NCT00404651

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Lot to Lot Consistency Study of DTaP-IPV-Hep B-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Mexican Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,189 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP\~T vaccine is consistent. The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP\~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series. The secondary objectives are: * To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series * To assess the overall safety in each group one month after the third dose of the primary series.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-HB-PRP~T vaccine	0.5 mL, intramuscular (IM)
BIOLOGICAL	DTaP-IPV-HB-PRP~T vaccine	0.5 mL, IM
BIOLOGICAL	DTaP-IPV-HB-PRP~T vaccine	0.5 mL, IM
BIOLOGICAL	DTaP-HBV-IPV vaccine	0.5 mL, IM

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-04-01
• Completion: 2008-07-01
• First posted: 2006-11-29
• Last updated: 2014-05-09
• Results posted: 2014-05-09

Locations

6 sites across 1 country: Mexico