Immunology and Safety of Menactra® in Children in Saudi Arabia

Sanofi

Status and phase: Completed; Phase 3

Conditions: Meningitis; Meningococcemia

Treatments: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00539032

MTA47

Details and patient eligibility

About

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.

Enrollment: 238 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Group 1: Menactra® Booster Group

Experimental group

Description:

Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Group 2: Menactra® Primary Vaccine (Control) Group

Experimental group

Description:

Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.

Treatment:

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate