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Trial record 1 of 1 for:    MTA51
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A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India

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ClinicalTrials.gov Identifier: NCT01086969
Recruitment Status : Completed
First Posted : March 15, 2010
Results First Posted : February 3, 2012
Last Update Posted : February 6, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningococcal Infection
Meningitis
Intervention Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
Enrollment 300
Recruitment Details Participants were enrolled from 11 June to 01 October 2010 in 3 clinical centers in India.
Pre-assignment Details A total of 300 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Hide Arm/Group Description Participants at age 2 to 11 years on enrollment. Participants aged 12 to 17 years at enrollment. Participants aged 18 to 55 years at enrollment
Period Title: Overall Study
Started 100 100 100
Completed 99 98 100
Not Completed 1 2 0
Reason Not Completed
Withdrawal by Subject             1             2             0
Arm/Group Title Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group Total
Hide Arm/Group Description Participants at age 2 to 11 years on enrollment. Participants aged 12 to 17 years at enrollment. Participants aged 18 to 55 years at enrollment Total of all reporting groups
Overall Number of Baseline Participants 100 100 100 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 100 participants 300 participants
<=18 years
100
 100.0%
100
 100.0%
0
   0.0%
200
  66.7%
Between 18 and 65 years
0
   0.0%
0
   0.0%
100
 100.0%
100
  33.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 100 participants 300 participants
7.2  (3.1) 14.2  (1.4) 34.8  (9.2) 18.7  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 100 participants 300 participants
Female
53
  53.0%
48
  48.0%
38
  38.0%
139
  46.3%
Male
47
  47.0%
52
  52.0%
62
  62.0%
161
  53.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 100 participants 100 participants 100 participants 300 participants
100 100 100 300
1.Primary Outcome
Title Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Hide Description Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Time Frame Baseline and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Menactra vaccine antibody titers were determined in the immunogenicity analysis set.
Arm/Group Title Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Hide Arm/Group Description:
Participants at age 2 to 11 years on enrollment.
Participants aged 12 to 17 years at enrollment.
Participants aged 18 to 55 years at enrollment
Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Participants
Serogroup A (Pre-vaccination; N= 100, 100, 100) 17 27 23
Serogroup A (Post-vaccination; N= 99, 97, 98) 95 94 97
Serogroup C (Pre-vaccination; N= 100, 100, 100) 24 43 66
Serogroup C (Post-vaccination; N= 99, 98, 100) 91 95 99
Serogroup Y (Pre-vaccination; N= 100, 100, 100) 92 92 89
Serogroup Y (Post-vaccination; N= 99, 97, 98) 99 97 98
Serogroup W-135 (Pre-vaccination; N=100, 100, 100) 54 68 52
Serogroup W-135 (Post-vaccination; N= 99, 97, 99) 96 97 99
2.Primary Outcome
Title Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Hide Description Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Time Frame Day 0 and Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were determined in the immunogenicity analysis set
Arm/Group Title Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Hide Arm/Group Description:
Participants at age 2 to 11 years on enrollment.
Participants aged 12 to 17 years at enrollment.
Participants aged 18 to 55 years at enrollment
Overall Number of Participants Analyzed 100 100 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: 1/dilution (1/dil)
Serogroup A (Pre-vaccination; N= 100, 100, 100)
9.51
(6.43 to 14.1)
15.0
(9.65 to 23.4)
9.78
(6.90 to 13.9)
Serogroup A (Post-vaccination; N= 99, 97, 98)
1145
(854 to 1536)
1324
(1002 to 1750)
2261
(1749 to 2924)
Serogroup C (Pre-vaccination; N= 100, 100, 100)
9.92
(7.01 to 14.0)
17.9
(12.2 to 26.2)
56.9
(36.6 to 88.3)
Serogroup C (Post-vaccination; N= 99, 98, 100)
610
(392 to 949)
2343
(1563 to 3512)
7486
(5380 to 10417)
Serogroup Y (Pre-vaccination; N= 100, 100, 100)
355
(256 to 491)
309
(222 to 430)
156
(110 to 222)
Serogroup Y (Post-vaccination; N= 99, 97, 98)
1964
(1607 to 2399)
3190
(2502 to 4067)
3926
(2855 to 5398)
Serogroup W-135 (Pre-vaccination; N=100, 100, 100)
31.3
(20.6 to 47.7)
47.8
(32.3 to 70.9)
28.6
(18.6 to 44.1)
Serogroup W-135 (Post-vaccination; N= 99, 97, 99)
1756
(1240 to 2486)
2538
(1947 to 3307)
3183
(2360 to 4293)
3.Primary Outcome
Title Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Hide Description Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Time Frame Day 0 to 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Four-fold antibody increase were determined in the immunogenicity analysis set
Arm/Group Title Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Hide Arm/Group Description:
Participants at age 2 to 11 years on enrollment.
