Phase ? Clinical Trial of an Inactivated Hepatitis A Vaccine

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 differentspecifications 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 200participants aged 16 years and older (adult dose group), and 480 participants aged 1 toless than 16 years (pediatric dose group).For the adult dose group: open‐label, single‐arm design, 200 participants aged 16 yearsand above will be enrolled to receive Healive® (1.0 mL).For the pediatric dose group: double‐blinded, randomized, positive‐controlled design, 480participants aged 1 to less than 16 years will be enrolled, and randomized in a 2:1 ratioto receive either Healive® (0.5 mL) or Avaxim® (0.5 mL). All participants will receivetwo doses of either Healive® or Avaxim® at 0 and 6 months.