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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01245049
• Collaborator: (none)
• Enrollment: 387
• Locations: 13
• Arms: 2
• Duration (Months): 12.1
• Patients Per Site: 29.8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Condition or Disease	Intervention/Treatment	Phase
Acellular Pertussis; Poliomyelitis; Tetanus; Diphtheria	Biological: Boostrix PolioTM; Biological: RepevaxTM; Biological: PriorixTM	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 387 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Mar 27, 2012
• Actual Study Completion Date: Apr 2, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Boostrix PolioTM; Single dose, intramuscular administration.; Biological: PriorixTM; Single dose, intramuscular or subcutaneous administration.
Active Comparator: 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.	Biological: RepevaxTM; Single dose, intramuscular administration.; Biological: PriorixTM; Single dose, intramuscular or subcutaneous administration.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens [At Month 1, one month after the booster vaccination]

   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.

2. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [At Month 1, one month after the booster vaccination]

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

3. Anti-Polio Virus Type 1, 2 and 3 Antibody Titers [At Month 1, one month after the booster vaccination]

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

Secondary Outcome Measures

1. Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

2. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

3. Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

4. Number of Seropositive Subjects for Anti-measles Antibody [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

5. Number of Seropositive Subjects for Anti-mumps Antibody [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

6. Number of Seropositive Subjects for Anti-rubella Antibody [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

7. Anti-D and Anti-T Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

8. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [At Month 0, before the booster vaccination]

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

9. Anti-mumps Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

10. Anti-measles Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

11. Anti-rubella Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

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

12. Anti-Polio Type 1, 2 and 3 Antibody Titers [At Month 0, before the booster vaccination]

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

13. Number of Subjects With a Booster Response to PT, FHA and PRN Antigens [At Month 1, one month after the booster vaccination]

    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.

14. Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens [At Month 1, one month after the booster vaccination]

    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.

15. Number of Seroconverted Subjects for Anti-measles [Before (Month 0) and one month after (Month 1) the booster vaccination]

    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)].

16. Number of Seroconverted Subjects for Anti-mumps [Before (Month 0) and one month after (Month 1) the booster vaccination]

    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)].

17. Number of Subjects With Any Solicited Local Symptoms [During the 4-day (Days 0-3) follow-up period after booster vaccination]

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

18. Number of Subjects With Any Solicited General Symptoms [During the 4-day (Days 0-3) follow-up period after booster vaccination]

    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.

19. Number of Subjects With Any Unsolicited Adverse Events (AEs) [During the 31-day (Days 0-30) follow-up period after booster vaccination]

    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.

20. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (From Day 0 to Month 1)]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 4 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.

• A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).

• Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).

• Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.

• Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Child in care.

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.

• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.

• Previous measles, mumps and/or rubella second dose vaccination.

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.

• Known exposure to measles, mumps and/or rubella within 30 days prior to study start.

• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

• Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation.

• Occurrence of any of the following adverse events after a previous administration of a

DTP vaccine:

• Hypersensitivity reaction to any component of the vaccine;

• Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;

• Fever >= 40°C within 48 hours of vaccination, not due to another identifiable cause;

• Collapse or shock-like state within 48 hours of vaccination;

• Convulsions with or without fever, occurring within 3 days of vaccination.

• Acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	St Austell	Cornwall	United Kingdom	PL26 7RL
2	GSK Investigational Site	Southampton	Hampshire	United Kingdom	SO16 6YD
3	GSK Investigational Site	Axbridge	Somerset	United Kingdom	BS26 2BJ
4	GSK Investigational Site	Taunton	Somerset	United Kingdom	TA1 1XQ
5	GSK Investigational Site	Atherstone	Warwickshire	United Kingdom	CV9 1EU
6	GSK Investigational Site	Bangor		United Kingdom	BT19 1PP
7	GSK Investigational Site	Bolton, Nr Manchester		United Kingdom	BL3 6TL
8	GSK Investigational Site	Bristol		United Kingdom	BS2 8AE
9	GSK Investigational Site	Crumpsall, Manchester		United Kingdom	M8 9JT
10	GSK Investigational Site	Exeter		United Kingdom	EX2 5DW
11	GSK Investigational Site	Lancashire		United Kingdom	BL1 6AP
12	GSK Investigational Site	Oxford		United Kingdom	OX3 7LJ
13	GSK Investigational Site	Randalstown		United Kingdom	BT41 3AE

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• IPD for this study will be made available via the Clinical Study Data Request site.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01245049
• Other Study ID Numbers: 111763
• First Posted: Nov 22, 2010
• Last Update Posted: Aug 17, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: MMR; dTpa-IPV; Boostrix Polio; Repevax; Priorix
• Additional relevant MeSH terms: Diphtheria; Poliomyelitis

