Menu
Enrolling by invitation NCT05095701

An Immunity Persistence Study of Live Attenuated Varicella Vaccine

Phase IV Interventional Varicella

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Investigational Live Attenuated Varicella Vaccine, Placebo (Freeze Dired Dilution).
Who it may be relevant to
Registry conditions: Varicella. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological Investigational Live Attenuated Varicella Vaccine
    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.
  • Biological Placebo (Freeze Dired Dilution)
    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.

Primary outcome measures

  • Immunogenicity index-seropositive rates of varicella antibody [Time frame: 5 years after primary immunization]
  • Immunogenicity index-GMT of varicella antibody [Time frame: 5 years after primary immunization]
  • Immunogenicity index-the seropositive rates of varicella antibody [Time frame: 8 years after primary immunization]
  • Immunogenicity index-the GMT of varicella antibody [Time frame: 8 years after primary immunization]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 2 centers
  • Xiangcheng County Center for Disease Control and Prevention — Xuchang
  • Biyang County Center for Disease Control and Prevention — Zhumadian

Identifiers

NCT: NCT05095701 · PRO-VZV-4004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