Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years

Phase III Clinical Trial of Lyophilized Live Attenuated Varicella Vaccine for Children Aged 1-12 Years

Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study

Inclusion Criteria:

• Ages ranging from 1 to 12 years for the general healthy population ;
• Obtain informed consent from the volunteer and/or their legal guardian, and sign the informed consent form;
• The volunteer and/or their legal guardian is able to comply with the requirements of the clinical trial protocol;
• Axillary body temperature ≤37.0℃.

Exclusion Criteria:

• Those who have previously been vaccinated against varicella, have a history of varicella or herpes zoster infection;
• Allergy to known components of the study vaccine, or a history of severe allergic reactions to any vaccination;
• A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders;
• Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or HIV-related immunocompromised individuals, or those with family members closely exposed to congenital immune diseases;
• Those with congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome);
• Known or suspected concurrent diseases, including respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors;
• Diagnosed with coagulation dysfunction (e.g., deficiency of coagulation factors, coagulation disorders, platelet abnormalities) or significant bruising or coagulation disorders;
• Receipt of blood products within the past 3 months;
• Receipt of attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days;
• Acute illnesses or acute exacerbations of chronic diseases in the past 7 days;
• A history of high fever (axillary body temperature ≥38.0℃) within the past 3 days;
• Any other factors deemed by the investigator as unsuitable for participation in the clinical trial.