VaricellaPhase 4NCT06484686
An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine
A Phase 4 study testing Live Attenuated Varicella Vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Live Attenuated Varicella Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2024to Dec 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Henan Provincial Center for Disease Control and Prevention
Zhengzhou, Henan, 450016
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Varicella
- Being tested
- Live Attenuated Varicella Vaccine
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Varicella VaccineBiological
lyophilized powder, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Subjects will be collected venous blood at 6 and 10 years after booster immunization. Receives: Biological: Live Attenuated Varicella Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositive rate
The seropositive rate of varicella-zoster virus (VZV) antibodies at 6 years after booster vaccination
Measured: at 6 years after booster vaccination
Seropositive rate
The seropositive rate of VZV antibodies at 10 years after booster vaccination
Measured: at 10 years after booster vaccination
GMT of VZV antibody
The GMT of VZV antibodies at 6 years after booster vaccination
Measured: at 6 years after booster vaccination
GMT of VZV antibody
The GMT of VZV antibodies at 10 years after booster vaccination
Measured: at 10 years after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start16 Sep 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lili Huang, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484686
- Sponsor's protocol ID
- PRO-VZV-4005
- Status last verified
- Jan 2025
- First submitted
- 26 Jun 2024
- Last updated
- 27 Jan 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06484686
- Acronym / sponsor ID
- PRO-VZV-4005
- Conditions
- Varicella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 3 Jul 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Live Attenuated Varicella VaccineSubjects will be collected venous blood at 6 and 10 years after booster immunization. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Live Attenuated Varicella Vaccinelyophilized powder, subcutaneous injection | Biological | Experimental Group |
Primary outcome
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
Seropositive rate
Time frame: at 10 years after booster vaccination
The seropositive rate of VZV antibodies at 10 years after booster vaccination
GMT of VZV antibody
Time frame: at 6 years after booster vaccination
The GMT of VZV antibodies at 6 years after booster vaccination
GMT of VZV antibody
Time frame: at 10 years after booster vaccination
The GMT of VZV antibodies at 10 years after booster vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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.
Lili Huang principal investigator
Henan Provincial Center for Disease Control and Prevention
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 Live Attenuated Varicella Vaccine in people with Varicella, 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 27 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
Seropositive rate (time frame: at 6 years after booster vaccination). The study lists 4 primary outcomes in all. 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 27 Jan 2025.