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Immunology and Safety of Menactra® in Children in Saudi Arabia

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00539032
First received: October 2, 2007
Last updated: December 22, 2010
Last verified: December 2010
History of Changes
Results First Received: September 9, 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
Meningococcemia
Intervention: Biological: Menactra®: 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 enrolled from 30 September to 03 November 2007, at 4 health centers in Saudi Arabia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 238 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Group 1: Menactra® Booster Group Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
Group 2: Menactra® Primary Vaccine (Control) Group Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.

Participant Flow:   Overall Study
    Group 1: Menactra® Booster Group     Group 2: Menactra® Primary Vaccine (Control) Group  
STARTED     153     85  
COMPLETED     151     84  
NOT COMPLETED     2     1  
Withdrawal by Subject                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Group 1: Menactra® Booster Group Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
Group 2: Menactra® Primary Vaccine (Control) Group Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
Total Total of all reporting groups

Baseline Measures
    Group 1: Menactra® Booster Group     Group 2: Menactra® Primary Vaccine (Control) Group     Total  
Number of Participants  
[units: participants]
 		  153     85     238  
Age  
[units: participants]
 		     
<=18 years     153     85     238  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation 		  6.12  ± 0.60     6.52  ± 1.22     6.26  ± 0.89  
Gender  
[units: participants]
 		     
Female     84     47     131  
Male     69     38     107  
Region of Enrollment  
[units: participants]
 		     
Saudi Arabia     153     85     238  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.   [ Time Frame: Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.   [ Time Frame: Day 28 Post-vaccination ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®   [ Time Frame: Days 0-7 Post-vaccination ]
  Show Outcome Measure 3


  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


No publications provided by Sanofi

Publications automatically indexed to this study:


Responsible Party: Medical Monitor, Sanofi Pasteur, Inc.
ClinicalTrials.gov Identifier: NCT00539032     History of Changes
Other Study ID Numbers: MTA47
Study First Received: October 2, 2007
Results First Received: September 9, 2009
Last Updated: December 22, 2010
Health Authority: Saudi Arabia: Ministry of Health