NCT03614702.

Trial name or title	Public title: Clinic trial to evaluate the safety and immunogenicity by different sequential schedules of bOPV and IPV Scientific title: Safety and immunogenicity evaluation of different sequential immunization schedules of type 1 + 2 bivalent oral poliovirus vaccine(bOPV) co‐administered with inactived poliovirus vaccine (IPV) in infants aged 2 months: a randomized, double blind, single centre, parallel trial
Methods	Design: randomised, double‐blind, single‐centre, parallel trial
Participants	Location: Guangxi Province, China Participants: infants Age: 2 months Sample size: 1200
Interventions	1 dose cIPV + 2 doses bOPV (candy) 1 dose sIPV + 2 doses bOPV (candy) 2 doses cIPV + 1 dose bOPV (candy) 2 doses sIPV + 1 dose bOPV (candy) 2 doses cIPV + 1 dose tOPV (candy) 2 doses sIPV + 1 dose tOPV (Candy) 1 dose cIPV + 2 doses bOPV (liquid)\ 1 dose sIPV + 2 doses bOPV (liquid) 2 doses cIPV + 1 dose bOPV (liquid) 2 doses sIPV + 1 dose bOPV (liquid) 2 doses cIPV + 1 dose tOPV (liquid) 2 doses sIPV + 1 dose tOPV (liquid)
Outcomes	Primary outcomes Antibody titres of anti‐poliovirus antibodies in serum of children who received 2 doses cIPV/sIPV + 1 dose tOPV or 2 doses cIPV/sIPV + 1 dose bOPV (time frame: at the 28 days after finishing the 3rd dose) Secondaary outcomes Safety: number of AEs and serious AEs (time frame: within 28 days after each dose injection) Long‐term safety: number of serious AEs (time frame: up to 6 months after finishing the 3rd dose) Antibody titres of anti‐poliovirus antibodies in serum of children who received 1 dose cIPV/sIPV + 2 doses bOPV (candy/liquid) or 2 doses cIPV/sIPV + 1 dose bOPV (time frame: at the 28 days after finishing the 3rd dose) Other outcomes Viral shedding (time frame: before the second dose, 7 days after the second dose, 14 days after the second dose, 28 days after the second dose, 7 days after the third dose, 14 days after the third dose, 28 days after the third dose)
Starting date	Start date: 15 September 2015 Completion date: August 2016
Contact information	Sponsor: Chinese Academy of Medical Sciences Collaborator: Guangxi Province Center for Diseases Control and Prevention Principal Investigator: Zhaojun Mo
Notes	Recruitment status: completed

AE: adverse events; bOPV: bivalent oral polio vaccine; CRO: country responsible officer; IPV: inactivated polio vaccine; cIPV: conventional inactivated polio virus; nOPV2: novel monovalent oral type 2 polio vaccine; RCT: randomised controlled trial; PCR: polymerase chain reaction; sIPV: Sabin strain of inactivated polio vaccine; tOPV: trivalent oral polio vaccine.