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Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

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ClinicalTrials.gov Identifier: NCT00874549
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : March 25, 2010
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningococcal Infections
Meningococcal Meningitis
Interventions Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide
Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 216
Recruitment Details Participants were enrolled and treated from 10 October 2007 to 25 August 2008 at 6 US clinical centers.
Pre-assignment Details A total of 216 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in the analyses.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0. Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0. Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14. Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Period Title: Overall Study
Started 51 56 51 58
Completed 50 55 47 56
Not Completed 1 1 4 2
Reason Not Completed
Adverse Event             0             0             1             0
Protocol Violation             1             0             2             1
Lost to Follow-up             0             0             1             0
Withdrawal by Subject             0             1             0             1
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28 Total
Hide Arm/Group Description Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0. Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0. Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14. Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28. Total of all reporting groups
Overall Number of Baseline Participants 51 56 51 58 216
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 56 participants 51 participants 58 participants 216 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  37.3%
19
  33.9%
19
  37.3%
18
  31.0%
75
  34.7%
>=65 years
32
  62.7%
37
  66.1%
32
  62.7%
40
  69.0%
141
  65.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 56 participants 51 participants 58 participants 216 participants
69.0  (7.2) 68.6  (7.0) 68.5  (7.2) 69.1  (7.3) 68.8  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 56 participants 51 participants 58 participants 216 participants
Female
29
  56.9%
27
  48.2%
34
  66.7%
34
  58.6%
124
  57.4%
Male
22
  43.1%
29
  51.8%
17
  33.3%
24
  41.4%
92
  42.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 56 participants 51 participants 58 participants 216 participants
51 56 51 58 216
1.Primary Outcome
Title Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1.
Hide Description Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Time Frame 0-7 days post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis post-vaccination 1 was on all enrolled and vaccinated participants, intent-to-treat population.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 51 56 51 58
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 26 20 28 23
Grade 3 Solicited Injection Site Reaction 4 0 1 3
Any Pain 12 16 24 18
Grade 3 Pain (Incapacitating) 1 0 0 1
Any Erythema 22 5 9 8
Grade 3 Erythema (≥ 5 cm) 3 0 1 0
Any Swelling 10 6 5 3
Grade 3 Swelling (≥ 5 cm) 0 0 1 2
Any Solicited Systemic Reaction 20 23 19 23
Grade 3 Solicited Systemic Reaction 3 1 3 3
Any Anorexia 3 4 1 2
Grade 3 Anorexia (Prevents daily activities) 2 0 1 0
Any Arthralgia 4 4 7 5
Grade 3 Arthralgia (Prevents daily activities) 1 0 2 2
Any Chills 4 4 1 1
Grade 3 Chills (Prevents daily activities) 1 0 0 1
Any Diarrhea 2 5 1 2
Grade 3 Diarrhea (Prevents daily activities) 0 0 0 0
Any Fever 3 2 0 3
Grade 3 Fever (> 102.2 ºF) 0 0 0 1
Any Headache 11 11 11 12
Grade 3 Headache (Prevents daily activities) 2 1 1 2
Any Malaise 6 6 5 9
Grade 3 Malaise (Prevents daily activities) 1 1 1 1
Any Myalgia 10 13 11 10
Grade 3 Myalgia (Prevents daily activities) 2 0 1 2
Any Urticaria 1 0 0 1
Grade 3 Urticaria (Prevents daily activities) 0 0 0 0
Any Vomiting 1 0 1 0
Grade 3 Vomiting (Prevents daily activities) 0 0 1 0
2.Primary Outcome
Title Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling.
Time Frame 0-7 Days Post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 56 51 58
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection site reaction 17 25 24
Grade 3 Solicited Injection site reaction 0 0 1
Any Pain 14 24 22
Grade 3 Pain (Incapacitating) 0 0 0
Any Erythema 7 5 6
Grade 3 Erythema (≥ 5 cm) 0 0 1
Any Swelling 5 5 3
Grade 3 Swelling (≥ 5 cm) 0 0 1
3.Primary Outcome
Title Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2
Hide Description Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.
