VaricellaPhase 4NCT05460429
Immunogenicity, Safety and Protective Effect of Live Attenuated Varicella Vaccine and Study on Antibody Level and Etiology of Varicella Zoster Virus
A Phase 4 study testing Live attenuated varicella vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 3 sites in China.
Trial summary
This is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization… Read more about this study
- Who is it for?
- Ages Up to 59 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
- 37,920 participants
- Where
- 3 sitesChina
- Study dates
- 30 Jul 2022to 15 May 2023
- 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 Up to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- History of 2 doses of varicella vaccination;
- Previous history of varicella or herpes zoster (not applicable to investigation of varicella antibody level);
- History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
- Suffering from acute disease or acute episode of chronic disease;
- Any confirmed or suspected immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
- Axillary temperature >37.0°C;
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- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 28 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- 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
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Laian Center for Disease Control and Prevention
Chuzhou, Anhui, 239299
Haiyan Wu, Bachelor, 18805505218, 2544285048@qq.com
- Recruiting
Liandu District Center for Disease Control and Prevention
Lishui, Zhejiang, 323050
Juqing Xu, Bachelor, 0578-2025951, 1026123729@qq.com
- Recruiting
Jiangshan Center for Disease Control and Prevention
Quzhou, Zhejiang, 324199
Huishu Mao, Bachelor, 13857027530, 1690894042@qq.com
About this study
Official title: An Open Clinical Trial to Evaluate Immunogenicity,Safety and Protective Effect of Live Attenuated Varicella Vaccine and a Clinical Trial on Antibody Level and Etiology of Varicella Zoster Virus in Zhejiang Province
This is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.
Read the detailed description
This study is Phase Ⅳ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of five parts,and A total of 37920 subjects will be enrolled.
Study 1,360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination ,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine.
Study 2,2530 subjects aged 0-59 years old will be enrolled and will be collected venous blood to detect varicella antibody and conduct investigation of varicella antibody level in healthy people.
Study 3,30000 subjects aged 1-12 years old will be enrolled to conduct safety observation study.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected.
Study 4,5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure.
Study 5,30 subjects aged 1-12 years old will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella.
- 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
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.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm. And the immunization schedule is one dose of live attenuated varicella vaccine on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Immunogenicity and safety group | Experimental | 360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine. Receives: Biological: Live attenuated varicella vaccine |
| Antibody level investigation study group | Experimental | Immunization levels will be monitored among 2530 subjects aged 0-59 years old and will be collected venous blood to detect varicella antibody. Receives: Biological: Live attenuated varicella vaccine |
| Safety group | Experimental | 30000 subjects aged 1-12 years old will be enrolled to conduct safety observation of mass vaccination of varicella vaccine.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected. Receives: Biological: Live attenuated varicella vaccine |
| Protective effect group | Experimental | 5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure. Receives: Biological: Live attenuated varicella vaccine |
| Etiology Group | Experimental | 30 varicella cases aged 1-12 years old from study 4 will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella. Receives: Biological: Live attenuated varicella vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT of varicella antibody in children aged 1-6 years
GMT of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Measured: 30 days after vaccination
GMT of varicella antibody in healthy people aged 0-59 years
GMT of varicella antibody at 30 days after vaccination in different age groups of healthy people aged 0-59 years.
Measured: 30 days after vaccination
Secondary outcomes (9)
Seroconversion rates of varicella antibody in children aged 1-6 years
Seroconversion rates of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Measured: 30 days after vaccination
GMI of varicella antibody in children aged 1-6 years
GMI of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Measured: 30 days after vaccination
Incidence of adverse reactions at 24 hours after vaccination
Incidence of adverse reactions at 24 hours after vaccination of varicella vaccine in children aged 1-6 years
Measured: 24 hours after vaccination
Incidence of adverse reactions at 3 days after vaccination
Incidence of adverse reactions at 3 days after vaccination of varicella vaccine in children aged 1-6 years
Measured: 3 days after vaccination
Incidence of adverse reactions at 14 days after vaccination
Incidence of adverse reactions at 14 days after vaccination of varicella vaccine in children aged 1-6 years.
Measured: 14 days after vaccination
Incidence of adverse reactions at 30 days after vaccination
Incidence of adverse reactions at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
Measured: 30 days after vaccination
Incidence of adverse reactions at 14 days after mass vaccination
Incidence of adverse reactions at 14 days after mass vaccination of varicella vaccine in children aged 1-12 years
Measured: 14 days after mass vaccination
Incidence of adverse reactions at 30 days after mass vaccination
Incidence of adverse reactions at 30 days after mass vaccination of varicella vaccine in children aged 1-12 years
Measured: 30 days after mass vaccination
seropositive rates of varicella antibody
Seropositive rates of varicella antibody at 30 days after vaccination in all age groups of healthy people.
