Trial Outcomes & Findings for US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease (NCT NCT00282295)

NCT ID: NCT00282295

Last Updated: 2018-08-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1344 participants
• Primary outcome timeframe: At Month 1 (post Boostrix vaccination)
• Results posted on: 2018-08-17

Participant Flow

Out of 1344 subjects enrolled, only 1341 were vaccinated.

Participant milestones

Measure	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.	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.	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.
Overall Study STARTED	446	446	449
Overall Study COMPLETED	443	429	441
Overall Study NOT COMPLETED	3	17	8

Reasons for withdrawal

Measure	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.	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.	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.
Overall Study Adverse Event	0	1	0
Overall Study Serious Adverse Events	0	0	1
Overall Study Protocol Violation	0	2	1
Overall Study Withdrawal by Subject	2	6	4
Overall Study Lost to Follow-up	1	7	2
Overall Study Other	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Boostrix + Menactra Group n=446 Participants 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.	Boostrix-Menactra Group n=446 Participants 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.	Menactra-Boostrix Group n=449 Participants 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 n=1341 Participants Total of all reporting groups
Age, Continuous	13.5 Years STANDARD_DEVIATION 2.31 • n=93 Participants	13.2 Years STANDARD_DEVIATION 2.07 • n=4 Participants	13.4 Years STANDARD_DEVIATION 2.27 • n=27 Participants	13.37 Years STANDARD_DEVIATION 2.22 • n=483 Participants
Sex: Female, Male Female	210 Participants n=93 Participants	233 Participants n=4 Participants	223 Participants n=27 Participants	666 Participants n=483 Participants
Sex: Female, Male Male	236 Participants n=93 Participants	213 Participants n=4 Participants	226 Participants n=27 Participants	675 Participants n=483 Participants

PRIMARY outcome

Timeframe: At Month 1 (post Boostrix vaccination)

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=428 Participants 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.	Boostrix-Menactra Group n=415 Participants 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.	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.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D	427 Participants	405 Participants	—
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T	425 Participants	412 Participants	—

PRIMARY outcome

Timeframe: At Month 1 (post Boostrix vaccination)

Population: 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

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

Outcome measures

Measure	Boostrix + Menactra Group n=428 Participants 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.	Boostrix-Menactra Group n=415 Participants 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.	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.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	253.4 EL.U/mL Interval 224.8 to 285.6	366.0 EL.U/mL Interval 321.6 to 416.6	—
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	63.9 EL.U/mL Interval 58.6 to 69.7	74.3 EL.U/mL Interval 67.9 to 81.3	—
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	444.8 EL.U/mL Interval 415.0 to 476.7	575.8 EL.U/mL Interval 532.8 to 622.1	—

PRIMARY outcome

Timeframe: At Month 1 (post Boostrix vaccination)

Population: 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.

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.

Outcome measures

Measure	Boostrix + Menactra Group n=427 Participants 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.	Boostrix-Menactra Group n=414 Participants 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.	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.
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PT, Total	322 Participants	333 Participants	—
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-FHA, Total	385 Participants	388 Participants	—
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PRN, Total	398 Participants	394 Participants	—

PRIMARY outcome

Timeframe: One month post Boostrix vaccination ((Month 1 for Boostrix + Menactra Group and Month 2 for Menactra-Boostrix Group)

Population: 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.

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.

Outcome measures

Measure	Boostrix + Menactra Group n=413 Participants 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.	Boostrix-Menactra Group n=418 Participants 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.	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.
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) rSBA-MenA, Total	329 Participants	328 Participants	—
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) rSBA-MenC, Total	390 Participants	383 Participants	—
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) rSBA-MenY, Total	369 Participants	358 Participants	—
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) rSBA-MenW-135, Total	404 Participants	394 Participants	—

SECONDARY outcome

Timeframe: At Day 0 (PRE) before Boostrix vaccination

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=427 Participants 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.	Boostrix-Menactra Group n=416 Participants 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.	Menactra-Boostrix Group n=431 Participants 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.
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies ANTI-D, PRE	109 Participants	93 Participants	120 Participants
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies ANTI-T, PRE	201 Participants	181 Participants	195 Participants