Time Frame Day 0 to 7 Post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis post-vaccination 2 was on all enrolled and vaccinated participants, intent-to-treat population. No data were collected for participants in Group 1 and Group 2.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 0 51 58
Measure Type: Number
Unit of Measure: Participants
Any Solicited Systemic Reaction 19 13
Grade 3 Solicited Systemic Reaction 3 1
Any Anorexia 1 2
Grade 3 Anorexia (Prevents daily activities) 0 0
Any Arthralgia 5 2
Grade 3 Arthralgia (Prevents daily activities) 1 2
Any Chills 4 1
Grade 3 Chills (Prevents daily activities) 0 1
Any Diarrhea 2 3
Grade 3 Diarrhea (Prevents daily activities) 0 0
Any Fever 0 3
Grade 3 Fever (> 102.2 ºF) 0 1
Any Headache 9 7
Grade 3 Headache (Prevents daily activities) 1 2
Any Malaise 10 3
Grade 3 Malaise (Prevents daily activities) 0 1
Any Myalgia 12 7
Grade 3 Myalgia (Prevents daily activities) 0 2
Any Urticaria 1 0
Grade 3 Urticaria (Prevents daily activities) 0 0
Any Vomiting 0 0
Grade 3 Vomiting (Prevents daily activities) 0 0
4.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1.
Hide Description [Not Specified]
Time Frame Day 28 Post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 49 0 41 48
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A 90 88 89
Meningococcal Serogroup C 86 68 75
Meningococcal Serogroup Y 84 56 54
Meningococcal Serogroup W-135 92 51 73
5.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2
Hide Description [Not Specified]
Time Frame Day 28 Post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) post-vaccination 2, were assessed in the per-protocol population. No data were collected for participants in Group 1.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 54 51 58
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A 91 90 98
Meningococcal Serogroup C 72 85 83
Meningococcal Serogroup Y 66 76 73
Meningococcal Serogroup W-135 72 73 81
6.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1
Hide Description [Not Specified]
Time Frame Day 0 and Day 28 Post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of serum bactericidal antibody using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 49 0 41 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal Serogroup A, Pre-dose 1
21.1
(11.0 to 40.5)
18.6
(9.1 to 38.1)
19.6
(10.0 to 38.3)
Meningococcal Serogroup C, Pre-dose 1
9.9
(6.1 to 16.1)
16.6
(8.5 to 32.2)
7.6
(4.9 to 11.6)
Meningococcal Serogroup Y, Pre-dose 1
27.4
(15.1 to 49.8)
28.9
(14.9 to 56.0)
14.9
(8.6 to 25.8)
Meningococcal Serogroup W-135, Pre-dose 1
13.3
(8.0 to 22.0)
10.3
(6.1 to 17.3)
11.6
(7.1 to 19.2)
Meningococcal Serogroup A, Post-dose 1
3870.7
(2611.0 to 5738.0)
2048.0
(1082.2 to 3875.7)
1874.6
(1199.7 to 2929.1)
Meningococcal Serogroup C, Post-dose 1
927.5
(433.6 to 1983.8)
529.6
(204.6 to 1370.9)
367.3
(155.6 to 867.1)
Meningococcal Serogroup Y, Post-dose 1
750.1
(434.8 to 1294.1)
141.7
(63.5 to 316.3)
143.7
(64.9 to 318.1)
Meningococcal Serogroup W-135, Post-dose 1
782.7
(404.5 to 1514.4)
78.4
(35.5 to 173.1)
221.6
(117.4 to 418.1)
7.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2
Hide Description [Not Specified]
Time Frame Day 0 and 28 days Post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of serum bactericidal antibody using baby rabbit complement pre-vaccination 1 and post-vaccination 2 was determined in per-protocol population. No data were collected for participants in Group 1.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 54 41 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal Serogroup A, Pre-dose 1
