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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01521897
• Collaborator: (none)
• Enrollment: 1,143
• Location: 1
• Duration (Months): 55
• Patients Per Site Per Month: 20.8

Study Details

Study Description

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°)

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Vaccine; Streptococcus Pneumoniae	Biological: 7-valent vaccine injection

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1143 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
7-valent vaccine injection Infants starting to receive Prevenar at the age of more than 2 and less than 7 months	Biological: 7-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.; Other Names: Prevenar, 7vPnC

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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".

3. 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).

4. 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 Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 2 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yokoyama Children's Clinic	Kasuga	Fukuoka	Japan	816-0801

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01521897
• Other Study ID Numbers: 0887X1-4447; B1841005
• First Posted: Jan 31, 2012
• Last Update Posted: Jan 20, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Pfizer: Pneumococcal Vaccine; Prevenar; 7-valent; Special Use-result surveillance
• Additional relevant MeSH terms: Pneumonia, Pneumococcal; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Period Title: Overall Study
STARTED	1143
COMPLETED	1120
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Overall Participants	1120
Age, Customized (Number) [Number]
2 to 4 < Months	528 47.1%
4 to 6 < Months	516 46.1%
6 to 7 < Months	76 6.8%
Sex: Female, Male (Count of Participants)
Female	550 49.1%
Male	570 50.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Reactions
Description	An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
Number [participants]	126 11.3%

2. Secondary Outcome

Title	Number of Participants With Serious Adverse Events
Description	A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
Number [participants]	20 1.8%

3. Secondary Outcome

Title	Number of Participants With Injection Site Reactions
Description	Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for "injection site erythema"; induration for "injection site erythema" and "injection site swelling"; tenderness for "injection site pain"; and warmth for "injection site warmth".
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
Erythema	46 4.1%
Induration	59 5.3%
Tenderness	0 0%
Warmth	1 0.1%

4. Secondary Outcome

Title	Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
Description	Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
No CVs: 1st (n =184)	1 0.1%
No CVs: 2nd (n =166)	1 0.1%
No CVs: 3rd (n =203)	1 0.1%
No CVs: 4th (n =450)	0 0%
Hib: 1st (n =327)	3 0.3%
Hib: 2nd (n =207)	0 0%
Hib: 3rd (n =303)	0 0%
Hib: 4th (n =39)	0 0%
DPT: 1st (n =176)	1 0.1%
DPT: 2nd (n =138)	1 0.1%
DPT: 3rd (n =72)	0 0%
DPT: 4th (n =8)	0 0%
MR: 1st (n =0)	0 0%
MR: 2nd (n =0)	0 0%
MR: 3rd (n =1)	0 0%
MR: 4th (n =179)	0 0%
Flu: 1st (n =0)	0 0%
Flu: 2nd (n =0)	0 0%
Flu: 3rd (n =3)	0 0%
Flu: 4th (n =29)	0 0%
BCG: 1st (n =10)	0 0%
BCG: 2nd (n =6)	0 0%
BCG: 3rd (n =3)	0 0%
BCG: 4th (n =0)	0 0%
VSV: 1st (n =0)	0 0%
VSV: 2nd (n =0)	0 0%
VSV: 3rd (n =0)	0 0%
VSV: 4th (n =10)	0 0%
Mumps: 1st (n =0)	0 0%
Mumps: 2nd (n =0)	0 0%
Mumps: 3rd (n =0)	0 0%
Mumps: 4th (n =3)	0 0%
HB: 1st (n =0)	0 0%
HB: 2nd (n =1)	0 0%
HB: 3rd (n =0)	0 0%
HB: 4th (n =3)	0 0%
OPV: 1st (n =1)	0 0%
OPV: 2nd (n =1)	0 0%
OPV: 3rd (n =0)	0 0%
OPV: 4th (n =2)	0 0%
IPV: 1st (n =0)	0 0%
IPV: 2nd (n =0)	0 0%
IPV: 3rd (n =0)	0 0%
IPV: 4th (n =4)	0 0%
DPT + Hib: 1st (n =412)	1 0.1%
DPT + Hib: 2nd (n =556)	1 0.1%
DPT + Hib: 3rd (n =420)	1 0.1%
DPT + Hib: 4th (n =34)	1 0.1%
Hib + MR: 1st (n =0)	0 0%
Hib + MR: 2nd (n =1)	0 0%
Hib + MR: 3rd (n =1)	0 0%
Hib + MR: 4th (n =12)	0 0%
Hib + Flu: 1st (n =0)	0 0%
Hib + Flu: 2nd (n =2)	0 0%
Hib + Flu: 3rd (n =1)	0 0%
Hib + Flu: 4th (n =5)	1 0.1%
Hib + HB: 1st (n =1)	0 0%
Hib + HB: 2nd (n =1)	0 0%
Hib + HB: 3rd (n =0)	0 0%
Hib + HB: 4th (n =0)	0 0%
BCG + Hib: 1st (n =8)	1 0.1%
BCG + Hib: 2nd (n =2)	0 0%
BCG + Hib: 3rd (n =3)	0 0%
BCG + Hib: 4th (n =0)	0 0%
OPV + Hib: 1st (n =1)	0 0%
OPV + Hib: 2nd (n =0)	0 0%
OPV + Hib: 3rd (n =4)	0 0%
OPV + Hib: 4th (n =0)	0 0%
DPT + MR: 1st (n =0)	0 0%
DPT + MR: 2nd (n =1)	0 0%
DPT + MR: 3rd (n =0)	0 0%
DPT + MR: 4th (n =0)	0 0%
DPT + Flu: 1st (n =0)	0 0%
DPT + Flu: 2nd (n =1)	0 0%
DPT + Flu: 3rd (n =0)	0 0%
DPT + Flu: 4th (n =1)	0 0%
DPT + VSV: 1st (n =0)	0 0%
DPT + VSV: 2nd (n =0)	0 0%
DPT + VSV: 3rd (n =0)	0 0%
DPT + VSV: 4th (n =2)	0 0%
DPT + Mumps: 1st (n =0)	0 0%
DPT + Mumps: 2nd (n =0)	0 0%
DPT + Mumps: 3rd (n =0)	0 0%
DPT + Mumps: 4th (n =0)	0 0%
MR + VSV: 1st (n =0)	0 0%
MR + VSV: 2nd (n =0)	0 0%
MR + VSV: 3rd (n =0)	0 0%
MR + VSV: 4th (n =3)	0 0%
MR + Mumps: 1st (n =0)	0 0%
MR + Mumps: 2nd (n =0)	0 0%
MR + Mumps: 3rd (n =0)	0 0%
MR + Mumps: 4th (n =2)	0 0%
MR + HB: 1st (n =0)	0 0%
MR + HB: 2nd (n =0)	0 0%
MR + HB: 3rd (n =0)	0 0%
MR + HB: 4th (n =1)	0 0%
Flu + MR: 1st (n =0)	0 0%
Flu + MR: 2nd (n =0)	0 0%
Flu + MR: 3rd (n =0)	0 0%
Flu + MR: 4th (n =3)	0 0%
Flu + Mumps: 1st (n =0)	0 0%
Flu + Mumps: 2nd (n =0)	0 0%
Flu + Mumps: 3rd (n =0)	0 0%
Flu + Mumps: 4th (n =1)	0 0%
VSV + Mumps: 1st (n =0)	0 0%
VSV + Mumps: 2nd (n =0)	0 0%
VSV + Mumps: 3rd (n =0)	0 0%
VSV + Mumps: 4th (n =4)	0 0%
MR + VSV + Mumps: 1st (n =0)	0 0%
MR + VSV + Mumps: 2nd (n =0)	0 0%
MR + VSV + Mumps: 3rd (n =0)	0 0%
MR + VSV + Mumps: 4th (n =34)	0 0%
DPT + Hib + MR: 1st (n =0)	0 0%
DPT + Hib + MR: 2nd (n =0)	0 0%
DPT + Hib + MR: 3rd (n =0)	0 0%
DPT + Hib + MR: 4th (n =1)	0 0%
Hib + MR + VSV: 1st (n =0)	0 0%
Hib + MR + VSV: 2nd (n =0)	0 0%
Hib + MR + VSV: 3rd (n =0)	0 0%
Hib + MR + VSV: 4th (n =1)	0 0%
DPT + Hib + Mumps: 1st (n =0)	0 0%
DPT + Hib + Mumps: 2nd (n =0)	0 0%
DPT + Hib + Mumps: 3rd (n =1)	0 0%
DPT + Hib + Mumps: 4th (n =0)	0 0%
DPT + Hib + HB: 1st (n =0)	0 0%
DPT + Hib + HB: 2nd (n =0)	0 0%
DPT + Hib + HB: 3rd (n =1)	0 0%
DPT + Hib + HB: 4th (n =0)	0 0%
DPT + Hib + IPV: 1st (n =0)	0 0%
DPT + Hib + IPV: 2nd (n =0)	0 0%
DPT + Hib + IPV: 3rd (n =1)	0 0%
DPT + Hib + IPV: 4th (n =0)	0 0%
VSV + Mumps + IPV: 1st (n =0)	0 0%
VSV + Mumps + IPV: 2nd (n =0)	0 0%
VSV + Mumps + IPV: 3rd (n =0)	0 0%
VSV + Mumps + IPV: 4th (n =2)	0 0%
Hib + MR + VSV + Mumps: 1st (n =0)	0 0%
Hib + MR + VSV + Mumps: 2nd (n =0)	0 0%
Hib + MR + VSV + Mumps: 3rd (n =0)	0 0%
Hib + MR + VSV + Mumps: 4th (n =1)	0 0%
Hib + MR + Mumps + IPV: 1st (n =0)	0 0%
Hib + MR + Mumps + IPV: 2nd (n =0)	0 0%
Hib + MR + Mumps + IPV: 3rd (n =0)	0 0%
Hib + MR + Mumps + IPV: 4th (n =1)	0 0%
MR + VSV + Mumps + HB: 1st (n =0)	0 0%
MR + VSV + Mumps + HB: 2nd (n =0)	0 0%
MR + VSV + Mumps + HB: 3rd (n =0)	0 0%
MR + VSV + Mumps + HB: 4th (n =1)	0 0%

