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Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454909
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : April 12, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Infections, Meningococcal
Interventions Biological: Meningococcal vaccine 134612
Biological: Menactra®
Enrollment 873
Recruitment Details Out of the 873 subjects enrolled in the study, only 872 subjects received the vaccination course and started the study.
Pre-assignment Details  
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 587 197 88
Completed 580 194 86
Not Completed 7 3 2
Reason Not Completed
Withdrawal by Subject             1             0             0
Migrated/moved from study area             0             0             1
Lost to follow-up (complete vaccination)             5             3             1
Others             1             0             0
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group Total
Hide Arm/Group Description Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 587 197 88 872
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 587 participants 197 participants 88 participants 872 participants
14.8  (2.69) 14.7  (2.78) 10  (0) 14.29  (2.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 197 participants 88 participants 872 participants
Female
274
  46.7%
101
  51.3%
51
  58.0%
426
  48.9%
Male
313
  53.3%
96
  48.7%
37
  42.0%
446
  51.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants 197 participants 88 participants 872 participants
African heritage/African American
35
   6.0%
12
   6.1%
9
  10.2%
56
   6.4%
American Indian or Alaskan Native
49
   8.3%
21
  10.7%
9
  10.2%
79
   9.1%
Asian-Central/South Asian heritage
5
   0.9%
3
   1.5%
1
   1.1%
9
   1.0%
Asian-East Asian heritage
17
   2.9%
1
   0.5%
5
   5.7%
23
   2.6%
Asian-Japanese heritage
7
   1.2%
4
   2.0%
0
   0.0%
11
   1.3%
Asian-South East Asian heritage
40
   6.8%
14
   7.1%
8
   9.1%
62
   7.1%
Native Hawaiian or other Pacific Islander
4
   0.7%
2
   1.0%
1
   1.1%
7
   0.8%
White-Arabic/North African heritage
2
   0.3%
2
   1.0%
1
   1.1%
5
   0.6%
White-Caucasian/European heritage
290
  49.4%
95
  48.2%
34
  38.6%
419
  48.1%
Unspecified
138
  23.5%
43
  21.8%
20
  22.7%
201
  23.1%
1.Primary Outcome
Title Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
Hide Description The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time Frame At Day 0 (PRE)
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 506 174 77
Measure Type: Count of Participants
Unit of Measure: Participants
hSBA-MenA Number Analyzed 503 participants 172 participants 77 participants
49
   9.7%
13
   7.6%
5
   6.5%
hSBA-MenC Number Analyzed 506 participants 174 participants 75 participants
275
  54.3%
113
  64.9%
40
  53.3%
hSBA-MenW-135 Number Analyzed 461 participants 151 participants 70 participants
114
  24.7%
51
  33.8%
11
  15.7%
hSBA-MenY Number Analyzed 491 participants 162 participants 73 participants
269
  54.8%
94
  58.0%
31
  42.5%
2.Primary Outcome
Title Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value
Hide Description The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Time Frame At Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 517 174 79
Measure Type: Count of Participants
Unit of Measure: Participants
hSBA-MenA Number Analyzed 507 participants 167 participants 79 participants
415
  81.9%
118
  70.7%
70
  88.6%
hSBA-MenC Number Analyzed 510 participants 173 participants 79 participants
490
  96.1%
171
  98.8%
78
  98.7%
hSBA-MenW-135 Number Analyzed 479 participants 149 participants 77 participants
438
  91.4%
114
  76.5%
73
  94.8%
hSBA-MenY Number Analyzed 517 participants 170 participants 79 participants
492
  95.2%
139
  81.8%
76
  96.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nimenrix 11-25Y Group, Menactra Group
Comments Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
