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

Study Overview

• Status: Completed
• Conditions: Chickenpox Vaccines
• Intervention / Treatment: Biological: Oka strain varicella attenuated live vaccine

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Huaian, Jiangsu, China, 223399
      • Huaiyin District Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live Attenuated Varicella vaccine candidates; 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.	Biological: Oka strain varicella attenuated live vaccine; lyophilized powder, subcutaneous injection
Active Comparator: Marketed Live Attenuated Varicella 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.	Biological: Oka strain varicella attenuated live vaccine; lyophilized powder, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seroconversion rate	The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies	42 days after completing the full course of vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
geometric mean titer (GMT)	geometric mean titer (GMT) of VZV antibodies 42 days after vaccination	42 days after completing the full course of vaccination.
geometric mean fold increase (GMFI)	geometric mean fold increase (GMFI) of VZV antibodies 42 days after vaccination	42 days after completing the full course of vaccination.

Collaborators and Investigators

• Sponsor: Southeast University, China
• Collaborators: Jiangsu CDC

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Chickenpox
• Other Study ID Numbers: JSVCT057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No