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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: An Effectiveness Trial (Phase IV) to Evaluate Protection of Pregnant Women by Hepatitis E Virus (HEV) Vaccine in Bangladesh and Risk Factors for Severe HEV Infection.

Brief 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.

Detailed Summary:
Sponsor: Norwegian Institute of Public Health

Current Primary Outcome: Effectiveness of HEV vaccine in preventing HEV diseases among women in Bangladesh [ Time Frame: 2 years ]

To determine the effectiveness of hepatitis E virus (HEV) vaccine in preventing HEV disease during pregnancy among women in rural Bangladesh


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with adverse events related to vaccination as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    To determine the safety and immunogenicity of HEV vaccine in Bangladeshi women of childbearing age
  • Effectiveness of HEV vaccine in preventing HEV disease in non-pregnant Bangladeshi women of childbearing age [ Time Frame: 2 years ]
  • Estimate serological correlates of protection [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Norwegian Institute of Public Health

Dates:
Date Received: March 21, 2016
Date Started: June 2016
Date Completion: December 2019
Last Updated: April 29, 2016
Last Verified: April 2016