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Phase 3 N=450 Randomized Quadruple-blind Prevention

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

Neisseria Meningitidis · Meningococcal Infections

Enrolled (actual)
450
Serious AEs
0.2%
Results posted
Mar 2011
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination — 651.5; 889.7; 441.1; 4116.3 Titers (1/dil)

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine (Biological); Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine (Biological)
Age
Pediatric, Adult · 16+ yrs
Sex
All
Sponsor
Sanofi Pasteur, a Sanofi Company
Primary completion
Feb 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
651.5; 889.7; 441.1; 4116.3; 3833.4; 6351.6
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
66; 62; 86; 71; 57; 81
SECONDARY
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
88; 71; 98; 85; 66; 95

Summary

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® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00444951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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