Status:
COMPLETED
Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Hepatitis A
Eligibility:
All Genders
16-25 years
Phase:
PHASE4
Brief Summary
A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose r...
Detailed Description
Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly divided into three groups. Group A and B were administrated with one-dose inactivated and live attenuated hepati...
Eligibility Criteria
Inclusion
- Healthy undergraduate students aged 16 to 25 years
- Sign the informed consent
- Provide ID
Exclusion
- Axillary temperature \> 37.0 centigrade at the time of dosing
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- History or family history of convulsions, epilepsy, brain disease and psychiatric
- History of any blood products within 3 months
- Administration of any other investigational research agents within 30 days
- Administration of any live attenuated vaccine within 30 days
- Administration of subunit or inactivated vaccines within 14 days
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
- anti-HBsAg positive
- anti-HAV positive
- Pregnancy test result is positive
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT01865968
Start Date
October 1 2008
End Date
September 1 2012
Last Update
May 14 2015
Active Locations (1)
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1
Nanchang Center for Disease prevention and Control
Nanchang, Jiangxi, China, 330000