Clinical Trial

Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

Recruiting Phase 2
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Record status
This record was last updated September 27, 2024 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-03-29; most recent amendment 2024-09-26.
Status change: Not Yet Recruiting → Recruiting 2024-09-26
Trial Details
NCT Number NCT05808166
Lead Sponsor International Vaccine Institute
Collaborators: Open Philanthropy, Bill and Melinda Gates Foundation, Thrasher Research Fund
Conditions Hepatitis E Infection
Enrollment 2,358 participants
Start Date 2024-05-02
Primary Completion 2025-11 (estimated)
Study Completion 2026-04 (estimated)
Updated on ClinicalTrials.gov 2024-09-27