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Enrolling by Invitation

NCT Number: NCT06484686

An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine

This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine 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 6 and 10 years after booster dose.

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Key information

Conditions

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

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Henan Provincial Center for Disease Control and Prevention

Zhengzhou, Henan, 450016, China

About this study

A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled. About 3.0ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects in PPS of previous phase Ⅲ clinical trial of varicella vaccine;
  • The subjects and/or guardian can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Exclusion criteria

  • Beyond the blood collection window period;
  • History of varicella or shingles;
  • History of varicella vaccination 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

Live Attenuated Varicella Vaccine

Biological

lyophilized powder, subcutaneous injection

Primary outcomes

  1. Seropositive rate

    Time frame: at 6 years after booster vaccination

    The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination

  2. Seropositive rate

    Time frame: at 10 years after booster vaccination

    The seropositive rate of VZV antibodies at 10 years after booster vaccination

  3. GMT of VZV antibody

    Time frame: at 6 years after booster vaccination

    The GMT of VZV antibodies at 6 years after booster vaccination

  4. GMT of VZV antibody

    Time frame: at 10 years after booster vaccination

    The GMT of VZV antibodies at 10 years after booster vaccination

Sponsors and collaborators

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Industry

Registry information

Official study title

An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 6 and 10 Years After Booster Dose Immunization with Live Attenuated Varicella Vaccine

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Jul 3, 2024
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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