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

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.

Timeline

Start

2006-08

Primary completion

2009-02

Completion

2009-03

Publications

• Halperin SA, Tapiero B, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee A, Li M, Tomovici A. Safety and immunogenicity of a toddler dose following an infant series of a hexavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b, hepatitis B vaccine administered concurrently or at separate visits with a heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Jan;33(1):73-80. doi: 10.1097/01.inf.0000437806.76221.20.
• Tapiero B, Halperin SA, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee AW, Li M, Tomovici A. Safety and immunogenicity of a hexavalent vaccine administered at 2, 4 and 6 months of age with or without a heptavalent pneumococcal conjugate vaccine: a randomized, open-label study. Pediatr Infect Dis J. 2013 Jan;32(1):54-61. doi: 10.1097/INF.0b013e3182717edf.

Drugs

Indications