Diphtheria, Poliomyelitis, Tetanus
Conditions
Brief summary
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
Interventions
1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 13 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution) | 1 month post-booster dose |
| 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 |
| Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL | 1 month post-booster dose |
| Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution) | 1 month post-booster dose |
| Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution) | 1 month post-booster dose |
| Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL | Pre-booster dose (Day 0) |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titer for tetanus | Pre-booster (Day 0) and 1 month post-booster dose |
| Geometric mean titer for polio type 1 | Pre-booster (Day 0) and 1 month post-booster dose |
| Geometric mean titer for polio type 2 | Pre-booster (Day 0) and 1 month post-booster dose |
| Geometric mean titer for polio type 3 | Pre-booster (Day 0) and 1 month post-booster dose |
| Solicited injection site and solicited systemic reactions | From Day 0 to Day 7 post vaccination |
| Unsolicited injection site reactions and unsolicited systemic adverse events | From Day 0 to Day 28 days post vaccination |
| Serious adverse events | From signature of informed consent up to last study visit of the subject |
| Geometric mean titer for diphtheria | Pre-booster (Day 0) and 1 month post-booster dose |
Countries
France
Outcome results
None listed