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Trial record 67 of 280 for:    Panama

Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

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ClinicalTrials.gov Identifier: NCT01154088
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Meningococcal
Interventions Biological: Mencevax ACWY
Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]
Enrollment 1170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 390 390 390
Completed 386 384 383
Not Completed 4 6 7
Reason Not Completed
Lost to Follow-up             4             6             7
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 390 390 390 1170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 390 participants 390 participants 390 participants 1170 participants
20.8  (2.14) 20.9  (2.10) 20.6  (1.94) 20.77  (2.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 390 participants 390 participants 390 participants 1170 participants
Female
197
  50.5%
225
  57.7%
204
  52.3%
626
  53.5%
Male
193
  49.5%
165
  42.3%
186
  47.7%
544
  46.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 390 participants 390 participants 390 participants 1170 participants
African heritage/African American
16
   4.1%
13
   3.3%
17
   4.4%
46
   3.9%
Asian - Central/South Asian heritage
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
Asian - East Asian heritage
2
   0.5%
1
   0.3%
2
   0.5%
5
   0.4%
Asian - Japanese heritage
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.1%
Asian - South East Asian heritage
258
  66.2%
259
  66.4%
257
  65.9%
774
  66.2%
White - Arabic/North African heritage
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.1%
White - Caucasian/European heritage
13
   3.3%
14
   3.6%
13
   3.3%
40
   3.4%
Other
100
  25.6%
102
  26.2%
100
  25.6%
302
  25.8%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 358 353 357
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA Number Analyzed 302 participants 298 participants 293 participants
239
  79.1%
238
  79.9%
216
  73.7%
rSBA-MenC Number Analyzed 346 participants 342 participants 353 participants
324
  93.6%
327
  95.6%
332
  94.1%
rSBA-MenW-135 Number Analyzed 338 participants 327 participants 337 participants
328
  97.0%
312
  95.4%
304
  90.2%
rSBA-MenY Number Analyzed 358 participants 353 participants 357 participants
334
  93.3%
324
  91.8%
308
  86.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Mencevax Group
Comments Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.
Method of Estimation Estimation Parameter Difference in vaccine response rate
Estimated Value 5.42
Confidence Interval (2-Sided) 95%
-1.41 to 12.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Mencevax Group
Comments Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.
Method of Estimation Estimation Parameter Difference in vaccine response rate
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-4.11 to 3.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Mencevax Group
Comments Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.
Method of Estimation Estimation Parameter Difference in vaccine response rate
Estimated Value 6.83
Confidence Interval (2-Sided) 95%
3.28 to 10.78
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Mencevax Group
Comments Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.
Method of Estimation Estimation Parameter Difference in vaccine response rate
Estimated Value 7.02
Confidence Interval (2-Sided) 95%
2.63 to 11.58
Estimation Comments [Not Specified]
2.Primary Outcome
Title rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
Hide Description Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 375 371 373
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
rSBA-MenA Number Analyzed 359 participants 343 participants 356 participants
4846.0
(4459.8 to 5265.7)
5064.6
(4657.5 to 5507.2)
3421.0
(3134.7 to 3733.4)
rSBA-MenC Number Analyzed 374 participants 370 participants 372 participants
6025.4
(5269.0 to 6890.2)
7070.7
(6225.3 to 8030.9)
5953.1
(5188.2 to 6830.7)
rSBA-MenW-135 Number Analyzed 375 participants 370 participants 372 participants
9836.7
(8939.2 to 10824.3)
8855.5
(8021.8 to 9775.9)
4675.1
(4145.9 to 5272.0)
rSBA-MenY Number Analyzed 375 participants 371 participants 373 participants
11632.5
(10675.1 to 12675.8)
10386.7
(9557.5 to 11287.9)
6315.9
(5787.9 to 6892.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Nimenrix-B Group
Comments Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.
Method of Estimation Estimation Parameter Adjusted GMT ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.92 to 1.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Nimenrix-B Group
Comments Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.
Method of Estimation Estimation Parameter Adjusted GMT ratio
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.96 to 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Nimenrix-B Group
Comments Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.
Method of Estimation Estimation Parameter Adjusted GMT ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.8 to 1.04
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nimenrix-A Group, Nimenrix-B Group
Comments Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.
Type of Statistical Test Non-Inferiority
Comments Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.
Method of Estimation Estimation Parameter Adjusted GMT ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.78 to 0.99
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Hide Description 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.
