 • 28 days
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.
|
|
Gastrointestinal disorders
Inguinal hernia
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0.09%
1/1120 • Number of events 1 • 28 days
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.
|
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General disorders
Pyrexia
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0.18%
2/1120 • Number of events 2 • 28 days
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.
|
|
General disorders
Injection site swelling
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0.09%
1/1120 • Number of events 1 • 28 days
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.
|
Other adverse events
| Measure |
Prevenar™ (7-valent)
n=1120 participants at risk
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.
|
|---|---|
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Infections and infestations
Bronchitis
|
10.6%
119/1120 • Number of events 119 • 28 days
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.
|
|
Infections and infestations
Exanthema subitum
|
2.2%
25/1120 • Number of events 25 • 28 days
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.
|
|
Infections and infestations
Gastroenteritis
|
7.6%
85/1120 • Number of events 85 • 28 days
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.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
2.1%
23/1120 • Number of events 23 • 28 days
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.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
77/1120 • Number of events 77 • 28 days
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.
|
|
Infections and infestations
Pharyngitis
|
7.1%
79/1120 • Number of events 79 • 28 days
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.
|
|
Infections and infestations
Rhinitis
|
2.2%
25/1120 • Number of events 25 • 28 days
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.
|
|
Eye disorders
Conjunctivitis
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2.9%
33/1120 • Number of events 33 • 28 days
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.2%
25/1120 • Number of events 25 • 28 days
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
12.9%
145/1120 • Number of events 145 • 28 days
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.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
33/1120 • Number of events 33 • 28 days
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
27/1120 • Number of events 27 • 28 days
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
3.4%
38/1120 • Number of events 38 • 28 days
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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.1%
91/1120 • Number of events 91 • 28 days
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.
|
|
Skin and subcutaneous tissue disorders
Asteatosis
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2.1%
24/1120 • Number of events 24 • 28 days
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.
|
|
General disorders
Injection site erythema
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4.3%
48/1120 • Number of events 48 • 28 days
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.
|
|
General disorders
Injection site swelling
|
4.4%
49/1120 • Number of events 49 • 28 days
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.
|
|
General disorders
Pyrexia
|
7.7%
86/1120 • Number of events 86 • 28 days
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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER