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Poliovirus Vaccine Trial in Bangladesh

NCT01633216 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2013-01-08

No results posted yet for this study

Summary

This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.

Conditions

  • Healthy Infants

Interventions

BIOLOGICAL

Bivalent OPV 2 week interval

Group A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses).

BIOLOGICAL

Bivalent OPV 4 week interval

Group B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses).

BIOLOGICAL

Monovalent OPV 2 week interval

Group C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses).

BIOLOGICAL

Monovalent OPV 4 week interval

Group D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses).

BIOLOGICAL

Trivalent OPV 4 week interval

Group E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule).

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Bangladesh

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 NCT01633216 on ClinicalTrials.gov