Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age (NCT NCT01767376)

NCT ID: NCT01767376

Last Updated: 2017-09-06

Results Overview

The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 692 participants
• Primary outcome timeframe: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)
• Results posted on: 2017-09-06

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. Out of the 692 subjects enrolled in this study, one subject was eliminated due to not receiving vaccination, hence only 691 subject started the study.

Participant milestones

Measure	Nimenrix+ Boostrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Overall Study STARTED	231	228	232
Overall Study COMPLETED	227	225	232
Overall Study NOT COMPLETED	4	3	0

Reasons for withdrawal

Measure	Nimenrix+ Boostrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Overall Study Lost to Follow-up	3	2	0
Overall Study Withdrawal by Subject	1	1	0

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age

Baseline characteristics by cohort

Measure	Nimenrix+ Boostrix Group n=231 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Total n=691 Participants Total of all reporting groups
Age, Continuous	18.1 Years STANDARD_DEVIATION 4.2 • n=5 Participants	18.2 Years STANDARD_DEVIATION 4.5 • n=7 Participants	18.3 Years STANDARD_DEVIATION 4.4 • n=5 Participants	18.2 Years STANDARD_DEVIATION 4.4 • n=4 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	126 Participants n=7 Participants	146 Participants n=5 Participants	400 Participants n=4 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	102 Participants n=7 Participants	86 Participants n=5 Participants	291 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Asian - East Asian Heritage	111 Participants n=5 Participants	109 Participants n=7 Participants	111 Participants n=5 Participants	331 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · White - Caucasian / European Heritage	60 Participants n=5 Participants	60 Participants n=7 Participants	61 Participants n=5 Participants	181 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Other	60 Participants n=5 Participants	59 Participants n=7 Participants	59 Participants n=5 Participants	178 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group.

Outcome measures

Measure	Nimenrix + Boostrix Group n=226 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=222 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenA	3415.3 EL.U/mL Interval 2917.8 to 3997.6	2860.4 EL.U/mL Interval 2478.6 to 3300.9	1577.4 EL.U/mL Interval 1354.4 to 1837.1
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenC	5092.5 EL.U/mL Interval 4268.7 to 6075.3	4597.6 EL.U/mL Interval 3703.1 to 5708.2	1912.6 EL.U/mL Interval 1593.9 to 2295.1
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenW-135	9608.5 EL.U/mL Interval 8522.5 to 10832.8	9052.8 EL.U/mL Interval 7510.3 to 10912.0	3164.6 EL.U/mL Interval 2534.0 to 3952.1
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenY	7775.8 EL.U/mL Interval 6862.3 to 8811.0	6032.6 EL.U/mL Interval 5025.7 to 7241.2	4134.4 EL.U/mL Interval 3582.3 to 4771.5

PRIMARY outcome

Timeframe: One month after Boostrix vaccination (i.e. Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). The reference cut-off value was an antibody concentration ≥ 1 IU/mL. The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group.

Outcome measures

Measure	Nimenrix + Boostrix Group n=225 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value Anti-D	200 Participants	203 Participants	—
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value Anti-T	224 Participants	223 Participants	—

PRIMARY outcome

Timeframe: One month after Boostrix vaccination (i.e. Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

The antibody concentrations were tabulated as adjusted geometric mean concentrations (GMCs) and expressed as international units per millilitre (IU/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group

Outcome measures

Measure	Nimenrix + Boostrix Group n=225 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	53.6 IU/mL Interval 47.2 to 60.8	68.0 IU/mL Interval 59.9 to 77.3	—
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	316.9 IU/mL Interval 288.0 to 348.6	545.0 IU/mL Interval 493.2 to 602.4	—
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	348.3 IU/mL Interval 293.8 to 412.9	499.0 IU/mL Interval 419.4 to 593.6	—

SECONDARY outcome

Timeframe: Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

The reference cut-off values of the assay were rSBA-Men antibody concentrations ≥ 1:128 and ≥ 1:8.

