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Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine
Sponsor: Sinovac Biotech Co., Ltd
Summary
This is a Phase Ⅲ, open-label, single arm design combined with randomized, double-blind, active-controlled design trial to assess the immunogenicity and safety of different specifications of Healive® (the 0.5 mL pediatric dosage and the 1 mL adult dosage). A total of 680 healthy participants aged 1 year and above will be enrolled, including 200 participants aged 16 years and older (adult dose group), and 480 participants aged 1 to less than 16 years (pediatric dose group). For the adult dose group: open-label, single-arm design, 200 participants aged 16 years and above will be enrolled to receive Healive® (1.0 mL). For the pediatric dose group: double-blinded, randomized, positive-controlled design, 480 participants aged 1 to less than 16 years will be enrolled, and randomized in a 2:1 ratio to receive either Healive® (0.5 mL) or Avaxim® (0.5 mL). All participants will receive two doses of either Healive® or Avaxim® at 0 and 6 months.
Official title: A Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Safety of an Inactivated Hepatitis A Vaccine (Human Diploid Cell) in Healthy Adults and Children Aged ≥1 Year
Key Details
Gender
All
Age Range
1 Year - Any
Study Type
INTERVENTIONAL
Enrollment
680
Start Date
2026-08-20
Completion Date
2027-09-15
Last Updated
2026-08-28
Healthy Volunteers
Yes
Conditions
Interventions
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (1 mL)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, adult dose (≥ 16 years)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) (0.5 mL)
Inactivated Hepatitis A Vaccine (Human Diploid Cell) manufactured by Sinovac, pediatric dose (1\~\<16 years)
Hepatitis A vaccine (inactivated, adsorbed)
Hepatitis A vaccine (inactivated, adsorbed) manufactured by Sanofi
Locations (1)
Hanoi Medical University
Hanoi, Vietnam