NCT00313911

Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,133 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Days – 71 Days
• Healthy volunteers: Accepted

Summary

To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject. To evaluate the overall safety in terms of: Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial. Immunogenicity: To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Haemophilus Influenzae Type b
• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-HB-PRP~T	0.5 mL, Intramuscular (IM)
BIOLOGICAL	Tritanrix-HepB/Hib	0.5 mL, Intramuscular

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-01-01
• Completion: 2008-02-01
• First posted: 2006-04-12
• Last updated: 2014-04-21
• Results posted: 2012-11-19

Locations

2 sites across 2 countries: Mexico, Peru