Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine

Inclusion criteria

• 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.

Exclusion criteria

• Prior vaccination with any hepatitis A vaccine or combined vaccines containing HAV components;
• Prior history of HAV infection;
• Female participants of reproductive potential who are pregnant (including a positive urine pregnancy test) or have a pregnancy plan within 30 days after the second vaccination, or who are currently lactating;
• Known allergy to vaccines or vaccines ingredients;
• Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
• Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
• Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
• Current or history of severe neurological diseases [epilepsy, convulsions or seizures (excluding history of febrile seizures)] or psychiatric disorders, or presence of a family history of psychiatric disorders;
• Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;
• Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
• Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
• Receipt of attenuated live vaccines or nucleic acid vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
• Fever on vaccination day, with axillary temperature >37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
• Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;
• Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
• Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.