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An Immunity Persistence Study of Live Attenuated Varicella Vaccine | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE4

An Immunity Persistence Study of Live Attenuated Varicella Vaccine

An Open Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 5 and 8 Years After Primary Immunization with Live Attenuated Varicella Vaccine

NCT05095701•Sinovac (Dalian) Vaccine Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This an open phase Ⅳ clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 5 and 8 years after primary immunization with live attenuated varicella vaccine.

Detailed Description

This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.

Eligibility

Age

1 - 17 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine;
•The subject and/or guardian can understand and voluntarily sign the informed consent form;
•Proven legal identity.

Exclusion Criteria

•History of chickenpox or shingles;
•History of varicella vaccination since phase Ⅲ clinical trial;
•Autoimmune disease or immunodeficiency / immunosuppression;
•History of immunosuppressive therapy since phase Ⅲ clinical trial;
•According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Locations (2)

Xiangcheng County Center for Disease Control and Prevention

Xuchang, Henan, China

Biyang County Center for Disease Control and Prevention

Zhumadian, Henan, China

Key Dates

Start Date

December 18, 2021

Primary Completion Date

December 19, 2021

Completion Date

October 1, 2025

Last Updated

January 27, 2025

Enrollment

703

ESTIMATED participants

Conditions

Varicella

Interventions

Investigational Live Attenuated Varicella Vaccine

BIOLOGICAL

Placebo (Freeze Dired Dilution)

BIOLOGICAL

Second Dose of Varicella Vaccine in Healthy Children

NCT07475000

Varicella (Chickenpox)Varicella Immunisation

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RECRUITINGPHASE2

Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination

NCT05422508

Varicella

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Immunity Persistence Study of Live Attenuated Varicella Vaccine

Inclusion Criteria

Exclusion Criteria

Second Dose of Varicella Vaccine in Healthy Children

Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination

Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine

Correlation of Protection Against Varicella in an Exploratory Study

Systems Biology of Zoster Vaccine

Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus