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

Woman and Man

| Country :
| organs :
| Specialty :

Extract

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

Inclusion criteria

Not applicable - Healthy volunteers - 6 year-old child

Kusajili – Clinical trials directory

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 pol...