Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00269477
First received: December 22, 2005
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: November 10, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Meningitis
Meningococcal Infection
Intervention: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 20 December 2005 to 31 May 2006, in 8 United States clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 145 participants who participated in a previous study MTA02 and other meningococcal-vaccine naive participants were enrolled.

Reporting Groups
  Description
Menactra® Vaccine Group 1 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Menactra® Vaccine Group 2 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Meningococcal Vaccine-naive Group 3 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
Meningococcal Vaccine-naive Group 4 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.

Participant Flow:   Overall Study
    Menactra® Vaccine Group 1     Menactra® Vaccine Group 2     Meningococcal Vaccine-naive Group 3     Meningococcal Vaccine-naive Group 4  
STARTED     9     18     58     60  
COMPLETED     4     12     57     60  
NOT COMPLETED     5     6     1     0  
Protocol Violation                 5                 5                 1                 0  
Missed post-vaccination blood draw                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Menactra® Vaccine Group 1 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Menactra® Vaccine Group 2 Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Meningococcal Vaccine-naive Group 3 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
Meningococcal Vaccine-naive Group 4 Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Total Total of all reporting groups

Baseline Measures
    Menactra® Vaccine Group 1     Menactra® Vaccine Group 2     Meningococcal Vaccine-naive Group 3     Meningococcal Vaccine-naive Group 4     Total  
Number of Participants  
[units: participants]
  9     18     58     60     145  
Age  
[units: participants]
         
<=18 years     5     10     53     54     122  
Between 18 and 65 years     4     8     5     6     23  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  18.1  ± 1.62     18.8  ± 1.86     16.4  ± 1.38     16.6  ± 1.81     17.9  ± 2.24  
Gender  
[units: participants]
         
Female     5     13     27     28     73  
Male     4     5     31     32     72  
Region of Enrollment  
[units: participants]
         
United States     9     18     58     60     145  



  Outcome Measures
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1.  Primary:   Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.   [ Time Frame: 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination) ]

2.  Other Pre-specified:   Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions   [ Time Frame: Day 0 to 7 post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided


Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00269477     History of Changes
Other Study ID Numbers: MTA35
Study First Received: December 22, 2005
Results First Received: November 10, 2009
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration