Immunology and Safety of Menactra® in Children in Saudi Arabia

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Response to a Single Dose of Menactra® in Children Aged 5 to 8 Years Who Had Previously Received Two Doses of Quadrivalent (A, C, Y, W-135) Meningococcal Polysaccharide Vaccine Before Age 2 Years in Saudi Arabia

Conditions
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Meningitis, Meningococcemia

Intervention / Treatment
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* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Menactra® Booster Group<br>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. | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra® Vaccine;|
| Experimental: Group 2: Menactra® Primary Vaccine (Control) Group<br>Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine. | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra® Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. |  | Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination | 
| Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. |  | Day 28 Post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N. meningitidis, Meningitis, Meningococcemia