NCT01177722

A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,375 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 55 Days – 65 Days
• Healthy volunteers: Accepted

Summary

The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines. Primary Objectives: * To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses. * To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™. Secondary Objectives: * To describe in each group the immunogenicity parameters for all antigens for each vaccine * To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

Detailed description

Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age. All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

Conditions

• Diphtheria
• Tetanus
• Whooping Cough
• Hepatitis B
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV-Hep B-PRP-T Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV-Hep B-PRP-T Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV-Hep B-PRP-T Vaccine	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-Hep B-IPV vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2010-08-09
• Last updated: 2014-05-05
• Results posted: 2014-05-05

Locations

2 sites across 2 countries: Colombia, Costa Rica