Trial Outcomes & Findings for Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination (NCT NCT01777308)
NCT ID: NCT01777308
Last Updated: 2019-01-25
Results Overview
Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
156 participants
Primary outcome timeframe
At Month 73, one month post-booster vaccination
Results posted on
2019-01-25
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.
Participant milestones
| Measure |
Menitorix Group
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
37
|
|
Overall Study
Completed up to Month 73
|
118
|
37
|
|
Overall Study
COMPLETED
|
105
|
34
|
|
Overall Study
NOT COMPLETED
|
14
|
3
|
Reasons for withdrawal
| Measure |
Menitorix Group
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Migrated/moved from study area
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
2
|
|
Overall Study
Blood draw refusal at Visit 3
|
1
|
0
|
Baseline Characteristics
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
Baseline characteristics by cohort
| Measure |
Menitorix Group
n=119 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.0 Years
STANDARD_DEVIATION 0.2 • n=99 Participants
|
7.0 Years
STANDARD_DEVIATION 0.0 • n=107 Participants
|
7.0 Years
STANDARD_DEVIATION 0.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian-East Asian Heritage
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian-South East Asian Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White-Caucasian/European Heritage
|
109 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian Heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Unspecified
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Month 73, one month post-booster vaccinationPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Month 73, which 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 for the blood sample taken one month post-vaccination.
Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
Outcome measures
| Measure |
Menitorix Group
n=104 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=34 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
rSBA-MenA
|
102 Participants
|
33 Participants
|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
rSBA-MenC
|
101 Participants
|
33 Participants
|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
rSBA-MenW-135
|
102 Participants
|
33 Participants
|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
rSBA-MenY
|
101 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: At Month 73, one month post-booster vaccinationPopulation: The analysis was performed on the Adapted ATP cohort at Month 73, which 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 for the blood sample taken one month post-vaccination.
The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.
Outcome measures
| Measure |
Menitorix Group
n=104 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=35 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenW-135, ≥ 1:128
|
102 Participants
|
35 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenY, ≥ 1:8
|
103 Participants
|
34 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenA, ≥ 1:8
|
102 Participants
|
35 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenA, ≥ 1:128
|
102 Participants
|
35 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenC, ≥ 1:8
|
102 Participants
|
35 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenC, ≥ 1:128
|
102 Participants
|
34 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenW-135, ≥ 1:8
|
102 Participants
|
35 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenY, ≥ 1:128
|
103 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: At Month 73, one month post-booster vaccinationPopulation: The analysis was performed on the Adapted ATP cohort at Month 73, which 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 for the blood sample taken one month post-vaccination.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menitorix Group
n=104 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=35 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
rSBA-MenA
|
3421.4 Titer
Interval 2659.3 to 4402.0
|
2925.1 Titer
Interval 1949.5 to 4389.0
|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
rSBA-MenC
|
11819.2 Titer
Interval 9026.4 to 15476.1
|
7419.7 Titer
Interval 4543.2 to 12117.3
|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
rSBA-MenW-135
|
17166.5 Titer
Interval 12745.9 to 23120.3
|
15747.7 Titer
Interval 10033.0 to 24717.7
|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
rSBA-MenY
|
4871 Titer
Interval 3932.7 to 6033.1
|
3495.9 Titer
Interval 2126.6 to 5746.8
|
SECONDARY outcome
Timeframe: At Month 73, one month post-booster vaccinationPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Month 73, which 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 for the blood sample taken one month post-vaccination.
The cut-off values for anti-T concentrations were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Outcome measures
| Measure |
Menitorix Group
n=103 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=34 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values
Anti-T ≥ 0.1 IU/mL
|
103 Participants
|
34 Participants
|
|
Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values
Anti-T ≥ 1 IU/mL
|
102 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: At Month 73, one month post-booster vaccinationPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Month 73, which 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 for the blood sample taken one month post-vaccination.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Outcome measures
| Measure |
Menitorix Group
n=103 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=34 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Antibody Concentrations Against Tetanus (Anti-T) Antigen
|
15.6 IU/mL
Interval 13.1 to 18.6
|
12.5 IU/mL
Interval 8.4 to 18.7
|
SECONDARY outcome
Timeframe: At Month 96, 24 months post-booster vaccinationPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 96, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen at 24 months post booster vaccination.
The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.
Outcome measures
| Measure |
Menitorix Group
n=100 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=33 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenA, ≥ 1:8
|
72 Participants
|
21 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenA, ≥ 1:128
|
67 Participants
|
17 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenC, ≥ 1:8
|
100 Participants
|
31 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenC, ≥ 1:128
|
90 Participants
|
26 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenW-135, ≥ 1:8
|
96 Participants
|
30 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenW-135, ≥ 1:128
|
96 Participants
|
30 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenY, ≥ 1:8
|
95 Participants
|
29 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
rSBA-MenY, ≥ 1:128
|
95 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: At Month 96, 24 months post-booster vaccinationPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 96, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen at 24 months post booster vaccination.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Menitorix Group
n=100 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=33 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
rSBA-MenA
|
174.9 Titers
Interval 102.4 to 298.7
|
79.0 Titers
Interval 29.6 to 210.4
|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
rSBA-MenC
|
333.1 Titers
Interval 278.3 to 398.8
|
175.4 Titers
Interval 104.1 to 295.5
|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
rSBA-MenW-135
|
1002.9 Titers
Interval 742.1 to 1355.5
|
941.5 Titers
Interval 448.4 to 1976.9
|
|
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
rSBA-MenY
|
929.3 Titers
Interval 678.0 to 1273.7
|
512.0 Titers
Interval 250.1 to 1048.3
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-booster vaccination period at Month 72Population: The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.
Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Menitorix Group
n=118 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain
|
69 Participants
|
15 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Redness
|
56 Participants
|
19 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling
|
30 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-booster vaccination period at Month 72Population: The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Menitorix Group
n=118 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms
Any Fatigue
|
31 Participants
|
10 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Gastrointestinal symptoms
|
29 Participants
|
5 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Headache
|
29 Participants
|
6 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fever
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-booster vaccination period at Month 72Population: The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
Menitorix Group
n=119 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-booster vaccination period at Month 72Population: The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster 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.
Outcome measures
| Measure |
Menitorix Group
n=119 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
36 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-booster vaccination period at Month 72Population: The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.
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 |
Menitorix Group
n=119 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Month 72 up to study end, at Month 96Population: The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.
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 |
Menitorix Group
n=119 Participants
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 Participants
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Menitorix Group
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Meningitec + Hiberix Group
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menitorix Group
n=119 participants at risk
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
Meningitec + Hiberix Group
n=37 participants at risk
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
47.1%
56/119 • Number of events 56 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
51.4%
19/37 • Number of events 19 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
|
General disorders
Fatigue
|
26.1%
31/119 • Number of events 31 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
27.0%
10/37 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
24.4%
29/119 • Number of events 29 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
13.5%
5/37 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
|
Nervous system disorders
Headache
|
25.2%
30/119 • Number of events 30 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
18.9%
7/37 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
|
General disorders
Pain
|
58.0%
69/119 • Number of events 69 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
40.5%
15/37 • Number of events 15 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
|
General disorders
Pyrexia
|
5.0%
6/119 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
5.4%
2/37 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
|
General disorders
Swelling
|
25.2%
30/119 • Number of events 30 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
21.6%
8/37 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
7/119 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
5.4%
2/37 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.
|
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