NCT05166031

Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine

A Phase III Study to Evaluate the Immunogenicity and Safety of Concomitant Administration of Two Doses of a Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine in Healthy Infants

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fidec Corporation · Academic / Other
• Sex: All
• Age: 7 Weeks – 10 Weeks
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	bOPV and nOPV2	Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-04-01
• Completion: 2021-10-18
• First posted: 2021-12-21
• Last updated: 2022-01-14