Trial Outcomes & Findings for Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds (NCT NCT01154088)
NCT ID: NCT01154088
Last Updated: 2018-11-26
Results Overview
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1170 participants
Primary outcome timeframe
At Month 1
Results posted on
2018-11-26
Participant Flow
Participant milestones
| Measure |
Nimenrix-A Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
390
|
390
|
390
|
|
Overall Study
COMPLETED
|
386
|
384
|
383
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
7
|
Reasons for withdrawal
| Measure |
Nimenrix-A Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
7
|
Baseline Characteristics
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds
Baseline characteristics by cohort
| Measure |
Nimenrix-A Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
Total
n=1170 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.8 Years
STANDARD_DEVIATION 2.14 • n=5 Participants
|
20.9 Years
STANDARD_DEVIATION 2.10 • n=7 Participants
|
20.6 Years
STANDARD_DEVIATION 1.94 • n=5 Participants
|
20.77 Years
STANDARD_DEVIATION 2.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
626 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
544 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian heritage
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian heritage
|
258 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
774 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European heritage
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
100 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
302 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Mencevax Group only.
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.
Outcome measures
| Measure |
Nimenrix-A Group
n=358 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=353 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=357 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
rSBA-MenA
|
239 Participants
|
238 Participants
|
216 Participants
|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
rSBA-MenC
|
324 Participants
|
327 Participants
|
332 Participants
|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
rSBA-MenW-135
|
328 Participants
|
312 Participants
|
304 Participants
|
|
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies
rSBA-MenY
|
334 Participants
|
324 Participants
|
308 Participants
|
PRIMARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. This primary outcome and the statistical analyses performed for this outcome concern the Nimenrix-A Group and Nimenrix-B Group only.
Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
Outcome measures
| Measure |
Nimenrix-A Group
n=375 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=371 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=373 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenA
|
4846.0 Titers
Interval 4459.8 to 5265.7
|
5064.6 Titers
Interval 4657.5 to 5507.2
|
3421.0 Titers
Interval 3134.7 to 3733.4
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenC
|
6025.4 Titers
Interval 5269.0 to 6890.2
|
7070.7 Titers
Interval 6225.3 to 8030.9
|
5953.1 Titers
Interval 5188.2 to 6830.7
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenW-135
|
9836.7 Titers
Interval 8939.2 to 10824.3
|
8855.5 Titers
Interval 8021.8 to 9775.9
|
4675.1 Titers
Interval 4145.9 to 5272.0
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenY
|
11632.5 Titers
Interval 10675.1 to 12675.8
|
10386.7 Titers
Interval 9557.5 to 11287.9
|
6315.9 Titers
Interval 5787.9 to 6892.1
|
SECONDARY outcome
Timeframe: At Day 0 and at Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Outcome measures
| Measure |
Nimenrix-A Group
n=376 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=373 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenA, Day 0
|
66 Participants
|
77 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenA, Month 1
|
376 Participants
|
371 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenC, Day 0
|
44 Participants
|
57 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenC, Month 1
|
371 Participants
|
360 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenW-135, Day 0
|
69 Participants
|
76 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenW-135, Month 1
|
371 Participants
|
362 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenY, Day 0
|
140 Participants
|
136 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenY, Month 1
|
376 Participants
|
367 Participants
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Outcome measures
| Measure |
Nimenrix-A Group
n=376 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=373 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenA, Day 0
|
47 Participants
|
53 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenA, Month 1
|
375 Participants
|
364 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenC, Day 0
|
20 Participants
|
34 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenC, Month 1
|
369 Participants
|
358 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenW-135, Day 0
|
42 Participants
|
54 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenW-135, Month 1
|
371 Participants
|
359 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenY, Day 0
|
114 Participants
|
120 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
rSBA-MenY, Month 1
|
376 Participants
|
367 Participants
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and at Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
Titers are presented as geometric mean titers (GMTs). The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Outcome measures
| Measure |
Nimenrix-A Group
n=376 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=373 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA, Day 0
|
4.7 Titers
Interval 3.9 to 5.7
|
5.3 Titers
Interval 4.4 to 6.5
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA, Month 1
|
3463.4 Titers
Interval 3152.6 to 3804.8
|
2186.0 Titers
Interval 1923.9 to 2483.8
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC, Day 0
|
3.2 Titers
Interval 2.8 to 3.6
|
3.7 Titers
Interval 3.2 to 4.4
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC, Month 1
|
4187.9 Titers
Interval 3563.8 to 4921.2
|
3649.1 Titers
Interval 3026.5 to 4399.8
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135, Day 0
|
4.8 Titers
Interval 3.9 to 5.8
|
5.5 Titers
Interval 4.4 to 6.8
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135, Month 1
|
12725.1 Titers
Interval 10998.4 to 14722.9
|
4365.4 Titers
Interval 3622.8 to 5260.1
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY, Day 0
|
13.3 Titers
Interval 10.3 to 17.2
|
12.6 Titers
Interval 9.8 to 16.3
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY, Month 1
|
5911.3 Titers
Interval 5315.2 to 6574.3
|
2554.9 Titers
Interval 2211.6 to 2951.4
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and at Month 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. The analysis was performed with the GSK rSBA assay.
