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Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

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ClinicalTrials.gov Identifier: NCT00862277
Recruitment Status : Completed
First Posted : March 16, 2009
Results First Posted : January 13, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Retrospective
Conditions Meningococcal Infections
Meningitis
Interventions Biological: Menactra®
Biological: Menomune®
Enrollment 763
Recruitment Details Participants were enrolled from 16 December 2008 to 16 March 2009 in 21 medical centers in the US.
Pre-assignment Details A total of 763 participants who met the inclusion and exclusion criteria were enrolled. One participant withdrew before sampling and is excluded from analysis and this report.
Arm/Group Title Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control
Hide Arm/Group Description Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21 Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04 Meningococcal vaccine-naive, age-matched participants
Period Title: Overall Study
Started 561 96 105
Completed 560 94 100
Not Completed 1 2 5
Reason Not Completed
Protocol Violation             1             2             5
Arm/Group Title Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control Total
Hide Arm/Group Description Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21 Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04 Meningococcal vaccine-naive, age-matched participants Total of all reporting groups
Overall Number of Baseline Participants 561 96 105 762
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 561 participants 96 participants 105 participants 762 participants
<=18 years
205
  36.5%
0
   0.0%
57
  54.3%
262
  34.4%
Between 18 and 65 years
356
  63.5%
96
 100.0%
48
  45.7%
500
  65.6%
>=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 561 participants 96 participants 105 participants 762 participants
19.1  (2.87) 23.3  (2.17) 19.3  (3.98) 19.7  (3.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 561 participants 96 participants 105 participants 762 participants
Female
264
  47.1%
49
  51.0%
64
  61.0%
377
  49.5%
Male
297
  52.9%
47
  49.0%
41
  39.0%
385
  50.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 561 participants 96 participants 105 participants 762 participants
561 96 105 762
1.Primary Outcome
Title Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Hide Description [Not Specified]
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
Arm/Group Title Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control
Hide Arm/Group Description:
Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
Meningococcal vaccine-naive, age-matched participants
Overall Number of Participants Analyzed 559 94 100
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A ≥ 8, [n = 557, 93, 99] 53 34 20
Serogroup A ≥ 128, [n = 557, 93, 99] 50 29 17
Serogroup C ≥ 8 [n = 557, 92, 99] 39 28 16
Serogroup C ≥ 128 [n = 557, 92, 99] 31 22 12
Serogroup Y ≥ 8 [n = 558, 93, 99] 91 83 72
Serogroup Y ≥ 128 [n = 558, 93, 99] 85 77 62
Serogroup W-135 ≥ 8 [n = 556, 92, 99] 84 64 50
Serogroup W-135 ≥128 [n = 556, 92, 99] 77 55 47
2.Primary Outcome
Title Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Hide Description [Not Specified]
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
Arm/Group Title Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control
Hide Arm/Group Description:
Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
Meningococcal vaccine-naive, age-matched participants
Overall Number of Participants Analyzed 559 94 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A [n = 557, 93, 99]
74.0
(58.2 to 94.2)
19.1
(11.7 to 31.2)
11.0
(7.08 to 17.0)
Serogroup C [n = 557, 92, 99]
24.9
(20.1 to 30.7)
16.9
(9.91 to 28.7)
8.58
(5.86 to 12.6)
Serogroup Y [n=558, 93, 99]
369
(317 to 430)
183
(121 to 277)
84.1
(54.9 to 129)
Serogroup W-135 [n = 556, 92, 99]
246
(205 to 295)
59.4
(37.6 to 93.8)
38.7
(23.6 to 63.3)
Time Frame There were no safety outcomes; safety data were not collected in this study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control
Hide Arm/Group Description Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21 Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04 Meningococcal vaccine-naive, age-matched participants
All-Cause Mortality
Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Menactra® From Previous Studies Group 2: Menomune® From Previous Study Group 3: Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00862277     History of Changes
Other Study ID Numbers: MTA64
First Submitted: March 13, 2009
First Posted: March 16, 2009
Results First Submitted: December 11, 2010
Results First Posted: January 13, 2011
Last Update Posted: April 14, 2016