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Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life

NCT02111135 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-07-20

No results posted yet for this study

Summary

Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life

Conditions

Interventions

BIOLOGICAL

b-OPV

BIOLOGICAL

m-OPV2

BIOLOGICAL

m-IPV HD

BIOLOGICAL

t-IPV

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Vaxtrials S.A.

    lead OTHER

Principal Investigators

  • Xavier Sáez, MD · Hospital Del Niño

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-09-30
Completion
2015-03-31

Countries

  • Panama

Study Locations

More Related Trials

Entities

Diseases

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 NCT02111135 on ClinicalTrials.gov