Study on Booster Immunization With Varicella Vaccine at Different Intervals

May 20, 2025 updated by: Sinovac (Dalian) Vaccine Technology Co., Ltd.

A Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Immunization With Varicella Vaccine at Different Intervals Among Children Aged 7-12 Years

The goal of this clinical trial is to evaluate the immunogenicity and safety of booster immunization of varicella live attenuated vaccine (varicella vaccine hereafter) at different intervals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy children aged 7-12 years;
  • Has previously received a single dose of varicella vaccine, with at least 3 months since the first dose;
  • The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old);
  • Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures;
  • Provide legal identity proof;

Exclusion Criteria:

  • History of varicella;
  • History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.);
  • Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease;
  • With any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy);
  • With a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases;
  • With encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of Guillain-Barre syndrome;
  • Body temperature >37℃ at the time of vaccination;
  • Receipt of blood products within 3 months before receiving investigational vaccine;
  • Receipt of another study drug within 30 days before receipt of the investigational vaccine;
  • Receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine;
  • Receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine;
  • Participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months;
  • The participant had any other factors that were ineligible for vaccination by in the investigator's judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination.
Biological: Varicella vaccine
lyophilized powder, subcutaneous injection
Experimental: Group B
Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination.
Biological: Varicella vaccine
lyophilized powder, subcutaneous injection
Experimental: Group C
Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination.
Biological: Varicella vaccine
lyophilized powder, subcutaneous injection
Experimental: Group D
Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.
Biological: Varicella vaccine
lyophilized powder, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies
Time Frame: 30 days after booster dose immunization
GMT of VZV antibodies 30 days after booster dose immunization
30 days after booster dose immunization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seroconversion rate of varicella-zoster virus (VZV) antibodies
Time Frame: 30 days after booster dose immunization
Seroconversion rate of VZV antibodies 30 days after booster dose immunization
30 days after booster dose immunization
Seropositive rate of varicella-zoster virus (VZV) antibodies
Time Frame: 30 days after booster dose immunization
Seropositive rate of VZV antibodies 30 days after booster dose immunization
30 days after booster dose immunization
Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies
Time Frame: 30 days after booster dose immunization
GMI of VZV antibodies 30 days after booster dose immunization
30 days after booster dose immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-VAR-MA4004-JS-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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