VaricellaPhase 4NCT05095701
An Immunity Persistence Study of Live Attenuated Varicella Vaccine
A Phase 4 study testing Investigational Live Attenuated Varicella Vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 2 sites in China.
Trial summary
This an open phase Ⅳ clinical trial of live attenuated varicella vaccines 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 5 and 8 years after primary immunization with live attenuated varicella… Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Investigational Live Attenuated Varicella Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 703 participants
- Where
- 2 sitesChina
- Study dates
- 18 Dec 2021to 1 Oct 2025
- 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 1 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine;
- The subject and/or guardian can understand and voluntarily sign the informed consent form;
- Proven legal identity.
Who cannot join
- History of chickenpox or shingles;
- History of varicella vaccination since phase Ⅲ clinical trial;
- Autoimmune disease or immunodeficiency / immunosuppression;
- History of immunosuppressive therapy 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, 461700
Biyang County Center for Disease Control and Prevention
Zhumadian, Henan, 463700
About this study
Official title: An Open Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 5 and 8 Years After Primary Immunization with Live Attenuated Varicella Vaccine
This an open phase Ⅳ clinical trial of live attenuated varicella vaccines 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 5 and 8 years after primary immunization with live attenuated varicella vaccine.
Read the detailed description
This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.
- Conditions
- Varicella
- Being tested
- Investigational Live Attenuated Varicella Vaccine, Placebo (Freeze Dired Dilution)
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Live Attenuated Varicella VaccineBiological
The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.
Placebo (Freeze Dired Dilution)Biological
The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization. Receives: Biological: Investigational Live Attenuated Varicella Vaccine |
| Control Group | Placebo comparator | 354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization. Receives: Biological: Placebo (Freeze Dired Dilution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity index-seropositive rates of varicella antibody
The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine
Measured: 5 years after primary immunization
Immunogenicity index-GMT of varicella antibody
GMT of varicella antibody in 5 years after primary immunization with varicella vaccine
Measured: 5 years after primary immunization
Immunogenicity index-the seropositive rates of varicella antibody
The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine
Measured: 8 years after primary immunization
Immunogenicity index-the GMT of varicella antibody
GMT of varicella antibody in 8 years after primary immunization with varicella
Measured: 8 years after primary immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start18 Dec 2021
- Primary completion19 Dec 2021
- Study completion1 Oct 2025 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 703 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, Bachelor, Principal investigator, Henan Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095701
- Sponsor's protocol ID
- PRO-VZV-4004
- Status last verified
- Jan 2025
- First submitted
- 14 Oct 2021
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 5 and 8 Years After Primary Immunization with Live Attenuated Varicella Vaccine
- ClinicalTrials.gov ID
- NCT05095701
- Acronym / sponsor ID
- PRO-VZV-4004
- Conditions
- Varicella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 703 participants (estimated)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 Oct 2021 (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 phase Ⅳ clinical trial of live attenuated varicella vaccines 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 5 and 8 years after primary immunization with live attenuated varicella vaccine.
Detailed description
This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Investigational Live Attenuated Varicella Vaccine349 subjects who enrolled in the experimental group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization. |
| Control Group | Placebo comparator | Biological: Placebo (Freeze Dired Dilution)354 subjects who enrolled in the control group of clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 will be collected venous blood 3.0~3.5ml at 5 and 8 years after primary immunization. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine;
- The subject and/or guardian can understand and voluntarily sign the informed consent form;
- Proven legal identity.
Key exclusion criteria (5 listed)
- History of chickenpox or shingles;
- History of varicella vaccination since phase Ⅲ clinical trial;
- Autoimmune disease or immunodeficiency / immunosuppression;
- History of immunosuppressive therapy 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 |
|---|---|---|
| Investigational Live Attenuated Varicella VaccineThe live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection. | Biological | Experimental Group |
| Placebo (Freeze Dired Dilution)The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate. | Biological | Control Group |
Primary outcome
Immunogenicity index-seropositive rates of varicella antibody
Time frame: 5 years after primary immunization
The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine
Immunogenicity index-GMT of varicella antibody
Time frame: 5 years after primary immunization
GMT of varicella antibody in 5 years after primary immunization with varicella vaccine
Immunogenicity index-the seropositive rates of varicella antibody
Time frame: 8 years after primary immunization
The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine
Immunogenicity index-the GMT of varicella antibody
Time frame: 8 years after primary immunization
GMT of varicella antibody in 8 years after primary immunization with varicella
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.
Related trials for Varicella
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
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, Bachelor principal investigator
Henan Provincial Center for Disease Prevention and Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Investigational Live Attenuated Varicella Vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 2 sites 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 5 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 2 sites 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. Some participants in this study may receive a placebo. 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?
Immunogenicity index-seropositive rates of varicella antibody (time frame: 5 years after primary immunization). 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.