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Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine

NCT05166031 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-01-14

No results posted yet for this study

Summary

The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

bOPV and nOPV2

Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Fidec Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2021-04-30
Completion
2021-10-18

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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 NCT05166031 on ClinicalTrials.gov