Phase 3
Completed N=238
Immunology and Safety of Menactra® in Children in Saudi Arabia
Meningitis · Meningococcemia
Source: ClinicalTrials.gov NCT00539032 ↗
Enrolled (actual)
238
Serious AEs
0.4%
Results posted
Jan 2011
Primary outcomePrimary: Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. — 168.9; 196.4; 6991.7; 8263.3 Titers
Summary
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 the serum bactericidal antibody it induces in the two study groups. Safety of Menactra® vaccine will be described.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. |
168.9; 196.4; 6991.7; 8263.3; 2.5; 4.1 | — |
| PRIMARY Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. |
94; 94; 84; 90; 97; 98 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00539032). 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. Informational only — not medical advice.