VZVPhase 4NCT06994052
Study on Booster Immunization With Varicella Vaccine at Different Intervals
A Phase 4 study testing Varicella vaccine in people with VZV and Varicella Immunisation, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- VZV, Varicella Immunisation
- What is being tested?
- Varicella vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2024to 30 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: 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.
- Conditions
- VZV, Varicella Immunisation
- Being tested
- Varicella vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella vaccineBiological
lyophilized powder, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination. Receives: Biological: Varicella vaccine |
| Group B | Experimental | Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination. Receives: Biological: Varicella vaccine |
| Group C | Experimental | Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination. Receives: Biological: Varicella vaccine |
| Group D | Experimental | Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination. Receives: Biological: Varicella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies
GMT of VZV antibodies 30 days after booster dose immunization
Measured: 30 days after booster dose immunization
Secondary outcomes (3)
Seroconversion rate of varicella-zoster virus (VZV) antibodies
Seroconversion rate of VZV antibodies 30 days after booster dose immunization
Measured: 30 days after booster dose immunization
Seropositive rate of varicella-zoster virus (VZV) antibodies
Seropositive rate of VZV antibodies 30 days after booster dose immunization
Measured: 30 days after booster dose immunization
Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies
GMI of VZV antibodies 30 days after booster dose immunization
Measured: 30 days after booster dose immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start21 Sep 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VZVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994052
- Sponsor's protocol ID
- PRO-VAR-MA4004-JS-1
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06994052
- Acronym / sponsor ID
- PRO-VAR-MA4004-JS-1
- Conditions
- VZV, Varicella Immunisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Varicella vaccineParticipants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination. |
| Group B | Experimental | Biological: Varicella vaccineParticipants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination. |
| Group C | Experimental | Biological: Varicella vaccineParticipants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination. |
| Group D | Experimental | Biological: Varicella vaccineParticipants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varicella vaccinelyophilized powder, subcutaneous injection | Biological | Group A, Group B, Group C, Group D |
Primary outcome
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
3 secondary outcomes
Seroconversion rate of varicella-zoster virus (VZV) antibodies
Time frame: 30 days after booster dose immunization
Seropositive rate of varicella-zoster virus (VZV) antibodies
Time frame: 30 days after booster dose immunization
Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies
Time frame: 30 days after booster dose immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varicella vaccine in people with VZV and Varicella Immunisation, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies (time frame: 30 days after booster dose immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.