Status:
COMPLETED
Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Hepatitis A
Eligibility:
All Genders
18-5 years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were ev...
Detailed Description
This was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with the Edinburgh ...
Eligibility Criteria
Inclusion
- Healthy children aged between 1.5 and 5 years, with no history of hepatitis A virus infection or hepatitis A vaccine vaccination
- Provided birth certification or vaccination card
- Parent(s) or legal guardian(s) are able to understand and sign the informed consent
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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01252680
Start Date
April 1 2010
End Date
May 1 2011
Last Update
March 15 2013
Active Locations (1)
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1
Tianjin Centers for Diseases Control and Prevention
Tianjin, Tianjin Municipality, China, 300011