SECONDARY outcome

Timeframe: At Month 2 (one month post Boostrix vaccination)

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=429 Participants 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.	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.	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.
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D	428 Participants	—	—
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T	426 Participants	—	—

SECONDARY outcome

Timeframe: PRE (Day 0) and POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=428 Participants 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.	Boostrix-Menactra Group n=416 Participants 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.	Menactra-Boostrix Group n=431 Participants 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.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens Anti-D, PRE	399 Participants	383 Participants	391 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens Anti-T, PRE	423 Participants	409 Participants	423 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens ANTI-D, POST	428 Participants	415 Participants	429 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens ANTI-T, POST	428 Participants	415 Participants	429 Participants

SECONDARY outcome

Timeframe: At one month POST Boostrix vaccination (Month 1 for Boostrix + Menactra Group and Boostrix-Menactra Group/ Month 2 for Menactra-Boostrix Group)

Population: 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.

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.

Outcome measures

Measure	Boostrix + Menactra Group n=427 Participants 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.	Boostrix-Menactra Group n=414 Participants 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.	Menactra-Boostrix Group n=428 Participants 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.
Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D, Total	422 Participants	377 Participants	422 Participants
Number of Subjects With Booster Responses for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T, Total	310 Participants	330 Participants	329 Participants

SECONDARY outcome

Timeframe: 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)

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=428 Participants 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.	Boostrix-Menactra Group n=416 Participants 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.	Menactra-Boostrix Group n=431 Participants 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.
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-D, PRE	0.5 IU/mL Interval 0.4 to 0.6	0.5 IU/mL Interval 0.4 to 0.5	0.5 IU/mL Interval 0.4 to 0.5
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-D, POST	40.1 IU/mL Interval 36.9 to 43.5	10.2 IU/mL Interval 9.3 to 11.2	27.3 IU/mL Interval 25.1 to 29.6
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-T, PRE	1.0 IU/mL Interval 0.9 to 1.1	0.8 IU/mL Interval 0.8 to 0.9	0.9 IU/mL Interval 0.8 to 1.0
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-T, POST	9.5 IU/mL Interval 8.9 to 10.2	12.7 IU/mL Interval 11.8 to 13.8	12.2 IU/mL Interval 11.3 to 13.2

SECONDARY outcome

Timeframe: At one month POST Menactra vaccination (Month 2 for Boostrix-Menactra Group and Month 1 for Menactra-Boostrix Group)

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=411 Participants 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.	Boostrix-Menactra Group n=430 Participants 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.	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.
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-D	16.5 IU/mL Interval 15.4 to 17.6	41.6 IU/mL Interval 38.1 to 45.5	—
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-T	10.0 IU/mL Interval 9.2 to 10.8	0.9 IU/mL Interval 0.8 to 1.0	—

SECONDARY outcome

Timeframe: At Month 2 (one month post Boostrix vaccination)

Population: 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.

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.

Outcome measures

Measure	Boostrix + Menactra Group n=428 Participants 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.	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.	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.
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PT, Total	338 Participants	—	—
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-FHA, Total	405 Participants	—	—
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PRN, Total	414 Participants	—	—

SECONDARY outcome

Timeframe: At Day 0 before (PRE) Boostrix vaccination

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=427 Participants 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.	Boostrix-Menactra Group n=416 Participants 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.	Menactra-Boostrix Group n=431 Participants 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.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	8.6 EL.U/mL Interval 7.7 to 9.6	10.0 EL.U/mL Interval 8.9 to 11.3	10.3 EL.U/mL Interval 9.2 to 11.6
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	46.5 EL.U/mL Interval 41.4 to 52.3	43.8 EL.U/mL Interval 39.1 to 49.0	47.8 EL.U/mL Interval 42.4 to 53.8
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	12.5 EL.U/mL Interval 11.1 to 14.1	10.6 EL.U/mL Interval 9.3 to 12.0	12.0 EL.U/mL Interval 10.6 to 13.5

SECONDARY outcome

Timeframe: At Month 2 (one month post Boostrix vaccination)

