A Phase III Clinical Trial Assessing the Immunogenicity and Safety of Lyophilized Live-Attenuated Varicella Vaccine in Healthy Subjects Aged 13 to 55 Years

Southeast University, China

Status and phase: Completed; Phase 3

Conditions: Chickenpox Vaccines

Treatments: Biological: Chickenpox Vaccines

Study type: Interventional

Funder types: Other

Identifiers

NCT06592456

JSVCT058

Details and patient eligibility

About

Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Adolescents and adults Aged 13-55 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study

Enrollment: 1,200 patients

Sex: All

Ages: 13 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals aged between 13 to 55 years who are permanent residents; Have obtained informed consent from the volunteer and/or their legal guardian, and signed the informed consent form; The volunteer and/or their legal guardian can comply with the requirements of the clinical trial protocol; Axillary temperature ≤37.0°C.

Exclusion criteria

• Females aged 18 to 55 years with a positive urine pregnancy test, pregnant women, women who are breastfeeding, or women planning to become pregnant within the next 3 months; Have a history of varicella vaccination, a history of chickenpox, or a history of herpes zoster infection; Allergic 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 having HIV-related immunocompromised status, or having close family members with congenital immune diseases; Have 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 (such as coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders; Have received blood products in the past 3 months; Have received live attenuated vaccines in the past 14 days or subunit or inactivated vaccines in the past 7 days; Have had various acute diseases or acute exacerbations of chronic diseases in the past 7 days; Have had a fever (axillary temperature ≥38.0°C) in 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

---

1,200 participants in 2 patient groups

Live Attenuated Varicella vaccine candidates

Experimental group

Description:

freezedried 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: Chickenpox Vaccines

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 human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers

Treatment:

Biological: Chickenpox Vaccines