Status: Recruiting
Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women
This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N=150) of which all participants in this arm will be included in the immunogenicity subset.
Participants needed: 2,358
Trial details
Phase: Phase 2Age: 16-45Biological sex: FemaleType: InterventionalSponsor: International Vaccine InstituteUpdated: Sep 27, 2024Locations: 1
Eligibility criteria
Healthy women 16-45 years of age who are between 14 0/7 and 34 6/7 weeks gestati... [+11]
Has received any hepatitis E vaccine in the past. [+16]