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Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh.

NCT02759991 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19460

Last updated 2024-08-15

No results posted yet for this study

Summary

The aim of the study is to determine the effectiveness of hepatitis E virus vaccine given in women of child bearing age in preventing HEV disease during pregnancy among women in rural Bangladesh.

Conditions

  • Hepatitis E Infection

Interventions

DRUG

Hecolin

0.6ml Hecolin vaccine im. on day 0, 1 month and 6 months.

DRUG

Hepa-B

1ml Hepa-B vaccine im. on day 0, 1 month and 6 months.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Sykehuset Innlandet HF

    collaborator OTHER

  • Norwegian Institute of Public Health

    lead OTHER_GOV

Principal Investigators

  • Susanne Dudman, MD, PhD · Norwegian Institute of Public Health

  • K Zaman, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh, Centre for Child and Adolescent Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-09-30
Completion
2019-09-30

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 NCT02759991 on ClinicalTrials.gov