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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00539032 |
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Date of registration:
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02/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Immunology and Safety of Menactra® in Children in Saudi Arabia
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Scientific 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 |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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238 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00539032 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi Pasteur Inc. |
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Key inclusion & exclusion 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.
Age minimum:
5 Years
Age maximum:
8 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Meningococcemia
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Meningitis
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Intervention(s)
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Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
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Primary Outcome(s)
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Percentage of Participants With = 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.
[Time Frame: Day 28 Post-vaccination]
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Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.
[Time Frame: Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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