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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 450

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination	Baseline (Day 0) and Day 28 after vaccination

Secondary Outcome Measures

Name	Time	Method
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	Baseline (Day 0) and Day 28 After Vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination	Day 0 to Day 7 Post-vaccination