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

NCT06895486 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Poliomyelitis

Interventions

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

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • PT Bio Farma

    collaborator INDUSTRY

  • Centers for Disease Control and Prevention

    collaborator FED

  • Technical Resources International, Inc. (TRI)

    collaborator UNKNOWN

  • Centro de Vacunación e Investigación (Cevaxin)

    collaborator UNKNOWN

  • PATH

    lead OTHER

Principal Investigators

  • Xavier Saez Llorens, MD · Cevaxin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
7 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-12-28
Completion
2026-12-28

Countries

  • Panama

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06895486 on ClinicalTrials.gov