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Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study

NCT03722004 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1256

Last updated 2021-02-21

No results posted yet for this study

Summary

This is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

mOPV1

Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

BIOLOGICAL

bOPV

Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.

BIOLOGICAL

fIPV

Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Days
Max Age
41 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • Bangladesh

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 NCT03722004 on ClinicalTrials.gov