Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01362322
• Collaborator: (none)
• Enrollment: 671
• Locations: 3
• Arms: 2
• Duration (Months): 14.1
• Patients Per Site: 223.7
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.

Condition or Disease	Intervention/Treatment	Phase
Diphtheria; Tetanus; Acellular Pertussis	Biological: Boostrix TM (new syringe presentation); Biological: Boostrix TM (previous syringe presentation)	Phase 4

Detailed Description

The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care.

The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.

Study Design

• Study Type: Interventional
• Actual Enrollment: 671 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Sep 3, 2012
• Actual Study Completion Date: Sep 3, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BOOSTRIX NEW GROUP Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Biological: Boostrix TM (new syringe presentation); Single dose, intramuscular administration in a new syringe presentation
Active Comparator: BOOSTRIX PREV GROUP Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.	Biological: Boostrix TM (previous syringe presentation); Single dose, intramuscular administration in previous syringe presentation

Outcome Measures

Primary Outcome Measures

1. Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [At Month 1]

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

2. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations [At Month 1]

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

3. Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [At Day 0]

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

4. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations [At Day 0]

   Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).

Secondary Outcome Measures

1. Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens [At Day 0 (PRE) and at Month 1 (POST)]

   A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).

2. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens [At Day 0 (PRE) vaccine and at Month 1 (POST)]

   A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).

3. Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) [At Day 0 (PRE) vaccine and at Month 1 (POST)]

   A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).

4. Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies [At Month 1]

   Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the 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 4 times the pre-vaccination concentration.

5. Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. [At Month 1]

   Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 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 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.

6. Number of Subjects With Any Solicited Local Symptoms [Within 4 days (Days 0-3) post vaccination period]

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

7. Number of Subjects With Unsolicited Adverse Events (AEs) [Within 31 days (Days 0-30) post]

   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.

8. Number of Subjects With Any Solicited General Symptoms [Within 4 days (Days 0-3) post vaccination period]

   Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.

9. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (Day 0 - 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: 10 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject's parent(s)/Legally Acceptable Representative(s) and subjects who the investigator believes can and are willing to comply with the requirements of the protocol.

• A male or female between 10 and 15 years of age at the time of booster vaccination.

• Prior to protocol amendment 2, subjects who have previously received 5 doses of diphtheria-tetanus-pertussis vaccine (whole cell/acellular [w/a]) as part of primary and booster vaccination, in line with local recommendations.

• After protocol amendment 2, subjects who have previously received 6 doses of either DT(P) (w/a)/ dTpa vaccine as part of primary and booster vaccination, in line with local recommendations.

• Healthy subjects as determined by the investigator based on medical history and clinical examination before entering into the study.

• Written informed consent to be obtained before study entry from the parent(s)/ Legally Acceptable Representative(s) of the subject.

• Written informed assent to be obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative(s), if required by local regulations.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has a negative pregnancy test on the day of vaccination,

• if sexually active, has practiced adequate contraception for 30 days prior to vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after booster vaccination.

Exclusion Criteria:

• Child in care.

• Use of any investigational or non-registered product other than the study vaccine 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 dose.

• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose of vaccine - with the exception of influenza vaccine which is allowed up to 7 days before the study vaccine dose, or planned in the period ≥ 7 days after the study vaccine dose.

• 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.

• A history of previous or intercurrent diphtheria, tetanus or pertussis disease.

• A history of vaccination against these diseases since the 5th or the 6th dose of DT(P)/dT(pa). For subjects who have received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine, the interval between the last DT(P)/dT(pa) vaccination and the administration of the study vaccine should be at least 18 months.

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

Boostrix vaccine :

• known hypersensitivity to any component of the vaccine, or have shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines,

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

• transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.

• Any confirmed or suspected immunosuppressive or immunodeficient 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 immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

• Acute disease and/or fever at the time of enrolment.

• Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptive precautions, if applicable.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Santiago		Chile
2	GSK Investigational Site	Monterrey	Nuevo León	Mexico	64460
3	GSK Investigational Site	Estado de Mexico		Mexico	55075

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01362322
• Other Study ID Numbers: 114778
• First Posted: May 30, 2011
• Last Update Posted: Aug 10, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: dTpa; Boostrix
• Additional relevant MeSH terms: Diphtheria

Study Results

Participant Flow

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Period Title: Overall Study
STARTED	335	336
COMPLETED	330	329
NOT COMPLETED	5	7

Baseline Characteristics

Arm/Group Title	Boostrix New Group	Boostrix Prev Group	Total
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.	Total of all reporting groups
Overall Participants	335	336	671
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	11.9 (1.59)	11.9 (1.61)	11.9 (1.6)
Sex: Female, Male (Count of Participants)
Female	179 53.4%	178 53%	357 53.2%
Male	156 46.6%	158 47%	314 46.8%

Outcome Measures

1. Primary Outcome

Title	Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Description	Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame	At Month 1

