NCT00362427

Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar®

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

Summary

PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3. Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar® Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.

Conditions

• Diphtheria
• Pertussis
• Polio
• Hepatitis B
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC	0.5 mL, 4 doses, IM
BIOLOGICAL	Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC	0.5 Ml, 4 doses, IM
BIOLOGICAL	Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC	0.5 mL, 4 doses, IM with concommitant vaccines

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2006-08-10
• Last updated: 2014-01-14

Locations

8 sites across 1 country: Canada