Phase 4 Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine

Institute of Medical Biology, Chinese Academy of Medical Sciences1 site in 1 country35,000 target enrollmentSeptember 2013

ConditionsHepatitis A

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hepatitis A
Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Enrollment: 35000
Locations: 1
Primary Endpoint: changes of hepatitis A antibody concentration
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.

Detailed Description

Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

June 2016

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Only subjects fulfilling all of the following criteria will be eligible for the study:
•People aged from 18 months to 65 years old.
•The subjects or subjects' guardians are able to understand and sign the informed consent
•The subjects or subjects' guardians allow to comply with the requirements of the protocol
•Subjects with temperature \<=37.0°C on axillary setting
•The subjects have signed informed consent already

Exclusion Criteria

•Subjects will not be eligible for the study if any of the following criteria is met:
•Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
•Have a history of neurological symptoms or signs
•Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
•Suffering from serious chronic diseases
•Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
•Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
•Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
•Any prior diseases including human immunodeficiency virus infection or related
•Bleeding constitution or prolong bleeding time situation