RecruitingPhase 2NCT06895486

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.


Sponsor

PATH

Enrollment

675 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 WeeksMax Age: 7 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Novel Oral Polio Vaccine Type 1 (nOPV1), a biological treatment called Novel Oral Polio Vaccine Type 2 (nOPV2), and others for people with poliomyelitis. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 6 Weeks to 7 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNovel Oral Polio Vaccine Type 1 (nOPV1)

nOPV1 containing \>10\^7.0 CCID50 per dose

BIOLOGICALNovel Oral Polio Vaccine Type 2 (nOPV2)

nOPV2 containing ≥10\^5.0 CCID50 per dose

BIOLOGICALPlacebo (Sterile Water)

Sterile, nonpyrogenic preparation of water which contains no bacteriostat, antimicrobial agent, or added buffer


Locations(3)

Cevaxin - 24 de Diciembre

Panama City, Panama

Cevaxin - Ave. México

Panama City, Panama

Cevaxin - Chorrera

Panama City, Panama

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NCT06895486


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