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Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00777790
First received: October 21, 2008
Last updated: April 23, 2010
Last verified: April 2010
History of Changes
Results First Received: December 2, 2008  
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
Meningococcemia
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
Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Menactra® Group Subjects that received Menactra® vaccine in Study MTA02
Menomune® Group Subjects that received Menomune® vaccine in Study MTA02
Control Group Meningococcal vaccine-naïve subjects

Participant Flow:   Overall Study
    Menactra® Group     Menomune® Group     Control Group  
STARTED     76     77     88  
COMPLETED     76     77     88  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Menactra® Group Subjects that received Menactra® vaccine in Study MTA02
Menomune® Group Subjects that received Menomune® vaccine in Study MTA02
Control Group Meningococcal vaccine-naïve subjects
Total Total of all reporting groups

Baseline Measures
    Menactra® Group     Menomune® Group     Control Group     Total  
Number of Participants  
[units: participants]
 		  76     77     88     241  
Age  
[units: participants]
 		       
<=18 years     56     57     68     181  
Between 18 and 65 years     20     20     20     60  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  16.6  ± 1.91     16.8  ± 1.85     15.7  ± 1.97     16.4  ± 1.97  
Gender  
[units: participants]
 		       
Female     30     31     44     105  
Male     46     46     44     136  
Region of Enrollment  
[units: participants]
 		       
United States     76     77     88     241  



  Outcome Measures

1.  Primary:   Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.   [ Time Frame: Day 0 and 8 and 28 days post-vaccination ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


Publications of Results:


Responsible Party: Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier: NCT00777790     History of Changes
Other Study ID Numbers: MTA19
Study First Received: October 21, 2008
Results First Received: December 2, 2008
Last Updated: April 23, 2010
Health Authority: United States: Food and Drug Administration