Trial Outcomes & Findings for Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612 (NCT NCT00974363)
NCT ID: NCT00974363
Last Updated: 2017-04-12
Results Overview
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.
COMPLETED
PHASE3
697 participants
At Month 24 post primary dose
2017-04-12
Participant Flow
Out of the 697 subjects enrolled in this study, only 689 were vaccinated and hence started the study.
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 |
Nimenrix™ Group
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
521
|
168
|
|
Overall Study
COMPLETED
|
521
|
168
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Baseline characteristics by cohort
| Measure |
Nimenrix™ Group
n=521 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=168 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Total
n=689 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.4 Years
STANDARD_DEVIATION 1.94 • n=5 Participants
|
16.4 Years
STANDARD_DEVIATION 2 • n=7 Participants
|
16.4 Years
STANDARD_DEVIATION 1.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
273 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
359 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
248 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
330 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 24 post primary dosePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.
Outcome measures
| Measure |
Nimenrix™ Group
n=407 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=132 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA- MenA, GSK laboratory [N=405;132]
|
404 Subjects
|
132 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA- MenC, GSK laboratory [N=407;132]
|
404 Subjects
|
131 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA- MenW-135, GSK laboratory [N=407;131]
|
405 Subjects
|
124 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA- MenY, GSK laboratory [N=407;130]
|
407 Subjects
|
126 Subjects
|
PRIMARY outcome
Timeframe: At Month 36 post primary dosePopulation: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Outcome measures
| Measure |
Nimenrix™ Group
n=449 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=150 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, PHE laboratory
|
368 Subjects
|
45 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenA, PHE laboratory
|
417 Subjects
|
124 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenC, PHE laboratory
|
409 Subjects
|
129 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenY, PHE laboratory
|
418 Subjects
|
87 Subjects
|
PRIMARY outcome
Timeframe: At Month 48 post primary dosePopulation: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Outcome measures
| Measure |
Nimenrix™ Group
n=391 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=130 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenA, PHE laboratory [N=391;130]
|
353 Subjects
|
105 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenY, PHE laboratory [N=389;130]
|
348 Subjects
|
63 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenC, PHE laboratory [N=390;130]
|
367 Subjects
|
113 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, PHE laboratory [N=390;130]
|
301 Subjects
|
35 Subjects
|
PRIMARY outcome
Timeframe: At Month 60 post primary dosePopulation: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses for this timepoint were performed solely at the Public Health of England's (PHE) laboratory.
Outcome measures
| Measure |
Nimenrix™ Group
n=236 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=86 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenC, PHE laboratory [N=236;85]
|
209 Subjects
|
74 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenA, PHE laboratory [N=236;86]
|
230 Subjects
|
80 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, PHE laboratory [N=236;86]
|
203 Subjects
|
30 Subjects
|
|
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenY, PHE laboratory [N=236;86]
|
228 Subjects
|
57 Subjects
|
SECONDARY outcome
Timeframe: At Months 24, 36, 48 and 60 post primary dosePopulation: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Outcome measures
| Measure |
Nimenrix™ Group
n=449 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=150 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M60, PHE laboratory [N=236;86]
|
219 Subjects
|
71 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M24, GSK laboratory [N=407;132]
|
396 Subjects
|
125 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M24, GSK laboratory [N=407;131]
|
403 Subjects
|
113 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M24, GSK laboratory [N=405;132]
|
403 Subjects
|
128 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M36, PHE laboratory [N=449;150]
|
398 Subjects
|
118 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M48, PHE laboratory [N=391;130]
|
335 Subjects
|
99 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M36, PHE laboratory [N=449;150]
|
380 Subjects
|
117 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M48, PHE laboratory [N=390;130]
|
347 Subjects
|
104 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M60, PHE laboratory [N=236;85]
|
188 Subjects
|
68 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M36, PHE laboratory [N=449;150]
|
350 Subjects
|
36 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M48, PHE laboratory [N=390;130]
|
284 Subjects
|
25 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M60, PHE laboratory [N=236;86]
|
195 Subjects
|
26 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M24, GSK laboratory [N=407;130]
|
407 Subjects
|
123 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M36, PHE laboratory [N=449;150]
|
401 Subjects
|
77 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M48, PHE laboratory [N=389;130]
|
333 Subjects
|
60 Subjects
|
|
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M60, PHE laboratory [N=236;86]
|
225 Subjects
|
56 Subjects
|
SECONDARY outcome
Timeframe: At Months 24, 36, 48 and 60 post primary dosePopulation: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Outcome measures
| Measure |
Nimenrix™ Group
n=449 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=150 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M24, GSK laboratory [N=407;132]
|
1137.5 Titers
Interval 1006.1 to 1286.0
|
1543 Titers
Interval 1145.8 to 2077.7
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M24, GSK laboratory [N=407;130]
|
3502.5 Titers
Interval 3203.2 to 3829.7
|
1028.3 Titers
Interval 797.3 to 1326.1
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M24, GSK laboratory [N=405;132]
|
1493.4 Titers
Interval 1369.0 to 1629.0
|
780.3 Titers
Interval 665.3 to 915.2
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M36, PHE laboratory [N=449;150]
|
448.3 Titers
Interval 381.4 to 527.1
|
206 Titers
Interval 147.4 to 288.1
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M48, PHE laboratory [N=391;130]
|
386.9 Titers
Interval 321.2 to 466.2
|
174.4 Titers
Interval 121.2 to 250.8
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenA, M60, PHE laboratory [N=236;86]
|
643.8 Titers
Interval 530.7 to 781.0
|
296 Titers
Interval 202.4 to 432.9
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M36, PHE laboratory [N=449;150]
|
371.4 Titers
Interval 309.4 to 445.8
|
389.8 Titers
Interval 262.0 to 579.9
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M48, PHE laboratory [N=390;130]
|
378.5 Titers
Interval 319.7 to 448.1
|
364 Titers
Interval 242.7 to 545.9
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenC, M60, PHE laboratory [N=236;85]
|
248.6 Titers
Interval 194.2 to 318.2
|
366.5 Titers
Interval 224.1 to 599.4
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M24, GSK laboratory [N=407;131]
|
1977.6 Titers
Interval 1775.0 to 2203.4
|
418.2 Titers
Interval 317.6 to 550.6
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M36, PHE laboratory [N=449;150]
|
338 Titers
Interval 268.4 to 425.6
|
16 Titers
Interval 10.9 to 23.6
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M48, PHE laboratory [N=390;130]
|
209.8 Titers
Interval 163.9 to 268.6
|
11.7 Titers
Interval 8.2 to 16.8
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenW-135, M60, PHE laboratory [N=236;86]
|
436.9 Titers
Interval 324.4 to 588.4
|
19.7 Titers
Interval 11.8 to 32.9
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M36, PHE laboratory [N=449;150]
|
740.5 Titers
Interval 620.0 to 884.3
|
69.6 Titers
Interval 44.6 to 108.6
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M48, PHE laboratory [N=389;130]
|
533.4 Titers
Interval 430.0 to 661.7
|
49.8 Titers
Interval 30.7 to 80.9
|
|
Antibody Titers Against the Vaccine Meningococcal Serogroups
rSBA-MenY, M60, PHE laboratory [N=236;86]
|
1000.2 Titers
Interval 824.1 to 1214.0
|
124.9 Titers
Interval 71.2 to 219.3
|
SECONDARY outcome
Timeframe: At Month 24 post primary dosePopulation: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nimenrix™ Group
n=208 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=66 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSA ≥ 0.3 µg/mL, [N=196; 65]
|
196 Subjects
|
65 Subjects
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSA ≥ 2.0 µg/mL, [N=196; 65]
|
179 Subjects
|
64 Subjects
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSC ≥ 0.3 µg/mL, [N=192; 66]
|
176 Subjects
|
66 Subjects
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSC ≥ 2.0 µg/mL, [N=192; 66]
|
96 Subjects
|
62 Subjects
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSW-135 ≥ 0.3 µg/mL, [N=198; 62]
|
187 Subjects
|
61 Subjects
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSW-135 ≥ 2.0 µg/mL, [N=198; 62]
|
127 Subjects
|
49 Subjects
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSY ≥ 0.3 µg/mL, [N=208; 65]
|
203 Subjects
|
63 Subjects
|
|
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSY ≥ 2.0 µg/mL, [N=208; 65]
|
130 Subjects
|
51 Subjects
|
SECONDARY outcome
Timeframe: At Month 24 post primary dosePopulation: The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.
Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Nimenrix™ Group
n=208 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
Mencevax™ Group
n=66 Participants
Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
|
|---|---|---|
|
Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSY [N=208;65]
|
3.63 μg/mL
Interval 3.0 to 4.4
|
6.99 μg/mL
Interval 4.83 to 10.11
|
|
Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSA [N=196; 65]
|
10.16 μg/mL
Interval 8.47 to 12.2
|
18.17 μg/mL
Interval 13.33 to 24.77
|
|
Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSC [N=192;66]
|
1.95 μg/mL
Interval 1.61 to 2.35
|
10.88 μg/mL
Interval 8.22 to 14.41
|
|
Antibody Concentrations Against the Vaccine Polysaccharides
Anti-PSW-135 [N=198;62]
|
3.29 μg/mL
Interval 2.71 to 4.0
|
5.22 μg/mL
Interval 3.74 to 7.27
|
Adverse Events
Nimenrix™ Group
Mencevax™ Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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