Clinical Trial Comparing the Safety and Immunogenicity of Two Combined Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliovirus (DTaP-IPV) Vaccines Administered to Healthy Children at 2, 3½, and 16 Months of Age

NCT00655148 Phase 3 COMPLETED

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.

Details

Lead sponsor	Statens Serum Institut
Phase	Phase 3
Status	COMPLETED
Enrolment	817
Start date	2003-09
Completion	2006-10

Conditions

• Active Immunization

Interventions

• DTaP-IPV vero vaccine
• DTaP-IPV mkc vaccine

Primary outcomes

• Simultaneous seroprotection percentages for neutralizing poliovirus antibodies (types 1, 2 and 3), when the defined limits of seroprotection is a titre value of >=4 for each of the three poliovirus types — One month after the third vaccination

Countries

Poland