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
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.
• Healthy participants aged 1 year and older;
• Participants (and/or their legal guardians) are able to understand and sign the informed consent voluntarily;
• Participants of reproductive potential and their sexual partners should voluntarily use effective contraception from signing the ICF to 30 days after the second vaccination and avoid donating sperm or eggs.
• Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
• Participants should agree to comply with the lifestyle precautions outlined in the protocol.