3.87 to 19.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nimenrix 11-25Y Group, Menactra Group
Comments Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -2.77
Confidence Interval (2-Sided) 95%
-5.08 to 0.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nimenrix 11-25Y Group, Menactra Group
Comments Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 14.93
Confidence Interval (2-Sided) 95%
8.24 to 22.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nimenrix 11-25Y Group, Menactra Group
Comments Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 13.40
Confidence Interval (2-Sided) 95%
7.90 to 20.10
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value
Hide Description The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame At Day 0 (PRE) and Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 517 174 79
Measure Type: Count of Participants
Unit of Measure: Participants
hSBA-MenA, PRE Number Analyzed 503 participants 172 participants 77 participants
68
  13.5%
18
  10.5%
7
   9.1%
hSBA-MenA, Month 1 Number Analyzed 507 participants 167 participants 79 participants
421
  83.0%
118
  70.7%
71
  89.9%
hSBA-MenC, PRE Number Analyzed 506 participants 174 participants 75 participants
276
  54.5%
114
  65.5%
40
  53.3%
hSBA-MenC, Month 1 Number Analyzed 510 participants 173 participants 79 participants
490
  96.1%
171
  98.8%
78
  98.7%
hSBA-MenW-135, PRE Number Analyzed 461 participants 151 participants 70 participants
118
  25.6%
51
  33.8%
11
  15.7%
hSBA-MenW-135, Month 1 Number Analyzed 479 participants 149 participants 77 participants
441
  92.1%
117
  78.5%
73
  94.8%
hSBA-MenY, PRE Number Analyzed 491 participants 162 participants 73 participants
273
  55.6%
94
  58.0%
32
  43.8%
hSBA-MenY, Month 1 Number Analyzed 517 participants 170 participants 79 participants
492
  95.2%
139
  81.8%
76
  96.2%
4.Secondary Outcome
Title hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
Hide Description Antibody titers are presented as geometric mean titers (GMTs).
Time Frame At Day 0 (PRE) and Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 517 174 79
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
hSBA-MenA, PRE Number Analyzed 503 participants 172 participants 77 participants
2.6
(2.5 to 2.8)
2.4
(2.2 to 2.6)
2.4
(2.1 to 2.9)
hSBA-MenA, Month 1 Number Analyzed 507 participants 167 participants 79 participants
57.2
(48.8 to 67.0)
36.0
(26.1 to 49.7)
91.5
(64.0 to 130.8)
hSBA-MenC, PRE Number Analyzed 506 participants 174 participants 75 participants
12.8
(10.9 to 15.1)
17.9
(13.5 to 23.6)
9.7
(6.7 to 14.2)
hSBA-MenC, Month 1 Number Analyzed 510 participants 173 participants 79 participants
506.7
(419.1 to 612.5)
285.8
(214.7 to 380.5)
765.9
(505.3 to 1160.9)
hSBA-MenW-135, PRE Number Analyzed 461 participants 151 participants 70 participants
5.7
(4.8 to 6.8)
8.6
(6.1 to 12.1)
4.2
(2.8 to 6.4)
hSBA-MenW-135, Month 1 Number Analyzed 479 participants 149 participants 77 participants
124.2
(106.2 to 145.2)
74.1
(51.1 to 107.5)
153.8
(109.9 to 215.1)
hSBA-MenY, PRE Number Analyzed 491 participants 162 participants 73 participants
22.6
(18.3 to 27.8)
27.6
(19.0 to 40.2)
13.7
(8.0 to 23.6)
hSBA-MenY, Month 1 Number Analyzed 517 participants 170 participants 79 participants
260.0
(225.2 to 300.2)
110.6
(77.6 to 157.9)
315.0
(223.6 to 443.7)
5.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 During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 579 194 86
Measure Type: Count of Participants
Unit of Measure: Participants
Pain, Any, D0-3
317
  54.7%
105
  54.1%
48
  55.8%
Pain, Grade 3, D0-3
9
   1.6%
2
   1.0%
0
   0.0%
Redness, Any, D0-3
77
  13.3%
21
  10.8%
15
  17.4%
Redness, Grade 3, D0-3
9
   1.6%
0
   0.0%
2
   2.3%
Swelling, Any, D0-3
62
  10.7%
13
   6.7%
18
  20.9%
Swelling, Grade 3, D0-3
11
   1.9%
1
   0.5%
3
   3.5%
Pain, Any, D0-7
318
  54.9%
105
  54.1%
