Immune Response and Safety Comparison of 3 Lots of GSK Bi... | NCT00148941

Label	Type	Description	Intervention Names
SB213503 lot 1 + M-M-R Group	Experimental	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.	Biological: SB213503 lot 1 Biological: M-M-R II
SB213503 lot 2 + M-M-R Group	Experimental	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.	Biological: SB213503 lot 2 Biological: M-M-R II
SB213503 lot 3 + M-M-R Group	Experimental	Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.	Biological: SB213503 lot 3 Biological: M-M-R II
Infanrix + IPOL + M-M-R Group	Active Comparator	Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Name	Type	Description	Arm Group Labels	Other Names
SB213503 lot 1	Biological	SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.	SB213503 lot 1 + M-M-R Group

Measure	Description	Time Frame
Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects	GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL).	At Month 1 (i.e. one month after vaccination)
Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects	GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in ELISA units per milliliter (EL.U/mL).	At Month 1 (i.e. one month after vaccination)
Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects	GMTs were measured by Neutralization assay and expressed in titers.	At Month 1 (i.e. one month after vaccination)
Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects	Vaccine response defined as: For initially seronegative subjects [pre-booster antibody concentration below (<) cut-off of 0.1 international units per milliliter (IU/mL)] with an increase of at least four times the cut-off one month after vaccination [post-booster antibody concentration greater than or equal to (≥) 0.4 IU/mL]. For initially seropositive subjects (pre-booster antibody concentration ≥ 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination.	At Month 1 (i.e. one month after vaccination)
Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects	Vaccine response defined as: For initially seronegative subjects [pre-booster antibody concentration below (<) cut-off of 5 EL.U/mL] with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-booster antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL with an increase of at least 4 times the pre-booster antibody concentration one month after vaccination. For initially seropositive subjects with pre-booster antibody concentration ≥ 20 EL.U/mL with an increase of at least 2 times the pre-booster antibody concentration one month after vaccination.

Measure	Description	Time Frame
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects	A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).	At Month 1 (i.e. one month after vaccination)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Little Rock	Arkansas	72205	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
18316985	Background	Black S, Friedland LR, Ensor K, Weston WM, Howe B, Klein NP. Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4-6 years of age. Pediatr Infect Dis J. 2008 Apr;27(4):341-6. doi: 10.1097/INF.0b013e3181616180.
18980534	Background	Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008 Nov;7(9):1309-20. doi: 10.1586/14760584.7.9.1309.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
213503/048	Statistical Analysis Plan	View IPD

ID	Title	Description
FG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects

GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in international units per milliliter (IU/mL).

The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002	SB213503 Lot 3 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG003	Infanrix + IPOL + M-M-R Group	Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Units	Counts
Participants	OG000284 OG001283 OG002284 OG003

Title	Denominators	Categories
Anti-D	ParticipantsOG000284 ParticipantsOG001282 ParticipantsOG002284 ParticipantsOG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.			GMC ratio	0.970			2-Sided	95	0.871	1.080					Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].

Primary

Geometric Mean Concentrations (GMCs) for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies in a Subset of Subjects

GMCs were measured by Enzyme-Linked Immunosorbent assay (ELISA), expressed in ELISA units per milliliter (EL.U/mL).

The anaylsis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Primary

Geometric Mean Titers (GMTs) for Anti-poliovirus Types 1, 2 and 3 Antibodies in a Subset of Subjects

GMTs were measured by Neutralization assay and expressed in titers.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002	SB213503 Lot 3 + M-M-R Group

Primary

Number of Subjects With Booster Response Against Diphtheria Toxoid (D) and Tetanus Toxoid (T) Antigens in a Subset of Subjects

Vaccine response defined as: For initially seronegative subjects [pre-booster antibody concentration below (<) cut-off of 0.1 international units per milliliter (IU/mL)] with an increase of at least four times the cut-off one month after vaccination [post-booster antibody concentration greater than or equal to (≥) 0.4 IU/mL]. For initially seropositive subjects (pre-booster antibody concentration ≥ 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination.

The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received study vaccines according to protocol and for whom immunogenicity data were available for the analyzed antigen.

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Primary

Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects

Vaccine response defined as: For initially seronegative subjects [pre-booster antibody concentration below (<) cut-off of 5 EL.U/mL] with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-booster antibody concentration ≥ 5 EL.U/mL and < 20 EL.U/mL with an increase of at least 4 times the pre-booster antibody concentration one month after vaccination. For initially seropositive subjects with pre-booster antibody concentration ≥ 20 EL.U/mL with an increase of at least 2 times the pre-booster antibody concentration one month after vaccination.

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001

Primary

Number of Subjects With Circumferential Swelling at the Injection Site

Swelling (at the SB213503 & Infanrix injection sites) was categorized as an increase of > or ≤ 30 mm in mid upper arm circumference compared to baseline measurement or with an increase in mid upper arm missing; extent of swelling > or ≤ 50 % of upper arm length, or diameter of injection site missing.

The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

Within 4 days (Day 0-3) after vaccination

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002	SB213503 Lot 3 + M-M-R Group

Secondary

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens in a Subset of Subjects

A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002

Secondary

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects

A seroprotected subject is defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 antibody titers greater than or equal to 1:8.

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002

Secondary

Number of Seropositive Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens in a Subset of Subjects

A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL).

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Secondary

Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to (≥) 1 IU/mL

The number of subjects with anti-D and anti-T antibody concentrations greater than or equal to (≥) 1 IU/mL is reported.

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002	SB213503 Lot 3 + M-M-R Group

Secondary

Number of Subjects With Booster Response for Poliovirus Types 1, 2 and 3 Antigens in a Subset of Subjects

Vaccine response defined as: For initially seronegative subjects (pre-booster antibody titer below cut-off of 1:8), an antibody titer ≥ 1:32 at one month after vaccination. For initially seropositive subjects (pre-booster antibody titer ≥1:8), an increase at least four times the pre-booster antibody titer at one month after vaccination.

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Secondary

Geometric Mean Titers (GMTs) for Serum Haemagglutination-inhibition (HI) Anti-H1N1, Anti-H3N2 and Anti-B Antibodies in a Subset of Subjects

GMTs were measured by hemagglutination inhibition assay and expressed in titers.

The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002

Secondary

Number of Seroconverted Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects

Seroconversion was defined as a post-vaccination haemagglutination-inhibition (HI) titer of ≥ 1:40 in an initially HI antibody seronegative subject (pre-vaccination HI titer < 1:10), or a ≥ 4 fold rise in HI titer in an initially HI antibody seropositive subject (pre-vaccination HI titer ≥ 1:10) The 3 flu strains assessed were H1N1, H3N2, and B.

The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.

Posted

Count of Participants

Participants

At Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Secondary

Number of Seroprotected Subjects Against Influenza Virus Strains H1N1, H3N2, and B in a Subset of Subjects

A seroprotected subject is defined as a vaccinated subject with anti-H1N1, anti-H3N2, and anti-B antibody titers greater than or equal to (≥) 1:40.

The analysis was performed on a subset of subjects (first 1340 enrolled subjects who agreed to participate in the subset) belonging to the ATP cohort for immunogenicity, which included all evaluable subjects who received concomitant influenza vaccine and for whom immunogenicity data were available for the analyzed antigen.

Posted

Count of Participants

Participants

At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness, and swelling (at the SB213503 & Infanrix vaccination sites). Any = any symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading up to or beyond 50 mm diameter.

The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.

Posted

Count of Participants

Participants

During the 4-day (Day 0-3) post-vaccination period

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002	SB213503 Lot 3 + M-M-R Group

Secondary

Number of Subjects With Any and Grade 3 Increase in the Mid-upper Arm Circumference at the Injection Site

Assessed specific symptom was increase in mid upper arm circumference (at the SB213503 & Infanrix injection sites). Any = any symptom regardless of intensity grade. Grade 3 increase in mid upper arm circumference = mid upper arm circumference greater than 30 mm.

The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.

Posted

Count of Participants

Participants

During the 4-day (Day 0-3) post-vaccination period

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002	SB213503 Lot 3 + M-M-R Group

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, fever (orally) [≥ 37.5 degrees Celsius (°C)] and loss of appetite. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever >39°C.

The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.

Posted

Count of Participants

Participants

During the 4-day (Day 0-3) post-vaccination period

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Specific to M-M-R II Vaccination

Solicited general symptoms specific to M-M-R II vaccination were fever [≥ 37.5 degrees Celsius (°C)], rash/exanthem, parotid/salivary gland swelling, and suspected signs of meningism including febrile convulsions . Any = any symptom regardless of intensity grade. Grade 3 = symptom that prevented normal everyday activity. Related = considered by the investigator to be related to the vaccine. Grade 3 fever = fever >39°C.

The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented and with symptom sheet completed.

Posted

Count of Participants

Participants

During the 15-day (Day 0-14) post-vaccination period

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

Within 31 days (Days 0-30) post-vaccination period

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) that were assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

The anaylsis was performed on the Total vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Posted

Count of Participants

Participants

During the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination])

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG002	SB213503 Lot 3 + M-M-R Group

Secondary

Number of Subjects With Onset of Chronic Illness(es) and AE(s) Leading to Emergency Room (ER) or to Physician Office Visits

Among assessed chronic illness(es) were: autoimmune disorders, asthma, type I diabetes, and allergies. AEs leading to emergency room (ER) visits or to physician office visits that were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis, and gastroenteritis.

The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all vaccinated subjects who had a follow-up contact during the ESFU period/who reported an unsolicited AE as specified in the protocol/onset of a chronic illness/SAE beyond Day 30, after the last vaccination.

