VaricellaPhase 4NCT05470855

Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Anhui Province

A Phase 4 study testing Live attenuated varicella vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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 protective effect of varicella vaccine in children aged 1-12 years and the correlation between varicella antibody and protective effect,to… Read more about this study

Who is it for?: Ages 1 year to 12 years
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: 45,400 participants
Where: 5 sitesChina
Study dates: 6 Jul 2022to 10 Feb 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 1 year to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

None listed.

Who cannot join

Received two doses of varicella vaccine from other manufacturers(applied to study 1 exclusion criteria);
Received two doses of varicella vaccine;
History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
Any confirmed or suspected immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
Axillary temperature >37.0°C;
Receipt of other investigational drugs in the past 30 days;

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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

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Susong County Center for Disease Control and Prevention
Anqing, Anhui, 246525
Laian Center for Disease Control and Prevention
Chuzhou, Anhui, 239299
Funan County Center for Disease Control and Prevention
Fuyang, Anhui, 236399
Huoqiu County Center for Disease Control and Prevention
Liu‘an, Anhui, 237483
Ningguo Center for Disease Control and Prevention
Xuancheng, Anhui, 242399

Other trials in China

About this study

Official title: A Clinical Trial to Evaluate Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Children Aged 1-12 Years

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 four parts,and A total of 45400 subjects will be enrolled.

Study 1,45000 subjects including 15000 subjects aged 1-3 years with no history of varicella vaccination ,15000 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,15000 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will be enrolled to evaluate protective effect of varicella vaccine. There will be 7500 subjects in the experimental group and 7500 in the control group in each age group.And subjects who voluntarily receive varicella vaccine will be included in the experimental group and other subjects will be included in the control group.All subjects in the experimental group will receive one dose of varicella vaccine.

Study 2,400 healthy children including 100 subjects aged 1-3 years with no history of varicella ,150 subjects aged 4-6 years(50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),150 subjects aged 7-12 years (50 children with no history of varicella vaccination and 100 children with a history of one dose of varicella vaccine),each subject will receive one or two doses (0,3 months) of varicella vaccine.

Study 3,30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.

Study 4,Herpes fluid collected from study 1 varicella cases will be used to conduct etiological study on the pathogenic strains of varicella cases.

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.

Study groups in NCT05470855
Study group	Role	What they receive
Experimental Group in Protective effect study	Experimental	22500 subjects including 7500 subjects aged 1-3 years with no history of varicella vaccination,7500 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,7500 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will receive one dose of varicella vaccine. Receives: Biological: Live attenuated varicella vaccine
Control Group in Protective effect study	No intervention	22500 subjects including 7500 subjects aged 1-3 years with no history of varicella vaccination,7500 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,7500 subjects aged 7-12 years with a history of 1 dose of varicella vaccine.
Safety group	Experimental	30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected. Receives: Biological: Live attenuated varicella vaccine
Etiological study group	Experimental	Herpes fluid collected from varicella cases in study 1 will be used to conduct etiological study on the pathogenic strains of varicella cases. Receives: Biological: Live attenuated varicella vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence density
The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
Measured: 42 days after vaccination
The protection rate
The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
Measured: 42 days after vaccination

Secondary outcomes (12)

GMT of varicella antibody
GMT of varicella antibody at 42 days after varicella vaccination.
Measured: 42 days after varicella vaccination
GMI of varicella antibody
GMI of varicella antibody at 42 days after varicella vaccination.
Measured: 42 days after varicella vaccination
Positive rates of varicella antibody
Positive rate of varicella antibody at 42 days after varicella vaccination.
Measured: 42 days after varicella vaccination
Immunogenicity index-GMT of varicella antibody
GMT of varicella antibody at 4 months after varicella vaccination.
Measured: 4 months after varicella vaccination
Immunogenicity index-GMI of varicella antibody
GMI of varicella antibody at 4 months after varicella vaccination.
Measured: 4 months after varicella vaccination
Immunogenicity index- positive rates
Positive rates of varicella antibody at 4 months after varicella vaccination.
Measured: 4 months after varicella vaccination
The incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions at 14 days after varicella vaccination.
Measured: 14 days after varicella vaccination
Incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions at 42 days after varicella vaccination.
Measured: 42 days after varicella vaccination.
Safety index-Incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 3 months after varicella vaccination.
Measured: 3 months after varicella vaccination
Safety index-incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 6 months after varicella vaccination.
Measured: 6 months after varicella vaccination
Safety index- incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 9 months after varicella vaccination.
Measured: 9 months after varicella vaccination
The incidence of adverse events, serious adverse events and adverse reactions
The incidence of adverse events, serious adverse events and adverse reactions in 12 months after varicella vaccination.
Measured: 12 months after varicella vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 202210 Feb 2023

