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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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16 December 2017 |
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Main ID: |
NCT00447525 |
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Date of registration:
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12/03/2007 |
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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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REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children
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Scientific title:
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Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age |
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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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760 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00447525 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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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, a Sanofi Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Healthy child without chronic severe disease of either gender,
2. 6 year-old child on vaccination day,
3. Child previously vaccinated with three doses of a diphtheria, tetanus and
poliomyelitis containing vaccine given alone or in combination within the first 6
months of life and a booster dose of a diphtheria, tetanus and poliomyelitis
containing vaccine given alone or in combination at 16 - 18 months of life (±2
months),
4. Consent form signed by both parents, or by the legal representative, properly informed
about the study.
Exclusion Criteria:
1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or
poliomyelitis containing vaccine,
2. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or
poliomyelitis,
3. Child who had received any vaccine in the previous 30 days or with a vaccination
scheduled during the course of the study,
4. Child who present with immune impairment or humoral/cellular deficiency, neoplastic
disease or depressed immunity,
5. Child who had received within the previous 150 days or who will receive during the
course of the study, any immunoglobulins or blood derived products,
6. Child with true hypersensitivity to at least one of the components of a study vaccine
or to streptomycin, neomycin or polymixin B,
7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or
unstable neurological condition,
8. Child who had presented severe hypersensitivity following an earlier immunization
against diphtheria and/or tetanus,
9. Known history of thrombocytopenia or any coagulation disorder that would
contraindicate intramuscular injection,
10. Acute severe febrile illness and/or oral temperature =37.5°C at the time of
vaccination
Age minimum:
6 Years
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tetanus
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Poliomyelitis
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Diphtheria
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Intervention(s)
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Biological: REVAXIS®
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Biological: DT-Polio®
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Secondary ID(s)
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F05-TdI-301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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