Posted

Count of Participants

Participants

During the extended safety follow-up phase (i.e. 5 months following the active phase [from Day 31 up to minimum 182 days post-vaccination])

ID	Title	Description
OG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
OG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Group IDs	Group Description	Statistical Method	Statistical Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	0.994	2-Sided	95	0.836	1.181	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG000 OG002	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	0.987	2-Sided	95	0.831	1.172	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG001 OG002	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	0.993	2-Sided	95	0.836	1.180	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG000 OG001	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	1.118	2-Sided	95	0.951	1.314	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG000 OG002	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	1.006	2-Sided	95	0.856	1.183	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG001 OG002	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	0.900	2-Sided	95	0.765	1.060	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5] for Anti-poliovirus type 2.
OG000 OG001	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	1.112	2-Sided	95	0.941	1.314	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG000 OG002	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	1.034	2-Sided	95	0.876	1.220	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG001 OG002	The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.	GMT ratio	0.930	2-Sided	95	0.787	1.099	Equivalence	Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].
OG000 OG001 OG002 OG003	Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	ANCOVA model: adjustment for baseline titer - pooled variance	GMT ration	0.792	2-Sided	95	0.680	0.922	Non-Inferiority	The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.	SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
OG000 OG001 OG002 OG003	Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	ANCOVA model: adjustment for baseline titer - pooled variance	GMT ratio	0.802	2-Sided	95	0.696	0.925	Non-Inferiority	The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.	SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
OG000 OG001 OG002 OG003	Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.	ANCOVA	ANCOVA model: adjustment for baseline titer - pooled variance	GMT ratio	0.938	2-Sided	95	0.811	1.085	Non-Inferiority	The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.	SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.	1,053	4	1,053	797	1,053
EG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.	1,051	7	1,051	783	1,051
EG002	SB213503 Lot 3 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.	1,052	1	1,052	814	1,052
EG003	Infanrix + IPOL + M-M-R Group	Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.	1,053	4	1,053	804	1,053

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dehydration	Metabolism and nutrition disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected1,053 at risk EG0012 events2 affected1,051 at risk EG0021 events1 affected1,052 at risk EG0031 events1 affected1,053 at risk
Pneumonia	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected1,053 at risk EG0010 events0 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Viral infection	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected1,053 at risk EG0010 events0 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Appendicitis perforated	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0010 events0 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0011 events1 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0011 events1 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Cellulitis	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0011 events1 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0011 events1 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0010 events0 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected1,053 at risk EG0010 events0 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0010 events0 affected1,051 at risk EG0021 events1 affected1,052 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0011 events1 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Optic atrophy	Eye disorders	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0011 events1 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Pneumonia necrotizing	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0001 events1 affected1,053 at risk EG0010 events0 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG0000 events0 affected1,053 at risk EG0011 events1 affected1,051 at risk EG0020 events0 affected1,052 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Decreased appetite	Metabolism and nutrition disorders	MedDRA 9.1	Systematic Assessment	EG000162 events162 affected1,053 at risk EG001160 events160 affected1,051 at risk EG002162 events162 affected1,052 at risk EG003166 events166 affected1,053 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 9.1	Systematic Assessment	EG000392 events391 affected1,053 at risk EG001400 events400 affected1,051 at risk EG002412 events412 affected1,052 at risk EG003
Pain	General disorders	MedDRA 9.1	Systematic Assessment	EG000622 events620 affected1,053 at risk EG001584 events583 affected1,051 at risk EG002642 events642 affected1,052 at risk EG003
Pyrexia	General disorders	MedDRA 9.1	Systematic Assessment	EG000229 events227 affected1,053 at risk EG001232 events228 affected1,051 at risk EG002241 events234 affected1,052 at risk EG003
Somnolence	Nervous system disorders	MedDRA 9.1	Systematic Assessment	EG000194 events194 affected1,053 at risk EG001217 events217 affected1,051 at risk EG002185 events185 affected1,052 at risk EG003
Swelling	General disorders	MedDRA 9.1	Systematic Assessment	EG000295 events295 affected1,053 at risk EG001266 events266 affected1,051 at risk EG002292 events292 affected1,052 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 9.1	Systematic Assessment	EG00056 events54 affected1,053 at risk EG00159 events57 affected1,051 at risk EG00271 events71 affected1,052 at risk EG003

ID	Term
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections

ID	Term
D013745	Tetanus Toxoid
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines
D022542	Measles-Mumps-Rubella Vaccine

ID	Title	Description
BG000	SB213503 Lot 1 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
BG001	SB213503 Lot 2 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
BG002	SB213503 Lot 3 + M-M-R Group	Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
BG003	Infanrix + IPOL + M-M-R Group	Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.
BG004	Total	Total of all reporting groups

ID	Term
D014121	Toxoids
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D004168	Diphtheria Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit
D008458	Measles Vaccine
D014765	Viral Vaccines
D009108	Mumps Vaccine
D012411	Rubella Vaccine