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CompletedNCT06994052Updated May 29, 2025

Study on Booster Immunization With Varicella Vaccine at Different Intervals

A Phase 4 interventional study of Varicella vaccine in VZV and Varicella Immunisation, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2024, registered May 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
412
Allocation
Non-randomized
Ages
7 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • VZV
  • Varicella Immunisation

Browse trials for

03

In context

Chickenpox

180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.

This study's enrollment of 412 is below the median of 475 across 149 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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, or receiving immunosuppressive therapy (including systemic 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 vaccine;
  • Receipt of another study drug within 30 days before receipt of the investigational vaccine;
  • Receipt of 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
412 participants (actual)

Study arms

  • Experimental
    Group A

    Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination.

    Biological: Varicella vaccine

  • Experimental
    Group B

    Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination.

    Biological: Varicella vaccine

  • Experimental
    Group C

    Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination.

    Biological: Varicella vaccine

  • Experimental
    Group D

    Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.

    Biological: Varicella vaccine

Interventions

06

What researchers measure

Primary outcomes

  1. Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies

    GMT of VZV antibodies 30 days after booster dose immunization

    Time frame: 30 days after booster dose immunization

Secondary outcomes

  1. Seroconversion rate of varicella-zoster virus (VZV) antibodies

    Seroconversion rate of VZV antibodies 30 days after booster dose immunization

    Time frame: 30 days after booster dose immunization

  2. Seropositive rate of varicella-zoster virus (VZV) antibodies

    Seropositive rate of VZV antibodies 30 days after booster dose immunization

    Time frame: 30 days after booster dose immunization

  3. Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies

    GMI of VZV antibodies 30 days after booster dose immunization

    Time frame: 30 days after booster dose immunization

07

Study locations

1 site
  • Jiangsu Provincial Center for Disease control and Prevention
    Nanjing, Jiangsu 210009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06994052
Responsible party
Sponsor
First posted
May 29, 2025
Start date
Sep 21, 2024
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024
Last update
May 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Chickenpox Vaccine

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