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

Southeast University, China

Status and phase: Completed; Phase 3

Conditions: Chickenpox Vaccines

Treatments: Biological: Oka strain varicella attenuated live vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06614816

JSVCT057

Details and patient eligibility

About

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

Enrollment: 1,200 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 2 patient groups

Live Attenuated Varicella vaccine candidates

Experimental group

Description:

The test group received the freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co., LTD., which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cells inoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers.

Treatment:

Biological: Oka strain varicella attenuated live vaccine

Marketed Live Attenuated Varicella vaccine

Active Comparator group

Description:

the active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers.

Treatment:

Biological: Oka strain varicella attenuated live vaccine