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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Neisseria Meningitidis Meningococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Menactra® group

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Mencevax® group

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous

Control group

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

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

0.5 mL, Subcutaneous

Intervention Type BIOLOGICAL

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

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Menactra® Mencevax® Menactra®

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes