US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00282295
• Collaborator: (none)
• Enrollment: 1,344
• Locations: 24
• Arms: 3
• Actual Duration (Months): 6.4
• Patients Per Site: 56
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief Summary

New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed) and MCV4 (Meningococcal conjugate vaccine against serotypes A, C, Y and W-135) vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated. Therefore, this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age.

Condition or Disease	Intervention/Treatment	Phase
Acellular Pertussis; Tetanus; Diphtheria	Biological: Boostrix®; Biological: Menactra™	Phase 4

Detailed Description

A phase IV, randomized, partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKline's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap Boostrix®] co-administered intramuscularly with Aventis-Pasteur's meningococcal (serogroups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra™) as compared to the administration of either vaccine alone in healthy adolescents 11-18 years of age. "Experimental design: Prospective, randomized, controlled multicenter study with three groups:

Group 1: Boostrix + Menactra on Day 0, blood samples at Month 0 and Month 1 Group 2: Boostrix on Day 0, Menactra at Month 1, blood samples at Month 0, Month 1, and Month 2 Group 3: Menactra on Day 0, Boostrix at Month 1, blood samples at Month 0, Month 1 and Month 2

Treatment allocation: randomized 1:1:1 Type of study: self-contained Duration of the study:

Approximately one month for each subject in Group 1 and approximately two months for each subject in the Group 2 and Group 3."

Study Design

• Study Type: Interventional
• Actual Enrollment: 1344 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Safety & Immunogenicity of a Booster Dose of dTPa Vaccine (Boostrix®) Co-admnd. With Aventis Pasteur's Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Vaccine (Menactra™) vs Admn. of Either Vaccine Alone in Healthy Adolescents
• Actual Study Start Date: Jan 25, 2006
• Actual Primary Completion Date: Aug 8, 2006
• Actual Study Completion Date: Aug 8, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Boostrix + Menactra Group Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.	Biological: Boostrix®; GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.; Biological: Menactra™; Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
Experimental: Boostrix-Menactra Group Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Biological: Boostrix®; GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.; Biological: Menactra™; Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.
Experimental: Menactra-Boostrix Group Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Biological: Boostrix®; GlaxoSmithKline (GSK) Biologicals' registered tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.; Biological: Menactra™; Aventis Pasteur's me ningococcal polysaccharide diphtheria toxoid conjugate vaccine containing Neisseria meningitidis serogroups, A, C, Y and W-135.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [At Month 1 (post Boostrix vaccination)]

   Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).

2. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [At Month 1 (post Boostrix vaccination)]

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

3. Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies [At Month 1 (post Boostrix vaccination)]

   Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.

4. Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135) [One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)]

   Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.

Secondary Outcome Measures

1. Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [At Day 0 (PRE) before Boostrix vaccination]

   Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).

2. Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [At Month 2 (one month post Boostrix vaccination)]

   Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).

3. Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens [PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)]

   Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).

4. Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies [At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)]

   Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.

5. Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)]

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

6. Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations [At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)]

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

7. Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies [At Month 2 (one month post Boostrix vaccination)]

   Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.

8. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [At Day 0 before (PRE) Boostrix vaccination]

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

9. Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations [At Month 2 (one month post Boostrix vaccination)]

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

10. Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies [PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)]

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

11. Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies [At Month 2 (one month after vaccination with Menactra vaccine)]

    Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine.

12. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [Within 4-days (Day 0-3) after each dose and across doses]

    Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).

13. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Within 4-days (Days 0-3) after each dose and across doses]

    Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms [gastro sympt]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.

14. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Within the 31-day (Days 0-30) period after each 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. Grade 3 AE =An AE which prevented normal, everyday activities. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.

15. Number of Subjects With Serious Adverse Events (SAEs) [Throughout the entire study period (Day 0 - Month 2)]

    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: 11 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

• Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases according to the recommended vaccination schedule at the time.

• Females of childbearing potential at the time of study entry are required to have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or use adequate contraceptive precautions for one month prior to vaccination. Subjects also are required to agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

• Administration of a pre-school booster of DTP vaccine within the previous 5 years

• Administration of a diphteria-tetanus (Td) booster within the previous 5 years

• Previous vaccination against N. meningitidis

• Hypersensitivity to latex

• History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphteria toxoid or pertussis-containing vaccine or any component of the study vaccines

• History of encephalopathy (e.g. coma, decreased level of consciousness, prolonged seizures) within seven days of administration of a previous dose of pertussis vaccine taht is not attributable to another identifiable cause

• Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized

• Previous history of Guillain-Barré syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Chandler	Arizona	United States	85224
2	GSK Investigational Site	Little Rock	Arkansas	United States	72205
3	GSK Investigational Site	Fountain Valley	California	United States	92708
4	GSK Investigational Site	Golden	Colorado	United States	80401
5	GSK Investigational Site	Marietta	Georgia	United States	30062
6	GSK Investigational Site	Louisville	Kentucky	United States	40202
7	GSK Investigational Site	Annapolis	Maryland	United States	21401
8	GSK Investigational Site	Frederick	Maryland	United States	21702
9	GSK Investigational Site	Omaha	Nebraska	United States	68178
10	GSK Investigational Site	Whitehouse Station	New Jersey	United States	08889
11	GSK Investigational Site	Pittsford	New York	United States	14534
12	GSK Investigational Site	Rochester	New York	United States	14620
13	GSK Investigational Site	Akron	Ohio	United States	44308-1062
14	GSK Investigational Site	University Heights	Ohio	United States	44118
15	GSK Investigational Site	Erie	Pennsylvania	United States	16505
16	GSK Investigational Site	Erie	Pennsylvania	United States	16508
17	GSK Investigational Site	Greenville	Pennsylvania	United States	16125
18	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19140
19	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15227
20	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15241
21	GSK Investigational Site	Temple	Texas	United States	76508
22	GSK Investigational Site	Salt Lake City	Utah	United States	84109
23	GSK Investigational Site	Salt Lake City	Utah	United States	84121
24	GSK Investigational Site	West Jordan	Utah	United States	84084

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: NCT00282295
• Other Study ID Numbers: 105753
• First Posted: Jan 26, 2006
• 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: tetanus; pertussis; Prophylaxis; meningococcus; diptheria
• Additional relevant MeSH terms: Whooping Cough; Tetanus; Diphtheria; Tetany

Study Results

Participant Flow

Pre-assignment Detail	Out of 1344 subjects enrolled, only 1341 were vaccinated.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Period Title: Overall Study
STARTED	446	446	449
COMPLETED	443	429	441
NOT COMPLETED	3	17	8

Baseline Characteristics

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group	Total
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-administered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Total of all reporting groups
Overall Participants	446	446	449	1341
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	13.5 (2.31)	13.2 (2.07)	13.4 (2.27)	13.37 (2.22)
Sex: Female, Male (Count of Participants)
Female	210 47.1%	233 52.2%	223 49.7%	666 49.7%
Male	236 52.9%	213 47.8%	226 50.3%	675 50.3%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Description	Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Time Frame	At Month 1 (post Boostrix vaccination)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available and (&) randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	428	415
Anti-D	427 95.7%	405 90.8%
Anti-T	425 95.3%	412 92.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was greater than (>) the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	2.18
	Confidence Interval	(2-Sided) 95%; 0.79 to 4.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The non-inferiority objective was demonstrated if the lower limit was greater than (>) the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -1.4 to 1.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Description	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 (post Boostrix vaccination)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	428	415
Anti-PT	63.9	74.3
Anti-FHA	444.8	575.8
Anti-PRN	253.4	366.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was greater than (>) the pre-defined limit of 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted GMC ratio
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted GMC ratio
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.69 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of 0.67
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted GMC ratio
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95%; 0.54 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Description	Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.
Time Frame	At Month 1 (post Boostrix vaccination)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	427	414
Anti-PT, Total	322 72.2%	333 74.7%
Anti-FHA, Total	385 86.3%	388 87%
Anti-PRN, Total	398 89.2%	394 88.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-4.38
	Confidence Interval	(2-Sided) 95%; -9.91 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-3.39
	Confidence Interval	(2-Sided) 95%; -7.03 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in booster response rate
	Estimated Value	-1.96
	Confidence Interval	(2-Sided) 95%; -5.25 to -1.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Number of Subjects With Vaccine Responses for Serum Bactericidal Assay Against Neisseria Meningitidis Serogroups A (rSBA-MenA), C (rSBA-MenC), Y (rSBA-MenY) and W-135 (rSBA-MenW-135)
Description	Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra vaccination; and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with Menactra vaccine.
Time Frame	One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	413	418
rSBA-MenA, Total	329 73.8%	328 73.5%
rSBA-MenC, Total	390 87.4%	383 85.9%
rSBA-MenY, Total	369 82.7%	358 80.3%
rSBA-MenW-135, Total	404 90.6%	394 88.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in vaccine response rate
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -4.85 to 4.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in vaccine response rate
	Estimated Value	1.69
	Confidence Interval	(2-Sided) 95%; -1.69 to 5.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in vaccine response rate
	Estimated Value	1.82
	Confidence Interval	() 95%; -2.58 to 6.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Boostrix + Menactra Group, Boostrix-Menactra Group
	Comments	Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in vaccine response rate
	Estimated Value	3.56
	Confidence Interval	(2-Sided) 95%; 0.96 to 6.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Description	Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Time Frame	At Day 0 (PRE) before Boostrix vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	427	416	431
ANTI-D, PRE	109 24.4%	93 20.9%	120 26.7%
ANTI-T, PRE	201 45.1%	181 40.6%	195 43.4%

6. Secondary Outcome

Title	Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Description	Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).
Time Frame	At Month 2 (one month post Boostrix vaccination)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	429
Anti-D	428 96%
Anti-T	426 95.5%

7. Secondary Outcome

Title	Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Description	Cut-off values assessed were greater than or equal to 0.1 international units per milliliter (IU/m L).
Time Frame	PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	428	416	431
Anti-D, PRE	399 89.5%	383 85.9%	391 87.1%
Anti-T, PRE	423 94.8%	409 91.7%	423 94.2%
ANTI-D, POST	428 96%	415 93%	429 95.5%
ANTI-T, POST	428 96%	415 93%	429 95.5%

8. Secondary Outcome

Title	Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Description	Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 0.1 IU/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥ 0.4 IU/mL), one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.
Time Frame	At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	427	414	428
Anti-D, Total	422 94.6%	377 84.5%	422 94%
Anti-T, Total	310 69.5%	330 74%	329 73.3%

9. Secondary 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	PRE (Day 0) and one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	428	416	431
Anti-D, PRE	0.5	0.5	0.5
Anti-D, POST	40.1	10.2	27.3
Anti-T, PRE	1.0	0.8	0.9
Anti-T, POST	9.5	12.7	12.2

10. Secondary 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 one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	411	430
Anti-D	16.5	41.6
Anti-T	10.0	0.9

11. Secondary Outcome

Title	Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies
Description	Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off concentration of 5 EL.U/mL): antibody concentrations at least four times the cut-off (postvaccination concentration ≥20 EL.U/mL) one month after vaccination with the Boostrix vaccine; for initially seropositive subjects with pre-vaccination concentration ≥5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination with the Boostrix vaccine; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration one month after vaccination with the Boostrix vaccine.
Time Frame	At Month 2 (one month post Boostrix vaccination)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	428
Anti-PT, Total	338 75.8%
Anti-FHA, Total	405 90.8%
Anti-PRN, Total	414 92.8%

12. Secondary Outcome

Title	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and 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 before (PRE) Boostrix vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-administered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	427	416	431
Anti-PT	8.6	10.0	10.3
Anti-FHA	46.5	43.8	47.8
Anti-PRN	12.5	10.6	12.0

13. Secondary Outcome

Title	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and 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 Month 2 (one month post Boostrix vaccination)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity,which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol

Arm/Group Title	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	429
Anti-PT	77.8
ANTI-FHA	653.0
Anti-PRN	412.5

14. Secondary Outcome

Title	Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies
Description	Antibody titers are presented as geometric mean titers (GMTs).
Time Frame	PRE (Day 0) and one month POST Menactra vaccination (Month 2 for Boostrix + Menactra Group and Boostrix-Menactra Group / Month 1 for Menactra-Boostrix Group)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	424	408	427
rSBA-MenA, PRE	533.4	490.8	449.4
rSBA-MenA, POST	10406.1	7220.0	9466.3
rSBA-MenC, PRE	21.0	16.4	18.7
rSBA-MenC, POST	2760.2	1137.0	2702.8
rSBA-MenY, PRE	53.8	51.4	56.2
rSBA-MenY, POST	3244.2	1470.7	3022.8
rSBA-MenW-135, PRE	23.7	28.0	32.2
rSBA-MenW-135, POST	4822.1	2143.1	4154.3

15. Secondary Outcome

Title	Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies
Description	Vaccine responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below the cut-off titer of 8): antibody titers at least four times the cut-off (post-vaccination concentration ≥ 32) one month after vaccination with Menactra the vaccine, and for initially seropositive subjects (pre-vaccination titer ≥ 8): antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination with the Menactra vaccine.
Time Frame	At Month 2 (one month after vaccination with Menactra vaccine)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects with immunogenicity data available & randomization code not broken who had received at least 1 dose of study vaccine (known administration site) & had not received a vaccine not specified or forbidden by the protocol.

Arm/Group Title	Boostrix-Menactra Group
Arm/Group Description	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	396
rSBA-MenA, Total	300 67.3%
rSBA-MenC, Total	351 78.7%
rSBA-MenY, Total	325 72.9%
rSBA-MenW-135, Total	360 80.7%

16. Secondary Outcome

Title	Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling with diameter ≥ 50 millimeters (mm).
Time Frame	Within 4-days (Day 0-3) after each dose and across doses

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 with the symptom sheet completed.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	441	433	446
Pain, Any, Dose 1	331 74.2%	304 68.2%	236 52.6%
Pain, Grade 3, Dose 1	26 5.8%	14 3.1%	6 1.3%
Redness, Any, Dose 1	118 26.5%	111 24.9%	84 18.7%
Redness, ≥ 50 mm, Dose 1	10 2.2%	1 0.2%	4 0.9%
Swelling, Any, Dose 1	99 22.2%	78 17.5%	56 12.5%
Swelling, ≥ 50 mm, Dose 1	8 1.8%	7 1.6%	5 1.1%
Pain, Any, Dose 2	NA NaN	260 58.3%	211 47%
Pain, Grade 3, Dose 2	NA NaN	13 2.9%	4 0.9%
Redness, Any, Dose 2	NA NaN	85 19.1%	79 17.6%
Redness, ≥ 50 mm, Dose 2	NA NaN	8 1.8%	2 0.4%
Swelling, Any, Dose 2	NA NaN	64 14.3%	53 11.8%
Swelling, ≥ 50 mm, Dose 2	NA NaN	9 2%	3 0.7%
Pain, Any, Across doses	331 74.2%	343 76.9%	291 64.8%
Pain, Grade 3, Across doses	26 5.8%	26 5.8%	9 2%
Redness, Any, Across doses	118 26.5%	141 31.6%	119 26.5%
Redness, ≥ 50 mm, Across doses	10 2.2%	8 1.8%	6 1.3%
Swelling, Any, Across doses	99 22.2%	105 23.5%	84 18.7%
Swelling, ≥ 50 mm, Across doses	8 1.8%	13 2.9%	8 1.8%

17. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms [gastro sympt]. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than (>) 39° C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.
Time Frame	Within 4-days (Days 0-3) after each dose and across doses

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 with the symptom sheet completed.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	446	446	449
Fatigue, Any, Dose 1	150 33.6%	139 31.2%	114 25.4%
Fatigue, Grade 3, Dose 1	13 2.9%	9 2%	5 1.1%
Fatigue, Related, Dose 1	120 26.9%	113 25.3%	86 19.2%
Fever (orally), Any, Dose 1	23 5.2%	15 3.4%	21 4.7%
Fever (orally), Grade 3, Dose 1	2 0.4%	1 0.2%	0 0%
Fever (orally), Related, Dose 1	20 4.5%	8 1.8%	16 3.6%
Gastro sympt., Any, Dose 1	67 15%	63 14.1%	60 13.4%
Gastro sympt, Grade 3, Dose 1	4 0.9%	4 0.9%	2 0.4%
Gastro sympt, Related, Dose 1	46 10.3%	41 9.2%	36 8%
Headache, Any, Dose 1	150 33.6%	133 29.8%	116 25.8%
Headache, Grade 3, Dose 1	12 2.7%	12 2.7%	7 1.6%
Headache, Related, Dose 1	127 28.5%	104 23.3%	85 18.9%
Fatigue, Any, Dose 2	NA NaN	103 23.1%	90 20%
Fatigue, Grade 3, Dose 2	NA NaN	5 1.1%	3 0.7%
Fatigue, Related, Dose 2	NA NaN	83 18.6%	70 15.6%
Fever (orally), Any, Dose 2	NA NaN	14 3.1%	10 2.2%
Fever (orally), Grade 3, Dose 2	NA NaN	1 0.2%	1 0.2%
Fever (orally), Related, Dose 2	NA NaN	9 2%	9 2%
Gastro sympt., Any, Dose 2	NA NaN	46 10.3%	34 7.6%
Gastro sympt., Grade 3, Dose 2	NA NaN	1 0.2%	3 0.7%
Gastro sympt., Related, Dose 2	NA NaN	32 7.2%	24 5.3%
Headache, Any, Dose 2	NA NaN	95 21.3%	75 16.7%
Headache, Grade 3, Dose 2	NA NaN	2 0.4%	2 0.4%
Headache, Related, Dose 2	NA NaN	72 16.1%	56 12.5%
Fatigue, Any, Across	150 33.6%	175 39.2%	160 35.6%
Fatigue, Grade 3, Across	13 2.9%	13 2.9%	7 1.6%
Fatigue, Related, Across	120 26.9%	146 32.7%	128 28.5%
Fever (orally), Any, Across	23 5.2%	28 6.3%	29 6.5%
Fever (orally), Grade 3, Across	2 0.4%	2 0.4%	1 0.2%
Fever (orally), Related, Across	20 4.5%	16 3.6%	23 5.1%
Gastro sympt., Any, Across	67 15%	96 21.5%	80 17.8%
Gastro sympt., Grade 3, Across	4 0.9%	5 1.1%	5 1.1%
Gastro sympt., Related, Across	46 10.3%	65 14.6%	54 12%
Headache, Any, Across	150 33.6%	177 39.7%	157 35%
Headache, Grade 3, Across	12 2.7%	13 2.9%	9 2%
Headache, Related, Across	127 28.5%	142 31.8%	121 26.9%