5. Secondary Outcome

Title	Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
Description	Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
No CVs: 1st (n =184)	6 0.5%
No CVs: 2nd (n =166)	1 0.1%
No CVs: 3rd (n =203)	3 0.3%
No CVs: 4th (n =450)	1 0.1%
Hib: 1st (n =327)	8 0.7%
Hib: 2nd (n =207)	4 0.4%
Hib: 3rd (n =303)	1 0.1%
Hib: 4th (n =39)	0 0%
DPT: 1st (n =176)	11 1%
DPT: 2nd (n =138)	3 0.3%
DPT: 3rd (n =72)	0 0%
DPT: 4th (n =8)	0 0%
MR: 1st (n =0)	0 0%
MR: 2nd (n =0)	0 0%
MR: 3rd (n =1)	0 0%
MR: 4th (n =179)	2 0.2%
Flu: 1st (n =0)	0 0%
Flu: 2nd (n =0)	0 0%
Flu: 3rd (n =3)	0 0%
Flu: 4th (n =29)	0 0%
BCG: 1st (n =10)	0 0%
BCG: 2nd (n =6)	0 0%
BCG: 3rd (n =3)	0 0%
BCG: 4th (n =0)	0 0%
VSV: 1st (n =0)	0 0%
VSV: 2nd (n =0)	0 0%
VSV: 3rd (n =0)	0 0%
VSV: 4th (n =10)	0 0%
Mumps: 1st (n =0)	0 0%
Mumps: 2nd (n =0)	0 0%
Mumps: 3rd (n =0)	0 0%
Mumps: 4th (n =3)	0 0%
HB: 1st (n =0)	0 0%
HB: 2nd (n =1)	0 0%
HB: 3rd (n =0)	0 0%
HB: 4th (n =3)	0 0%
OPV: 1st (n =1)	0 0%
OPV: 2nd (n =1)	0 0%
OPV: 3rd (n =0)	0 0%
OPV: 4th (n =2)	0 0%
IPV: 1st (n =0)	0 0%
IPV: 2nd (n =0)	0 0%
IPV: 3rd (n =0)	0 0%
IPV: 4th (n =4)	0 0%
DPT + Hib: 1st (n =412)	15 1.3%
DPT + Hib: 2nd (n =556)	14 1.3%
DPT + Hib: 3rd (n =420)	3 0.3%
DPT + Hib: 4th (n =34)	1 0.1%
Hib + MR: 1st (n =0)	0 0%
Hib + MR: 2nd (n =1)	0 0%
Hib + MR: 3rd (n =1)	0 0%
Hib + MR: 4th (n =12)	0 0%
Hib + Flu: 1st (n =0)	0 0%
Hib + Flu: 2nd (n =2)	0 0%
Hib + Flu: 3rd (n =1)	0 0%
Hib + Flu: 4th (n =5)	1 0.1%
Hib + HB: 1st (n =1)	0 0%
Hib + HB: 2nd (n =1)	0 0%
Hib + HB: 3rd (n =0)	0 0%
Hib + HB: 4th (n =0)	0 0%
BCG + Hib: 1st (n =8)	1 0.1%
BCG + Hib: 2nd (n =2)	0 0%
BCG + Hib: 3rd (n =3)	0 0%
BCG + Hib: 4th (n =0)	0 0%
OPV + Hib: 1st (n =1)	0 0%
OPV + Hib: 2nd (n =0)	0 0%
OPV + Hib: 3rd (n =4)	0 0%
OPV + Hib: 4th (n =0)	0 0%
DPT + MR: 1st (n =0)	0 0%
DPT + MR: 2nd (n =1)	0 0%
DPT + MR: 3rd (n =0)	0 0%
DPT + MR: 4th (n =0)	0 0%
DPT + Flu: 1st (n =0)	0 0%
DPT + Flu: 2nd (n =1)	0 0%
DPT + Flu: 3rd (n =0)	0 0%
DPT + Flu: 4th (n =1)	0 0%
DPT + VSV: 1st (n =0)	0 0%
DPT + VSV: 2nd (n =0)	0 0%
DPT + VSV: 3rd (n =0)	0 0%
DPT + VSV: 4th (n =2)	0 0%
DPT + Mumps: 1st (n =0)	0 0%
DPT + Mumps: 2nd (n =0)	0 0%
DPT + Mumps: 3rd (n =0)	0 0%
DPT + Mumps: 4th (n =0)	0 0%
MR + VSV: 1st (n =0)	0 0%
MR + VSV: 2nd (n =0)	0 0%
MR + VSV: 3rd (n =0)	0 0%
MR + VSV: 4th (n =3)	0 0%
MR + Mumps: 1st (n =0)	0 0%
MR + Mumps: 2nd (n =0)	0 0%
MR + Mumps: 3rd (n =0)	0 0%
MR + Mumps: 4th (n =2)	0 0%
MR + HB: 1st (n =0)	0 0%
MR + HB: 2nd (n =0)	0 0%
MR + HB: 3rd (n =0)	0 0%
MR + HB: 4th (n =1)	0 0%
Flu + MR: 1st (n =0)	0 0%
Flu + MR: 2nd (n =0)	0 0%
Flu + MR: 3rd (n =0)	0 0%
Flu + MR: 4th (n =3)	1 0.1%
Flu + Mumps: 1st (n =0)	0 0%
Flu + Mumps: 2nd (n =0)	0 0%
Flu + Mumps: 3rd (n =0)	0 0%
Flu + Mumps: 4th (n =1)	0 0%
VSV + Mumps: 1st (n =0)	0 0%
VSV + Mumps: 2nd (n =0)	0 0%
VSV + Mumps: 3rd (n =0)	0 0%
VSV + Mumps: 4th (n =4)	0 0%
MR + VSV + Mumps: 1st (n =0)	0 0%
MR + VSV + Mumps: 2nd (n =0)	0 0%
MR + VSV + Mumps: 3rd (n =0)	0 0%
MR + VSV + Mumps: 4th (n =34)	1 0.1%
DPT + Hib + MR: 1st (n =0)	0 0%
DPT + Hib + MR: 2nd (n =0)	0 0%
DPT + Hib + MR: 3rd (n =0)	0 0%
DPT + Hib + MR: 4th (n =1)	0 0%
Hib + MR + VSV: 1st (n =0)	0 0%
Hib + MR + VSV: 2nd (n =0)	0 0%
Hib + MR + VSV: 3rd (n =0)	0 0%
Hib + MR + VSV: 4th (n =1)	0 0%
DPT + Hib + Mumps: 1st (n =0)	0 0%
DPT + Hib + Mumps: 2nd (n =0)	0 0%
DPT + Hib + Mumps: 3rd (n =1)	0 0%
DPT + Hib + Mumps: 4th (n =0)	0 0%
DPT + Hib + HB: 1st (n =0)	0 0%
DPT + Hib + HB: 2nd (n =0)	0 0%
DPT + Hib + HB: 3rd (n =1)	0 0%
DPT + Hib + HB: 4th (n =0)	0 0%
DPT + Hib + IPV: 1st (n =0)	0 0%
DPT + Hib + IPV: 2nd (n =0)	0 0%
DPT + Hib + IPV: 3rd (n =1)	0 0%
DPT + Hib + IPV: 4th (n =0)	0 0%
VSV + Mumps + IPV: 1st (n =0)	0 0%
VSV + Mumps + IPV: 2nd (n =0)	0 0%
VSV + Mumps + IPV: 3rd (n =0)	0 0%
VSV + Mumps + IPV: 4th (n =2)	0 0%
Hib + MR + VSV + Mumps: 1st (n =0)	0 0%
Hib + MR + VSV + Mumps: 2nd (n =0)	0 0%
Hib + MR + VSV + Mumps: 3rd (n =0)	0 0%
Hib + MR + VSV + Mumps: 4th (n =1)	0 0%
Hib + MR + Mumps + IPV: 1st (n =0)	0 0%
Hib + MR + Mumps + IPV: 2nd (n =0)	0 0%
Hib + MR + Mumps + IPV: 3rd (n =0)	0 0%
Hib + MR + Mumps + IPV: 4th (n =1)	0 0%
MR + VSV + Mumps + HB: 1st (n =0)	0 0%
MR + VSV + Mumps + HB: 2nd (n =0)	0 0%
MR + VSV + Mumps + HB: 3rd (n =0)	0 0%
MR + VSV + Mumps + HB: 4th (n =1)	0 0%