16.8
(8.7 to 32.5)
18.6
(9.1 to 38.1)
19.6
(10.0 to 38.3)
Meningococcal Serogroup C, Pre-dose 1
11.0
(6.5 to 18.6)
16.6
(8.5 to 32.2)
7.6
(4.9 to 11.6)
Meningococcal Serogroup Y, Pre-dose 1
22.6
(14.2 to 36.1)
28.9
(14.9 to 56.0)
14.9
(8.6 to 25.8)
Meningococcal Serogroup W-135, Pre-dose 1
12.9
(7.4 to 22.2)
10.3
(6.1 to 17.3)
11.6
(7.1 to 19.2)
Meningococcal Serogroup A, Post-dose 2
3168.6
(2056.7 to 4881.7)
2871.9
(1823.9 to 4522.1)
2543.3
(1791.8 to 3610.0)
Meningococcal Serogroup C, Post-dose 2
568.5
(240.0 to 1346.2)
1041.5
(492.4 to 2202.9)
574.7
(251.7 to 1312.1)
Meningococcal Serogroup Y, Post-dose 2
311.5
(173.4 to 559.5)
264.8
(135.7 to 516.9)
259.7
(128.0 to 527.0)
Meningococcal Serogroup W-135, Post-dose 2
276.9
(135.1 to 567.4)
212.6
(96.3 to 469.2)
566.5
(299.3 to 1071.9)
8.Other Pre-specified Outcome
Title Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1
Hide Description [Not Specified]
Time Frame Day 28 Post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody titers using baby rabbit complement (SBA-BR) pre- and post-vaccination 1 were assessed in the per-protocol population. No data were collected for participants in Group 2.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 49 0 41 48
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A ≥ 1:8 Pre-Dose 1 38 34 35
Meningococcal Serogroup C ≥ 1:8 Pre-Dose 1 25 34 19
Meningococcal Serogroup Y ≥1:8 Pre-Dose 1 55 54 38
Meningococcal Serogroup W-135 ≥ 1:8 Pre-Dose 1 35 29 33
Meningococcal Serogroup A ≥ 1:8 Post-Dose 1 100 95 98
Meningococcal Serogroup C ≥ 1:8 Post-Dose 1 88 78 79
Meningococcal Serogroup Y ≥ 1:8 Post-Dose 1 96 78 71
Meningococcal Serogroup W-135 ≥ 1:8 Post-Dose 1 94 68 90
9.Other Pre-specified Outcome
Title Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2
Hide Description [Not Specified]
Time Frame Day 0 and Day 28 Post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody using baby rabbit complement titer pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 54 41 48
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A, ≥ 1:8 Pre-dose 1 28 34 35
Meningococcal Serogroup C, ≥ 1:8 Pre-dose 1 24 34 19
Meningococcal Serogroup Y, ≥ 1:8 Pre-dose 1 54 54 38
Meningococcal Serogroup W-135, ≥ 1:8 Pre-dose 1 30 29 33
Meningococcal Serogroup A, ≥ 1:8 Post-dose 2 98 100 100
Meningococcal Serogroup C, ≥ 1:8 Post-dose 2 79 90 83
Meningococcal Serogroup Y, ≥ 1:8 Post-dose 2 93 90 85
Meningococcal Serogroup W-135, ≥ 1:8 Post-dose 2 83 81 94
10.Post-Hoc Outcome
Title Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 1
Hide Description [Not Specified]
Time Frame Day 28 Post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 49 0 41 48
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A 37 63 44
Meningococcal Serogroup C 31 44 35
Meningococcal Serogroup Y 49 20 29
Meningococcal Serogroup W-135 47 20 33
11.Post-Hoc Outcome
Title Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Human Complement (SBA-HC) Post-vaccination 2
Hide Description [Not Specified]
Time Frame 28 Days post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody using human complements (SBA-HC) titers post-vaccination 2 was determined in the per-protocol population. No data were collected for participants in Group 1.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 54 41 48
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A 65 68 44
Meningococcal Serogroup C 48 44 48
Meningococcal Serogroup Y 48 29 40
Meningococcal Serogroup W-135 44 27 46
12.Post-Hoc Outcome
Title Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre- and Post-vaccination 1
