NCT03554798

A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine

A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Novel Oral Polio Type 2 (nOPV2) Vaccine Candidates in Healthy Children Aged 1 to 5 Years and in Healthy Bivalent Oral Polio Vaccine-inactivated Polio Vaccine (bOPV-IPV) Vaccinated Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,025 (actual)
• Sponsor: Fidec Corporation · Academic / Other
• Sex: All
• Age: 6 Weeks – 5 Years
• Healthy volunteers: Accepted

Summary

This will be a single center, age de-escalation, partly-blinded, randomized study. The trial will be performed with the participation of 100 healthy children age 1-5 years who have been vaccinated with inactivated polio vaccine (IPV) and/or oral polio vaccine (OPV) in their first year of life and of 648 healthy 6 week-old infants, who will be pre-vaccinated with bOPV-IPV before being randomized to study groups. The allocation of 18-22 week-old infants to groups will be performed in a randomized manner. Following completion and Data Safety Monitoring Board (DSMB) review of follow-up for general safety data (Serioius Adverse Events -SAEs-, Important Medical Events -IMEs- and severe adverse events -AEs), a DSMB recommendation to proceed will result in randomization of the final cohort of infants. Allocation of 1 to 5 year-old children to groups will be performed in a randomized manner. The DSMB will establish and continuously assess stopping rules for safety.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	nOPV2 (monovalent oral polio vaccine)	Cohort A: 150 IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1 or 2; two 10‸6 CCID50 (50% cell culture infective dose) doses separated by 28 days. Cohort B: 972 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 10‸5 CCID50 dose of candidate 1 or 2.

Timeline

• Start date: 2018-12-04
• Primary completion: 2020-02-19
• Completion: 2020-02-19
• First posted: 2018-06-13
• Last updated: 2024-01-19
• Results posted: 2022-03-23

Locations

2 sites across 1 country: Panama