6. Other Pre-specified Outcome

Title	Number of Participants by Month of Age at Each Vaccination Time
Description	Number of participants was counted by month of age at each vaccination time (first to fourth).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
2 to less than 3 months: 1st (n =1120)	248 22.1%
2 to less than 3 months: 2nd (n =1083)	5 0.4%
2 to less than 3 months: 3rd (n =1017)	0 0%
2 to less than 3 months: 4th (n =836)	0 0%
3 to less than 4 months: 1st (n =1120)	280 25%
3 to less than 4 months: 2nd (n =1083)	193 17.2%
3 to less than 4 months: 3rd (n =1017)	7 0.6%
3 to less than 4 months: 4th (n =836)	0 0%
4 to less than 5 months: 1st (n =1120)	297 26.5%
4 to less than 5 months: 2nd (n =1083)	235 21%
4 to less than 5 months: 3rd (n =1017)	97 8.7%
4 to less than 5 months: 4th (n =836)	0 0%
5 to less than 6 months: 1st (n =1120)	219 19.6%
5 to less than 6 months: 2nd (n =1083)	276 24.6%
5 to less than 6 months: 3rd (n =1017)	207 18.5%
5 to less than 6 months: 4th (n =836)	0 0%
6 to less than 7 months: 1st (n =1120)	76 6.8%
6 to less than 7 months: 2nd (n =1083)	213 19%
6 to less than 7 months: 3rd (n =1017)	241 21.5%
6 to less than 7 months: 4th (n =836)	0 0%
7 to less than 8 months: 1st (n =1120)	0 0%
7 to less than 8 months: 2nd (n =1083)	93 8.3%
7 to less than 8 months: 3rd (n =1017)	229 20.4%
7 to less than 8 months: 4th (n =836)	1 0.1%
8 to less than 9 months: 1st (n =1120)	0 0%
8 to less than 9 months: 2nd (n =1083)	20 1.8%
8 to less than 9 months: 3rd (n =1017)	108 9.6%
8 to less than 9 months: 4th (n =836)	1 0.1%
9 to less than 10 months: 1st (n =1120)	0 0%
9 to less than 10 months: 2nd (n =1083)	7 0.6%
9 to less than 10 months: 3rd (n =1017)	45 4%
9 to less than 10 months: 4th (n =836)	2 0.2%
10 to less than 11 months: 1st (n =1120)	0 0%
10 to less than 11 months: 2nd (n =1083)	3 0.3%
10 to less than 11 months: 3rd (n =1017)	18 1.6%
10 to less than 11 months: 4th (n =836)	1 0.1%
11 to less than 12 months: 1st (n =1120)	0 0%
11 to less than 12 months: 2nd (n =1083)	4 0.4%
11 to less than 12 months: 3rd (n =1017)	11 1%
11 to less than 12 months: 4th (n =836)	7 0.6%
12 to less than 16 months: 1st (n =1120)	0 0%
12 to less than 16 months: 2nd (n =1083)	2 0.2%
12 to less than 16 months: 3rd (n =1017)	16 1.4%
12 to less than 16 months: 4th (n =836)	650 58%
16 to less than 18 months: 1st (n =1120)	0 0%
16 to less than 18 months: 2nd (n =1083)	1 0.1%
16 to less than 18 months: 3rd (n =1017)	2 0.2%
16 to less than 18 months: 4th (n =836)	57 5.1%
18 to less than 24 months: 1st (n =1120)	0 0%
18 to less than 24 months: 2nd (n =1083)	0 0%
18 to less than 24 months: 3rd (n =1017)	4 0.4%
18 to less than 24 months: 4th (n =836)	88 7.9%
24 months and order: 1st (n =1120)	0 0%
24 months and order: 2nd (n =1083)	0 0%
24 months and order: 3rd (n =1017)	1 0.1%
24 months and order: 4th (n =836)	6 0.5%
Unknown: 1st (n =1120)	0 0%
Unknown: 2nd (n =1083)	31 2.8%
Unknown: 3rd (n =1017)	31 2.8%
Unknown: 4th (n =836)	23 2.1%

