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Immunogenicity and Safety of Menactra Vaccine in Adolescents in Saudi Arabia

This study is ongoing, but not recruiting participants.

Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00444951
  Purpose

This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine, this study will evaluate the booster administration of Menactra® compared with Mencevax® in terms of their serum bactericidal antibody and total and serogroup-specific salivary IgG and IgA antibody responses.


Condition Intervention Phase
Neisseria Meningitidis
Meningococcal Infections
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Biological: Group A, C, W135 and Y polysaccharide meningococcal vaccine
Phase III

MedlinePlus related topics:   Diphtheria   

Drug Information available for:   Meningococcal Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immune response of Menactra® after vaccination. [ Time Frame: 28 Days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety after administration of Menactra®. [ Time Frame: 28 Days post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   429
Study Start Date:   February 2007
Estimated Study Completion Date:   June 2009
Estimated Primary Completion Date:   February 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Menactra® group: Have received previously a dose of an A, C, Y, W 135 and at least one dose of an A, C meningococcal polysaccharide vaccine
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
2: Experimental
Mencevax® group: Have received previously a dose of an A, C, Y, W 135 and at least one dose of an A, C meningococcal polysaccharide vaccine
Biological: Group A, C, W135 and Y polysaccharide meningococcal vaccine
0.5 mL, Subcutaneous
3: Experimental
Control group: Have not previously received any meningococcal vaccine
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular

  Eligibility
Ages Eligible for Study:   16 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Healthy, as determined by medical history and physical examination.
  • Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive).
  • For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment.
  • For the Control group, no previous history of any meningococcal vaccination.
  • Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old
  • Able to provide a vaccination log or has available vaccination record in the Health Center
  • Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

  • Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
  • Known or suspected impairment of immunologic function.
  • Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 37.5°C at the time of inclusion.
  • Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment.
  • Oral or injected antibiotic therapy within the 72 hours prior to vaccination
  • Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
  • Previous history of documented invasive meningococcal disease.
  • Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine.
  • Personal or family history of Guillain Barré syndrome.
  • For female, known or suspected to be pregnant at the time of inclusion
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444951

Locations
Saudi Arabia
      Makkah, Saudi Arabia
Saudi Arabia, Quassim
      Buraidah, Quassim, Saudi Arabia

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Medical Monitor     Sanofi Pasteur Inc    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Sanofi pasteur Inc ( Mecdical Monitor )
Study ID Numbers:   MTA40
First Received:   March 7, 2007
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00444951
Health Authority:   Saudi Arabia: Ministry of Health

Keywords provided by Sanofi-Aventis:
N meningitidis  

Study placed in the following topic categories:
Bacterial Infections
Meningococcal Infections
Neisseria meningitidis
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 31, 2008




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