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Trial record 1 of 1 for:    MTA19
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Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

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ClinicalTrials.gov Identifier: NCT00777790
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : March 19, 2009
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcemia
Intervention Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 241
Recruitment Details Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US.
Pre-assignment Details A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated.
Arm/Group Title Menactra® Group Menomune® Group Control Group
Hide Arm/Group Description Subjects that received Menactra® vaccine in Study MTA02 Subjects that received Menomune® vaccine in Study MTA02 Meningococcal vaccine-naïve subjects
Period Title: Overall Study
Started 76 77 88
Completed 76 77 88
Not Completed 0 0 0
Arm/Group Title Menactra® Group Menomune® Group Control Group Total
Hide Arm/Group Description Subjects that received Menactra® vaccine in Study MTA02 Subjects that received Menomune® vaccine in Study MTA02 Meningococcal vaccine-naïve subjects Total of all reporting groups
Overall Number of Baseline Participants 76 77 88 241
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 77 participants 88 participants 241 participants
<=18 years
56
  73.7%
57
  74.0%
68
  77.3%
181
  75.1%
Between 18 and 65 years
20
  26.3%
20
  26.0%
20
  22.7%
60
  24.9%
>=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 76 participants 77 participants 88 participants 241 participants
16.6  (1.91) 16.8  (1.85) 15.7  (1.97) 16.4  (1.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 77 participants 88 participants 241 participants
Female
30
  39.5%
31
  40.3%
44
  50.0%
105
  43.6%
Male
46
  60.5%
46
  59.7%
44
  50.0%
136
  56.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 77 participants 88 participants 241 participants
76 77 88 241
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Hide Description Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
Time Frame Day 0 and 8 and 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMT results were on the per-protocol population for immunogenicity.
Arm/Group Title Menactra® Group Menomune® Group Control Group
Hide Arm/Group Description:
Subjects that received Menactra® vaccine in Study MTA02
Subjects that received Menomune® vaccine in Study MTA02
Meningococcal vaccine-naïve subjects
Overall Number of Participants Analyzed 71 72 84
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Serogroup A (Day 0)
1075.2
(763.6 to 1514.1)
193.6
(113.7 to 329.9)
83.3
(47.3 to 146.8)
Serogroup A (Day 8)
9300.5
(7539.3 to 11473.2)
4423.9
(3272.7 to 5980.0)
12897.1
(9908.1 to 16787.9)
Serogroup A (Day 28)
4300.9
(3408.5 to 5427.0)
3219.9
(2413.6 to 4295.5)
6239.2
(4922.7 to 7907.8)
Serogroup C (Day 0)
246.2
(139.2 to 435.5)
124.4
(65.9 to 234.8)
39.7
(24.1 to 65.2)
Serogroup C (Day 8)
17888.7
(14004.2 to 22850.7)
1149.4
(692.8 to 1907.0)
7003.3
(4979.4 to 9849.7)
Serogroup C (Day 28)
8601.8
(6552.2 to 11292.6)
664.0
(396.3 to 1112.5)
2802.3
(1932.3 to 4063.9)
Serogroup Y (Day 0)
570.0
(353.9 to 918.3)
398.6
(259.8 to 611.7)
204.3
(131.4 to 317.8)
Serogroup Y (Day 8)
13088.9
(9486.0 to 18060.2)
3098.2
(2170.0 to 4423.4)
7061.3
(5029.8 to 9913.2)
Serogroup Y (Day 28)
5821.0
(4140.6 to 8183.3)
2489.6
(1786.5 to 3469.3)
4411.8
(3117.8 to 6242.7)
Serogroup W-135 (Day 0)
451.0
(300.2 to 677.4)
126.8
(80.0 to 200.9)
23.0
(15.7 to 33.7)
Serogroup W-135 (Day 8)
9861.6
(7442.9 to 13066.4)
2008.9
(1516.2 to 2661.9)
6036.6
(4555.5 to 7999.3)
Serogroup W-135 (Day 28)
4882.9
(3712.1 to 6422.9)
1625.5
(1250.6 to 2112.8)
3018.3
(2369.7 to 3844.4)
Time Frame Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Group Menomune® Group Control Group
Hide Arm/Group Description Subjects that received Menactra® vaccine in Study MTA02 Subjects that received Menomune® vaccine in Study MTA02 Meningococcal vaccine-naïve subjects
All-Cause Mortality
Menactra® Group Menomune® Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Group Menomune® Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/76 (0.00%)      0/77 (0.00%)      0/88 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menactra® Group Menomune® Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/76 (9.21%)      5/77 (6.49%)      9/88 (10.23%)    
Reproductive system and breast disorders       
Dysmenorrhoea * 1  1/76 (1.32%)  1 3/77 (3.90%)  3 5/88 (5.68%)  5
Respiratory, thoracic and mediastinal disorders       
Pharyngolaryngeal pain * 1  6/76 (7.89%)  6 2/77 (2.60%)  3 4/88 (4.55%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
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: NCT00777790     History of Changes
Other Study ID Numbers: MTA19
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: December 2, 2008
Results First Posted: March 19, 2009
Last Update Posted: February 14, 2014