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 evaluated.
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 version of the Declaration of Helsinki. The study was approved by the Ethics Committee. Parents or legal guardians of all participants gave written informed consent prior to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled, children were randomized to four equal groups with different intervention. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines were evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
303
Hepatitis A vaccine (Healive), 250 u per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Healive, followed by another dose of Havrix after 6 months
Hepatitis A vaccine (Havrix), 720 ELU per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
Tianjin Centers for Diseases Control and Prevention
Tianjin, Tianjin Municipality, China
Immunogenicity and interchangeability of two inactivated hepatitis A vaccines
Time frame: 7 months
safety of two inactivated hepatitis A vaccines
Time frame: 7 months
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Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Havrix, followed by another dose of Healive after 6 months