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Study identifier: NCT05808166 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

Condition: Hepatitis E Infection  ·  Sponsor: International Vaccine Institute

PhasePhase 2
Planned participants2358
Who can joinFemale, 16 Years to 45 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Katerina Rok Song, M.D.  ·  +82-2-881-1228  ·  katerina.song@ivi.int

Always discuss trial participation with your own doctor first.

Locations (1)

The Aga Khan UniversityKarachi, Sindh, PakistanRecruiting

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Source record: clinicaltrials.gov/study/NCT05808166