18. Secondary Outcome

Title	Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE =An AE which prevented normal, everyday activities. Such an AE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy. Related = AE assessed by the investigator as related to the vaccination.
Time Frame	Within the 31-day (Days 0-30) period after each 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.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	446	446	449
Any AEs	124 27.8%	149 33.4%	155 34.5%
Grade 3 AEs	16 3.6%	15 3.4%	22 4.9%
Related AEs	37 8.3%	44 9.9%	29 6.5%

19. 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	Throughout the entire study period (Day 0 - Month 2)

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.

Arm/Group Title	Boostrix + Menactra Group	Boostrix-Menactra Group	Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix co-admisistered with Menactra at Day 0. The Boostrix vaccine was administered intramuscularly into the left deltoid region and Menactra vaccine was administered intramuscularly into the right deltoid region.	Subjects, 11 through 18 years of age, received one dose of Boostrix vaccine at Day 0, followed by one dose of Menactra vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.	Subjects, 11 through 18 years of age, received one dose of Menactra vaccine at Day 0 followed by one dose of Boostrix vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
Measure Participants	446	446	449
Count of Participants [Participants]	1 0.2%	0 0%	1 0.2%

Adverse Events

Time Frame	Solicited local and general symptoms during the 4-day (Day 0-3) follow-up period, unsolicited AEs during the 31-day (Day 0-30) follow-up period after each vaccination and SAEs throughout the study (Day 0 - Month 2).
Arm/Group Title	Boostrix + Menactra Group		Boostrix-Menactra Group		Menactra-Boostrix Group
Arm/Group Description	Subjects, 11 through 18 years of age, received a booster dose of Boostrix® co-admisistered with Menactra™ at Day 0. The Boostrix® vaccine was administered intramuscularly into the left deltoid region and Menactra™ vaccine was administered intramuscularly into the right deltoid region.		Subjects, 11 through 18 years of age, received one dose of Boostrix® vaccine at Day 0, followed by one dose of Menactra™ vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.		Subjects, 11 through 18 years of age, received one dose of Menactra™ vaccine at Day 0 followed by one dose of Boostrix® vaccine at Month 1. Both vaccines were administered intramuscularly into the left deltoid region.
All Cause Mortality
	Boostrix + Menactra Group		Boostrix-Menactra Group		Menactra-Boostrix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Boostrix + Menactra Group		Boostrix-Menactra Group		Menactra-Boostrix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/446 (0.2%)		0/446 (0%)		1/449 (0.2%)
Injury, poisoning and procedural complications
Extradural hematoma	1/446 (0.2%)		0/446 (0%)		0/449 (0%)
Facial bones fracture	1/446 (0.2%)		0/446 (0%)		0/449 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia	0/446 (0%)		0/446 (0%)		1/449 (0.2%)
Other (Not Including Serious) Adverse Events
	Boostrix + Menactra Group		Boostrix-Menactra Group		Menactra-Boostrix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	371/446 (83.2%)		385/446 (86.3%)		358/449 (79.7%)
General disorders
Pain	331/446 (74.2%)		343/446 (76.9%)		291/449 (64.8%)
Redness	118/446 (26.5%)		141/446 (31.6%)		119/449 (26.5%)
Swelling	99/446 (22.2%)		105/446 (23.5%)		84/449 (18.7%)
Fatigue	150/446 (33.6%)		175/446 (39.2%)		160/449 (35.6%)
Fever (orally)	23/446 (5.2%)		28/446 (6.3%)		29/449 (6.5%)
Gastrointestinal symptoms	67/446 (15%)		96/446 (21.5%)		80/449 (17.8%)
Headache	150/446 (33.6%)		177/446 (39.7%)		157/449 (35%)

Limitations/Caveats

None reported.

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.