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Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine

NCT02291263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 738

Last updated 2015-08-27

No results posted yet for this study

Summary

This study will be an open-label phase III randomized clinical trial comparing different combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV administered at 6 weeks or 14 weeks or 6 and 14 weeks of age. All participants will also receive bOPV at 6, 10 and 14 weeks of age.

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

bOPV/IPV (6 weeks)

bOPV at 6, 10 and 14 weeks of age IPV at 6 weeks of age

BIOLOGICAL

bOPV/IPV (14 weeks)

bOPV at 6, 10 and 14 weeks of age IPV at 14 weeks of age

BIOLOGICAL

bOPV/IPV (6 & 14 weeks)

bOPV at 6, 10 and 14 weeks of age IPV at 6 and14 weeks of age

Sponsors & Collaborators

Principal Investigators

  • Md. Khalequzzaman, MBBS, PhD · International Center for Diarrhoeal Disease Research, Bangladesh

  • Abhijeet Anand, MBBS, MPH · Centers for Disease Control and Prevention

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
2014-10-31
Primary Completion
2015-07-31
Completion
2015-08-31

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 NCT02291263 on ClinicalTrials.gov