NCT05033561

Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants

A Phase III Open-label Randomized Controlled Study to Evaluate the Safety and Immunogenicity of nOPV2 at Different Intervals of Administration in Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 905 (actual)
• Sponsor: Fidec Corporation · Academic / Other
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

Summary

Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants

Detailed description

This will be a multicenter, randomized, controlled, open-label, parallel-group Phase III study in healthy infants aged 6 to 8 weeks who have never been vaccinated against poliomyelitis. Approximately 900 infants will be included in the study and randomized with a 1:1:1 ratio to the following treatment groups: * Group A: approximately 300 subjects to receive 2 doses of nOPV2 administered 1 week apart, at Day 0 and Day 7; * Group B: approximately 300 subjects to receive 2 doses of nOPV2 administered 2 weeks apart, at Day 0 and Day 14; * Group C (control group): approximately 300 subjects to receive 2 doses of nOPV2 administered 4 weeks apart, at Day 0 and Day 28. A total of 4 on-site visits are planned. Approximately 7 days after each administration of study vaccine, a phone call or on-site visit will be performed to monitor subjects' safety and review with the subject's parent(s)/guardian(s) any solicited AEs reported in the electronic diary card. All subjects will have a safety follow-up phone call 6 months after the last dose of study vaccine.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	nOPV2	Novel Oral Poliomyelitis Type 2 Vaccine

Timeline

• Start date: 2021-12-16
• Primary completion: 2022-05-24
• Completion: 2022-10-25
• First posted: 2021-09-05
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

2 sites across 1 country: Dominican Republic