Pneumococcal Vaccine, Streptococcus Pneumoniae
Conditions
Keywords
Pneumococcal Vaccine, Prevenar, 7-valent, Special Use-result surveillance
Brief summary
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice. This surveillance will specifically focus on the occurrence of the following: 1. Local reactions at the injection site 2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)
Detailed description
This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.
Interventions
BIOLOGICAL7-valent vaccine injection
For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* Infants at the age of more than 2 and less than 7 months * Infants who have been vaccinated with Prevenar for the first time * Infants expected to complete four vaccinations with Prevenar
Exclusion criteria
Vaccination with Prevenar must not be given to any of the following; * History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid * Evident pyrexia * Evident serious acute disease * Any other infants or children ineligible for vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Reactions | 28 days | 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.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events | 28 days | 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. |
| Number of Participants With Injection Site Reactions | 28 days | 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. |
| Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | 28 days | 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). |
| Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | 28 days | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Vaccination Sites at Each Vaccination Time | 28 days | Number of participants was counted by vaccination sites at each vaccination time (first to fourth). |
| Number of Participants by Pattern of Concomitant Vaccines | 28 days | 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). |
| Number of Participants by Pattern of Concomitant Vaccination Sites | 28 days | 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. |
| Number of Participants by Month of Age at Each Vaccination Time | 28 days | Number of participants was counted by month of age at each vaccination time (first to fourth). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,120 |
| Total | 1,120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Protocol Violation | 18 |
Baseline characteristics
| Characteristic | Prevenar™ (7-valent) |
|---|---|
| Age, Customized 2 to 4 < Months | 528 Participants |
| Age, Customized 4 to 6 < Months | 516 Participants |
| Age, Customized 6 to 7 < Months | 76 Participants |
| Sex: Female, Male Female | 550 Participants |
| Sex: Female, Male Male | 570 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 464 / 1,120 |
| serious Total, serious adverse events | 20 / 1,120 |
Outcome results
Primary
Number of Participants With Adverse Reactions
An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).
Time frame: 28 days
Population: The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar™ (7-valent) | Number of Participants With Adverse Reactions | 126 participants |
Secondary
Number of Participants With Injection Site Reactions
Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for injection site erythema; induration for injection site erythema and injection site swelling; tenderness for injection site pain; and warmth for injection site warmth.
Time frame: 28 days
Population: The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar™ (7-valent) | Number of Participants With Injection Site Reactions | Erythema | 46 Participants |
| Prevenar™ (7-valent) | Number of Participants With Injection Site Reactions | Induration | 59 Participants |
| Prevenar™ (7-valent) | Number of Participants With Injection Site Reactions | Tenderness | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Injection Site Reactions | Warmth | 1 Participants |
Secondary
Number of Participants With Serious Adverse Events
A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: 28 days
Population: The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevenar™ (7-valent) | Number of Participants With Serious Adverse Events | 20 participants |
Secondary
Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time frame: 28 days
Population: The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG: 3rd (n =3) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | No CVs: 1st (n =184) | 6 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | No CVs: 2nd (n =166) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | No CVs: 3rd (n =203) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | No CVs: 4th (n =450) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib: 1st (n =327) | 8 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib: 2nd (n =207) | 4 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib: 3rd (n =303) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib: 4th (n =39) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT: 4th (n =8) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR: 3rd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu: 4th (n =29) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG: 1st (n =10) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG: 2nd (n =6) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV: 4th (n =10) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Mumps: 4th (n =3) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | HB: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | IPV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | HB: 2nd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | HB: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | HB: 4th (n =3) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV: 1st (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV: 2nd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV: 4th (n =2) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | IPV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | IPV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | IPV: 4th (n =4) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib: 1st (n =412) | 15 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib: 2nd (n =556) | 14 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib: 3rd (n =420) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR: 2nd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR: 3rd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR: 4th (n =12) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + Flu: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + Flu: 2nd (n =2) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + Flu: 3rd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + Flu: 4th (n =5) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + HB: 1st (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + HB: 2nd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + HB: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + HB: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG + Hib: 3rd (n =3) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG + Hib: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV + Hib: 1st (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV + Hib: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV + Hib: 3rd (n =4) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | OPV + Hib: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + MR: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + Mumps: 4th (n =2) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Flu: 2nd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + Mumps: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT: 1st (n =176) | 11 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT: 2nd (n =138) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT: 3rd (n =72) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR: 4th (n =179) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu: 3rd (n =3) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Mumps: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib: 4th (n =34) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG + Hib: 1st (n =8) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | BCG + Hib: 2nd (n =2) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + MR: 2nd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + MR: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + MR: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Flu: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Flu: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Flu: 4th (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + VSV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + VSV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + VSV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + