A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine

This is an interventional prevention trial for Varicella focused on measuring live attenuated varicella vaccine, consistency, immunogenicity, safety, children Read More

Inclusion Criteria:

• Healthy volunteer between 1-3 years old;
• legal identity;
• Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Exclusion Criteria:

• Prior vaccination with varicella vaccine or with history of varicella infection;
• Axillaty temperature > 37.0 °C before vaccination;
• History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
• Epilepsy (except febrile seizures), history of seizures or convulsions, a family history of mental illness, autoimmune disease, or immunodeficiency;
• Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
• Acute disease or acute stage of chronic disease within 7 days prior to study entry;
• Receipt of any blood product, immunosuppressant, hormone, other investigational medicine(s) within 30 days prior to study entry;
• Receipt of any live attenuated vaccine within 1 month prior to study entry, or receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
• Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
• Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded.