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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: |
NCT00444951 |
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Date of registration:
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07/03/2007 |
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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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Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
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Scientific title:
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Evaluation of the Response to a Single Dose of Menactra® in Adolescents Aged 16 to 19 Years Who Previously Received One Dose of Quadrivalent (A, C, Y, W 135) and at Least One Dose of Bivalent (A, C) Meningococcal Polysaccharide Vaccine in Saudi Arabia. |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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450 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00444951 |
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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 Monitor |
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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 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
Age minimum:
16 Years
Age maximum:
19 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Meningococcal Infections
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Neisseria Meningitidis
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Intervention(s)
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Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
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Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine
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Primary Outcome(s)
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Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
[Time Frame: Baseline (Day 0) and Day 28 after vaccination]
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Secondary Outcome(s)
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Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
[Time Frame: Day 0 to Day 7 Post-vaccination]
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Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
[Time Frame: Baseline (Day 0) and Day 28 After 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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