48
  55.8%
Pain, Grade 3, D0-7
9
   1.6%
2
   1.0%
0
   0.0%
Redness, Any, D0-7
77
  13.3%
21
  10.8%
15
  17.4%
Redness, Grade 3, D0-7
9
   1.6%
0
   0.0%
2
   2.3%
Swelling, Any, D0-7
63
  10.9%
13
   6.7%
18
  20.9%
Swelling, Grade 3, D0-7
11
   1.9%
1
   0.5%
3
   3.5%
6.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, fever [defined as orally temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 579 194 86
Measure Type: Count of Participants
Unit of Measure: Participants
Fatigue, Any, D0-3
156
  26.9%
55
  28.4%
24
  27.9%
Fatigue, Grade 3, D0-3
10
   1.7%
2
   1.0%
3
   3.5%
Fatigue, Related, D0-3
139
  24.0%
49
  25.3%
21
  24.4%
Fever (orally), Any, D0-3
34
   5.9%
11
   5.7%
6
   7.0%
Fever (orally), Grade 3, D0-3
0
   0.0%
0
   0.0%
0
   0.0%
Fever (orally), Related, D0-3
28
   4.8%
9
   4.6%
5
   5.8%
Gastrointestinal symptoms, Any, D0-3
87
  15.0%
26
  13.4%
11
  12.8%
Gastrointestinal symptoms, Grade 3, D0-3
4
   0.7%
2
   1.0%
0
   0.0%
Gastrointestinal symptoms, Related, D0-3
74
  12.8%
22
  11.3%
9
  10.5%
Headache, Any, D0-3
161
  27.8%
60
  30.9%
27
  31.4%
Headache, Grade 3, D0-3
11
   1.9%
1
   0.5%
1
   1.2%
Headache, Related, D0-3
139
  24.0%
51
  26.3%
21
  24.4%
Fatigue, Any, D0-7
172
  29.7%
62
  32.0%
27
  31.4%
Fatigue, Grade 3, D0-7
19
   3.3%
4
   2.1%
3
   3.5%
Fatigue, Related, D0-7
147
  25.4%
53
  27.3%
23
  26.7%
Fever (orally), Any, D0-7
41
   7.1%
16
   8.2%
7
   8.1%
Fever (orally), Grade 3, D0-7
1
   0.2%
0
   0.0%
0
   0.0%
Fever (orally), Related, D0-7
29
   5.0%
13
   6.7%
6
   7.0%
Gastrointestinal symptoms, Any, D0-7
109
  18.8%
32
  16.5%
15
  17.4%
Gastrointestinal symptoms, Grade 3, D0-7
8
   1.4%
3
   1.5%
2
   2.3%
Gastrointestinal symptoms, Related, D0-7
86
  14.9%
24
  12.4%
9
  10.5%
Headache, Any, D0-7
191
  33.0%
72
  37.1%
30
  34.9%
Headache, Grade 3, D0-7
16
   2.8%
2
   1.0%
2
   2.3%
Headache, Related, D0-7
157
  27.1%
57
  29.4%
24
  27.9%
7.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 During the 31-day (Days 0-30) follow-up period after vaccination
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Hide Analysis Population Description
The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 587 197 88
Measure Type: Count of Participants
Unit of Measure: Participants
104
  17.7%
37
  18.8%
13
  14.8%
8.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Day 0 to Month 6
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Hide Analysis Population Description
The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 587 197 88
Measure Type: Count of Participants
Unit of Measure: Participants
5
   0.9%
2
   1.0%
2
   2.3%
9.Secondary Outcome
Title Number of Subjects With New Onset Chronic Illness(es) (NOCI)
Hide Description NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame From Day 0 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 587 197 88
Measure Type: Count of Participants
Unit of Measure: Participants
8
   1.4%
2
   1.0%
1
   1.1%
10.Secondary Outcome
Title Number of Subjects Reporting Rash
Hide Description Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Time Frame From Day 0 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 587 197 88
Measure Type: Count of Participants
Unit of Measure: Participants
14
   2.4%
3
   1.5%
2
   2.3%
11.Secondary Outcome
Title Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Hide Description [Not Specified]
Time Frame From Day 0 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description:
Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 587 197 88
Measure Type: Count of Participants
Unit of Measure: Participants
24
   4.1%
9
   4.6%
2
   2.3%
Time Frame Solicited local/general symptoms: during the 4-day and 8-day post-vaccination period (Days 0-3 and Days 0-7), Unsolicited AEs: during the 31-day post-vaccination (Days 0-30), SAEs: during the entire study period (Day 0 - Month 6).
