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. 2019 Dec 5;2019(12):CD011260. doi: 10.1002/14651858.CD011260.pub2

NCT02412514.

Trial name or title Public title: Intestinal humoral immunity of sequential polio vaccination schedules
Scientific title: Assessing the intestinal and humoral immunity of sequential schedules of inactivated poliovirus vaccine and bivalent oral poliovirus vaccine for routine childhood immunization in Bangladesh
Methods Design: randomised, open‐label trial
Participants Location: Dhaka, Bangladesh
Participants: healthy infants
Sample size: 456
Age: 6 weeks (range: 42‐48 days)
Interventions Arm A (I+O)OO: IPV + bOPV, bOPV and bOPV, administered at 6, 10, and 14 weeks, respectively
Arm B (IOO): IPV, bOPV and bOPV, administered at 6, 10, and 14 weeks, respectively
Outcomes Primary outcomes
  • Change in type 1 and 3 excretion of vaccine poliovirus particles in stool one week after administration of the bOPV challenge dose (time frame: 1 week).

  • Change in type 1, 2 and 3 poliovirus antibody responses prior to administration of poliovirus vaccinations compared to after completion of poliovirus vaccinations (time frame: 12 weeks).


Secondary outcome
  • Change in type 1 and 3 excretion of vaccine poliovirus in stool two weeks after administration of the bOPV challenge dose at 18 weeks of age.

Starting date Start date: April 2015
Completion date: December 2015
Contact information Sponsor: Centers for Disease Control and Prevention
Collabator: International Centre for Diarrhoeal Disease Research, Bangladesh
Principal Investigator: not stated
Notes Recruitment status: completed