Not applicable - Healthy volunteers - 6 year-old child
Conditions
Interventions
Trade Name: REVAXIS
Product Name: REVAXIS
Pharmaceutical Form: Injection*
INN or Proposed INN: Purified Diphtheria Toxoid
Concentration unit: IU international unit(s)
Concentration type: not less then
Sponsors
Sanofi Pasteur MSD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects will be included in the study if they meet all of the following inclusion criteria: 1. Healthy child without chronic severe disease of either gender and affiliated to a health social secrurity system, 2. 6 year-old child (from 1st day to last day of 7th year), 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 14 - 20 months of life, 4. Consent form signed by both parents, or by the legal representative, properly informed about the study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will not be included in the study if they meet any of the non-inclusion criteria: 1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine given alone or in combination, 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, neoplasic disease or depressed immunity or who had received within the previous 30 days or who will receive during the course of the study, a treatment likely to alter the immune response (any long-term ( = 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses [= 20mg/day prednisone equivalent] ), 5. Child who had received within the previous 3 months (150 days) or who will receive during the course of the study, any immunoglobulin or blood 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 immunisation against diphtheria and/or tetanus, 9. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, 10. Any medical condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives, 11. Child who had participated in another clinical study in the previous 30 days or who will participate in another clinical study during the whole study period, 12. Acute severe febrile illness and/or rectal equivalent temperature = 38.0°C at the time of vaccination. Defer vaccination until 72 hours after fever resolution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the Diphtheria seroprotection response (defined as anti-diphtheria antibody titre (SN) = 0.1 IU/mL), the Tetanus seroprotection response (defined as an anti-tetanus antibody titre (EIA) = 0.1 IU/mL) and the Poliomyelitis type 1, 2 and 3 seroprotection responses (defined as an anti-poliovirus antibody type 1, 2 and 3 titre (SN) = 8 (1/dil)) one month (28 to 35 days) after a single dose of REVAXIS® (dT-IPV vaccine) is non inferior to the Diphtheria, Tetanus and Poliomyelitis type 1, 2 and 3 seroprotection responses one month after a single dose of DT Polio® (DT-IPV vaccine) when given as a second booster to healthy 6 year-old children whose 3-dose primary series given within the first 6 months of life and first booster given at 16-18 months of life (+/- 2 months) included D-T-IPV;Secondary Objective: Immunogenicity: To describe the Diphtheria, Tetanus and Poliomyelitis antibody titres and the seroresponses defined as: ? an anti-diphtheria antibody titre (SN) = 1.0 IU/mL, ? an anti-diphtheria antibody titre (EIA) = 0.1 IU/mL, ? an anti-diphtheria antibody titre (EIA) = 1.0 IU/mL, ? an anti-tetanus antibody titre (EIA) = 1.0 IU/mL, one month (28 to 35 days) after a single dose of REVAXIS® (dT-IPV vaccine) or DT Polio® (DT-IPV vaccine) given as a second booster to healthy 6 year-old children whose 3-dose primary series given within the first 6 months of life and first booster given at 16-18 months of life (+/- 2 months) included D-T-IPV Safety: To describe the safety profile of a single dose of REVAXIS® (dT-IPV vaccine) or DT Polio® (DT-IPV vaccine) given as a second booster to healthy 6 year-old children whose 3-dose primary series given before 6 months of life and first booster given at 16-18 months of life (+/- 2 months) included D-T-IPV ;Primary end point(s): Primary evaluation criteria ? 1 month (28 to 35 days) post booster seroprotection responses for Diphtheria, Tetanus and Poliomyelitis type 1, 2 and 3 defined as: ? an anti-di | — |
Countries
France
Outcome results
None listed