Outcome measures

Measure	Nimenrix + Boostrix Group n=226 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=222 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenA ≥ 1:128	48 Participants	46 Participants	33 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenC ≥ 1:128	224 Participants	220 Participants	220 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenW-135 ≥ 1:128	13 Participants	33 Participants	30 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenY ≥ 1:128	225 Participants	218 Participants	220 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenA ≥ 1:8	31 Participants	29 Participants	23 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenC ≥ 1:8	226 Participants	220 Participants	216 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenW-135 ≥ 1:8	80 Participants	56 Participants	70 Participants
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values rSBA-MenY ≥ 1:8	226 Participants	219 Participants	222 Participants

SECONDARY outcome

Timeframe: One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:

• For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): number of subjects with rSBA antibody titers ≥ 1:32 one month after vaccination.
• For initially seropositive subjects (pre-vaccination titer ≥ 1:8): number of subjects with rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination.

Outcome measures

Measure	Nimenrix + Boostrix Group n=226 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=222 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenA	217 Participants	207 Participants	214 Participants
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenC	225 Participants	210 Participants	215 Participants
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenW-135	225 Participants	216 Participants	211 Participants
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies rSBA-MenY	220 Participants	214 Participants	212 Participants

SECONDARY outcome

Timeframe: Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).

Outcome measures

Measure	Nimenrix + Boostrix Group n=225 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=220 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Anti-D Antibody Concentrations Anti-D, PRE	0.3 IU/mL Interval 0.3 to 0.4	0.3 IU/mL Interval 0.3 to 0.4	0.3 IU/mL Interval 0.3 to 0.4
Anti-D Antibody Concentrations Anti-D, POST	4.0 IU/mL Interval 3.4 to 4.6	4.6 IU/mL Interval 3.9 to 5.4	4.7 IU/mL Interval 4.0 to 5.4

SECONDARY outcome

Timeframe: Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).

Outcome measures

Measure	Nimenrix + Boostrix Group n=225 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=222 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Anti-T Antibody Concentrations Anti-T, pre-vaccination	0.6 IU/mL Interval 0.5 to 0.8	0.6 IU/mL Interval 0.5 to 0.7	0.7 IU/mL Interval 0.5 to 0.8
Anti-T Antibody Concentrations Anti-T, Month 1	23.5 IU/mL Interval 20.8 to 26.5	18.5 IU/mL Interval 16.0 to 21.3	13.5 IU/mL Interval 12.3 to 14.8
Anti-T Antibody Concentrations Anti-T, Month 2	—	13.0 IU/mL Interval 11.7 to 14.5	16.3 IU/mL Interval 14.6 to 18.2

SECONDARY outcome

Timeframe: Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

The reference cut-off value of the assay was an antibody concentration ≥ 5.0 ELISA units per milliliter (EL.U/mL)

Outcome measures

Measure	Nimenrix + Boostrix Group n=225 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=222 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value Anti-PRN, Month 1/Month 2	223 Participants	218 Participants	221 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value Anti-PT, PRE	162 Participants	156 Participants	153 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value Anti-PT, Month 1/Month 2	221 Participants	220 Participants	223 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value Anti-FHA, PRE	222 Participants	221 Participants	220 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value Anti-FHA, Month 1/Month 2	225 Participants	220 Participants	223 Participants
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value Anti-PRN, PRE	200 Participants	200 Participants	207 Participants

SECONDARY outcome

Timeframe: One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

Population: The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.

Booster response to the pertussis components is defined as:

• For initially seronegative subjects, antibody concentration ≥ 4*cut_off (IU/mL) at one month post-vaccination;
• For initially seropositive subjects with pre-vaccination antibody concentration < 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 4 fold the pre-vaccination antibody concentration;
• For initially seropositive subjects with pre-vaccination antibody concentration ≥ 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 2 fold the pre-vaccination antibody concentration.

Outcome measures

Measure	Nimenrix + Boostrix Group n=222 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=220 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=223 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations Anti-PT antibody (assay cut-off=2.693 IU/mL)	201 Participants	188 Participants	201 Participants
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations Anti-FHA antibody (assay cut-off=2.046 IU/mL)	208 Participants	210 Participants	213 Participants
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations Anti-PRN antibody (assay cut-off=2.187 IU/mL)	209 Participants	198 Participants	207 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) following each vaccination

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

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Results are presented across doses, after each vaccination (with Nimenrix, Boostrix, total).