Outcome measures
| Measure |
Nimenrix-A Group
n=375 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=371 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=373 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenA, Day 0
|
296 Participants
|
314 Participants
|
295 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenA, Month 1
|
359 Participants
|
343 Participants
|
356 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenC, Day 0
|
211 Participants
|
213 Participants
|
224 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenC, Month 1
|
374 Participants
|
370 Participants
|
372 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenW- 135, Day 0
|
296 Participants
|
286 Participants
|
298 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenW- 135, Month 1
|
375 Participants
|
370 Participants
|
372 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenY, Day 0
|
335 Participants
|
338 Participants
|
336 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
rSBA-MenY, Month 1
|
375 Participants
|
371 Participants
|
373 Participants
|
SECONDARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs). The analysis was performed with the GSK rSBA assay.
Outcome measures
| Measure |
Nimenrix-A Group
n=363 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=359 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=364 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenA
|
348.4 Titers
Interval 293.0 to 414.2
|
401.4 Titers
Interval 347.2 to 464.1
|
424.4 Titers
Interval 362.9 to 496.5
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenC
|
36.3 Titers
Interval 29.3 to 45.0
|
44.7 Titers
Interval 35.6 to 56.2
|
46.9 Titers
Interval 37.2 to 59.0
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenW-135
|
185.9 Titers
Interval 153.1 to 225.6
|
191.2 Titers
Interval 155.9 to 234.4
|
205.5 Titers
Interval 167.6 to 252.0
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
rSBA-MenY
|
387.5 Titers
Interval 324.9 to 462.2
|
426.8 Titers
Interval 362.2 to 502.8
|
412.6 Titers
Interval 346.8 to 490.8
|
SECONDARY outcome
Timeframe: At Month 1Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available. No testing was performed by the HPA assay on subjects from the Nimenrix-B Group.
Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Outcome measures
| Measure |
Nimenrix-A Group
n=362 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=360 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-Men
|
356 Participants
|
353 Participants
|
—
|
|
Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-MenC
|
354 Participants
|
347 Participants
|
—
|
|
Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-MenW-135
|
356 Participants
|
345 Participants
|
—
|
|
Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
rSBA-MenY
|
355 Participants
|
343 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 4-days (Days 0-3) post-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.
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.
Outcome measures
| Measure |
Nimenrix-A Group
n=386 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=384 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=383 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
208 Participants
|
210 Participants
|
141 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
6 Participants
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
93 Participants
|
84 Participants
|
57 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
57 Participants
|
63 Participants
|
42 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 4-days (Days 0-3) post-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature \[defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Nimenrix-A Group
n=386 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=384 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=383 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
117 Participants
|
110 Participants
|
115 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
113 Participants
|
100 Participants
|
109 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms
|
50 Participants
|
43 Participants
|
45 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms
|
44 Participants
|
38 Participants
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
105 Participants
|
119 Participants
|
103 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Relate Headache
|
96 Participants
|
111 Participants
|
95 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature
|
28 Participants
|
23 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature
|
27 Participants
|
20 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Within 31-days (Days 0-30) post-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
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 |
Nimenrix-A Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
103 Participants
|
94 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Within 31-days (Days 0-30) post-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
Nimenrix-A Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=390 Participants
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With New Onset Chronic Illnesses (NOCI)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Nimenrix-A Group
Serious events: 0 serious events
Other events: 274 other events
Deaths: 0 deaths
Nimenrix-B Group
Serious events: 1 serious events
Other events: 271 other events
Deaths: 0 deaths
Mencevax Group
Serious events: 0 serious events
Other events: 237 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix-A Group
n=390 participants at risk
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=390 participants at risk
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=390 participants at risk
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.00%
0/390 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
0.26%
1/390 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
0.00%
0/390 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
Other adverse events
| Measure |
Nimenrix-A Group
n=390 participants at risk
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot A vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix-B Group
n=390 participants at risk
Healthy male and female subjects, aged 18-25 years, received a single dose of Nimenrix Lot B vaccine administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax Group
n=390 participants at risk
Healthy male and female subjects, aged 18-25 years, received a single dose of Mencevax vaccine administered by subcutaneous injection in the upper region of the non-dominant arm.
|
|---|---|---|---|
|
General disorders
Pain
|
53.9%
208/386 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
54.7%
210/384 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
36.8%
141/383 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
|
General disorders
Redness
|
24.1%
93/386 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
21.9%
84/384 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
14.9%
57/383 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
|
General disorders
Swelling
|
14.8%
57/386 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
16.4%
63/384 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
11.0%
42/383 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
|
General disorders
Fatigue
|
30.3%
117/386 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
28.6%
110/384 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
30.0%
115/383 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
|
General disorders
Gastrointestinal
|
13.0%
50/386 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
11.2%
43/384 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
11.7%
45/383 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
|
General disorders
Headache
|
27.2%
105/386 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
31.0%
119/384 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
26.9%
103/383 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
|
General disorders
Temperature /(Orally)
|
7.3%
28/386 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
6.0%
23/384 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
6.8%
26/383 • Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 1).
|
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