7. Other Pre-specified Outcome

Title	Number of Participants by Vaccination Sites at Each Vaccination Time
Description	Number of participants was counted by vaccination sites at each vaccination time (first to fourth).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
Upper Arm: 1st (n =1120)	1110 99.1%
Upper Arm: 2nd (n =1083)	1074 95.9%
Upper Arm: 3rd (n =1017)	1013 90.4%
Upper Arm: 4th (n =836)	836 74.6%
Other: 1st (n =1120)	10 0.9%
Other: 2nd (n =1083)	9 0.8%
Other: 3rd (n =1017)	4 0.4%
Other: 4th (n= 836)	0 0%

8. Other Pre-specified Outcome

Title	Number of Participants by Pattern of Concomitant Vaccines
Description	Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
No CVs: 1st (n =1120)	184 16.4%
No CVs: 2nd (n =1083)	166 14.8%
No CVs: 3rd (n =1017)	203 18.1%
No CVs: 4th (n =836)	450 40.2%
Hib: 1st (n =1120)	327 29.2%
Hib: 2nd (n =1083)	207 18.5%
Hib: 3rd (n =1017)	303 27.1%
Hib: 4th (n =836)	39 3.5%
DPT: 1st (n =1120)	176 15.7%
DPT: 2nd (n =1083)	138 12.3%
DPT: 3rd (n =1017)	72 6.4%
DPT: 4th (n =836)	8 0.7%
MR: 1st (n =1120)	0 0%
MR: 2nd (n =1083)	0 0%
MR: 3rd (n =1017)	1 0.1%
MR: 4th (n =836)	179 16%
Flu: 1st (n =1120)	0 0%
Flu: 2nd (n =1083)	0 0%
Flu: 3rd (n =1017)	3 0.3%
Flu: 4th (n =836)	29 2.6%
BCG: 1st (n =1120)	10 0.9%
BCG: 2nd (n =1083)	6 0.5%
BCG: 3rd (n =1017)	3 0.3%
BCG: 4th (n =836)	0 0%
VSV: 1st (n =1120)	0 0%
VSV: 2nd (n =1083)	0 0%
VSV: 3rd (n =1017)	0 0%
VSV: 4th (n =836)	10 0.9%
Mumps: 1st (n =1120)	0 0%
Mumps: 2nd (n =1083)	0 0%
Mumps: 3rd (n =1017)	0 0%
Mumps: 4th (n =836)	3 0.3%
HB: 1st (n =1120)	0 0%
HB: 2nd (n =1083)	1 0.1%
HB: 3rd (n =1017)	0 0%
HB: 4th (n =836)	3 0.3%
OPV: 1st (n =1120)	1 0.1%
OPV: 2nd (n =1083)	1 0.1%
OPV: 3rd (n =1017)	0 0%
OPV: 4th (n =836)	2 0.2%
IPV: 1st (n =1120)	0 0%
IPV: 2nd (n =1083)	0 0%
IPV: 3rd (n =1017)	0 0%
IPV: 4th (n =836)	4 0.4%
DPT + Hib: 1st (n =1120)	412 36.8%
DPT + Hib: 2nd (n =1083)	556 49.6%
DPT + Hib: 3rd (n =1017)	420 37.5%
DPT + Hib: 4th (n =836)	34 3%
Hib + MR: 1st (n =1120)	0 0%
Hib + MR: 2nd (n =1083)	1 0.1%
Hib + MR: 3rd (n =1017)	1 0.1%
Hib + MR: 4th (n =836)	12 1.1%
Hib + Flu: 1st (n =1120)	0 0%
Hib + Flu: 2nd (n =1083)	2 0.2%
Hib + Flu: 3rd (n =1017)	1 0.1%
Hib + Flu: 4th (n =836)	5 0.4%
Hib + HB: 1st (n =1120)	1 0.1%
Hib + HB: 2nd (n =1083)	1 0.1%
Hib + HB: 3rd (n =1017)	0 0%
Hib + HB: 4th (n =836)	0 0%
BCG + Hib: 1st (n =1120)	8 0.7%
BCG + Hib: 2nd (n =1083)	2 0.2%
BCG + Hib: 3rd (n =1017)	3 0.3%
BCG + Hib: 4th (n =836)	0 0%
OPV + Hib: 1st (n =1120)	1 0.1%
OPV + Hib: 2nd (n =1083)	0 0%
OPV + Hib: 3rd (n =1017)	4 0.4%
OPV + Hib: 4th (n =836)	0 0%
DPT + MR: 1st (n =1120)	0 0%
DPT + MR: 2nd (n =1083)	1 0.1%
DPT + MR: 3rd (n =1017)	0 0%
