VaricellaPhase 1NCT02965404
A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
A Phase 1 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 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children. Read more about this study
- Who is it for?
- Ages 1 year to 49 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
- 270 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Aug 2016
- Phase
- Phase 1
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy volunteer between 1 - 49 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 infant 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;
- Breast feeding, pregnant, or expected to conceive during the period of this trial;
- 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;
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- 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;
- 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 of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity:
- Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
- Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
- Urine routine tests: urine protein, urine glucose, urine erythrocyte
- Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, 461700
About this study
Official title: A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children
The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.
Read the detailed description
This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.
- Conditions
- Varicella
- Being tested
- Investigational live attenuated varicella vaccine, control live attenuated varicella vaccine, diluent of lyophilized vaccine
- Keywords
- live attenuated varicella vaccine, safety, adult, adolescent, 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.
control live attenuated varicella vaccineBiological
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
diluent of lyophilized vaccineBiological
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology
| 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 |
| Positive Control Group | Active comparator | * Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
* Intervention: control live attenuated varicella vaccine. Receives: Biological: control live attenuated varicella vaccine |
| Negative 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 adverse events (AEs) of each group
AEs occurred within 30 days after injection will be collected.
Measured: 30 days
Secondary outcomes (2)
The incidences of abnormal results of lab tests
Cases of abnormal results of laboratory tests will be collected.
Measured: 30 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after injection will be collected.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionAug 2016
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
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
- NCT02965404
- Sponsor's protocol ID
- PRO-VZV-1001
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children
- ClinicalTrials.gov ID
- NCT02965404
- Acronym / sponsor ID
- PRO-VZV-1001
- Conditions
- Varicella
- Keywords
- live attenuated varicella vaccine, safety, adult, adolescent, child
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Nov 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 safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.
Detailed description
This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| 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. |
| Positive Control Group | Active comparator | Biological: control live attenuated varicella vaccine* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated varicella vaccine. |
| Negative 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 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy volunteer between 1 - 49 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 infant being included into this study;
Key exclusion criteria (18 listed)
- Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
- Axillaty temperature > 37.0 °C;
- Breast feeding, pregnant, or expected to conceive during the period of this trial;
- 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;
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 |
| control live attenuated varicella vaccineThe control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP) | Biological | Positive Control Group |
| diluent of lyophilized vaccineThe diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology | Biological | Negative Control Group |
Primary outcome
The incidences of adverse events (AEs) of each group
Time frame: 30 days
AEs occurred within 30 days after injection will be collected.
2 secondary outcomes
The incidences of abnormal results of lab tests
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group
Time frame: 30 days
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.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 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 18 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 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 adverse events (AEs) of each group (time frame: 30 days). 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 26 Oct 2017.