NCT05095701

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
703

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2021

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

October 14, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 18, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2021

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

1 day

First QC Date

October 14, 2021

Last Update Submit

January 23, 2025

Conditions

Varicella

Outcome Measures

Primary Outcomes (4)

  • Immunogenicity index-seropositive rates of varicella antibody

    The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine

    5 years after primary immunization

  • Immunogenicity index-GMT of varicella antibody

    GMT of varicella antibody in 5 years after primary immunization with varicella vaccine

    5 years after primary immunization

  • Immunogenicity index-the seropositive rates of varicella antibody

    The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine

    8 years after primary immunization

  • Immunogenicity index-the GMT of varicella antibody

    GMT of varicella antibody in 8 years after primary immunization with varicella

    8 years after primary immunization

Study Arms (2)

Experimental Group

EXPERIMENTAL

349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0\~3.5ml at 5 and 8 years after primary immunization.

Biological: Investigational Live Attenuated Varicella Vaccine

Control Group

PLACEBO COMPARATOR

354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0\~3.5ml at 5 and 8 years after primary immunization.

Biological: Placebo (Freeze Dired Dilution)

Interventions

Investigational 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.

Experimental Group
Placebo (Freeze Dired Dilution)BIOLOGICAL

The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.

Control Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xiangcheng County Center for Disease Control and Prevention

Xuchang, Henan, 461700, China

Location

Biyang County Center for Disease Control and Prevention

Zhumadian, Henan, 463700, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Lili Huang, Bachelor

    Henan 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

October 14, 2021

First Posted

October 27, 2021

Study Start

December 18, 2021

Primary Completion

December 19, 2021

Study Completion

October 1, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

CN(2)