VaricellaPhase 3NCT02981836
A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
A Phase 3 study testing Investigational live attenuated varicella vaccine and diluent of lyophilized vaccine in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Investigational live attenuated varicella vaccine and diluent of lyophilized vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,997 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2016to Sep 2017
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy volunteer between 1 - 12 years old;
- Proven legal identity;
- Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study;
Who cannot join
- Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
- Axillaty temperature > 37.0 °C;
- History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency;
- Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
- Acute disease or acute stage of chronic disease within 7 days prior to study entry;
Show all 12Show fewer
- Receipt of any of the following products:
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any live attenuated vaccine within 1 month prior to study entry;
- Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry;
- Any significant abnormity of heart, lung, skin, or pharynx;
- Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Trial locations and contacts
2 sites in 1 country.
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: A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
Read the detailed description
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.
- Conditions
- Varicella
- Being tested
- Investigational live attenuated varicella vaccine, diluent of lyophilized vaccine
- Keywords
- live attenuated varicella vaccine, protective effect, safety, immunogenicity, child
- 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 investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
diluent of lyophilized vaccineBiological
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | * Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
* Intervention: investigational live attenuated varicella vaccine; Receives: Biological: Investigational live attenuated varicella vaccine |
| Control Group | Sham comparator | * Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
* Intervention: diluent of lyophilized vaccine; Receives: Biological: diluent of lyophilized vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidences of varicella of each group
The first 30 cases of varicella occurred 30 days after injection will be collected.
Measured: ≥30 cases reported 30 days after injection
The protection rate of the vaccine
The protection rate will be calculated based on the reported cases occurred 30 days after injection.
Measured: ≥30 cases reported after 30 days of the injection
Secondary outcomes (5)
The incidences of adverse events (AEs) of each group
AEs occurred within 30 days after injection will be collected.
Measured: 30 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 6 months after injection will be collected.
Measured: 6 months
The seroconversion rate of the immunogenicity group
Seroconversion rate of the immonogenicity group 30 days after injection will be collected.
Measured: 30 days after injection
The geometric mean titer (GMT) of the immunogenicity group
Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.
Measured: 30 days
The geometric mean fold increase (GMI) of the immunogenicity group
Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.
Measured: 30 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 5,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shengli Xia, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981836
- Sponsor's protocol ID
- PRO-VZV-3001
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang Y, Wang L, Wang Y, Zhang W, Jia N, Xie Z, Huang L, You W, Lu W, Li E, Gao F, Hu Y, Meng F, Xia S. Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years. Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.
PubMed 35632416Hao B, Chen Z, Zeng G, Huang L, Luan C, Xie Z, Chen J, Bao M, Tian X, Xu B, Wang Y, Wu J, Xia S, Yuan L, Huang J. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019 Aug;25(8):1026-1031. doi: 10.1016/j.cmi.2018.12.033. Epub 2019 Jan 4.
PubMed 30616012
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children
- ClinicalTrials.gov ID
- NCT02981836
- Acronym / sponsor ID
- PRO-VZV-3001
- Conditions
- Varicella
- Keywords
- live attenuated varicella vaccine, protective effect, safety, immunogenicity, child
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,997 participants (actual)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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 purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
Detailed description
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Investigational live attenuated varicella vaccine* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated varicella vaccine; |
| Control Group | Sham comparator | Biological: diluent of lyophilized vaccine* Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; * Intervention: diluent of lyophilized vaccine; |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy volunteer between 1 - 12 years old;
- Proven legal identity;
- Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study;
Key exclusion criteria (12 listed)
- Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
- Axillaty temperature > 37.0 °C;
- History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency;
- Severe malnutrition, congenital malformation, developmental disorders, or serious chronic 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 |
|---|---|---|
| Investigational live attenuated varicella vaccineThe investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. | Biological | Experimental Group |
| diluent of lyophilized vaccineThe diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. | Biological | Control Group |
Primary outcome
The incidences of varicella of each group
Time frame: ≥30 cases reported 30 days after injection
The first 30 cases of varicella occurred 30 days after injection will be collected.
The protection rate of the vaccine
Time frame: ≥30 cases reported after 30 days of the injection
The protection rate will be calculated based on the reported cases occurred 30 days after injection.
5 secondary outcomes
The incidences of adverse events (AEs) of each group
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group
Time frame: 6 months
The seroconversion rate of the immunogenicity group
Time frame: 30 days after injection
The geometric mean titer (GMT) of the immunogenicity group
Time frame: 30 days
The geometric mean fold increase (GMI) of the immunogenicity group
Time frame: 30 days after injection
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 26 Oct 2017.
- Derived from this study: PubMed 35632416Zhang Y, Wang L, Wang Y, Zhang W, Jia N, Xie Z, Huang L, You W, Lu W, Li E, Gao F, Hu Y, Meng F, Xia S. Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years. Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.
- Derived from this study: PubMed 30616012Hao B, Chen Z, Zeng G, Huang L, Luan C, Xie Z, Chen J, Bao M, Tian X, Xu B, Wang Y, Wu J, Xia S, Yuan L, Huang J. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019 Aug;25(8):1026-1031. doi: 10.1016/j.cmi.2018.12.033. Epub 2019 Jan 4.
- 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.
Shengli Xia principal investigator
Henan Provincial Center for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Investigational live attenuated varicella vaccine and diluent of lyophilized 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 12 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 26 Oct 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The incidences of varicella of each group (time frame: ≥30 cases reported 30 days after injection). 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 NCT02981836, which also lists 2 linked publications.
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 26 Oct 2017.