Immune Response to Oral Polio Vaccine Clinical Trial
Official title:
A Phase III, Observer Blind, Active Controlled, Randomized, Clinical Study Comparing Safety and Immunogenicity of BBio Bivalent Oral Polio Vaccine With a Licensed Bivalent Oral Polio Vaccine
Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study will also assess lot-to-lot consistency among three lots of BBio bOPV.
Bilthoven Biologicals has developed a new bivalent OPV containing WHO approved Sabin strains
of poliovirus type 1 and type 3. This phase III study will be conducted in two parts:
Part 1 - 40 children of 60 to 83 months of age will be given single dose of BBio bOPV or
licensed bOPV in 1:1 ratio. Primary objective is to assess safety of BBio bOPV.
Part 2 - A total of 1080 infants of 42 to 56 days of age will be randomized to receive three
doses of either BBio bOPV from one of the three lots or a licensed bOPV in 1:1:1:1 ratio as
primary immunization series at 6, 10 and 14 weeks of age.
Primary objective of this study is to assess non-inferiority of bOPV manufactured by BBio to
that of licensed bOPV in terms of seroconversion. This study also will assess lot-to-lot
consistency among three lots of BBio bOPV.
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