Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00444951
First received: March 7, 2007
Last updated: January 21, 2014
Last verified: January 2014
Results First Received: February 9, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Neisseria Meningitidis
Meningococcal Infections
Interventions: Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine

  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 17 February 2007, to 01 July 2007, in 7 clinic 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 450 participants who met the inclusion and exclusion criteria were enrolled, and 446 were vaccinated.

Reporting Groups
  Description
Menactra® Group Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
Mencevax® Group Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
Control Group Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.

Participant Flow:   Overall Study
    Menactra® Group     Mencevax® Group     Control Group  
STARTED     145     142     163  
COMPLETED     140     136     160  
NOT COMPLETED     5     6     3  
Lost to Follow-up                 1                 1                 0  
Withdrawal by Subject                 4                 5                 3  



  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® Group Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
Mencevax® Group Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
Control Group Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
Total Total of all reporting groups

Baseline Measures
    Menactra® Group     Mencevax® Group     Control Group     Total  
Number of Participants  
[units: participants]
  145     142     163     450  
Age  
[units: participants]
       
<=18 years     110     115     134     359  
Between 18 and 65 years     35     27     29     91  
>=65 years     0     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  17.90  ± 1.20     17.77  ± 1.15     17.85  ± 1.15     17.84  ± 1.16  
Gender  
[units: participants]
       
Female     78     78     53     209  
Male     67     64     110     241  
Region of Enrollment  
[units: participants]
       
Saudi Arabia     145     142     163     450  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination   [ Time Frame: Baseline (Day 0) and Day 28 after vaccination ]

2.  Secondary:   Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination   [ Time Frame: Baseline (Day 0) and Day 28 After Vaccination ]

3.  Secondary:   Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination   [ Time Frame: Day 0 to Day 7 Post-vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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


Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00444951     History of Changes
Other Study ID Numbers: MTA40
Study First Received: March 7, 2007
Results First Received: February 9, 2011
Last Updated: January 21, 2014
Health Authority: Saudi Arabia: Ministry of Health