Outcome measures

Measure	Nimenrix + Boostrix Group n=231 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, post-Boostrix	1 Participants	6 Participants	4 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling, post-Boostrix	48 Participants	47 Participants	33 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness, post-Boostrix	61 Participants	54 Participants	39 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain, Total	176 Participants	148 Participants	167 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Total	15 Participants	19 Participants	8 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness, Total	81 Participants	75 Participants	76 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Total	4 Participants	10 Participants	6 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling, Total	71 Participants	71 Participants	68 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Total	5 Participants	9 Participants	7 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain, post-Nimenrix	155 Participants	121 Participants	156 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, post-Nimenrix	13 Participants	12 Participants	8 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness, post-Nimenrix	64 Participants	56 Participants	65 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, post-Nimenrix	3 Participants	5 Participants	5 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling, post-Nimenrix	57 Participants	51 Participants	54 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, post-Nimenrix	3 Participants	4 Participants	7 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain, post-Boostrix	121 Participants	101 Participants	92 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, post-Boostrix	7 Participants	8 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, post-Boostrix	3 Participants	5 Participants	1 Participants

SECONDARY outcome

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

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

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Results are presented across doses.

Outcome measures

Measure	Nimenrix + Boostrix Group n=231 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Headache	49 Participants	67 Participants	53 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	75 Participants	77 Participants	81 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	2 Participants	5 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	70 Participants	67 Participants	70 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms	23 Participants	31 Participants	25 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms	2 Participants	2 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms	20 Participants	25 Participants	18 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Headache	51 Participants	76 Participants	65 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	2 Participants	5 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Temperature	14 Participants	17 Participants	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Temperature	10 Participants	15 Participants	9 Participants

SECONDARY outcome

Timeframe: Throughout the study (Month 0 up to Month 2)

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

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Measure	Nimenrix + Boostrix Group n=231 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects With New Onset of Chronic Diseases (NOCDs)	1 Participants	5 Participants	3 Participants

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the 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. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Nimenrix + Boostrix Group n=231 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects With Unsolicited Adverse Events AE(s)	36 Participants	44 Participants	58 Participants

SECONDARY outcome

Timeframe: Throughout the study (Month 0 up to Month 2)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the 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	Nimenrix + Boostrix Group n=231 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 Participants Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Number of Subjects With Serious Adverse Events SAE(s)	0 Participants	0 Participants	3 Participants

Adverse Events

Nimenrix+ Boostrix Group

Serious events: 0 serious events

Other events: 190 other events

Deaths: 0 deaths

Nimenrix Group

Serious events: 0 serious events

Other events: 166 other events

Deaths: 0 deaths

Boostrix Group

Serious events: 3 serious events

Other events: 180 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nimenrix+ Boostrix Group n=231 participants at risk Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 participants at risk Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 participants at risk Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Infections and infestations Gastroenteritis	0.00% 0/231 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	0.00% 0/228 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	0.43% 1/232 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
Nervous system disorders Orthostatic intolerance	0.00% 0/231 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	0.00% 0/228 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	0.43% 1/232 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
Psychiatric disorders Depression	0.00% 0/231 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	0.00% 0/228 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	0.43% 1/232 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).

Other adverse events

Measure	Nimenrix+ Boostrix Group n=231 participants at risk Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.	Nimenrix Group n=228 participants at risk Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.	Boostrix Group n=232 participants at risk Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.
Skin and subcutaneous tissue disorders Erythema	35.1% 81/231 • Number of events 81 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	32.9% 75/228 • Number of events 110 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	32.8% 76/232 • Number of events 104 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
General disorders Fatigue	32.5% 75/231 • Number of events 75 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	33.8% 77/228 • Number of events 108 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	34.9% 81/232 • Number of events 110 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
Gastrointestinal disorders Gastrointestinal disorder	10.0% 23/231 • Number of events 23 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	13.6% 31/228 • Number of events 36 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	10.8% 25/232 • Number of events 28 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
Nervous system disorders Headache	23.4% 54/231 • Number of events 54 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	34.2% 78/228 • Number of events 94 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	28.9% 67/232 • Number of events 84 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
Infections and infestations Nasopharyngitis	2.6% 6/231 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	3.5% 8/228 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	6.5% 15/232 • Number of events 16 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
General disorders Pain	76.2% 176/231 • Number of events 176 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	64.9% 148/228 • Number of events 222 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	72.0% 167/232 • Number of events 248 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
General disorders Pyrexia	6.5% 15/231 • Number of events 15 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	7.5% 17/228 • Number of events 18 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	4.7% 11/232 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).
General disorders Swelling	30.7% 71/231 • Number of events 71 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	31.1% 71/228 • Number of events 98 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).	29.3% 68/232 • Number of events 87 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: throughout the study (Month 0 - Month 2).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER