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

Phase 3

Completed

• Conditions: Chickenpox Vaccines
• Interventions: Biological: Oka strain varicella attenuated live vaccine

• Registration Number: NCT06614816
• Lead Sponsor: Southeast University, China

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-10
• Primary Completion: 2021-07-15
• Study Completion: 2022-06-20
• Status Verified: 2024-09
• Study First Submitted: 2024-09-08
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Live Attenuated Varicella vaccine candidates	Oka strain varicella attenuated live vaccine	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.
Marketed Live Attenuated Varicella vaccine	Oka strain varicella attenuated live vaccine	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.

Primary Outcome Measures

Name	Time	Method
seroconversion rate	42 days after completing the full course of vaccination.	The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies

Secondary Outcome Measures

Name	Time	Method
geometric mean titer (GMT)	42 days after completing the full course of vaccination.	geometric mean titer (GMT) of VZV antibodies 42 days after vaccination
geometric mean fold increase (GMFI)	42 days after completing the full course of vaccination.	geometric mean fold increase (GMFI) of VZV antibodies 42 days after vaccination

Trial Locations

Locations (1)

Huaiyin District Center for Disease Control and Prevention; 🇨🇳 Huaian, Jiangsu, China