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

NCT05033561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 905

Last updated 2024-08-23

Study results available
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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

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

nOPV2

Novel Oral Poliomyelitis Type 2 Vaccine

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Fidec Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-16
Primary Completion
2022-05-24
Completion
2022-10-25

Countries

  • Dominican Republic

Study Locations

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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 NCT05033561 on ClinicalTrials.gov