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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Meningococcal Infections; Neisseria Meningitidis

Treatments: Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine; Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444951

MTA40

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 16 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

450 participants in 3 patient groups

Menactra® group

Experimental group

Description:

Have received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.

Treatment:

Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine

Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine

Mencevax® group

Experimental group

Description:

Have received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.

Treatment:

Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine

Control group

Experimental group

Description:

Participants have not previously received any meningococcal vaccine, will receive a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.

Treatment:

Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine

Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine