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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
PRIMARY OBJECTIVES * To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3 * To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3 SECONDARY OBJECTIVES * To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens * To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE * To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 278 |
| Start date | 2012-02 |
| Completion | 2012-12 |
Conditions
- Diphtheria
- Tetanus
- Poliomyelitis
Interventions
- Diphtheria, tetanus, polio and pertussis vaccination
Primary outcomes
- Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL — Pre-booster dose (Day 0)
- Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL — Pre-booster dose (Day 0)
- Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution) — Pre-booster dose (Day 0)
- Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution) — Pre-booster dose (Day 0)
- Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution) — Pre-booster dose (Day 0)
- Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL — 1 month post-booster dose
Countries
France