Adverse Event Reporting Description The solicited local and general symptoms were collected only from those subjects who filled in their symptom sheets.
 
Arm/Group Title Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Hide Arm/Group Description Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
All-Cause Mortality
Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/587 (0.00%)   0/197 (0.00%)   0/88 (0.00%) 
Hide Serious Adverse Events
Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/587 (0.85%)   2/197 (1.02%)   2/88 (2.27%) 
Gastrointestinal disorders       
Pancreatitis  1  0/587 (0.00%)  1/197 (0.51%)  0/88 (0.00%) 
General disorders       
Swelling  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
Infections and infestations       
Appendicitis  1  2/587 (0.34%)  0/197 (0.00%)  1/88 (1.14%) 
Cellulitis  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  0/587 (0.00%)  1/197 (0.51%)  0/88 (0.00%) 
Lower limb fracture  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
Post procedural diarrhoea  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
Procedural nausea  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
Procedural vomiting  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
Metabolism and nutrition disorders       
Type 1 diabetes mellitus  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
Psychiatric disorders       
Suicidal ideation  1  0/587 (0.00%)  0/197 (0.00%)  1/88 (1.14%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory distress  1  1/587 (0.17%)  0/197 (0.00%)  0/88 (0.00%) 
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nimenrix 11-25Y Group Menactra Group Nimenrix 10Y Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   438/587 (74.62%)   142/197 (72.08%)   68/88 (77.27%) 
General disorders       
Pain (Days 0-3)  1  317/579 (54.75%)  105/194 (54.12%)  48/86 (55.81%) 
Redness (Days 0-3)  1  77/579 (13.30%)  21/194 (10.82%)  15/86 (17.44%) 
Swelling (Days 0-3)  1  62/579 (10.71%)  13/194 (6.70%)  18/86 (20.93%) 
Pain (Days 0-7)  1  318/579 (54.92%)  105/194 (54.12%)  48/86 (55.81%) 
Redness (Days 0-7)  1  77/579 (13.30%)  21/194 (10.82%)  15/86 (17.44%) 
Swelling (Days 0-7)  1  63/579 (10.88%)  13/194 (6.70%)  18/86 (20.93%) 
Fatigue (Days 0-3)  1  156/579 (26.94%)  55/194 (28.35%)  24/86 (27.91%) 
Fever/Orally (Days 0-3)  1  34/579 (5.87%)  11/194 (5.67%)  6/86 (6.98%) 
Gastrointestinal (Days 0-3)  1  87/579 (15.03%)  26/194 (13.40%)  11/86 (12.79%) 
Headache (Days 0-3)  1  161/579 (27.81%)  60/194 (30.93%)  27/86 (31.40%) 
Fatigue (Days 0-7)  1  172/579 (29.71%)  62/194 (31.96%)  27/86 (31.40%) 
Fever/Orally (Days 0-7)  1  41/579 (7.08%)  16/194 (8.25%)  7/86 (8.14%) 
Gastrointestinal (Days 0-7)  1  109/579 (18.83%)  32/194 (16.49%)  15/86 (17.44%) 
Headache (Days 0-7)  1  191/579 (32.99%)  72/194 (37.11%)  30/86 (34.88%) 
1
Term from vocabulary, MedDRA 12.0
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
Publications:
Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00454909    
Other Study ID Numbers: 109377
First Submitted: March 30, 2007
First Posted: April 2, 2007
Results First Submitted: March 1, 2017
Results First Posted: April 12, 2017
Last Update Posted: June 8, 2018