NCT05150392

Brief Summary

This is an open-labelled 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 the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,193

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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 11, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

November 22, 2021

Last Update Submit

December 8, 2021

Conditions

Varicella

Outcome Measures

Primary Outcomes (5)

  • Immunogenicity index-seroconversion rate of antibody

    seroconversion rates of antibody 1 year after primary immunization

    1 year after primary immunization

  • Immunogenicity index-seroconversion rate of antibody

    seroconversion rates of antibody 2 years after primary immunization

    2 years after primary immunization

  • Immunogenicity index-seroconversion rate of antibody

    seroconversion rates of antibody 3 years after primary immunization

    3 years after primary immunization

  • Immunogenicity index-Seroconversion rate of antibody

    Seroconversion rate of the neutralizing antibody 30 days after booster immunization

    30 days after booster immunization

  • Immunogenicity index-seropositivity rate of antibody

    Seropositivity rate of antibody 30 days after booster immunization

    30 days after booster immunization

Secondary Outcomes (7)

  • Immunogenicity index-Seropositivity rate of antibody

    Before the booster dose immunization

  • Immunogenicity index-GMT of the antibody

    Before the booster dose immunization

  • Immunogenicity index- GMT of the antibody

    30 days after booster immunization

  • Immunogenicity index- GMI of the antibody

    30 days after booster immunization

  • Safety index-Incidence of solicited local or systemic AE

    within 14 days after vaccination

  • +2 more secondary outcomes

Study Arms (3)

Booster immunization 1 year after primary immunization

EXPERIMENTAL

Subjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization.

Biological: Investigational live attenuated varicella vaccine

Booster immunization 2 year after primary immunization

EXPERIMENTAL

Subjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization.

Biological: Investigational live attenuated varicella vaccine

Booster immunization 3 year after primary immunization

EXPERIMENTAL

Subjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization.

Biological: Investigational live attenuated varicella vaccine

Interventions

Investigational live attenuated varicella vaccineBIOLOGICAL

The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection

Booster immunization 1 year after primary immunizationBooster immunization 2 year after primary immunizationBooster immunization 3 year after primary immunization

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Received one dose live attenuated varicella vaccine in the phase Ⅲ lot-consistency clinical trial;
  • Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

You may not qualify if:

  • Received one dose live attenuated varicella vaccine at the end of the phase Ⅲ lot-consistency clinical trial;
  • 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 (1)

Xiangfu County Center for Disease Control and Prevention

Kaifeng, Henan, 461700, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Shengli Xia, Master

    Henan Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 9, 2021

Study Start

July 11, 2018

Primary Completion

August 11, 2018

Study Completion

August 14, 2020

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations

CN(1)