Trial Outcomes & Findings for Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children (NCT NCT01245049)

NCT ID: NCT01245049

Last Updated: 2018-08-17

Results Overview

Booster response was defined as: For initially seronegative subjects \[i.e. pre-vaccination concentration below (\<) cut-off value of 0.1 international units per milliliter (IU/mL)\] antibody concentrations at least four times the assay cut-off \[post vaccination concentration greater than or equal to (≥) 0.4 IU/ml\]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 387 participants
• Primary outcome timeframe: At Month 1, one month after the booster vaccination
• Results posted on: 2018-08-17

Participant Flow

2 subjects did not receive vaccination.

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Boostrix Polio Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Overall Study STARTED	255	130
Overall Study COMPLETED	254	126
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Boostrix Polio Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Overall Study Migrated/moved from study area	0	1
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

Baseline characteristics by cohort

Measure	Boostrix Polio Group n=255 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=130 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.	Total n=385 Participants Total of all reporting groups
Age, Continuous	3.1 Years STANDARD_DEVIATION 0.2 • n=5 Participants	3.1 Years STANDARD_DEVIATION 0.2 • n=7 Participants	3.1 Years STANDARD_DEVIATION 0.2 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	65 Participants n=7 Participants	188 Participants n=5 Participants
Sex: Female, Male Male	132 Participants n=5 Participants	65 Participants n=7 Participants	197 Participants n=5 Participants
Race/Ethnicity, Customized African heritage/African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian heritage	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian-South East Asian heritage	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	226 Participants n=5 Participants	111 Participants n=7 Participants	337 Participants n=5 Participants
Race/Ethnicity, Customized Not specified	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 1, one month after the booster vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)] antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (≥) 0.4 IU/ml]. For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.

Outcome measures

Measure	Boostrix Polio Group n=177 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=90 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens Anti-D	176 Participants	90 Participants
Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens Anti-T	173 Participants	90 Participants

PRIMARY outcome

Timeframe: At Month 1, one month after the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Measure	Boostrix Polio Group n=195 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=96 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	70.1 EL.U/mL Interval 62.2 to 79.0	47.8 EL.U/mL Interval 39.9 to 57.3
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	358.3 EL.U/mL Interval 312.5 to 410.8	164.8 EL.U/mL Interval 138.5 to 196.1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	151.4 EL.U/mL Interval 127.5 to 179.6	209.8 EL.U/mL Interval 168.5 to 261.3

PRIMARY outcome

Timeframe: At Month 1, one month after the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Measure	Boostrix Polio Group n=159 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=81 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-Polio Virus Type 1, 2 and 3 Antibody Titers Anti-Polio 1	2183.3 Titers Interval 1812.4 to 2630.1	1876.1 Titers Interval 1472.8 to 2389.7
Anti-Polio Virus Type 1, 2 and 3 Antibody Titers Anti-Polio 2	2693.1 Titers Interval 2176.3 to 3332.5	2203.8 Titers Interval 1681.0 to 2889.4
Anti-Polio Virus Type 1, 2 and 3 Antibody Titers Anti-Polio 3	3762.4 Titers Interval 3080.9 to 4594.6	4185.1 Titers Interval 3318.3 to 5278.3

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).

Outcome measures

Measure	Boostrix Polio Group n=195 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=96 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-D, M0	136 Participants	75 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-D, M1	195 Participants	96 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-T, M0	116 Participants	63 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Anti-T, M1	194 Participants	96 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.

Outcome measures

Measure	Boostrix Polio Group n=195 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=96 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PT, M0	31 Participants	18 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PT, M1	194 Participants	96 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, M0	112 Participants	60 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA, M1	195 Participants	95 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN, M0	61 Participants	37 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN, M1	194 Participants	94 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.

Outcome measures

Measure	Boostrix Polio Group n=160 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=81 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 1, M0	95 Participants	49 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 1, M1	156 Participants	75 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 2, M0	109 Participants	55 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 2, M1	123 Participants	71 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 3, M0	100 Participants	47 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Anti-polio 3, M1	158 Participants	81 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.

