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Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

StatusUnknown
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to May 2, 2024
    • Site details revised
    v3
  3. Primary completion date: Jul 2024 to Nov 2025
    • Start date: May 2023 to Jun 2024
    • Study completion date: May 2025 to Apr 2026
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05808166
Lead Sponsor International Vaccine Institute
Collaborators: Coefficient Giving, Bill and Melinda Gates Foundation, Thrasher Research Fund
Conditions
(from sponsor)		 Hepatitis E Infection
Enrollment 2,358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov