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

NCT ID: NCT06614816

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2022-06-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oka strain varicella attenuated live vaccine

Intervention Type: BIOLOGICAL

lyophilized powder, subcutaneous injection

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.

Group Type: ACTIVE_COMPARATOR

Oka strain varicella attenuated live vaccine

Intervention Type: BIOLOGICAL

lyophilized powder, subcutaneous injection

Interventions

Oka strain varicella attenuated live vaccine

lyophilized powder, subcutaneous injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu CDC

UNKNOWN

Sponsor Role: collaborator

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Shiyuan Wang

MD, Department of epidemiology and biostatistics, School of public health,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Huaiyin District Center for Disease Control and Prevention

Huaian, Jiangsu, China

Countries

China

Other Identifiers

JSVCT057

Identifier Type: -

Identifier Source: org_study_id