NCT05460429

Brief Summary

This is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37,920

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

July 30, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

January 12, 2023

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

July 12, 2022

Last Update Submit

January 11, 2023

Conditions

Varicella

Outcome Measures

Primary Outcomes (2)

  • GMT of varicella antibody in children aged 1-6 years

    GMT of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.

    30 days after vaccination

  • GMT of varicella antibody in healthy people aged 0-59 years

    GMT of varicella antibody at 30 days after vaccination in different age groups of healthy people aged 0-59 years.

    30 days after vaccination

Secondary Outcomes (9)

  • Seroconversion rates of varicella antibody in children aged 1-6 years

    30 days after vaccination

  • GMI of varicella antibody in children aged 1-6 years

    30 days after vaccination

  • Incidence of adverse reactions at 24 hours after vaccination

    24 hours after vaccination

  • Incidence of adverse reactions at 3 days after vaccination

    3 days after vaccination

  • Incidence of adverse reactions at 14 days after vaccination

    14 days after vaccination

  • +4 more secondary outcomes

Study Arms (5)

Immunogenicity and safety group

EXPERIMENTAL

360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine.

Biological: Live attenuated varicella vaccine

Antibody level investigation study group

EXPERIMENTAL

Immunization levels will be monitored among 2530 subjects aged 0-59 years old and will be collected venous blood to detect varicella antibody.

Biological: Live attenuated varicella vaccine

Safety group

EXPERIMENTAL

30000 subjects aged 1-12 years old will be enrolled to conduct safety observation of mass vaccination of varicella vaccine.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected.

Biological: Live attenuated varicella vaccine

Protective effect group

EXPERIMENTAL

5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure.

Biological: Live attenuated varicella vaccine

Etiology Group

EXPERIMENTAL

30 varicella cases aged 1-12 years old from study 4 will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella.

Biological: Live attenuated varicella vaccine

Interventions

Live attenuated varicella vaccineBIOLOGICAL

The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0.5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm. And the immunization schedule is one dose of live attenuated varicella vaccine on day 0.

Antibody level investigation study groupEtiology GroupImmunogenicity and safety groupProtective effect groupSafety group

Eligibility Criteria

AgeUp to 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants aged 1-12 years ;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-12 years, both subjects and guardians need to sign the informed consent form) and be able to follow all research procedures;
  • Proven legal identity.
  • Be able to participate in the whole process of vaccination and blood collection;
  • Healthy children aged 1-3 years with no history of varicella vaccination;
  • Healthy children aged 4-6 years with a history of 1 dose of varicella vaccine.
  • Healthy people aged 0-59 years and participate voluntarily for the study;
  • Have no serious chronic disease or acute disease;
  • Participants aged 1-3 years with no history of varicella vaccination;
  • Participants aged 4-12 years with no history of varicella vaccination or with a history of 1 dose of varicella vaccine.
  • Children aged 1-12 years exposed to varicella outbreaks;
  • History with no varicella or shingles;
  • Clinical cases of varicella consent for herpes zoster or pharyngeal swab collection.

You may not qualify if:

  • History of 2 doses of varicella vaccination;
  • Previous history of varicella or herpes zoster (not applicable to investigation of varicella antibody level);
  • History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
  • Suffering from acute disease or acute episode of chronic disease;
  • Any confirmed or suspected immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
  • Axillary temperature \>37.0°C;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 28 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Laian Center for Disease Control and Prevention

Chuzhou, Anhui, 239299, China

RECRUITING

Liandu District Center for Disease Control and Prevention

Lishui, Zhejiang, 323050, China

RECRUITING

Jiangshan Center for Disease Control and Prevention

Quzhou, Zhejiang, 324199, China

RECRUITING

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Hanqing He

    Zhejiang Provincial Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanqing He, Master

CONTACT

13819483847hanqinghe@cdc.zj.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 15, 2022

Study Start

July 30, 2022

Primary Completion

March 15, 2023

Study Completion

May 15, 2023

Last Updated

January 12, 2023

Record last verified: 2022-04

Locations

CN(3)