Hide Description [Not Specified]
Time Frame Day 0 and Day 28 Post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean of serum bactericidal antibody titers using human complements (SBA-HC) pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 49 0 41 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal Serogroup A, Pre-dose 1
4.6
(3.5 to 6.0)
4.3
(3.3 to 5.6)
4.1
(3.1 to 5.3)
Meningococcal Serogroup C, Pre-dose 1
3.9
(2.9 to 5.4)
3.1
(2.3 to 4.2)
3.4
(2.6 to 4.5)
Meningococcal Serogroup Y, Pre-dose 1
5.2
(3.4 to 7.9)
3.4
(2.3 to 4.9)
3.3
(2.4 to 4.4)
Meningococcal Serogroup W-135, Pre-dose 1
2.8
(2.3 to 3.4)
2.8
(2.3 to 3.4)
3.1
(2.4 to 4.0)
Meningococcal Serogroup A, Post-dose 1
14.3
(8.8 to 23.1)
40.5
(20.3 to 80.8)
22.6
(13.0 to 39.4)
Meningococcal Serogroup C, Post-dose 1
15.1
(8.2 to 27.8)
18.9
(9.2 to 38.9)
14.9
(7.7 to 28.8)
Meningococcal Serogroup Y, Post-dose 1
23.8
(12.8 to 44.2)
6.8
(4.0 to 11.4)
10.4
(5.9 to 18.3)
Meningococcal Serogroup W-135, Post-dose 1
13.5
(8.6 to 21.1)
7.1
(4.3 to 11.8)
12.5
(6.7 to 23.2)
13.Post-Hoc Outcome
Title Geometric Mean Titers of Serum Bactericidal Antibody Using Human Complement (SBA-HC) Pre-vaccination 1 and Post-vaccination 2
Hide Description [Not Specified]
Time Frame Day 0 and Day 28 Post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean of serum bactericidal antibody titers using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 56 51 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal Serogroup A, Pre-dose 1
4.9
(3.5 to 6.9)
4.3
(3.3 to 5.6)
4.1
(3.1 to 5.3)
Meningococcal Serogroup C, Pre-dose 1
3.9
(2.9 to 5.3)
3.1
(2.3 to 4.2)
3.4
(2.6 to 4.5)
Meningococcal Serogroup Y Pre-dose 1
5.4
(3.8 to 7.7)
3.4
(2.3 to 4.2)
3.3
(2.4 to 4.4)
Meningococcal Serogroup W-135, Pre-dose 1
4.3
(3.1 to 5.8)
2.8
(2.3 to 3.4)
3.1
(2.4 to 4.0)
Meningococcal Serogroup A, Post-dose 2
47.6
(26.9 to 84.2)
48.0
(27.4 to 84.2)
21.1
(12.6 to 35.0)
Meningococcal Serogroup C, Post-dose 2
25.7
(13.8 to 47.9)
17.7
(8.9 to 35.3)
18.8
(9.9 to 35.6)
Meningococcal Serogroup Y, Post-dose 2
28.1
(16.0 to 49.6)
10.1
(5.7 to 18.0)
12.7
(7.3 to 22.1)
Meningococcal Serogroup W-135, Post-dose 2
26.1
(14.0 to 48.5)
9.3
(5.5 to 15.7)
18.2
(10.3 to 32.3)
14.Post-Hoc Outcome
Title Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1.
Hide Description [Not Specified]
Time Frame Day 28 Post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody using human complement (SBA-HC) titers pre- and post-vaccination 1 were determined in the per-protocol population. No data were collected for participants in Group 2.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 49 0 41 48
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A, Pre-dose 1 39 32 27
Meningococcal Serogroup C, Pre-dose 1 22 15 19
Meningococcal Serogroup Y, Pre-dose 1 31 17 17
Meningococcal Serogroup W-135, Pre-dose 1 16 12 19
Meningococcal Serogroup A, Post-dose 1 63 76 73
Meningococcal Serogroup C, Post-dose 1 57 56 52
Meningococcal Serogroup Y, Post-dose 1 63 37 44
Meningococcal Serogroup W-135, Post-dose 1 63 46 50
15.Post-Hoc Outcome
Title Percentage of Participants Achieving Serum Bactericidal Antibody Using Human Complement (SBA-HC) Titers of at Least 1:8 (≥1:8) Pre-vaccination 1 and Post-vaccination 2
Hide Description [Not Specified]
Time Frame Day 0 and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum bactericidal antibody using human complement (SBA-HC) pre-vaccination 1 and post-vaccination 2 were determined in the per-protocol population. No data were collected for participants in Group 1.