Population: 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

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

Outcome measures

Measure	Boostrix + Menactra Group n=429 Participants 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.	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.	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.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	77.8 EL.U/mL Interval 71.5 to 84.6	—	—
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ANTI-FHA	653.0 EL.U/mL Interval 603.6 to 706.5	—	—
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	412.5 EL.U/mL Interval 364.5 to 466.9	—	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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

Outcome measures

Measure	Boostrix + Menactra Group n=424 Participants 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.	Boostrix-Menactra Group n=408 Participants 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.	Menactra-Boostrix Group n=427 Participants 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.
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenW-135, POST	4822.1 Titers Interval 4351.6 to 5343.4	2143.1 Titers Interval 1913.9 to 2399.8	4154.3 Titers Interval 3690.9 to 4675.9
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenA, PRE	533.4 Titers Interval 464.6 to 612.3	490.8 Titers Interval 428.4 to 562.3	449.4 Titers Interval 383.4 to 526.6
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenA, POST	10406.1 Titers Interval 9687.2 to 11178.3	7220.0 Titers Interval 6613.3 to 7882.4	9466.3 Titers Interval 8765.6 to 10222.9
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenC, PRE	21.0 Titers Interval 17.2 to 25.5	16.4 Titers Interval 13.6 to 19.8	18.7 Titers Interval 15.3 to 22.8
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenC, POST	2760.2 Titers Interval 2387.5 to 3191.1	1137.0 Titers Interval 969.6 to 1333.3	2702.8 Titers Interval 2292.6 to 3186.5
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenY, PRE	53.8 Titers Interval 43.6 to 66.5	51.4 Titers Interval 41.6 to 63.5	56.2 Titers Interval 45.1 to 70.1
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenY, POST	3244.2 Titers Interval 2884.1 to 3649.1	1470.7 Titers Interval 1311.4 to 1649.3	3022.8 Titers Interval 2687.0 to 3400.6
Titers for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenW-135, PRE	23.7 Titers Interval 19.5 to 28.6	28.0 Titers Interval 23.1 to 34.0	32.2 Titers Interval 26.6 to 39.0

SECONDARY outcome

Timeframe: At Month 2 (one month after vaccination with Menactra vaccine)

Population: 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.

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.

Outcome measures

Measure	Boostrix + Menactra Group n=396 Participants 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.	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.	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.
Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenA, Total	300 Participants	—	—
Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenC, Total	351 Participants	—	—
Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenY, Total	325 Participants	—	—
Number of Subjects With Vaccine Responses for rSBA-MenA, rSBA-MenC, rSBA-MenY and rSBA-MenW-135 Antibodies rSBA-MenW-135, Total	360 Participants	—	—

SECONDARY outcome

Timeframe: Within 4-days (Day 0-3) after each dose and across doses

Population: 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.

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).

Outcome measures

Measure	Boostrix + Menactra Group n=441 Participants 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.	Boostrix-Menactra Group n=433 Participants 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.	Menactra-Boostrix Group n=446 Participants 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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any, Dose 1	331 Participants	304 Participants	236 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3, Dose 1	26 Participants	14 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any, Dose 1	118 Participants	111 Participants	84 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, ≥ 50 mm, Dose 1	10 Participants	1 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any, Dose 1	99 Participants	78 Participants	56 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, ≥ 50 mm, Dose 1	8 Participants	7 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	260 Participants	211 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	13 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	85 Participants	79 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, ≥ 50 mm, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	8 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	64 Participants	53 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, ≥ 50 mm, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	9 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any, Across doses	331 Participants	343 Participants	291 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3, Across doses	26 Participants	26 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any, Across doses	118 Participants	141 Participants	119 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, ≥ 50 mm, Across doses	10 Participants	8 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any, Across doses	99 Participants	105 Participants	84 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, ≥ 50 mm, Across doses	8 Participants	13 Participants	8 Participants

SECONDARY outcome

Timeframe: Within 4-days (Days 0-3) after each dose and across doses

Population: 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.

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.

Outcome measures

Measure	Boostrix + Menactra Group n=446 Participants 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.	Boostrix-Menactra Group n=446 Participants 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.	Menactra-Boostrix Group n=449 Participants 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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	5 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	83 Participants	70 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Any, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	14 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related, Dose 1	127 Participants	104 Participants	85 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	103 Participants	90 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3, Across	12 Participants	13 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any, Dose 1	150 Participants	139 Participants	114 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3, Dose 1	13 Participants	9 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related, Dose 1	120 Participants	113 Participants	86 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Any, Dose 1	23 Participants	15 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Grade 3, Dose 1	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Related, Dose 1	20 Participants	8 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Any, Dose 1	67 Participants	63 Participants	60 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt, Grade 3, Dose 1	4 Participants	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt, Related, Dose 1	46 Participants	41 Participants	36 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any, Dose 1	150 Participants	133 Participants	116 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3, Dose 1	12 Participants	12 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Grade 3, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Related, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	9 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Any, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	46 Participants	34 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Grade 3, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Related, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	32 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	95 Participants	75 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related, Dose 2	NA Participants Not applicable, as both vaccines were administered at the same timepoint.	72 Participants	56 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any, Across	150 Participants	175 Participants	160 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3, Across	13 Participants	13 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related, Across	120 Participants	146 Participants	128 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Any, Across	23 Participants	28 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Grade 3, Across	2 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), Related, Across	20 Participants	16 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Any, Across	67 Participants	96 Participants	80 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Grade 3, Across	4 Participants	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Related, Across	46 Participants	65 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any, Across	150 Participants	177 Participants	157 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related, Across	127 Participants	142 Participants	121 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) period after each vaccination

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

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.

Outcome measures

Measure	Boostrix + Menactra Group n=446 Participants 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.	Boostrix-Menactra Group n=446 Participants 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.	Menactra-Boostrix Group n=449 Participants 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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AEs	124 Participants	149 Participants	155 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AEs	16 Participants	15 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AEs	37 Participants	44 Participants	29 Participants

SECONDARY outcome

Timeframe: Throughout the entire study period (Day 0 - Month 2)

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

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

Outcome measures

Measure	Boostrix + Menactra Group n=446 Participants 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.	Boostrix-Menactra Group n=446 Participants 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.	Menactra-Boostrix Group n=449 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	0 Participants	1 Participants

Adverse Events

Boostrix + Menactra Group

Serious events: 1 serious events

Other events: 371 other events

Deaths: 0 deaths

Boostrix-Menactra Group

Serious events: 0 serious events

Other events: 385 other events

Deaths: 0 deaths

Menactra-Boostrix Group

Serious events: 1 serious events

Other events: 358 other events

Deaths: 0 deaths

Serious adverse events

Measure	Boostrix + Menactra Group n=446 participants at risk 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.	Boostrix-Menactra Group n=446 participants at risk 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.	Menactra-Boostrix Group n=449 participants at risk 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.
Injury, poisoning and procedural complications Extradural hematoma	0.22% 1/446 • 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).	0.00% 0/446 • 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).	0.00% 0/449 • 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).
Injury, poisoning and procedural complications Facial bones fracture	0.22% 1/446 • 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).	0.00% 0/446 • 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).	0.00% 0/449 • 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia	0.00% 0/446 • 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).	0.00% 0/446 • 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).	0.22% 1/449 • 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).

Other adverse events

Measure	Boostrix + Menactra Group n=446 participants at risk 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.	Boostrix-Menactra Group n=446 participants at risk 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.	Menactra-Boostrix Group n=449 participants at risk 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.
General disorders Pain	74.2% 331/446 • 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).	76.9% 343/446 • 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).	64.8% 291/449 • 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).
General disorders Redness	26.5% 118/446 • 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).	31.6% 141/446 • 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).	26.5% 119/449 • 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).
General disorders Swelling	22.2% 99/446 • 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).	23.5% 105/446 • 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).	18.7% 84/449 • 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).
General disorders Fatigue	33.6% 150/446 • 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).	39.2% 175/446 • 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).	35.6% 160/449 • 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).
General disorders Fever (orally)	5.2% 23/446 • 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).	6.3% 28/446 • 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).	6.5% 29/449 • 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).
General disorders Gastrointestinal symptoms	15.0% 67/446 • 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).	21.5% 96/446 • 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).	17.8% 80/449 • 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).
General disorders Headache	33.6% 150/446 • 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).	39.7% 177/446 • 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).	35.0% 157/449 • 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).

Additional Information

GSK Response Center

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Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER