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

NCT06614816 | Completed Phase 3

• 1 other identifier: JSVCT057
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Conditions

Chickenpox Vaccines

Outcome Measures

Primary Outcomes (1)

• seroconversion rate

  The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies

  42 days after completing the full course of vaccination.

Secondary Outcomes (2)

• geometric mean titer (GMT)

  42 days after completing the full course of vaccination.

• geometric mean fold increase (GMFI)

  42 days after completing the full course of vaccination.

Study Arms (2)

Live Attenuated Varicella vaccine candidates

EXPERIMENTAL

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

Marketed Live Attenuated Varicella vaccine

ACTIVE COMPARATOR

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

Interventions

Oka strain varicella attenuated live vaccine BIOLOGICAL

lyophilized powder, subcutaneous injection

Live Attenuated Varicella vaccine candidates; Marketed Live Attenuated Varicella vaccine

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead
• Jiangsu CDC: collaborator

Study Sites (1)

Huaiyin District Center for Disease Control and Prevention

Huaian, Jiangsu, 223399, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Department of epidemiology and biostatistics, School of public health,

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 26, 2024
• Study Start: February 10, 2019
• Primary Completion: July 15, 2021
• Study Completion: June 20, 2022
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)