A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine

Inclusion Criteria:

• Males and females able to provide legal identity certificate, aged ≥ 40 yearsinclusive at the time of signing the ICF;
• Able to understand the study procedures, voluntarily agree to participate in thestudy, and sign the ICF;
• Female subjects are not pregnant or lactating. Female subjects with childbearingpotential should take reliable contraceptive measures, and have no pregnancy andfertility plan within 7 months;
• Axillary temperature ≤ 37.0℃ on the day of enrollment;
• Able to attend all scheduled follow-up visits and able to comply with protocolrequirements;

Exclusion Criteria:

• Subjects who have had herpes zoster within the previous 5 years;
• Previous vaccination against varicella or shingles (including use of a registeredproduct or participation in a clinical trial of varicella or shingles vaccine);
• Hypersensitivity to any of the components of the test vaccine: or priorhypersensitivity to any recombinant vaccine of CHO cell origin [e.g., recombinanthepatitis B vaccine (CHO cell)], polysorbate, etc.; or prior history of severeallergy* to any of the vaccinations; *Severe allergies: anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura,thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction),severe urticaria.
• Developed immunodeficiency diseases (congenital or acquired immunodeficiency diseases,human immunodeficiency virus infection) or received immunosuppressive/cytotoxictreatments (cancer chemotherapy, organ transplantation, or treatment planned during aclinical trial in the 6 months prior to vaccination);
• Receiving immunosuppressive therapy (e.g., long-term systemic glucocorticoidapplication for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day of prednisone orprednisone-equivalent dose) within 3 months prior to vaccination or within 1 monthafter the planned full course of immunization；
• Received an inactivated or recombinant vaccine or mRNA vaccine within 14 days or anylive attenuated vaccine within 28 days prior to vaccination;
• Subjects who are suffering from an acute illness or are in the acute exacerbationphase of a chronic disease within 3 days prior to vaccination;
• History of asplenia or functional asplenia, and asplenia or splenectomy due to anycondition;
• Treatment with blood products or globulins within 3 months prior to enrollment, orplanned use of such products within 2 months of vaccination;
• Participating in other clinical studies of investigational or un-registered products (drugs, vaccines or devices, etc.), or planning to participate in other clinicalstudies before the end of this clinical study;
• Significant underlying medical conditions that, in the opinion of the investigator,may prevent completion of the trial (e.g., life-threatening disease that may limitsurvival to less than 4 years) or any other condition