Participants aged 12 to 17 years at enrollment.
Participants aged 18 to 55 years at enrollment
Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A (N = 99, 97, 98) 85 85 96
Serogroup C (N = 99, 98, 100) 88 91 96
Serogroup Y (N = 99, 97, 98) 68 75 89
Serogroup W-135 (N = 99, 97, 99) 93 96 97
4.Primary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Hide Description Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia
Time Frame Day 0 to 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety parameters were assessed in the safety analysis set
Arm/Group Title Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Hide Arm/Group Description:
Participants at age 2 to 11 years on enrollment.
Participants aged 12 to 17 years at enrollment.
Participants aged 18 to 55 years at enrollment
Overall Number of Participants Analyzed 100 100 100
Measure Type: Number
Unit of Measure: Participants
Any Solicited injection site pain 30 23 38
Grade 3 pain (Incapacitating) 0 0 0
Any Solicited injection site erythema 7 1 0
Grade 3 erythema (≥5 cm [2-11 years] or >10 cm) 0 0 0
Any Solicited injection site swelling 10 4 0
Grade 3 swelling (≥5 cm [2-11 years] or >10 cm) 0 0 0
Any Solicited fever 11 3 5
Grade 3 fever (≥ 39.0°C) 3 2 2
Any Solicited headache 12 19 19
Grade 3 headache (significant) 0 0 0
Any Solicited malaise 9 13 5
Grade 3 malaise (significant) 0 0 0
Any Solicited myalgia 13 8 12
Grade 3 myalgia (significant) 0 0 0
Time Frame Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Hide Arm/Group Description Participants at age 2 to 11 years on enrollment. Participants aged 12 to 17 years at enrollment. Participants aged 18 to 55 years at enrollment
All-Cause Mortality
Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      0/100 (0.00%)      0/100 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Age 2 to 11 Years Group Age 12 to 17 Years Group Age 18 to 55 Years Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/100 (30.00%)      23/100 (23.00%)      38/100 (38.00%)    
General disorders       
Fever  1  11/100 (11.00%)  11 3/100 (3.00%)  3 5/100 (5.00%)  5
Malaise  1  9/100 (9.00%)  9 13/100 (13.00%)  13 5/100 (5.00%)  5
Injection site pain  1  30/100 (30.00%)  30 23/100 (23.00%)  23 38/100 (38.00%)  38
Injection site erythema  1  7/100 (7.00%)  7 1/100 (1.00%)  1 0/100 (0.00%)  0
Injection site swelling  1  10/100 (10.00%)  10 4/100 (4.00%)  4 0/100 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Myalgia  1  13/100 (13.00%)  13 8/100 (8.00%)  8 12/100 (12.00%)  12
Nervous system disorders       
Headache  1  12/100 (12.00%)  12 19/100 (19.00%)  19 19/100 (19.00%)  19
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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
ClinicalTrials.gov Identifier: NCT01086969     History of Changes
Other Study ID Numbers: MTA51
UTN: U1111-1111-5608 ( Other Identifier: WHO )
First Submitted: March 11, 2010
First Posted: March 15, 2010
Results First Submitted: January 3, 2012
Results First Posted: February 3, 2012
Last Update Posted: February 6, 2012