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The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children
The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.
In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008. This study is the fifth-year follow-up research for the previous clinical trial.
Age
1 - 2 years
Sex
ALL
Healthy Volunteers
Yes
Tianjin center for disease prevention and control
Tianjin, China
Start Date
October 1, 2008
Primary Completion Date
November 1, 2013
Completion Date
June 1, 2014
Last Updated
July 14, 2016
332
ACTUAL participants
Inactivated HAV vaccine
BIOLOGICAL
Attenuated alive HAV vaccine
BIOLOGICAL
Lead Sponsor
Sinovac Biotech Co., Ltd
NCT07032610
NCT03855176
Data Source & Attribution
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