Outcome measures

Measure	Boostrix Polio Group n=159 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=76 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seropositive Subjects for Anti-measles Antibody Anti-Measles, M0	155 Participants	74 Participants
Number of Seropositive Subjects for Anti-measles Antibody Anti-Measles, M1	136 Participants	68 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.

Outcome measures

Measure	Boostrix Polio Group n=156 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=76 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seropositive Subjects for Anti-mumps Antibody Anti-Mumps, M0	140 Participants	69 Participants
Number of Seropositive Subjects for Anti-mumps Antibody Anti-Mumps, M1	133 Participants	68 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.

Outcome measures

Measure	Boostrix Polio Group n=158 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=76 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seropositive Subjects for Anti-rubella Antibody Anti-Rubella, M0	158 Participants	76 Participants
Number of Seropositive Subjects for Anti-rubella Antibody Anti-Rubella, M1	134 Participants	68 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Outcome measures

Measure	Boostrix Polio Group n=195 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=96 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-D and Anti-T Antibody Concentrations Anti-D, M0	0.228 IU/mL Interval 0.194 to 0.267	0.259 IU/mL Interval 0.209 to 0.32
Anti-D and Anti-T Antibody Concentrations Anti-D, M1	8.113 IU/mL Interval 7.259 to 9.068	11.948 IU/mL Interval 10.003 to 14.271
Anti-D and Anti-T Antibody Concentrations Anti-T, M0	0.209 IU/mL Interval 0.173 to 0.253	0.241 IU/mL Interval 0.184 to 0.315
Anti-D and Anti-T Antibody Concentrations Anti-T, M1	6.787 IU/mL Interval 5.961 to 7.727	9.194 IU/mL Interval 7.565 to 11.175

SECONDARY outcome

Timeframe: At Month 0, before the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

Outcome measures

Measure	Boostrix Polio Group n=175 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=91 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	3.4 EL.U/mL Interval 3.0 to 3.9	3.2 EL.U/mL Interval 2.9 to 3.6
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	12.9 EL.U/mL Interval 10.0 to 16.6	10.7 EL.U/mL Interval 7.9 to 14.5
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	4.3 EL.U/mL Interval 3.8 to 5.0	4.3 EL.U/mL Interval 3.7 to 5.0

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.

Outcome measures

Measure	Boostrix Polio Group n=156 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=76 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-mumps Antibody Concentrations Anti-Mumps, M0	1035.3 U/mL Interval 869.8 to 1232.3	971.7 U/mL Interval 752.1 to 1255.5
Anti-mumps Antibody Concentrations Anti-Mumps, M1	6801.9 U/mL Interval 6155.0 to 7516.8	6219.4 U/mL Interval 5365.8 to 7208.8

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

Outcome measures

Measure	Boostrix Polio Group n=159 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=76 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-measles Antibody Concentrations Anti-Measles, M0	2644 mIU/mL Interval 2261.3 to 3091.6	2702.6 mIU/mL Interval 2146.0 to 3403.6
Anti-measles Antibody Concentrations Anti-Measles, M1	3817.7 mIU/mL Interval 3422.3 to 4258.8	3798 mIU/mL Interval 3262.6 to 4421.1

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Outcome measures

Measure	Boostrix Polio Group n=158 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=76 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-rubella Antibody Concentrations Anti-Rubella, M0	66.5 IU/mL Interval 59.1 to 74.8	72.6 IU/mL Interval 59.8 to 88.1
Anti-rubella Antibody Concentrations Anti-Rubella, M1	134.3 IU/mL Interval 120.7 to 149.4	130.3 IU/mL Interval 111.7 to 152.0

SECONDARY outcome

Timeframe: At Month 0, before the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Measure	Boostrix Polio Group n=160 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=79 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Anti-Polio Type 1, 2 and 3 Antibody Titers Anti-Polio 1	12.8 Titers Interval 10.6 to 15.5	13.2 Titers Interval 10.2 to 17.1
Anti-Polio Type 1, 2 and 3 Antibody Titers Anti-Polio 2	15.5 Titers Interval 12.8 to 18.8	14.6 Titers Interval 11.3 to 18.8
Anti-Polio Type 1, 2 and 3 Antibody Titers Anti-Polio 3	15.4 Titers Interval 12.7 to 18.8	14.5 Titers Interval 10.4 to 20.1

SECONDARY outcome

Timeframe: At Month 1, one month after the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.

