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A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) in Healthy Volunteers Aged Over 65 Years

NCT02417597•Xiamen Innovax Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy people aged over 18 years old on the day of enrollment
•2. Axillary temperature is below than 37.0 ℃
•3. Blood pressure is not higher than 160/100 mmHg (with or without any medicine)
•4. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
•5. Able to understand this study information and willing to comply with all study requirements.
•6. Willing to participate in this study and sign informed consent form.

Exclusion Criteria

•1. Participated in any other clinical trial during the study period.
•2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
•3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
•4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
•5. Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
•6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
•7. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
•8. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
•9. Pregnant or breastfeeding
•10. Allergic history to any component of this vaccine.
+1 more criteria

Locations (1)

Kaihua Center for Disease Control and Prevention

Quzhou, Zhejiang, China

Key Dates

Start Date

April 1, 2015

Primary Completion Date

May 1, 2016

Completion Date

May 1, 2016

Last Updated

May 18, 2016

Enrollment

600

ACTUAL participants

Conditions

Hepatitis E

Interventions

Recombinant Hepatitis E Vaccine (Escherichia Coli)

BIOLOGICAL

Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women

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Hepatitis E Infection

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COMPLETEDPHASE3

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Hepatitis E

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.