Trial Outcomes & Findings for Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children. (NCT NCT00871000)

NCT ID: NCT00871000

Last Updated: 2018-06-06

Results Overview

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 303 participants
• Primary outcome timeframe: At Month 1, one month post-vaccination
• Results posted on: 2018-06-06

Participant Flow

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, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Study STARTED	151	152
Overall Study COMPLETED	150	152
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Boostrix Polio Group Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

Baseline characteristics by cohort

Measure	Boostrix Polio Group n=151 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=152 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Total n=303 Participants Total of all reporting groups
Age, Continuous	5 Years STANDARD_DEVIATION 0.14 • n=5 Participants	5 Years STANDARD_DEVIATION 0.14 • n=7 Participants	5 Years STANDARD_DEVIATION 0.14 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	68 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	84 Participants n=7 Participants	154 Participants n=5 Participants
Race/Ethnicity, Customized African heritage/African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian heritage	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European heritage	147 Participants n=5 Participants	147 Participants n=7 Participants	294 Participants n=5 Participants
Race/Ethnicity, Customized Not specified	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-D	9.207 IU/mL Interval 8.057 to 10.522	21.393 IU/mL Interval 19.165 to 23.88
Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-T	12.527 IU/mL Interval 10.957 to 14.323	11.07 IU/mL Interval 9.872 to 12.413

PRIMARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-Polio 1	1145.6 Titers Interval 978.7 to 1340.9	948 Titers Interval 817.5 to 1099.4
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-Polio 2	1076.4 Titers Interval 908.7 to 1274.9	1315.3 Titers Interval 1123.1 to 1540.3
Anti-poliovirus Types 1, 2 and 3 Antibody Titres Anti-Polio 3	1937.8 Titers Interval 1631.4 to 2301.8	1657.3 Titers Interval 1385.5 to 1982.6

PRIMARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 Anti-Polio 1	139 Participants	144 Participants
Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 Anti-Polio 2	139 Participants	144 Participants
Number of Seroprotected Subjects Against Polio Types 1, 2 and 3 Anti-Polio 3	138 Participants	144 Participants

PRIMARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Seropositive Subjects for Anti-D and Anti-T Antibodies Anti-D	139 Participants	144 Participants
Number of Seropositive Subjects for Anti-D and Anti-T Antibodies Anti-T	139 Participants	144 Participants

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens Anti-D	138 Participants	144 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens Anti-T	137 Participants	143 Participants

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	59.8 EL.U/mL Interval 52.2 to 68.5	75.9 EL.U/mL Interval 65.7 to 87.7
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	556.2 EL.U/mL Interval 491.4 to 629.5	613.5 EL.U/mL Interval 547.0 to 688.2
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	354.8 EL.U/mL Interval 280.2 to 449.4	7.8 EL.U/mL Interval 6.5 to 9.2

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN	138 Participants	87 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT	139 Participants	144 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA	139 Participants	144 Participants

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=146 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-measles	139 Participants	146 Participants
Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-mumps	139 Participants	144 Participants
Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-rubella	139 Participants	145 Participants
Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-varicella	135 Participants	140 Participants

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=146 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Anti-measles and Anti-varicella Antibody Concentrations Anti-measles	2743.9 mIU/mL Interval 2411.4 to 3122.2	2863 mIU/mL Interval 2534.6 to 3233.9
Anti-measles and Anti-varicella Antibody Concentrations Anti-varicella	856.7 mIU/mL Interval 671.8 to 1092.4	909.9 mIU/mL Interval 721.0 to 1148.2

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=146 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Anti-mumps Antibody Concentrations	4141.3 U/mL Interval 3590.5 to 4776.5	3837.6 U/mL Interval 3275.1 to 4496.7

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=146 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Anti-rubella Antibody Concentrations	154.5 IU/mL Interval 141.3 to 168.9	162.5 IU/mL Interval 145.8 to 181.0

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 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-vaccination concentration.

Outcome measures

Measure	Boostrix Polio Group n=137 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=143 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Booster Responses to Anti-D and Anti-T Anti-D	130 Participants	136 Participants
Number of Subjects With Booster Responses to Anti-D and Anti-T Anti-T	137 Participants	142 Participants

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.

Outcome measures

Measure	Boostrix Polio Group n=139 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=144 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 Anti-Polio 1	115 Participants	112 Participants
Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 Anti-Polio 2	113 Participants	122 Participants
Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3 Anti-Polio 3	126 Participants	127 Participants

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the 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-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-vaccination concentration.

Outcome measures

Measure	Boostrix Polio Group n=137 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=143 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Anti-PT	123 Participants	130 Participants
Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	129 Participants	134 Participants
Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	129 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 1, one month post-vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.

Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.

Outcome measures

Measure	Boostrix Polio Group n=36 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=34 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-measles	2 Participants	1 Participants
Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-mumps	13 Participants	12 Participants
Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-rubella	0 Participants	0 Participants
Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Anti-varicella	35 Participants	32 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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=151 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=152 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Any Solicited Local Symptoms Any Swelling	55 Participants	62 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain	96 Participants	96 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	58 Participants	66 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Assessed solicited general symptoms were fatigue, gastrointestinal, headache 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=151 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=152 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Any Solicited General Symptoms Any Fatigue	40 Participants	36 Participants
Number of Subjects With Any Solicited General Symptoms Any Gastrointestinal	23 Participants	15 Participants
Number of Subjects With Any Solicited General Symptoms Any Headache	18 Participants	20 Participants
Number of Subjects With Any Solicited General Symptoms Any Temperature	32 Participants	30 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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=151 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=152 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	23 Participants	20 Participants

SECONDARY outcome

Timeframe: During the whole study period (from Month 0 to Month 1)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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=151 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=152 Participants Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants

Adverse Events

Boostrix Polio Group

Serious events: 0 serious events

Other events: 117 other events

Deaths: 0 deaths

Tetravac Group

Serious events: 0 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Boostrix Polio Group n=151 participants at risk Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.	Tetravac Group n=152 participants at risk Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
General disorders Pain	63.6% 96/151 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).	63.2% 96/152 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Redness	38.4% 58/151 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).	43.4% 66/152 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Swelling	36.4% 55/151 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).	40.8% 62/152 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Fatigue	26.5% 40/151 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).	23.7% 36/152 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Gastrointestinal	15.2% 23/151 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).	9.9% 15/152 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Headache	11.9% 18/151 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).	13.2% 20/152 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Temperature	21.2% 32/151 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).	19.7% 30/152 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).

Additional Information

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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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