First posted22 Jul 2022
Study start6 Jul 2022
Primary completion30 Nov 2022
Study completion10 Feb 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: 45,400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05470855
Sponsor's protocol ID: PRO-VAR-MA4003-AH
Status last verified: Jul 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Varicella trials

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: A Clinical Trial to Evaluate Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Children Aged 1-12 Years
ClinicalTrials.gov ID: NCT05470855
Acronym / sponsor ID: PRO-VAR-MA4003-AH
Conditions: Varicella
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 45,400 participants (estimated)
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Jul 2022 (actual)
Primary completion: 30 Nov 2022 (actual)
Study completion: 10 Feb 2023 (estimated)
First posted: 22 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.

Detailed description

Study 3,30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.

Study 4,Herpes fluid collected from study 1 varicella cases will be used to conduct etiological study on the pathogenic strains of varicella cases.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Experimental Group in Protective effect study	Experimental	Biological: Live attenuated varicella vaccine22500 subjects including 7500 subjects aged 1-3 years with no history of varicella vaccination,7500 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,7500 subjects aged 7-12 years with a history of 1 dose of varicella vaccine will receive one dose of varicella vaccine.
Control Group in Protective effect study	No intervention	–22500 subjects including 7500 subjects aged 1-3 years with no history of varicella vaccination,7500 subjects aged 4-6 years with a history of 1 dose of varicella vaccine,7500 subjects aged 7-12 years with a history of 1 dose of varicella vaccine.
Safety group	Experimental	Biological: Live attenuated varicella vaccine30000 subjects from study 1 will be enrolled to conduct safety observation study,all adverse events of all subjects will be collected.
Etiological study group	Experimental	Biological: Live attenuated varicella vaccineHerpes fluid collected from varicella cases in study 1 will be used to conduct etiological study on the pathogenic strains of varicella cases.

Who may qualify

Ages: 1 year to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

Received two doses of varicella vaccine from other manufacturers(applied to study 1 exclusion criteria);
Received two doses of varicella vaccine;
History of severe allergic reactions to vaccines (e.g.acute anaphylaxis, angioneurotic edema, dyspnea, etc.);
Any confirmed or suspected immunodeficiency disease, including human immunodeficiency virus (HIV) infection;
Axillary temperature >37.0°C;

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.	Biological	Etiological study group, Experimental Group in Protective effect study, Safety group

Primary outcome

The incidence density
Time frame: 42 days after vaccination
The incidence density will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.
The protection rate
Time frame: 42 days after vaccination
The protection rate will be calculated by the number of confirmed cases of varicella at 42 days after vaccination.

12 secondary outcomes

GMT of varicella antibody
Time frame: 42 days after varicella vaccination
GMI of varicella antibody
Time frame: 42 days after varicella vaccination
Positive rates of varicella antibody
Time frame: 42 days after varicella vaccination
Immunogenicity index-GMT of varicella antibody
Time frame: 4 months after varicella vaccination
Immunogenicity index-GMI of varicella antibody
Time frame: 4 months after varicella vaccination
Immunogenicity index- positive rates
Time frame: 4 months after varicella vaccination
The incidence of adverse events, serious adverse events and adverse reactions
Time frame: 14 days after varicella vaccination
Incidence of adverse events, serious adverse events and adverse reactions
Time frame: 42 days after varicella vaccination.
Safety index-Incidence of adverse events, serious adverse events and adverse reactions
Time frame: 3 months after varicella vaccination
Safety index-incidence of adverse events, serious adverse events and adverse reactions
Time frame: 6 months after varicella vaccination
Safety index- incidence of adverse events, serious adverse events and adverse reactions
Time frame: 9 months after varicella vaccination
The incidence of adverse events, serious adverse events and adverse reactions
Time frame: 12 months after varicella 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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Active, not recruitingPhase 2
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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.

Jihai Tang, Master principal investigator

Anhui Provincial Center for Disease Prevention and Control

5 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 5 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 9 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 5 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?

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?

The incidence density (time frame: 42 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?

On the ClinicalTrials.gov record for NCT05470855.

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.