Completed PHASE1 INTERVENTIONAL 2-arm NCT02603055

A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults

A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Healthy Adults Aged 16 to 65 Years Old in China

Sponsor: Changchun Institute of Biological Products Co., Ltd.

Conditions Hepatitis E

Interventions 30μg/0.5ml Hepatitis E vaccine 30μg/0.5ml Recombinant Hepatitis E vaccine

Updated 5 times since 2017 Last updated: Aug 30, 2016 Started: Jul 31, 2015 Primary completion: Apr 30, 2016 Completion: Aug 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Hepatitis E and is currently completed. Changchun Institute of Biological Products Co., Ltd. leads this study, which shows 5 recorded versions since 2015 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Jul 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Changchun Institute of Biological Products Co., Ltd.
Jiangsu Province Centers for Disease Control and Prevention

Data source: Jiangsu Province Centers for Disease Control and Prevention

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Nanjing, China