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Immunogenicity of Monovalent Type 2 Oral Poliovirus Vaccine

NCT02643368 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2018-01-25

No results posted yet for this study

Summary

This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the first dose of mOPV2, in a two dose schedule with a four week interval, is administered simultaneously with IPV.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

mOPV2 at 6 and 7 weeks of age

Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 7 weeks of age

BIOLOGICAL

mOPV2 at 6 and 8 weeks of age

Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 8 weeks of age

BIOLOGICAL

mOPV2 at 6 and 10 weeks of age

Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 10 weeks of age

BIOLOGICAL

IPV at 6 weeks of age

Participants assigned to this intervention will receive a dose of inactivated polio vaccine (IPV) 6 weeks of age

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Bangladesh

Study Locations

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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 NCT02643368 on ClinicalTrials.gov