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Enrolling by Invitation

NCT Number: NCT05095701

An Immunity Persistence Study of Live Attenuated Varicella Vaccine

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.

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Key information

Conditions

Varicella Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xiangcheng County Center for Disease Control and Prevention, Xuchang, Henan, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational live attenuated varicella vaccine

Biological

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.

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.

Primary outcomes

  1. Immunogenicity index-seropositive rates of varicella antibody

    Time frame: 5 years after primary immunization

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

  2. Immunogenicity index-GMT of varicella antibody

    Time frame: 5 years after primary immunization

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

  3. Immunogenicity index-the seropositive rates of varicella antibody

    Time frame: 8 years after primary immunization

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

  4. Immunogenicity index-the GMT of varicella antibody

    Time frame: 8 years after primary immunization

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

Sponsors and collaborators

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2025
First posted
Oct 27, 2021
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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