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The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months.
The trial was conducted in accordance with the principles of good clinical practice and the ethical principles in the Declaration of Helsinki, with a protocol approved by the Institutional Review Board of the Christian Medical.To mitigate the risks associated with OPV withdrawal, the World Health Organization (WHO) has recommended universal introduction of at least 1 dose of inactivated poliovirus vaccine (IPV) to infant immunization schedules worldwide .A single dose of IPV administered at 14 weeks of age or later protects at least 50% of recipients against poliomyelitis and provides an immunity base for subsequent boosting with IPV if required .Oversight of the study was provided by an independent data safety and monitoring board.
Children were randomized in a 1:1:1 ratio to receive a dose of IPV 5 months after enrollment (Arm A), at enrollment (Arm B), or no IPV (Arm C).Children were excluded if they had received IPV previously.
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