NCT00655148

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 817 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 28 Days – 49 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Active Immunization

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV vero vaccine	DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
BIOLOGICAL	DTaP-IPV mkc vaccine	DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2008-04-09
• Last updated: 2013-01-21

Locations

5 sites across 1 country: Poland