NCT06895486

Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation

A Phase 2, Randomized, Double- Dummy, Observer-Blind Study to Evaluate the Safety and Immunogenicity of Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines in Healthy Young Infants Relative to Monovalent Vaccines Alone in Panama.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 675 (estimated)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 6 Weeks – 7 Weeks
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.

Detailed description

This is a randomized, double dummy, observer blind, active comparator-controlled study. The study population will comprise healthy infants randomized at 16 weeks of age equally across three study groups, nOPV1 only group (N=225), nOPV2 only group (N=225) and co-administered nOPV1+ nOPV2 group (N=225). The participants in the nOPV1 and nOPV2 groups will receive concomitant oral placebo (sterile water) to blind the study arms for parents. Participants will be screened (screening period 10 weeks), randomized and administered the first dose of study vaccine(s) at 16 weeks of age. The second and third dose of study vaccine(s) will be administered at 20 and 24 weeks of age, respectively. Participants will be consented and screened at 6 weeks of age and receive their routine Expanded Program on Immunization (EPI) vaccines by the study team. For each group, blood will be collected for immunologic testing at 16 (baseline), 20, 24, and 28 weeks of age. Serum specimens will be tested for humoral responses to vaccination by measurement of serum neutralizing antibody (NAb) according to established World Health Organization (WHO) protocols. Stool samples will be collected at various timepoints to evaluate type-specific shedding of polio virus following vaccination. Following vaccination, participants will be monitored for at least 30 minutes for any immediate adverse events (AEs). Reactogenicity (solicited AEs) will be assessed during the 7 days (day of vaccination and 6 following days) after each vaccination. Parents will be given a post-immunization memory aid to record any local and systemic solicited reactions. In addition, data for unsolicited AEs will be collected for 28 days (day of study vaccination and 27 following days) after each vaccination. Data for SAEs will be collected throughout the study period following vaccination.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Novel Oral Polio Vaccine Type 1 (nOPV1)	nOPV1 containing \>10\^7.0 CCID50 per dose
BIOLOGICAL	Novel Oral Polio Vaccine Type 2 (nOPV2)	nOPV2 containing ≥10\^5.0 CCID50 per dose
BIOLOGICAL	Placebo (Sterile Water)	Sterile, nonpyrogenic preparation of water which contains no bacteriostat, antimicrobial agent, or added buffer

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-12-28
• Completion: 2026-12-28
• First posted: 2025-03-26
• Last updated: 2026-01-09

Locations

3 sites across 1 country: Panama