NCT05470855

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 protective effect of varicella vaccine in children aged 1-12 years and the correlation between varicella antibody and protective effect,to evaluate the immunogenicity and safety of varicella vaccine in children aged 1-12 years.

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
45,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

5 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
Last Updated

January 12, 2023

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 12, 2022

Last Update Submit

January 11, 2023

Conditions

Varicella

Outcome Measures

Primary Outcomes (2)

  • The incidence density

    The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.

    42 days after vaccination

  • The protection rate

    The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.

    42 days after vaccination

Secondary Outcomes (12)

  • GMT of varicella antibody

    42 days after varicella vaccination

  • GMI of varicella antibody

    42 days after varicella vaccination

  • Positive rates of varicella antibody

    42 days after varicella vaccination

  • Immunogenicity index-GMT of varicella antibody

    4 months after varicella vaccination

  • Immunogenicity index-GMI of varicella antibody

    4 months after varicella vaccination

  • +7 more secondary outcomes

Study Arms (4)

Experimental Group in Protective effect study

EXPERIMENTAL

22500 subjects including 7500 subjects aged 1-3 years with no history of varicella vaccination,7500 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,7500 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will receive one dose of varicella vaccine.

Biological: Live attenuated varicella vaccine

Control Group in Protective effect study

NO INTERVENTION

22500 subjects including 7500 subjects aged 1-3 years with no history of varicella vaccination,7500 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,7500 subjects aged 7-12 years with a history of 1 dose of varicella vaccine.

Safety group

EXPERIMENTAL

30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.

Biological: Live attenuated varicella vaccine

Etiological study group

EXPERIMENTAL

Herpes fluid collected from varicella cases in study 1 will be used to conduct etiological study on the pathogenic strains of varicella cases.

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.

Etiological study groupExperimental Group in Protective effect studySafety group

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children aged 1-12 years without a history of varicella;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8 years and above, both subjects and guardians need to sign the informed consent form);
  • Healthy children aged 1-12 years without a history of varicella;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8 years and above, both subjects and guardians need to sign the informed consent form);
  • The subjects and their guardians voluntarily participate in the study and are able to follow all study procedures;
  • Proven legal identity.
  • Healthy children aged 1-12 years without a history of varicella;
  • The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8 years and above, both subjects and guardians need to sign the informed consent form);
  • The subjects and their guardians voluntarily participate in the study and are able to follow all study procedures;
  • Proven legal identity;
  • Subjects'guardians can fill in adverse events using mobile apps;
  • Varicella cases among study 1 enrolled subjects who signed informed consent for biological samples collection.

You may not qualify if:

  • Received two doses of varicella vaccine;
  • History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
  • 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 (5)

Susong County Center for Disease Control and Prevention

Anqing, Anhui, 246525, China

Location

Laian Center for Disease Control and Prevention

Chuzhou, Anhui, 239299, China

Location

Funan County Center for Disease Control and Prevention

Fuyang, Anhui, 236399, China

Location

Huoqiu County Center for Disease Control and Prevention

Liu‘an, Anhui, 237483, China

Location

Ningguo Center for Disease Control and Prevention

Xuancheng, Anhui, 242399, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Jihai Tang, Master

    Anhui Provincial Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

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 22, 2022

Study Start

July 6, 2022

Primary Completion

November 30, 2022

Study Completion

February 10, 2023

Last Updated

January 12, 2023

Record last verified: 2022-07

Locations

CN(5)