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-D	6.784	6.493
Anti-T	18.937	18.515

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix New Group, Boostrix Prev Group
	Comments	Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted radio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix New Group, Boostrix Prev Group
	Comments	Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted Ratio
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.86 to 1.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

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

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-PT	140.2	125.9
Anti-FHA	1080.2	1013.7
Anti-PRN	652.4	619.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix New Group, Boostrix Prev Group
	Comments	Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix New Group, Boostrix Prev Group
	Comments	Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted Ratio
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Boostrix New Group, Boostrix Prev Group
	Comments	Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Description	Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame	At Day 0

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-D	0.472	0.456
Anti-T	0.956	0.899

4. Primary Outcome

Title	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations
Description	Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
Time Frame	At Day 0

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-PT PRE	7.5	7.2
Anti-FHA PRE	48.9	49.4
Anti-PRN PRE	14	13.4

5. Secondary Outcome

Title	Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens
Description	A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).
Time Frame	At Day 0 (PRE) and at Month 1 (POST)

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-D PRE	284 84.8%	286 85.1%
Anti-D POST	320 95.5%	319 94.9%
Anti-T PRE	311 92.8%	314 93.5%
Anti-T POST	321 95.8%	319 94.9%

6. Secondary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
Description	A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).
Time Frame	At Day 0 (PRE) vaccine and at Month 1 (POST)

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-D PRE	83 24.8%	89 26.5%
Anti-D POST	315 94%	310 92.3%
Anti-T PRE	151 45.1%	143 42.6%
Anti-T POST	321 95.8%	319 94.9%

7. Secondary Outcome

Title	Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)
Description	A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
Time Frame	At Day 0 (PRE) vaccine and at Month 1 (POST)

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-PT PRE	175 52.2%	175 52.1%
Anti-PT POST	316 94.3%	315 93.8%
Anti-FHA PRE	310 92.5%	310 92.3%
Anti-FHA POST	319 95.2%	319 94.9%
Anti-PRN PRE	269 80.3%	272 81%
Anti-PRN POST	321 95.8%	318 94.6%

8. Secondary Outcome

Title	Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies
Description	Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the 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 4 times the pre-vaccination concentration.
Time Frame	At Month 1

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	319
Anti-D	257 76.7%	252 75%
Anti-T	266 79.4%	270 80.4%

9. Secondary Outcome

Title	Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.
Description	Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 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 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.
Time Frame	At Month 1

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 New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	321	318
Anti-PT	298 89%	295 87.8%
Anti-FHA	305 91%	304 90.5%
Anti-PRN	315 94%	317 94.3%

10. 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	Within 4 days (Days 0-3) post vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.

Arm/Group Title	Boostrix New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	330	329
Any Pain	237 70.7%	248 73.8%
Any Redness	113 33.7%	94 28%
Any Swelling	98 29.3%	90 26.8%

11. Secondary Outcome

Title	Number of Subjects With 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	Within 31 days (Days 0-30) post

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.

Arm/Group Title	Boostrix New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	335	336
Count of Participants [Participants]	44 13.1%	45 13.4%

12. Secondary Outcome

Title	Number of Subjects With Any Solicited General Symptoms
Description	Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.
Time Frame	Within 4 days (Days 0-3) post vaccination period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.

Arm/Group Title	Boostrix New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	330	329
Any Fatigue	83 24.8%	86 25.6%
Any Gastrointestinal symptoms	32 9.6%	42 12.5%
Any Headache	88 26.3%	108 32.1%
Any Temperature	9 2.7%	6 1.8%

13. 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 (Day 0 - Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.

Arm/Group Title	Boostrix New Group	Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Measure Participants	335	336
Count of Participants [Participants]	1 0.3%	0 0%

Adverse Events

Time Frame	Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
Arm/Group Title	Boostrix New Group		Boostrix Prev Group
Arm/Group Description	Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.		Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
All Cause Mortality
	Boostrix New Group		Boostrix Prev Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Boostrix New Group		Boostrix Prev Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/335 (0.3%)		0/336 (0%)
Injury, poisoning and procedural complications
Injury	1/335 (0.3%)	1	0/336 (0%)	0
Other (Not Including Serious) Adverse Events
	Boostrix New Group		Boostrix Prev Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	263/335 (78.5%)		279/336 (83%)
Gastrointestinal disorders
Gastrointestinal disorder	32/335 (9.6%)	32	42/336 (12.5%)	42
General disorders
Fatigue	83/335 (24.8%)	83	86/336 (25.6%)	86
Pain	237/335 (70.7%)	237	248/336 (73.8%)	248
Swelling	98/335 (29.3%)	98	90/336 (26.8%)	90
Nervous system disorders
Headache	89/335 (26.6%)	90	109/336 (32.4%)	110
Skin and subcutaneous tissue disorders
Erythema	113/335 (33.7%)	113	94/336 (28%)	94

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.