Time Frame At Day 0 and at Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Mencevax Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 376 373
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA, Day 0 Number Analyzed 366 participants 368 participants
66
  18.0%
77
  20.9%
rSBA-MenA, Month 1 Number Analyzed 376 participants 372 participants
376
 100.0%
371
  99.7%
rSBA-MenC, Day 0 Number Analyzed 367 participants 368 participants
44
  12.0%
57
  15.5%
rSBA-MenC, Month 1 Number Analyzed 375 participants 372 participants
371
  98.9%
360
  96.8%
rSBA-MenW-135, Day 0 Number Analyzed 366 participants 368 participants
69
  18.9%
76
  20.7%
rSBA-MenW-135, Month 1 Number Analyzed 373 participants 370 participants
371
  99.5%
362
  97.8%
rSBA-MenY, Day 0 Number Analyzed 364 participants 367 participants
140
  38.5%
136
  37.1%
rSBA-MenY, Month 1 Number Analyzed 376 participants 373 participants
376
 100.0%
367
  98.4%
4.Secondary Outcome
Title Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Hide Description 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.
Time Frame At Day 0 and Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Mencevax Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 376 373
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA, Day 0 Number Analyzed 366 participants 368 participants
47
  12.8%
53
  14.4%
rSBA-MenA, Month 1 Number Analyzed 376 participants 372 participants
375
  99.7%
364
  97.8%
rSBA-MenC, Day 0 Number Analyzed 367 participants 368 participants
20
   5.4%
34
   9.2%
rSBA-MenC, Month 1 Number Analyzed 375 participants 372 participants
369
  98.4%
358
  96.2%
rSBA-MenW-135, Day 0 Number Analyzed 366 participants 368 participants
42
  11.5%
54
  14.7%
rSBA-MenW-135, Month 1 Number Analyzed 373 participants 370 participants
371
  99.5%
359
  97.0%
rSBA-MenY, Day 0 Number Analyzed 364 participants 367 participants
114
  31.3%
120
  32.7%
rSBA-MenY, Month 1 Number Analyzed 376 participants 373 participants
376
 100.0%
367
  98.4%
5.Secondary Outcome
Title rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Hide Description Titers are presented as geometric mean titers (GMTs). The analysis was performed with the Health Protection Agency (HPA) rSBA assay.
Time Frame At Day 0 and at Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Mencevax Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 376 373
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
rSBA-MenA, Day 0 Number Analyzed 366 participants 368 participants
4.7
(3.9 to 5.7)
5.3
(4.4 to 6.5)
rSBA-MenA, Month 1 Number Analyzed 376 participants 372 participants
3463.4
(3152.6 to 3804.8)
2186.0
(1923.9 to 2483.8)
rSBA-MenC, Day 0 Number Analyzed 367 participants 368 participants
3.2
(2.8 to 3.6)
3.7
(3.2 to 4.4)
rSBA-MenC, Month 1 Number Analyzed 375 participants 372 participants
4187.9
(3563.8 to 4921.2)
3649.1
(3026.5 to 4399.8)
rSBA-MenW-135, Day 0 Number Analyzed 366 participants 368 participants
4.8
(3.9 to 5.8)
5.5
(4.4 to 6.8)
rSBA-MenW-135, Month 1 Number Analyzed 373 participants 370 participants
12725.1
(10998.4 to 14722.9)
4365.4
(3622.8 to 5260.1)
rSBA-MenY, Day 0 Number Analyzed 364 participants 367 participants
13.3
(10.3 to 17.2)
12.6
(9.8 to 16.3)
rSBA-MenY, Month 1 Number Analyzed 376 participants 373 participants
5911.3
(5315.2 to 6574.3)
2554.9
(2211.6 to 2951.4)
6.Secondary Outcome
Title Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value
Hide Description 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.
Time Frame At Day 0 and at Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 375 371 373
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA, Day 0 Number Analyzed 320 participants 328 participants 310 participants
296
  92.5%
314
  95.7%
295
  95.2%
rSBA-MenA, Month 1 Number Analyzed 359 participants 343 participants 356 participants
359
 100.0%
343
 100.0%
356
 100.0%
rSBA-MenC, Day 0 Number Analyzed 351 participants 350 participants 361 participants
211
  60.1%
213
  60.9%
224
  62.0%
rSBA-MenC, Month 1 Number Analyzed 374 participants 370 participants 372 participants
374
 100.0%
370
 100.0%
372
 100.0%
rSBA-MenW- 135, Day 0 Number Analyzed 343 participants 333 participants 345 participants
296
  86.3%
286
  85.9%
298
  86.4%
rSBA-MenW- 135, Month 1 Number Analyzed 375 participants 370 participants 372 participants
375
 100.0%
370
 100.0%
372
 100.0%
rSBA-MenY, Day 0 Number Analyzed 363 participants 359 participants 364 participants
335
  92.3%
338
  94.2%
336
  92.3%
rSBA-MenY, Month 1 Number Analyzed 375 participants 371 participants 373 participants
375
 100.0%
371
 100.0%
373
 100.0%
7.Secondary Outcome
Title rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Hide Description Titers are presented as geometric mean titers (GMTs). The analysis was performed with the GSK rSBA assay.
