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Immunology and Safety of Menactra in Children in Saudi Arabia
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00539032
  Purpose

This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W 135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of their serum bactericidal antibody and total and serogroup-specific antibody responses for the two study groups. Safety of Menactra vaccine will be described


Condition Intervention Phase
Meningitis
Meningococcemia
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Phase III

MedlinePlus related topics: Diphtheria Meningitis
Drug Information available for: Meningococcal Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of tetravalent meningococcal diphtheria conjugate vaccine. [ Time Frame: 28 Days, post-vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: September 2007
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Control group got same intervention
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Healthy, as determined by medical history and physical examination.
  • Aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before 9th birthday inclusive).
  • For the Booster Group , two doses of a quadrivalent (A, C, Y, W 135) meningococcal polysaccharide vaccine received before age 2 years
  • For the Control Group , no previous history of any meningococcal vaccination
  • Informed consent form signed by the parent(s) or other legal representative
  • 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 a 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 trial 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 trial vaccination, or scheduled to receive any vaccination during the 14-day period after trial vaccination.
  • Previous history of documented invasive meningococcal disease.
  • For the Control Group, previous history of any meningococcal vaccination.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539032

Locations
Saudi Arabia, Quassim
Buraidah, Quassim, Saudi Arabia
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  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. ( Medical Monitor )
Study ID Numbers: MTA47
Study First Received: October 2, 2007
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00539032  
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by Sanofi-Aventis:
N. meningitidis
Meningitis
Meningococcemia

Study placed in the following topic categories:
Meningococcemia
Central Nervous System Infections
Central Nervous System Diseases
Neisseria meningitidis
Meningitis

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009