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=99 Participants
|
18.2 Years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
18.3 Years
STANDARD_DEVIATION 4.4 • n=206 Participants
|
18.2 Years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
400 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
291 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian - East Asian Heritage
|
111 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
331 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian - South East Asian Heritage
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White - Caucasian / European Heritage
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
181 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
60 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
178 Participants
n=7 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 |
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.
|
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.
|
|---|---|---|---|
|
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
rSBA-MenA
|
1577.4 EL.U/mL
Interval 1354.4 to 1837.1
|
3415.3 EL.U/mL
Interval 2917.8 to 3997.6
|
2860.4 EL.U/mL
Interval 2478.6 to 3300.9
|
|
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
rSBA-MenC
|
1912.6 EL.U/mL
Interval 1593.9 to 2295.1
|
5092.5 EL.U/mL
Interval 4268.7 to 6075.3
|
4597.6 EL.U/mL
Interval 3703.1 to 5708.2
|
|
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
rSBA-MenW-135
|
3164.6 EL.U/mL
Interval 2534.0 to 3952.1
|
9608.5 EL.U/mL
Interval 8522.5 to 10832.8
|
9052.8 EL.U/mL
Interval 7510.3 to 10912.0
|
|
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
rSBA-MenY
|
4134.4 EL.U/mL
Interval 3582.3 to 4771.5
|
7775.8 EL.U/mL
Interval 6862.3 to 8811.0
|
6032.6 EL.U/mL
Interval 5025.7 to 7241.2
|
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 |
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.
|
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.
|
|---|---|---|---|
|
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 |
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.
|
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.
|
|---|---|---|---|
|
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 |
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.
|
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.
|
|---|---|---|---|
|
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
|
33 Participants
|
48 Participants
|
46 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
|
220 Participants
|
224 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
|
30 Participants
|
13 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-MenY ≥ 1:128
|
220 Participants
|
225 Participants
|
218 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
|
23 Participants
|
31 Participants
|
29 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
|
216 Participants
|
226 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 ≥ 1:8
|
70 Participants
|
80 Participants
|
56 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
|
222 Participants
|
226 Participants
|
219 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 |
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.
|
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.
|
|---|---|---|---|
|
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-MenA
|
214 Participants
|
217 Participants
|
207 Participants
|
|
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-MenC
|
215 Participants
|
225 Participants
|
210 Participants
|
|
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-MenW-135
|
211 Participants
|
225 Participants
|
216 Participants
|
|
Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-MenY
|
212 Participants
|
220 Participants
|
214 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 |
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.
|
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.
|
|---|---|---|---|
|
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
|
4.7 IU/mL
Interval 4.0 to 5.4
|
4.0 IU/mL
Interval 3.4 to 4.6
|
4.6 IU/mL
Interval 3.9 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 vaccinationPopulation: 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 |
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.
|
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.
|
|---|---|---|---|
|
Anti-T Antibody Concentrations
Anti-T, pre-vaccination
|
0.7 IU/mL
Interval 0.5 to 0.8
|
0.6 IU/mL
Interval 0.5 to 0.8
|
0.6 IU/mL
Interval 0.5 to 0.7
|
|
Anti-T Antibody Concentrations
Anti-T, Month 1
|
13.5 IU/mL
Interval 12.3 to 14.8
|
23.5 IU/mL
Interval 20.8 to 26.5
|
18.5 IU/mL
Interval 16.0 to 21.3
|
|
Anti-T Antibody Concentrations
Anti-T, Month 2
|
16.3 IU/mL
Interval 14.6 to 18.2
|
—
|
13.0 IU/mL
Interval 11.7 to 14.5
|
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 |
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value
Anti-FHA, Month 1/Month 2
|
223 Participants
|
225 Participants
|
220 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value
Anti-PT, PRE
|
153 Participants
|
162 Participants
|
156 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
|
223 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, PRE
|
220 Participants
|
222 Participants
|
221 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value
Anti-PRN, PRE
|
207 Participants
|
200 Participants
|
200 Participants
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value
Anti-PRN, Month 1/Month 2
|
221 Participants
|
223 Participants
|
218 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 |
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.
|
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.
|
|---|---|---|---|
|
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations
Anti-PT antibody (assay cut-off=2.693 IU/mL)
|
201 Participants
|
201 Participants
|
188 Participants
|
|
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations
Anti-FHA antibody (assay cut-off=2.046 IU/mL)
|
213 Participants
|
208 Participants
|
210 Participants
|
|
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations
Anti-PRN antibody (assay cut-off=2.187 IU/mL)
|
207 Participants
|
209 Participants
|
198 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) following each vaccinationPopulation: 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 |
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, post-Boostrix
|
92 Participants
|
121 Participants
|
101 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, post-Boostrix
|
33 Participants
|
48 Participants
|
47 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, post-Boostrix
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, post-Nimenrix
|
8 Participants
|
13 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness, post-Nimenrix
|
65 Participants
|
64 Participants
|
56 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, post-Nimenrix
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, post-Nimenrix
|
54 Participants
|
57 Participants
|
51 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, post-Nimenrix
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, post-Boostrix
|
0 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness, post-Boostrix
|
39 Participants
|
61 Participants
|
54 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, post-Boostrix
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, Total
|
167 Participants
|
176 Participants
|
148 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Total
|
8 Participants
|
15 Participants
|
19 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness, Total
|
76 Participants
|
81 Participants
|
75 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Total
|
6 Participants
|
4 Participants
|
10 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, Total
|
68 Participants
|
71 Participants
|
71 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Total
|
7 Participants
|
5 Participants
|
9 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, post-Nimenrix
|
156 Participants
|
155 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) period following each vaccinationPopulation: 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 |
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
70 Participants
|
70 Participants
|
67 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms
|
18 Participants
|
20 Participants
|
25 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
53 Participants
|
49 Participants
|
67 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
81 Participants
|
75 Participants
|
77 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms
|
25 Participants
|
23 Participants
|
31 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
65 Participants
|
51 Participants
|
76 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Temperature
|
11 Participants
|
14 Participants
|
17 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
|
9 Participants
|
10 Participants
|
15 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 |
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects With New Onset of Chronic Diseases (NOCDs)
|
3 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: 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 |
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events AE(s)
|
58 Participants
|
36 Participants
|
44 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 |
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events SAE(s)
|
3 Participants
|
0 Participants
|
0 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