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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
460
0.5 mL, 4 doses, IM
0.5 Ml, 4 doses, IM
0.5 mL, 4 doses, IM with concommitant vaccines
Unnamed facility
Coquitlam, British Columbia, Canada
Unnamed facility
Surrey, British Columbia, Canada
Unnamed facility
Winnipeg, Manitoba, Canada
Unnamed facility
Halifax, Nova Scotia, Canada
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Beauport, Quebec, Canada
Unnamed facility
Montreal, Quebec, Canada
Unnamed facility
Montreal, Quebec, Canada
To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar
Time frame: 14 Months
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