Time Frame At Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 363 359 364
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
rSBA-MenA Number Analyzed 320 participants 328 participants 310 participants
348.4
(293.0 to 414.2)
401.4
(347.2 to 464.1)
424.4
(362.9 to 496.5)
rSBA-MenC Number Analyzed 351 participants 350 participants 361 participants
36.3
(29.3 to 45.0)
44.7
(35.6 to 56.2)
46.9
(37.2 to 59.0)
rSBA-MenW-135 Number Analyzed 343 participants 333 participants 345 participants
185.9
(153.1 to 225.6)
191.2
(155.9 to 234.4)
205.5
(167.6 to 252.0)
rSBA-MenY Number Analyzed 363 participants 359 participants 364 participants
387.5
(324.9 to 462.2)
426.8
(362.2 to 502.8)
412.6
(346.8 to 490.8)
8.Secondary Outcome
Title Number of Subjects With Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Hide Description 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.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Mencevax Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 362 360
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-Men Number Analyzed 362 participants 360 participants
356
  98.3%
353
  98.1%
rSBA-MenC Number Analyzed 362 participants 360 participants
354
  97.8%
347
  96.4%
rSBA-MenW-135 Number Analyzed 360 participants 358 participants
356
  98.9%
345
  96.4%
rSBA-MenY Number Analyzed 360 participants 360 participants
355
  98.6%
343
  95.3%
9.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description 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.
Time Frame Within 4-days (Days 0-3) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 386 384 383
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
208
  53.9%
210
  54.7%
141
  36.8%
Grade 3 Pain
6
   1.6%
8
   2.1%
3
   0.8%
Any Redness
93
  24.1%
84
  21.9%
57
  14.9%
Grade 3 Redness
2
   0.5%
0
   0.0%
0
   0.0%
Any Swelling
57
  14.8%
63
  16.4%
42
  11.0%
Grade 3 Swelling
4
   1.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description 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.
Time Frame Within 4-days (Days 0-3) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 386 384 383
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
117
  30.3%
110
  28.6%
115
  30.0%
Grade 3 Fatigue
1
   0.3%
3
   0.8%
0
   0.0%
Related Fatigue
113
  29.3%
100
  26.0%
109
  28.5%
Any Gastrointestinal symptoms
50
  13.0%
43
  11.2%
45
  11.7%
Grade 3 Gastrointestinal symptoms
2
   0.5%
2
   0.5%
1
   0.3%
Related Gastrointestinal symptoms
44
  11.4%
38
   9.9%
36
   9.4%
Any Headache
105
  27.2%
119
  31.0%
103
  26.9%
Grade 3 Headache
1
   0.3%
3
   0.8%
2
   0.5%
Relate Headache
96
  24.9%
111
  28.9%
95
  24.8%
Any Temperature
28
   7.3%
23
   6.0%
26
   6.8%
Grade 3 Temperature
0
   0.0%
0
   0.0%
0
   0.0%
Related Temperature
27
   7.0%
20
   5.2%
24
   6.3%
11.Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame Within 31-days (Days 0-30) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 390 390 390
Measure Type: Count of Participants
Unit of Measure: Participants
103
  26.4%
94
  24.1%
86
  22.1%
12.Secondary Outcome
Title Number of Subjects With New Onset Chronic Illnesses (NOCI)
Hide Description NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame Within 31-days (Days 0-30) post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 390 390 390
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nimenrix-A Group Nimenrix-B Group Mencevax Group
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Nimenrix-A Group Nimenrix-B Group Mencevax Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/390 (0.00%)   0/390 (0.00%)   0/390 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nimenrix-A Group Nimenrix-B Group Mencevax Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/390 (0.00%)   1/390 (0.26%)   0/390 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Blighted ovum  1  0/390 (0.00%)  1/390 (0.26%)  0/390 (0.00%) 
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nimenrix-A Group Nimenrix-B Group Mencevax Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   274/390 (70.26%)   271/390 (69.49%)   237/390 (60.77%) 
General disorders       
Pain  1  208/386 (53.89%)  210/384 (54.69%)  141/383 (36.81%) 
Redness  1  93/386 (24.09%)  84/384 (21.88%)  57/383 (14.88%) 
Swelling  1  57/386 (14.77%)  63/384 (16.41%)  42/383 (10.97%) 
Fatigue  1  117/386 (30.31%)  110/384 (28.65%)  115/383 (30.03%) 
Gastrointestinal  1  50/386 (12.95%)  43/384 (11.20%)  45/383 (11.75%) 
Headache  1  105/386 (27.20%)  119/384 (30.99%)  103/383 (26.89%) 
Temperature /(Orally)  1  28/386 (7.25%)  23/384 (5.99%)  26/383 (6.79%) 
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01154088     History of Changes
Other Study ID Numbers: 114248
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: March 27, 2017
Results First Posted: November 26, 2018
Last Update Posted: November 26, 2018