Outcome measures

Measure	Boostrix Polio Group n=175 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=90 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Subjects With a Booster Response to PT, FHA and PRN Antigens Anti-PT	154 Participants	73 Participants
Number of Subjects With a Booster Response to PT, FHA and PRN Antigens Anti-FHA	165 Participants	79 Participants
Number of Subjects With a Booster Response to PT, FHA and PRN Antigens Anti-PRN	169 Participants	89 Participants

SECONDARY outcome

Timeframe: At Month 1, one month after the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.

Outcome measures

Measure	Boostrix Polio Group n=131 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=68 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens Anti-Polio 1	129 Participants	63 Participants
Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens Anti-Polio 2	99 Participants	59 Participants
Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens Anti-Polio 3	124 Participants	68 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)].

Outcome measures

Measure	Boostrix Polio Group n=4 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=2 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seroconverted Subjects for Anti-measles Anti-measles, M0	0 Participants	0 Participants
Number of Seroconverted Subjects for Anti-measles Anti-measles, M1	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 231 units per millilitre (U/mL)].

Outcome measures

Measure	Boostrix Polio Group n=16 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=7 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Seroconverted Subjects for Anti-mumps Anti-mumps, M0	0 Participants	0 Participants
Number of Seroconverted Subjects for Anti-mumps Anti-mumps, M1	11 Participants	6 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	Boostrix Polio Group n=255 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=125 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Subjects With Any Solicited Local Symptoms Any Pain	127 Participants	70 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	146 Participants	73 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling	92 Participants	53 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in and for whom data were available.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	Boostrix Polio Group n=255 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=125 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Subjects With Any Solicited General Symptoms Any Drowsiness	77 Participants	39 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability	107 Participants	49 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite	67 Participants	30 Participants
Number of Subjects With Any Solicited General Symptoms Any Temperature	18 Participants	9 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.

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.

Outcome measures

Measure	Boostrix Polio Group n=255 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=130 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	88 Participants	36 Participants

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 to Month 1)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Boostrix Polio Group n=255 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix™ Polio vaccine co-administered with Priorix™ vaccine at Day 0. Boostrix™ Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=130 Participants Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix™ and Polio™ vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax™ vaccine co-administered with Priorix™ vaccine at Day 0. Repevax™ vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix™ vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	0 Participants

Adverse Events

Boostrix Polio Group

Serious events: 1 serious events

Other events: 215 other events

Deaths: 0 deaths

Repevax Group

Serious events: 0 serious events

Other events: 108 other events

Deaths: 0 deaths

Serious adverse events

Measure	Boostrix Polio Group n=255 participants at risk Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=130 participants at risk Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.39% 1/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	0.00% 0/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).

Other adverse events

Measure	Boostrix Polio Group n=255 participants at risk Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.	Repevax Group n=130 participants at risk Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
General disorders Pain	49.8% 127/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	53.8% 70/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).
General disorders Redness	57.3% 146/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	56.2% 73/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).
General disorders Swelling	36.1% 92/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	40.8% 53/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).
General disorders Drowsiness	30.2% 77/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	30.0% 39/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).
General disorders Irritability	42.0% 107/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	37.7% 49/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).
General disorders Loss of appetite	26.3% 67/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	23.1% 30/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).
General disorders Temperature (Axillary)	7.1% 18/255 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).	6.9% 9/130 • Solicited local and general symptoms: during the 4-day (Days 0-3) following vaccination. Unsolicited adverse events: during the 31-day (Days 0-30) following vaccination. Serious adverse events: during the entire study period (from Month 0 to Month 1).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

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