NCT00655148: Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine

Summary

The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines: A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh. Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.

Timeline

Start: 2003-09
Primary completion: 2006-10
Completion: 2006-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	DTaP-IPV mkc vaccine	Unknown	0.5 ml	Intramuscular
Subject	DTaP-IPV vero vaccine	Unknown	0.5 ml	Intramuscular

Indications

No indication recorded.