VSV: 4th (n =2) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Mumps: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Mumps: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV: 4th (n =3) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + HB: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + HB: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + HB: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + HB: 4th (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + MR: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + MR: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + MR: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + MR: 4th (n =3) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + Mumps: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Flu + Mumps: 4th (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps: 4th (n =4) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 4th (n =34) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 4th (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 4th (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 3rd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 3rd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 3rd (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 4th (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 4th (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 4th (n =2) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 4th (n =1) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 1st (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 2nd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 3rd (n =0) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 4th (n =1) | 0 participants |
Secondary
Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time frame: 28 days
Population: The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | IPV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | IPV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | IPV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | IPV: 4th (n =4) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib: 1st (n =412) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib: 2nd (n =556) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib: 3rd (n =420) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib: 4th (n =34) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR: 2nd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR: 4th (n =12) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + Flu: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + Flu: 2nd (n =2) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + Flu: 3rd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + Flu: 4th (n =5) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + HB: 1st (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + HB: 2nd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + HB: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + HB: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG + Hib: 1st (n =8) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG + Hib: 2nd (n =2) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG + Hib: 3rd (n =3) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG + Hib: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR: 3rd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + MR: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Flu: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + VSV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + VSV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Mumps: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Mumps: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV: 4th (n =3) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + Mumps: 4th (n =2) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + HB: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + HB: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + HB: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + HB: 4th (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + MR: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + MR: 4th (n =3) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + Mumps: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + Mumps: 4th (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps: 4th (n =4) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps: 4th (n =34) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 3rd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + Mumps: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 3rd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + HB: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 3rd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + IPV: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps + IPV: 4th (n =2) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV + Mumps: 4th (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + Mumps + IPV: 4th (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV + Mumps + HB: 4th (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | No CVs: 1st (n =184) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | No CVs: 2nd (n =166) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | No CVs: 3rd (n =203) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | No CVs: 4th (n =450) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib: 1st (n =327) | 3 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib: 2nd (n =207) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib: 3rd (n =303) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib: 4th (n =39) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT: 1st (n =176) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT: 2nd (n =138) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT: 3rd (n =72) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT: 4th (n =8) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR: 3rd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR: 4th (n =179) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu: 3rd (n =3) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu: 4th (n =29) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG: 1st (n =10) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG: 2nd (n =6) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG: 3rd (n =3) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | BCG: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV: 4th (n =10) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Mumps: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Mumps: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Mumps: 4th (n =3) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | HB: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | HB: 2nd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | HB: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | HB: 4th (n =3) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV: 1st (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV: 2nd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV: 4th (n =2) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV + Hib: 1st (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV + Hib: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV + Hib: 3rd (n =4) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | OPV + Hib: 4th (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + MR: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + MR: 2nd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + MR: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Flu: 2nd (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Flu: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Flu: 4th (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + VSV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + VSV: 4th (n =2) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + VSV: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | MR + Mumps: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + MR: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + MR: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Flu + Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps: 1st (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | VSV + Mumps: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | DPT + Hib + MR: 4th (n =1) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 2nd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 3rd (n =0) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Hib + MR + VSV: 4th (n =1) | 0 Participants |
Other Pre-specified
Number of Participants by Month of Age at Each Vaccination Time
Number of participants was counted by month of age at each vaccination time (first to fourth).
Time frame: 28 days
Population: The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 2 to less than 3 months: 3rd (n =1017) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 2 to less than 3 months: 4th (n =836) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 3 to less than 4 months: 1st (n =1120) | 280 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 2 to less than 3 months: 2nd (n =1083) | 5 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 2 to less than 3 months: 1st (n =1120) | 248 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 3 to less than 4 months: 2nd (n =1083) | 193 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 3 to less than 4 months: 3rd (n =1017) | 7 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 3 to less than 4 months: 4th (n =836) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 4 to less than 5 months: 1st (n =1120) | 297 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 4 to less than 5 months: 2nd (n =1083) | 235 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 4 to less than 5 months: 3rd (n =1017) | 97 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 4 to less than 5 months: 4th (n =836) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 5 to less than 6 months: 1st (n =1120) | 219 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 5 to less than 6 months: 2nd (n =1083) | 276 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 5 to less than 6 months: 3rd (n =1017) | 207 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 5 to less than 6 months: 4th (n =836) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 6 to less than 7 months: 1st (n =1120) | 76 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 6 to less than 7 months: 2nd (n =1083) | 213 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 6 to less than 7 months: 3rd (n =1017) | 241 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 6 to less than 7 months: 4th (n =836) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 7 to less than 8 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 7 to less than 8 months: 2nd (n =1083) | 93 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 7 to less than 8 months: 3rd (n =1017) | 229 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 7 to less than 8 months: 4th (n =836) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 8 to less than 9 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 8 to less than 9 months: 2nd (n =1083) | 20 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 8 to less than 9 months: 3rd (n =1017) | 108 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 8 to less than 9 months: 4th (n =836) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 9 to less than 10 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 9 to less than 10 months: 2nd (n =1083) | 7 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 9 to less than 10 months: 3rd (n =1017) | 45 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 9 to less than 10 months: 4th (n =836) | 2 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 10 to less than 11 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 10 to less than 11 months: 2nd (n =1083) | 3 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 10 to less than 11 months: 3rd (n =1017) | 18 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 10 to less than 11 months: 4th (n =836) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 11 to less than 12 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 11 to less than 12 months: 2nd (n =1083) | 4 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 11 to less than 12 months: 3rd (n =1017) | 11 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 11 to less than 12 months: 4th (n =836) | 7 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 12 to less than 16 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 12 to less than 16 months: 2nd (n =1083) | 2 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 12 to less than 16 months: 3rd (n =1017) | 16 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 12 to less than 16 months: 4th (n =836) | 650 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 16 to less than 18 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 16 to less than 18 months: 2nd (n =1083) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 16 to less than 18 months: 3rd (n =1017) | 2 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 16 to less than 18 months: 4th (n =836) | 57 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 18 to less than 24 months: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 18 to less than 24 months: 2nd (n =1083) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 18 to less than 24 months: 3rd (n =1017) | 4 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 18 to less than 24 months: 4th (n =836) | 88 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 24 months and order: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 24 months and order: 2nd (n =1083) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 24 months and order: 3rd (n =1017) | 1 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | 24 months and order: 4th (n =836) | 6 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | Unknown: 1st (n =1120) | 0 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | Unknown: 2nd (n =1083) | 31 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | Unknown: 3rd (n =1017) | 31 Participants |
| Prevenar™ (7-valent) | Number of Participants by Month of Age at Each Vaccination Time | Unknown: 4th (n =836) | 23 Participants |
Other Pre-specified
Number of Participants by Pattern of Concomitant Vaccination Sites
Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.
Time frame: 28 days
Population: The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | No CVs: 2nd (n =1083) | 166 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | No CVs: 3rd (n =1017) | 203 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA: 4th (n =836) | 39 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2: 1st (n =1120) | 181 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + O: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + O: 3rd (n =1017) | 4 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, unknown X2: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, unknown X2: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2 + same F: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2 + same F: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2 + same F: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA + other F X2: 2nd (n=1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA + other F X2: 4th (n=836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, R F; CVs, R UA + L UA: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, R F; CVs, R UA + L UA: 3rd (n =1017) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, R F; CVs, R UA + L UA: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, same UA + other UA: 1st (n =1120) | 5 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | No CVs: 1st (n =1120) | 184 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | No CVs: 4th (n =836) | 450 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same UA: 1st (n =1120) | 5 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same UA: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same UA: 3rd (n =1017) | 5 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same UA: 4th (n =836) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, other UA: 1st (n =1120) | 508 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, other UA: 2nd (n =1083) | 351 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, other UA: 3rd (n =1017) | 375 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, other UA: 4th (n =836) | 270 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same F: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same F: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same F: 3rd (n =1017) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, same F: 4th (n =836) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, O: 1st (n =1120) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, O: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, O: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CV, O: 4th (n =836) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA: 1st (n =1120) | 214 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA: 2nd (n =1083) | 301 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA: 3rd (n =1017) | 236 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2: 2nd (n =1083) | 234 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2: 3rd (n =1017) | 167 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2: 4th (n =836) | 24 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same F: 1st (n =1120) | 11 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same F: 2nd (n =1083) | 12 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same F: 3rd (n =1017) | 7 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same F: 4th (n =836) | 5 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other F: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other F: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other F: 3rd (n =1017) | 4 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other F: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + O: 1st (n =1120) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + O: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other UB: 1st (n =1120) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other UB: 2nd (n =1083) | 5 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other UB: 3rd (n =1017) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + other UB: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UB: 1st (n =1120) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UB: 2nd (n =1083) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UB: 3rd (n =1017) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UB: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, unknown X2: 1st (n =1120) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, unknown X2: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA X2: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA X2: 2nd (n=1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA X2: 3rd (n =1017) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA + other UA X2: 4th (n =836) | 36 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA X2: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA X2: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA X2: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA X2: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA X2 + same F: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2 + other UA X2: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2 + other UA X2: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2 + other UA X2: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, same UA X2 + other UA X2: 4th (n=836) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA + other F X2: 1st (n=1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | CVs, other UA + same UA + other F X2: 3rd (n=1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, R F; CVs, R UA + L UA: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, L F; CVs, L UA + R UA: 1st (n =1120) | 4 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, L F; CVs, L UA + R UA: 2nd (n =1083) | 8 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, L F; CVs, L UA + R UA: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, L F; CVs, L UA + R UA: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, same UA + other UA: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, same UA + other UA: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, same UA + other UA: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, R UA + L UA: 1st (n =1120) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, R UA + L UA: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, R UA + L UA: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccination Sites | PVN7, F; CVs, R UA + L UA: 4th (n =836) | 0 participants |
Other Pre-specified
Number of Participants by Pattern of Concomitant Vaccines
Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time frame: 28 days
Population: The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib: 1st (n =1120) | 327 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib: 2nd (n =1083) | 207 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG: 2nd (n =1083) | 6 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG: 3rd (n =1017) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | IPV: 4th (n =836) | 4 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + HB: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + MR: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + MR: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps + IPV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps + IPV: 4th (n =836) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | No CVs: 1st (n =1120) | 184 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | No CVs: 2nd (n =1083) | 166 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | No CVs: 3rd (n =1017) | 203 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | No CVs: 4th (n =836) | 450 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib: 3rd (n =1017) | 303 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib: 4th (n =836) | 39 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT: 1st (n =1120) | 176 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT: 2nd (n =1083) | 138 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT: 3rd (n =1017) | 72 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT: 4th (n =836) | 8 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR: 4th (n =836) | 179 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu: 3rd (n =1017) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu: 4th (n =836) | 29 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG: 1st (n =1120) | 10 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV: 4th (n =836) | 10 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Mumps: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Mumps: 4th (n =836) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | HB: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | HB: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | HB: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | HB: 4th (n =836) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV: 1st (n =1120) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV: 4th (n =836) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | IPV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | IPV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | IPV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib: 1st (n =1120) | 412 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib: 2nd (n =1083) | 556 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib: 3rd (n =1017) | 420 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib: 4th (n =836) | 34 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR: 4th (n =836) | 12 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + Flu: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + Flu: 2nd (n =1083) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + Flu: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + Flu: 4th (n =836) | 5 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + HB: 1st (n =1120) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + HB: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + HB: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG + Hib: 1st (n =1120) | 8 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG + Hib: 2nd (n =1083) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG + Hib: 3rd (n =1017) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | BCG + Hib: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV + Hib: 1st (n =1120) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV + Hib: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV + Hib: 3rd (n =1017) | 4 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | OPV + Hib: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + MR: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + MR: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Flu: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Flu: 2nd (n =1083) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Flu: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Flu: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + VSV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + VSV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + VSV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + VSV: 4th (n =836) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Mumps: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Mumps: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV: 4th (n =836) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + Mumps: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + Mumps: 4th (n =836) | 2 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + HB: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + HB: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + HB: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + HB: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + MR: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + MR: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + MR: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + MR: 4th (n =836) | 3 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + Mumps: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Flu + Mumps: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps: 4th (n =836) | 4 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps: 4th (n =836) | 34 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + MR: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + MR: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + MR: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + MR: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + Mumps: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + Mumps: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + HB: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + HB: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + HB: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + HB: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + IPV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + IPV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + IPV: 3rd (n =1017) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | DPT + Hib + IPV: 4th (n =836) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps + IPV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | VSV + Mumps + IPV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV + Mumps: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV + Mumps: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV + Mumps: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + VSV + Mumps: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + Mumps + IPV: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | HIb + MR + Mumps + IPV: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + Mumps + IPV: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | Hib + MR + Mumps + IPV: 4th (n =836) | 1 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps + HB: 1st (n =1120) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps + HB: 2nd (n =1083) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps + HB: 3rd (n =1017) | 0 participants |
| Prevenar™ (7-valent) | Number of Participants by Pattern of Concomitant Vaccines | MR + VSV + Mumps + HB: 4th (n =836) | 1 participants |
Other Pre-specified
Number of Participants by Vaccination Sites at Each Vaccination Time
Number of participants was counted by vaccination sites at each vaccination time (first to fourth).
Time frame: 28 days
Population: The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Upper Arm: 4th (n =836) | 836 Participants |
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Upper Arm: 1st (n =1120) | 1110 Participants |
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Upper Arm: 2nd (n =1083) | 1074 Participants |
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Upper Arm: 3rd (n =1017) | 1013 Participants |
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Other: 1st (n =1120) | 10 Participants |
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Other: 2nd (n =1083) | 9 Participants |
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Other: 3rd (n =1017) | 4 Participants |
| Prevenar™ (7-valent) | Number of Participants by Vaccination Sites at Each Vaccination Time | Other: 4th (n= 836) | 0 Participants |