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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: |
NCT01546909 |
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Date of registration:
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02/03/2012 |
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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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Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
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Scientific title:
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Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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278 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01546909 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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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:
- Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301
Exclusion Criteria:
- Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study
F05-TdI-301
- Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or
poliomyelitis
- Known or suspected immune dysfunction
- Receipt of medications / vaccination that may interfere with study assessments
- Known true hypersensitivity to any of the vaccine components or to a vaccine
containing the same substances
- Known personal history of encephalopathy, seizure disorder or progressive, evolving or
unstable neurological condition
- Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular
injection
- Any medical condition that might interfere with the evaluation of the study objectives
- Febrile illness
Age minimum:
11 Years
Age maximum:
13 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diphtheria
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Poliomyelitis
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Tetanus
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Intervention(s)
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Biological: Diphtheria, tetanus, polio and pertussis vaccination
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Primary Outcome(s)
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Proportion of subjects with an anti-diphtheria concentration =0.1 IU/mL
[Time Frame: 1 month post-booster dose]
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Proportion of subjects with an anti-polio type 2 titer = 8 (1/dilution)
[Time Frame: Pre-booster dose (Day 0)]
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Proportion of subjects with an anti-polio type 3 titer = 8 (1/dilution)
[Time Frame: Pre-booster dose (Day 0)]
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Proportion of subjects with an anti-tetanus concentration =0.01 IU/mL
[Time Frame: Pre-booster dose (Day 0)]
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Proportion of subjects with an anti-diphtheria concentration =0.01 IU/mL
[Time Frame: Pre-booster dose (Day 0)]
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Proportion of subjects with an anti-polio type 1 titer =8 (1/dilution)
[Time Frame: 1 month post-booster dose]
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Proportion of subjects with an anti-polio type 1 titer = 8 (1/dilution)
[Time Frame: Pre-booster dose (Day 0)]
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Proportion of subjects with an anti-polio type 2 titer =8 (1/dilution)
[Time Frame: 1 month post-booster dose]
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Proportion of subjects with an anti-polio type 3 titer =8 (1/dilution)
[Time Frame: 1 month post-booster dose]
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Proportion of subjects with an anti-tetanus concentration =0.1 IU/mL
[Time Frame: 1 month post-booster dose]
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Secondary Outcome(s)
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Geometric mean titer for polio type 1
[Time Frame: Pre-booster (Day 0) and 1 month post-booster dose]
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Geometric mean titer for polio type 2
[Time Frame: Pre-booster (Day 0) and 1 month post-booster dose]
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Solicited injection site and solicited systemic reactions
[Time Frame: From Day 0 to Day 7 post vaccination]
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Geometric mean titer for polio type 3
[Time Frame: Pre-booster (Day 0) and 1 month post-booster dose]
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Serious adverse events
[Time Frame: From signature of informed consent up to last study visit of the subject]
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Geometric mean titer for diphtheria
[Time Frame: Pre-booster (Day 0) and 1 month post-booster dose]
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Unsolicited injection site reactions and unsolicited systemic adverse events
[Time Frame: From Day 0 to Day 28 days post vaccination]
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Geometric mean titer for tetanus
[Time Frame: Pre-booster (Day 0) and 1 month post-booster dose]
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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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