VaricellaPhase 3NCT03555071
A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine
A Phase 3 study testing Vaccine manufactured at commercialized scale and Vaccine manufactured at trial-scale in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd..
Trial summary
The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Vaccine manufactured at commercialized scale and Vaccine manufactured at trial-scale
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,197 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2014to 14 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 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy volunteer between 1-3 years old;
- legal identity;
- Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.
Who cannot join
- Prior vaccination with varicella vaccine or with history of varicella infection;
- Axillaty temperature > 37.0 °C before vaccination;
- 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;
- Epilepsy (except febrile seizures), history of seizures or convulsions, 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;
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- Receipt of any blood product, immunosuppressant, hormone, other investigational medicine(s) within 30 days prior to study entry;
- Receipt of any live attenuated vaccine within 1 month prior to study entry, or receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
- Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded.
About this study
Official title: A Double-blind, Randomized, Bridging Clinical Trial to Evaluate the Consistency, Immunogenicity and Safety of Live Attenuated Varicella Vaccines for Children
The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.
Read the detailed description
The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .
- Conditions
- Varicella
- Being tested
- Vaccine manufactured at commercialized scale, Vaccine manufactured at trial-scale
- Keywords
- live attenuated varicella vaccine, consistency, immunogenicity, safety, children
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine manufactured at commercialized scaleBiological
Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
Vaccine manufactured at trial-scaleBiological
Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group1 | Experimental | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale.
Intervention: Live attenuated varicella vaccine manufactured at commercialized scale Receives: Biological: Vaccine manufactured at commercialized scale |
| Experimental Group2 | Experimental | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale.
Intervention: Live attenuated varicella vaccine manufactured at commercialized scale Receives: Biological: Vaccine manufactured at commercialized scale |
| Experimental Group3 | Experimental | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale.
Intervention: Live attenuated varicella vaccine manufactured at commercialized scale Receives: Biological: Vaccine manufactured at commercialized scale |
| Control Group | Active comparator | The control vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at trial-scale.
Intervention: Live attenuated varicella vaccine manufactured at trial-scale Receives: Biological: Vaccine manufactured at trial-scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
The post-immune geometric mean titer (GMT) of susceptible subjects in each group.
Subjects whose pre-immune antibody titer < 1:4 are considered susceptible. The GMT were measured using the method of Fluorescent Antibody to Membrane Antigen (FAMA).
Measured: 30 days
The overall seroconversion rates (SCRs) of each group.
Subjects whose pre-immune antibody titer< 1:4 and post-immune antibody titer≥ 1:4, or those whose pre-immune antibody titer≥1:4 and the increase of post-immune antibody titer≥4 folds are considered seroconverted.
Measured: 30 days
Secondary outcomes (6)
The seroconversion rates (SCRs) of susceptible subjects in each group
Subjects whose pre-immune antibody titer < 1:4 are considered susceptible.
Measured: 30 days
The geometric mean increase (GMI) of susceptible subjects in each group
Increase of post-immune GMT compared with pre-immune GMT.Subjects whose pre-immune antibody titer < 1:4 are considered susceptible.
Measured: 30 days
The overall post-immune GMT of each group
The GMT of all the subjects in each group.
Measured: 30 days
The overall GMI of each group
The GMI of all the subjects in each group.
Measured: 30 days
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 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 posted13 Jun 2018
- Study start7 Apr 2014
- Primary completion20 May 2017
- Study completion14 Sep 2017
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,197 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
- NCT03555071
- Sponsor's protocol ID
- PRO-VZV-3002
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 13 Jun 2018
- 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 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Bridging Clinical Trial to Evaluate the Consistency, Immunogenicity and Safety of Live Attenuated Varicella Vaccines for Children
- ClinicalTrials.gov ID
- NCT03555071
- Acronym / sponsor ID
- PRO-VZV-3002
- Conditions
- Varicella
- Keywords
- live attenuated varicella vaccine, consistency, immunogenicity, safety, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,197 participants (actual)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2014 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 13 Jun 2018 (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.
The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.
Detailed description
The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group1 | Experimental | Biological: Vaccine manufactured at commercialized scaleThe investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
| Experimental Group2 | Experimental | Biological: Vaccine manufactured at commercialized scaleThe investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
| Experimental Group3 | Experimental | Biological: Vaccine manufactured at commercialized scaleThe investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
| Control Group | Active comparator | Biological: Vaccine manufactured at trial-scaleThe control vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at trial-scale. Intervention: Live attenuated varicella vaccine manufactured at trial-scale |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy volunteer between 1-3 years old;
- legal identity;
- Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.
Key exclusion criteria (10 listed)
- Prior vaccination with varicella vaccine or with history of varicella infection;
- Axillaty temperature > 37.0 °C before vaccination;
- 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;
- Epilepsy (except febrile seizures), history of seizures or convulsions, 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 |
|---|---|---|
| Vaccine manufactured at commercialized scaleSingle subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0 | Biological | Experimental Group1, Experimental Group2, Experimental Group3 |
| Vaccine manufactured at trial-scaleSingle subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0 | Biological | Control Group |
Primary outcome
The post-immune geometric mean titer (GMT) of susceptible subjects in each group.
Time frame: 30 days
Subjects whose pre-immune antibody titer < 1:4 are considered susceptible. The GMT were measured using the method of Fluorescent Antibody to Membrane Antigen (FAMA).
The overall seroconversion rates (SCRs) of each group.
Time frame: 30 days
Subjects whose pre-immune antibody titer< 1:4 and post-immune antibody titer≥ 1:4, or those whose pre-immune antibody titer≥1:4 and the increase of post-immune antibody titer≥4 folds are considered seroconverted.
6 secondary outcomes
The seroconversion rates (SCRs) of susceptible subjects in each group
Time frame: 30 days
The geometric mean increase (GMI) of susceptible subjects in each group
Time frame: 30 days
The overall post-immune GMT of each group
Time frame: 30 days
The overall GMI of each group
Time frame: 30 days
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: 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 13 Jun 2018.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaccine manufactured at commercialized scale and Vaccine manufactured at trial-scale in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd..
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 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: finished, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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 post-immune geometric mean titer (GMT) of susceptible subjects in each group. (time frame: 30 days). 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 13 Jun 2018.