Measured: 30 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start30 Jul 2022
- Primary completion15 Mar 2023 (estimated)
- Study completion15 May 2023 (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
- 37,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanqing He, Principal investigator, Zhejiang Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460429
- Sponsor's protocol ID
- PRO-VAR-MA4002-ZJ
- Status last verified
- Apr 2022
- First submitted
- 12 Jul 2022
- Last updated
- 12 Jan 2023
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Trial to Evaluate Immunogenicity,Safety and Protective Effect of Live Attenuated Varicella Vaccine and a Clinical Trial on Antibody Level and Etiology of Varicella Zoster Virus in Zhejiang Province
- ClinicalTrials.gov ID
- NCT05460429
- Acronym / sponsor ID
- PRO-VAR-MA4002-ZJ
- Conditions
- Varicella
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37,920 participants (estimated)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 15 Jul 2022 (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 is Phase 4 clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity and safety of a single dose of varicella vaccine in healthy children aged 1-6 years with different varicella immunization histories, to evaluate the antibody level of varicella-zoster virus in healthy people aged 0-59 years in Zhejiang Province.
Detailed description
This study is Phase Ⅳ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.This clinical trial consists of five parts,and A total of 37920 subjects will be enrolled.
Study 1,360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination ,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine.
Study 2,2530 subjects aged 0-59 years old will be enrolled and will be collected venous blood to detect varicella antibody and conduct investigation of varicella antibody level in healthy people.
Study 3,30000 subjects aged 1-12 years old will be enrolled to conduct safety observation study.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected.
Study 4,5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure.
Study 5,30 subjects aged 1-12 years old will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Immunogenicity and safety group | Experimental | Biological: Live attenuated varicella vaccine360 subjects including 120 subjects aged 1-3 years with no history of varicella vaccination,240 subjects aged 4-6 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate the immunogenicity and safety of varicella vaccine.All subjects will receive one dose of varicella vaccine. |
| Antibody level investigation study group | Experimental | Biological: Live attenuated varicella vaccineImmunization levels will be monitored among 2530 subjects aged 0-59 years old and will be collected venous blood to detect varicella antibody. |
| Safety group | Experimental | Biological: Live attenuated varicella vaccine30000 subjects aged 1-12 years old will be enrolled to conduct safety observation of mass vaccination of varicella vaccine.All subjects will receive one dose of varicella vaccine and all adverse events of all subjects will be collected. |
| Protective effect group | Experimental | Biological: Live attenuated varicella vaccine5000 subjects aged 1-12 years old will be enrolled to conduct protective effect study of varicella vaccine after exposure. |
| Etiology Group | Experimental | Biological: Live attenuated varicella vaccine30 varicella cases aged 1-12 years old from study 4 will be enrolled. Herpes fluid or pharyngeal swab samples of subjects will be collected to study the pathogenicity of varicella. |
Who may qualify
- Ages
- Up to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- History of 2 doses of varicella vaccination;
- Previous history of varicella or herpes zoster (not applicable to investigation of varicella antibody level);
- History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
- Suffering from acute disease or acute episode of chronic disease;
- Any confirmed or suspected immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
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 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.The routine of administration is intramuscular injection into deltoid region of the lateral upper arm. And the immunization schedule is one dose of live attenuated varicella vaccine on day 0. | Biological | Antibody level investigation study group, Etiology Group, Immunogenicity and safety group, Protective effect group, Safety group |
Primary outcome
GMT of varicella antibody in children aged 1-6 years
Time frame: 30 days after vaccination
GMT of varicella antibody at 30 days after vaccination of varicella vaccine in children aged 1-6 years.
GMT of varicella antibody in healthy people aged 0-59 years
Time frame: 30 days after vaccination
GMT of varicella antibody at 30 days after vaccination in different age groups of healthy people aged 0-59 years.
9 secondary outcomes
Seroconversion rates of varicella antibody in children aged 1-6 years
Time frame: 30 days after vaccination
GMI of varicella antibody in children aged 1-6 years
Time frame: 30 days after vaccination
Incidence of adverse reactions at 24 hours after vaccination
Time frame: 24 hours after vaccination
Incidence of adverse reactions at 3 days after vaccination
Time frame: 3 days after vaccination
Incidence of adverse reactions at 14 days after vaccination
Time frame: 14 days after vaccination
Incidence of adverse reactions at 30 days after vaccination
Time frame: 30 days after vaccination
Incidence of adverse reactions at 14 days after mass vaccination
Time frame: 14 days after mass vaccination
Incidence of adverse reactions at 30 days after mass vaccination
Time frame: 30 days after mass vaccination
seropositive rates of varicella antibody
Time frame: 30 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
Hanqing He principal investigator
Zhejiang Provincial Center for Disease Prevention and Control
3 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 Live attenuated varicella vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 3 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 0 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanqing He, Master (13819483847, hanqinghe@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMT of varicella antibody in children aged 1-6 years (time frame: 30 days after vaccination). The study lists 2 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 12 Jan 2023.