DPT + MR: 4th (n =836)	0 0%
DPT + Flu: 1st (n =1120)	0 0%
DPT + Flu: 2nd (n =1083)	1 0.1%
DPT + Flu: 3rd (n =1017)	0 0%
DPT + Flu: 4th (n =836)	1 0.1%
DPT + VSV: 1st (n =1120)	0 0%
DPT + VSV: 2nd (n =1083)	0 0%
DPT + VSV: 3rd (n =1017)	0 0%
DPT + VSV: 4th (n =836)	2 0.2%
DPT + Mumps: 1st (n =1120)	0 0%
DPT + Mumps: 2nd (n =1083)	0 0%
DPT + Mumps: 3rd (n =1017)	0 0%
DPT + Mumps: 4th (n =836)	0 0%
MR + VSV: 1st (n =1120)	0 0%
MR + VSV: 2nd (n =1083)	0 0%
MR + VSV: 3rd (n =1017)	0 0%
MR + VSV: 4th (n =836)	3 0.3%
MR + Mumps: 1st (n =1120)	0 0%
MR + Mumps: 2nd (n =1083)	0 0%
MR + Mumps: 3rd (n =1017)	0 0%
MR + Mumps: 4th (n =836)	2 0.2%
MR + HB: 1st (n =1120)	0 0%
MR + HB: 2nd (n =1083)	0 0%
MR + HB: 3rd (n =1017)	0 0%
MR + HB: 4th (n =836)	1 0.1%
Flu + MR: 1st (n =1120)	0 0%
Flu + MR: 2nd (n =1083)	0 0%
Flu + MR: 3rd (n =1017)	0 0%
Flu + MR: 4th (n =836)	3 0.3%
Flu + Mumps: 1st (n =1120)	0 0%
Flu + Mumps: 2nd (n =1083)	0 0%
Flu + Mumps: 3rd (n =1017)	0 0%
Flu + Mumps: 4th (n =836)	1 0.1%
VSV + Mumps: 1st (n =1120)	0 0%
VSV + Mumps: 2nd (n =1083)	0 0%
VSV + Mumps: 3rd (n =1017)	0 0%
VSV + Mumps: 4th (n =836)	4 0.4%
MR + VSV + Mumps: 1st (n =1120)	0 0%
MR + VSV + Mumps: 2nd (n =1083)	0 0%
MR + VSV + Mumps: 3rd (n =1017)	0 0%
MR + VSV + Mumps: 4th (n =836)	34 3%
DPT + Hib + MR: 1st (n =1120)	0 0%
DPT + Hib + MR: 2nd (n =1083)	0 0%
DPT + Hib + MR: 3rd (n =1017)	0 0%
DPT + Hib + MR: 4th (n =836)	1 0.1%
Hib + MR + VSV: 1st (n =1120)	0 0%
Hib + MR + VSV: 2nd (n =1083)	0 0%
Hib + MR + VSV: 3rd (n =1017)	0 0%
Hib + MR + VSV: 4th (n =836)	1 0.1%
DPT + Hib + Mumps: 1st (n =1120)	0 0%
DPT + Hib + Mumps: 2nd (n =1083)	0 0%
DPT + Hib + Mumps: 3rd (n =1017)	1 0.1%
DPT + Hib + Mumps: 4th (n =836)	0 0%
DPT + Hib + HB: 1st (n =1120)	0 0%
DPT + Hib + HB: 2nd (n =1083)	0 0%
DPT + Hib + HB: 3rd (n =1017)	1 0.1%
DPT + Hib + HB: 4th (n =836)	0 0%
DPT + Hib + IPV: 1st (n =1120)	0 0%
DPT + Hib + IPV: 2nd (n =1083)	0 0%
DPT + Hib + IPV: 3rd (n =1017)	1 0.1%
DPT + Hib + IPV: 4th (n =836)	0 0%
VSV + Mumps + IPV: 1st (n =1120)	0 0%
VSV + Mumps + IPV: 2nd (n =1083)	0 0%
VSV + Mumps + IPV: 3rd (n =1017)	0 0%
VSV + Mumps + IPV: 4th (n =836)	2 0.2%
Hib + MR + VSV + Mumps: 1st (n =1120)	0 0%
Hib + MR + VSV + Mumps: 2nd (n =1083)	0 0%
Hib + MR + VSV + Mumps: 3rd (n =1017)	0 0%
Hib + MR + VSV + Mumps: 4th (n =836)	1 0.1%
Hib + MR + Mumps + IPV: 1st (n =1120)	0 0%
HIb + MR + Mumps + IPV: 2nd (n =1083)	0 0%
Hib + MR + Mumps + IPV: 3rd (n =1017)	0 0%
Hib + MR + Mumps + IPV: 4th (n =836)	1 0.1%
MR + VSV + Mumps + HB: 1st (n =1120)	0 0%
MR + VSV + Mumps + HB: 2nd (n =1083)	0 0%
MR + VSV + Mumps + HB: 3rd (n =1017)	0 0%
MR + VSV + Mumps + HB: 4th (n =836)	1 0.1%

9. Other Pre-specified Outcome

Title	Number of Participants by Pattern of Concomitant Vaccination Sites
Description	Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.

Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
Measure Participants	1120
No CVs: 1st (n =1120)	184 16.4%
No CVs: 2nd (n =1083)	166 14.8%
No CVs: 3rd (n =1017)	203 18.1%
No CVs: 4th (n =836)	450 40.2%
CV, same UA: 1st (n =1120)	5 0.4%
CV, same UA: 2nd (n =1083)	1 0.1%
CV, same UA: 3rd (n =1017)	5 0.4%
CV, same UA: 4th (n =836)	2 0.2%
CV, other UA: 1st (n =1120)	508 45.4%
CV, other UA: 2nd (n =1083)	351 31.3%
CV, other UA: 3rd (n =1017)	375 33.5%
CV, other UA: 4th (n =836)	270 24.1%
CV, same F: 1st (n =1120)	0 0%
CV, same F: 2nd (n =1083)	0 0%
CV, same F: 3rd (n =1017)	2 0.2%
CV, same F: 4th (n =836)	3 0.3%
CV, O: 1st (n =1120)	1 0.1%
CV, O: 2nd (n =1083)	1 0.1%
CV, O: 3rd (n =1017)	0 0%
CV, O: 4th (n =836)	2 0.2%
CVs, same UA X2: 1st (n =1120)	0 0%
CVs, same UA X2: 2nd (n =1083)	0 0%
CVs, same UA X2: 3rd (n =1017)	1 0.1%
CVs, same UA X2: 4th (n =836)	0 0%
CVs, same UA + other UA: 1st (n =1120)	214 19.1%
CVs, same UA + other UA: 2nd (n =1083)	301 26.9%
CVs, same UA + other UA: 3rd (n =1017)	236 21.1%
CVs, same UA + other UA: 4th (n =836)	39 3.5%
CVs, other UA X2: 1st (n =1120)	181 16.2%
CVs, other UA X2: 2nd (n =1083)	234 20.9%
CVs, other UA X2: 3rd (n =1017)	167 14.9%
CVs, other UA X2: 4th (n =836)	24 2.1%
CVs, other UA + same F: 1st (n =1120)	11 1%
CVs, other UA + same F: 2nd (n =1083)	12 1.1%
CVs, other UA + same F: 3rd (n =1017)	7 0.6%
CVs, other UA + same F: 4th (n =836)	5 0.4%
CVs, other UA + other F: 1st (n =1120)	0 0%
CVs, other UA + other F: 2nd (n =1083)	1 0.1%
CVs, other UA + other F: 3rd (n =1017)	4 0.4%
CVs, other UA + other F: 4th (n =836)	0 0%
CVs, other UA + O: 1st (n =1120)	1 0.1%
CVs, other UA + O: 2nd (n =1083)	0 0%
CVs, other UA + O: 3rd (n =1017)	4 0.4%
CVs, other UA + O: 4th (n =836)	0 0%
CVs, other UA + other UB: 1st (n =1120)	2 0.2%
CVs, other UA + other UB: 2nd (n =1083)	5 0.4%
CVs, other UA + other UB: 3rd (n =1017)	3 0.3%
CVs, other UA + other UB: 4th (n =836)	0 0%
CVs, other UA + same UB: 1st (n =1120)	2 0.2%
CVs, other UA + same UB: 2nd (n =1083)	2 0.2%
CVs, other UA + same UB: 3rd (n =1017)	3 0.3%
CVs, other UA + same UB: 4th (n =836)	0 0%
CVs, unknown X2: 1st (n =1120)	1 0.1%
CVs, unknown X2: 2nd (n =1083)	0 0%
CVs, unknown X2: 3rd (n =1017)	0 0%
CVs, unknown X2: 4th (n =836)	0 0%
CVs, same UA + other UA X2: 1st (n =1120)	0 0%
CVs, same UA + other UA X2: 2nd (n=1083)	0 0%
CVs, same UA + other UA X2: 3rd (n =1017)	2 0.2%
CVs, same UA + other UA X2: 4th (n =836)	36 3.2%
CVs, other UA + same UA X2: 1st (n =1120)	0 0%
CVs, other UA + same UA X2: 2nd (n =1083)	0 0%
CVs, other UA + same UA X2: 3rd (n =1017)	1 0.1%
CVs, other UA + same UA X2: 4th (n =836)	1 0.1%
CVs, other UA X2 + same F: 1st (n =1120)	0 0%
CVs, other UA X2 + same F: 2nd (n =1083)	0 0%
CVs, other UA X2 + same F: 3rd (n =1017)	0 0%
CVs, other UA X2 + same F: 4th (n =836)	1 0.1%
CVs, same UA X2 + other UA X2: 1st (n =1120)	0 0%
CVs, same UA X2 + other UA X2: 2nd (n =1083)	0 0%
CVs, same UA X2 + other UA X2: 3rd (n =1017)	0 0%
CVs, same UA X2 + other UA X2: 4th (n=836)	2 0.2%
CVs, other UA + same UA + other F X2: 1st (n=1120)	0 0%
CVs, other UA + same UA + other F X2: 2nd (n=1083)	0 0%
CVs, other UA + same UA + other F X2: 3rd (n=1017)	0 0%
CVs, other UA + same UA + other F X2: 4th (n=836)	1 0.1%
PVN7, R F; CVs, R UA + L UA: 1st (n =1120)	0 0%
PVN7, R F; CVs, R UA + L UA: 2nd (n =1083)	1 0.1%
PVN7, R F; CVs, R UA + L UA: 3rd (n =1017)	3 0.3%
PVN7, R F; CVs, R UA + L UA: 4th (n =836)	0 0%
PVN7, L F; CVs, L UA + R UA: 1st (n =1120)	4 0.4%
PVN7, L F; CVs, L UA + R UA: 2nd (n =1083)	8 0.7%
PVN7, L F; CVs, L UA + R UA: 3rd (n =1017)	0 0%
PVN7, L F; CVs, L UA + R UA: 4th (n =836)	0 0%
PVN7, F; CVs, same UA + other UA: 1st (n =1120)	5 0.4%
PVN7, F; CVs, same UA + other UA: 2nd (n =1083)	0 0%
PVN7, F; CVs, same UA + other UA: 3rd (n =1017)	1 0.1%
PVN7, F; CVs, same UA + other UA: 4th (n =836)	0 0%
PVN7, F; CVs, R UA + L UA: 1st (n =1120)	1 0.1%
PVN7, F; CVs, R UA + L UA: 2nd (n =1083)	0 0%
PVN7, F; CVs, R UA + L UA: 3rd (n =1017)	0 0%
PVN7, F; CVs, R UA + L UA: 4th (n =836)	0 0%