Arm/Group Title Group 1: Menomune® Day 0 Group 2: Menactra® Day 0 x 2 Group 3: Menactra® Day 0 and 14 Group 4: Menactra® Day 0 and 28
Hide Arm/Group Description:
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
Overall Number of Participants Analyzed 0 54 41 48
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A, Pre-dose 1 33 32 27
Meningococcal Serogroup C, Pre-dose 1 22 15 19
Meningococcal Serogroup Y, Pre-dose 1 37 17 17
Meningococcal Serogroup W-135, Pre-dose 1 26 12 19
Meningococcal Serogroup A, Post-dose 2 82 81 75
Meningococcal Serogroup C, Post-dose 2 65 56 65
Meningococcal Serogroup Y, Post-dose 2 72 54 54
Meningococcal Serogroup W-135, Post-dose 2 63 56 63
Time Frame Adverse events data were collected from day of enrollment to 6 Months after the last vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menomune® Day 0 Menactra® Day 0 x 2 Menactra® Day 0 and Day 14 Menactra® Day 0 and Day 28
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Menomune® Day 0 Menactra® Day 0 x 2 Menactra® Day 0 and Day 14 Menactra® Day 0 and Day 28
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menomune® Day 0 Menactra® Day 0 x 2 Menactra® Day 0 and Day 14 Menactra® Day 0 and Day 28
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/51 (7.84%)      3/56 (5.36%)      1/51 (1.96%)      0/58 (0.00%)    
Cardiac disorders         
Syncope * 1  1/51 (1.96%)  1 0/56 (0.00%)  0 0/51 (0.00%)  0 0/58 (0.00%)  0
Myocardial infarction * 1  0/51 (0.00%)  0 1/56 (1.79%)  1 0/51 (0.00%)  0 0/58 (0.00%)  0
Endocrine disorders         
Diabetes mellitus non-insulin-dependent * 1  0/51 (0.00%)  0 1/56 (1.79%)  1 0/51 (0.00%)  0 0/58 (0.00%)  0
Gastrointestinal disorders         
Diverticulitis * 1  0/51 (0.00%)  0 1/56 (1.79%)  1 0/51 (0.00%)  0 0/58 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Non-cardiac chest pain * 1  1/51 (1.96%)  1 0/56 (0.00%)  0 1/51 (1.96%)  1 0/58 (0.00%)  0
Vascular disorders         
Femoral artery occlusion * 1  1/51 (1.96%)  1 0/56 (0.00%)  0 0/51 (0.00%)  0 0/58 (0.00%)  0
Transient ischaemic attack * 1  1/51 (1.96%)  1 0/56 (0.00%)  0 0/51 (0.00%)  0 0/58 (0.00%)  0
Deep vein thrombosis * 1  1/51 (1.96%)  1 0/56 (0.00%)  0 0/51 (0.00%)  0 0/58 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menomune® Day 0 Menactra® Day 0 x 2 Menactra® Day 0 and Day 14 Menactra® Day 0 and Day 28
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/51 (5.88%)      5/56 (8.93%)      8/51 (15.69%)      12/58 (20.69%)    
Infections and infestations         
Upper respiratory tract infection * 1  1/51 (1.96%)  1 1/56 (1.79%)  1 5/51 (9.80%)  5 5/58 (8.62%)  5
Musculoskeletal and connective tissue disorders         
Back pain * 1  1/51 (1.96%)  2 1/56 (1.79%)  1 2/51 (3.92%)  2 4/58 (6.90%)  5
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/51 (1.96%)  1 3/56 (5.36%)  4 2/51 (3.92%)  2 1/58 (1.72%)  1
Pharyngolaryngeal pain * 1  0/51 (0.00%)  0 0/56 (0.00%)  0 0/51 (0.00%)  0 3/58 (5.17%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00874549     History of Changes
Other Study ID Numbers: MTA29
First Submitted: March 31, 2009
First Posted: April 2, 2009
Results First Submitted: March 8, 2010
Results First Posted: March 25, 2010
Last Update Posted: September 20, 2013