The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.
Seroconversion rate
Assessment and comparison of seroconversion rate to poliovirus types 1, 2 and 3 28 days following co-administration of two doses of nOPV2 and bOPV with two doses of nOPV2 or two doses of bOPV
Time frame: 2 months
Incidence of serious adverse reactions (SARs) , important medical reactions (IMRs) and severe solicited adverse reactions (ARs)
Number of serious adverse reactions, important medical reactions and severe solicited adverse reactions following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV
Time frame: 6 months
Immunogenicity to poliovirus type 2
Assessment and comparison of geometric mean neutralizing antibody titers against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
Time frame: 2 months
Immunogenicity to poliovirus type 2
Assessment and comparison of seroconversion rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
Time frame: 2 months
Immunogenicity to poliovirus type 2
Assessment and comparison of seroprotection rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
Time frame: 2 months
Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Assessment and comparison of the seroprotection rates against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV.
Time frame: 2 months
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Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Assessment and comparison of the geometric mean neutralizing against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV.
Time frame: 2 months
Assesment of SAEs, IMEs and any AEs
Number, severity and causality of any serious adverse event (SAE), any solicited AE, any unsolicited AE and any important medical events (IME) following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV
Time frame: 6 months
Assessment and comparison of viral shedding
Assessment and comparison of viral shedding in stool at fixed time points following administration of nOPV2, bOPV or the co-administration of nOPV2 and bOPV.
Time frame: 1 month