Study Results

Participant Flow

Recruitment Details	2 subjects did not receive vaccination.
Pre-assignment Detail	During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	255	130
COMPLETED	254	126
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Boostrix Polio Group	Repevax Group	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	255	130	385
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	3.1 (0.2)	3.1 (0.2)	3.1 (0.2)
Sex: Female, Male (Count of Participants)
Female	123 48.2%	65 50%	188 48.8%
Male	132 51.8%	65 50%	197 51.2%
Race/Ethnicity, Customized (Count of Participants)
African heritage/African American	2 0.8%	4 3.1%	6 1.6%
Asian-Central/South Asian heritage	4 1.6%	4 3.1%	8 2.1%
Asian-South East Asian heritage	3 1.2%	1 0.8%	4 1%
White-Arabic/North African heritage	2 0.8%	1 0.8%	3 0.8%
White-Caucasian/European heritage	226 88.6%	111 85.4%	337 87.5%
Not specified	18 7.1%	9 6.9%	27 7%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens
Description	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.
Time Frame	At Month 1, one month after the booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	177	90
Anti-D	176 69%	90 69.2%
Anti-T	173 67.8%	90 69.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix Polio Group, Repevax Group
	Comments	Non-inferiority in terms of booster response to D
	Type of Statistical Test	Non-Inferiority
	Comments	To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups'difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; -3.55 to 3.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix Polio Group, Repevax Group
	Comments	Non-inferiority in terms of booster response to T
	Type of Statistical Test	Non-Inferiority
	Comments	To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups' difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -2.43 to 4.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame	At Month 1, one month after the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	195	96
Anti-PT	70.1	47.8
Anti-FHA	358.3	164.8
Anti-PRN	151.4	209.8

3. Primary Outcome

Title	Anti-Polio Virus Type 1, 2 and 3 Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	At Month 1, one month after the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	159	81
Anti-Polio 1	2183.3	1876.1
Anti-Polio 2	2693.1	2203.8
Anti-Polio 3	3762.4	4185.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix Polio Group, Repevax Group
	Comments	Immune response difference to anti-Polio 1 antigen
	Type of Statistical Test	Non-Inferiority
	Comments	Criterion for evaluation of the corresponding objective: Upper limit (UL) of the 95% confidence interval (CI) on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) was lower than or equal to (≤) 2.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in adjusted GMT ratio
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix Polio Group, Repevax Group
	Comments	Immune response difference to anti-Polio 2 antigen
	Type of Statistical Test	Non-Inferiority
	Comments	Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in adjusted GMT ratio
	Estimated Value	0.78
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Boostrix Polio Group, Repevax Group
	Comments	Immune response difference to anti-Polio 3 antigen
	Type of Statistical Test	Non-Inferiority
	Comments	Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in adjusted GMT ratio
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; 0.93 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
Description	A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	195	96
Anti-D, M0	136 53.3%	75 57.7%
Anti-D, M1	195 76.5%	96 73.8%
Anti-T, M0	116 45.5%	63 48.5%
Anti-T, M1	194 76.1%	96 73.8%

5. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Description	A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	195	96
Anti-PT, M0	31 12.2%	18 13.8%
Anti-PT, M1	194 76.1%	96 73.8%
Anti-FHA, M0	112 43.9%	60 46.2%
Anti-FHA, M1	195 76.5%	95 73.1%
Anti-PRN, M0	61 23.9%	37 28.5%
Anti-PRN, M1	194 76.1%	94 72.3%

6. Secondary Outcome

Title	Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Description	A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres ≥ the value of 8.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	160	81
Anti-polio 1, M0	95 37.3%	49 37.7%
Anti-polio 1, M1	156 61.2%	75 57.7%
Anti-polio 2, M0	109 42.7%	55 42.3%
Anti-polio 2, M1	123 48.2%	71 54.6%
Anti-polio 3, M0	100 39.2%	47 36.2%
Anti-polio 3, M1	158 62%	81 62.3%

7. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-measles Antibody
Description	A seropositive subject was defined as a subject with anti-measles antibody titers ≥ 150 mIU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	159	76
Anti-Measles, M0	155 60.8%	74 56.9%
Anti-Measles, M1	136 53.3%	68 52.3%

8. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-mumps Antibody
Description	A seropositive subject was defined as a subject with anti-mumps antibody titers ≥ 231 U/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	156	76
Anti-Mumps, M0	140 54.9%	69 53.1%
Anti-Mumps, M1	133 52.2%	68 52.3%

9. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-rubella Antibody
Description	A seropositive subject was defined as a subject with anti-rubella antibody titers ≥ 4 IU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	158	76
Anti-Rubella, M0	158 62%	76 58.5%
Anti-Rubella, M1	134 52.5%	68 52.3%

10. Secondary Outcome

Title	Anti-D and Anti-T Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	195	96
Anti-D, M0	0.228	0.259
Anti-D, M1	8.113	11.948
Anti-T, M0	0.209	0.241
Anti-T, M1	6.787	9.194

11. Secondary Outcome

Title	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame	At Month 0, before the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	175	91
Anti-PT	3.4	3.2
Anti-FHA	12.9	10.7
Anti-PRN	4.3	4.3

12. Secondary Outcome

Title	Anti-mumps Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	156	76
Anti-Mumps, M0	1035.3	971.7
Anti-Mumps, M1	6801.9	6219.4

13. Secondary Outcome

Title	Anti-measles Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	159	76
Anti-Measles, M0	2644	2702.6
Anti-Measles, M1	3817.7	3798

14. Secondary Outcome

Title	Anti-rubella Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	158	76
Anti-Rubella, M0	66.5	72.6
Anti-Rubella, M1	134.3	130.3

15. Secondary Outcome

Title	Anti-Polio Type 1, 2 and 3 Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	At Month 0, before the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	160	79
Anti-Polio 1	12.8	13.2
Anti-Polio 2	15.5	14.6
Anti-Polio 3	15.4	14.5

16. Secondary Outcome

Title	Number of Subjects With a Booster Response to PT, FHA and PRN Antigens
Description	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.
Time Frame	At Month 1, one month after the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	175	90
Anti-PT	154 60.4%	73 56.2%
Anti-FHA	165 64.7%	79 60.8%
Anti-PRN	169 66.3%	89 68.5%

17. Secondary Outcome

Title	Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens
Description	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.
Time Frame	At Month 1, one month after the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	131	68
Anti-Polio 1	129 50.6%	63 48.5%
Anti-Polio 2	99 38.8%	59 45.4%
Anti-Polio 3	124 48.6%	68 52.3%

18. Secondary Outcome

Title	Number of Seroconverted Subjects for Anti-measles
Description	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)].
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	4	2
Anti-measles, M0	0 0%	0 0%
Anti-measles, M1	4 1.6%	2 1.5%

19. Secondary Outcome

Title	Number of Seroconverted Subjects for Anti-mumps
Description	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)].
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	16	7
Anti-mumps, M0	0 0%	0 0%
Anti-mumps, M1	11 4.3%	6 4.6%

20. Secondary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	255	125
Any Pain	127 49.8%	70 53.8%
Any Redness	146 57.3%	73 56.2%
Any Swelling	92 36.1%	53 40.8%

21. Secondary Outcome

Title	Number of Subjects With Any Solicited General Symptoms
Description	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.
Time Frame	During the 4-day (Days 0-3) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	255	125
Any Drowsiness	77 30.2%	39 30%
Any Irritability	107 42%	49 37.7%
Any Loss of appetite	67 26.3%	30 23.1%
Any Temperature	18 7.1%	9 6.9%

22. Secondary Outcome

Title	Number of Subjects With Any Unsolicited Adverse Events (AEs)
Description	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.
Time Frame	During the 31-day (Days 0-30) follow-up period after booster vaccination

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	255	130
Count of Participants [Participants]	88 34.5%	36 27.7%

23. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	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.
Time Frame	During the entire study period (From Day 0 to Month 1)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Boostrix Polio Group	Repevax Group
Arm/Group Description	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.	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.
Measure Participants	255	130
Count of Participants [Participants]	1 0.4%	0 0%

Adverse Events

Time Frame	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).
Arm/Group Title	Boostrix Polio Group		Repevax Group
Arm/Group Description	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.		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.
All Cause Mortality
	Boostrix Polio Group		Repevax Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/255 (0%)		0/130 (0%)
Serious Adverse Events
	Boostrix Polio Group		Repevax Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/255 (0.4%)		0/130 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/255 (0.4%)		0/130 (0%)
Other (Not Including Serious) Adverse Events
	Boostrix Polio Group		Repevax Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	215/255 (84.3%)		108/130 (83.1%)
General disorders
Pain	127/255 (49.8%)		70/130 (53.8%)
Redness	146/255 (57.3%)		73/130 (56.2%)
Swelling	92/255 (36.1%)		53/130 (40.8%)
Drowsiness	77/255 (30.2%)		39/130 (30%)
Irritability	107/255 (42%)		49/130 (37.7%)
Loss of appetite	67/255 (26.3%)		30/130 (23.1%)
Temperature (Axillary)	18/255 (7.1%)		9/130 (6.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.