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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,120
A single dose of 2 drops (0.1 ml) orally of BBio bOPV to 20 children 60 to 83 months of age.
Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 1 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 2 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
Matlab Hospital Research Centre, International Center for Diarrheal Disease Research, Matlab
Matlab South, Chandpur District, Chittagong, Bangladesh
Part 1 study: Frequency of adverse events (AEs)
Safety of single dose of BBio bOPV will be assessed at 4 days after vaccination.
Time frame: 4 Days
Part 2 study: Percentage of seroconversion to poliovirus type 1 and type 3
Percentage of seroconversion to poliovirus type 1 and type 3 one month after administration of third dose of the BBio bOPV to that of control group bOPV to assess non-inferiority of BBio bOPV to that of a licensed bOPV.
Time frame: one month after dose 3
Part 1 study: Frequency of AEs and serious AEs (SAEs)
Safety of single dose of BBio bOPV will be assessed at 28 days after vaccination.
Time frame: 28 days
Part 1 study: Percentage of seroprotection to poliovirus type 1 and type 3
Percentage of seroprotection to poliovirus type 1 and type 3 one month after administration of single dose of the BBio bOPV to that of control group.
Time frame: one month
Part 1 study: Geometric mean titers (GMTs) of poliovirus neutralizing antibody (PVNA) to poliovirus type 1 and type 3
GMTs of PVNA to poliovirus type 1 and type 3 at one month after administration of single dose of the BBio bOPV.
Time frame: one month
Part 2 study: GMTs of serum PVNA for the three lots of BBio bOPV
Serum PVNA concentrations expressed as GMTs for the BBio bOPV to assess equivalence in manufacturing consistency among three current Good Manufacturing Practices (cGMP) lots of the BBio bOPV.
Time frame: one month after dose 3
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Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 3 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
Three doses of 2 drops (0.1 ml) orally of a licensed bOPV to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
A single dose of 2 drops (0.1 ml) orally of a licensed bOPV to 20 children 60 to 83 months of age.
Part 2 study: GMTs of PVNA to poliovirus type 1 and type 3
Comparison of GMTs of PVNA to poliovirus type 1 and type 3 at one month after administration of third dose of the BBio bOPV to that of control group bOPV.
Time frame: one month after dose 3
Part 2 study: Percentage of seroprotection to poliovirus type 1 and type 3
Percentage of seroprotection to poliovirus type 1 and type 3 one month after administration of third dose of the BBio bOPV to that of control group bOPV.
Time frame: one month after dose 3
Part 2 study: Frequency of adverse events within 4 days following the administration of each dose of vaccine
Frequency of adverse events within 4 days following the administration of each dose of vaccine
Time frame: 4 days after each dose of vaccine
Part 2 study: Frequency of adverse events and serious adverse events
Time frame: 84 days