Adverse Events

Time Frame	28 days
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Prevenar™ (7-valent)
Arm/Group Description	Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
All Cause Mortality
	Prevenar™ (7-valent)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Prevenar™ (7-valent)
	Affected / at Risk (%)	# Events
Total	20/1120 (1.8%)
Gastrointestinal disorders
Inguinal hernia	1/1120 (0.1%)	1
General disorders
Pyrexia	2/1120 (0.2%)	2
Injection site swelling	1/1120 (0.1%)	1
Infections and infestations
Cellulitis orbital	1/1120 (0.1%)	1
Gastroenteritis	1/1120 (0.1%)	1
Gastroenteritis adenovirus	1/1120 (0.1%)	1
Gastroenteritis rotavirus	1/1120 (0.1%)	1
Otitis media	3/1120 (0.3%)	3
Otitis media acute	4/1120 (0.4%)	4
Respiratory syncytial virus bronchiolitis	1/1120 (0.1%)	1
Urinary tract infection	1/1120 (0.1%)	1
Respiratory syncytial virus infection	3/1120 (0.3%)	3
Metabolism and nutrition disorders
Feeding disorder neonatal	1/1120 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant	1/1120 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/1120 (0.1%)	1
Vascular disorders
Kawasaki's disease	1/1120 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Prevenar™ (7-valent)
	Affected / at Risk (%)	# Events
Total	464/1120 (41.4%)
Eye disorders
Conjunctivitis	33/1120 (2.9%)	33
Gastrointestinal disorders
Constipation	33/1120 (2.9%)	33
Diarrhoea	27/1120 (2.4%)	27
General disorders
Injection site erythema	48/1120 (4.3%)	48
Injection site swelling	49/1120 (4.4%)	49
Pyrexia	86/1120 (7.7%)	86
Infections and infestations
Bronchitis	119/1120 (10.6%)	119
Exanthema subitum	25/1120 (2.2%)	25
Gastroenteritis	85/1120 (7.6%)	85
Hand-foot-and-mouth disease	23/1120 (2.1%)	23
Nasopharyngitis	77/1120 (6.9%)	77
Pharyngitis	79/1120 (7.1%)	79
Rhinitis	25/1120 (2.2%)	25
Respiratory, thoracic and mediastinal disorders
Asthma	25/1120 (2.2%)	25
Upper respiratory tract inflammation	145/1120 (12.9%)	145
Skin and subcutaneous tissue disorders
Dermatitis diaper	38/1120 (3.4%)	38
Eczema	91/1120 (8.1%)	91
Asteatosis	24/1120 (2.1%)	24

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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