Phase 3
N=450
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Neisseria Meningitidis · Meningococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT00444951 ↗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
| Outcome | Result | p-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
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.