VaricellaPhase 3NCT05158777
Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
A Phase 3 study testing Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. and Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd in people with Varicella, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. and Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,480 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2022to 14 Nov 2022
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy population aged 13 years and above;
- Proven legal identity;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form).
Who cannot join
- Disease history or vaccine history of chickenpox or shingles;
- Have fever before vaccination, axillary temperature >37.0°C;
- Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
- History of severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Autoimmune disease or immunodeficiency / immunosuppression;
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- Severe chronic diseases, severe cardiovascular diseases, hypertension (adult field measurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg) that could not be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
- Family history of psychosis,severe neurological disease (epilepsy, convulsions or twitching) or mental illness;
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- History of alcohol or drug abuse;
- Receipt of blood products within in the past 6 months;
- Participating in other drug/vaccine clinical trial;
- Receipt of attenuated live vaccines in the past 28 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- 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
1 site in 1 country.
China1 site
Henan Provincial Center for Disease Prevention and Control
Zhenzhou, Henan
About this study
Official title: A Randomized, Blind, Controlled Clinical Trial to Evaluate Safety and Immunogenicity of Live Attenuated Varicella Vaccine After a Two-dose Vaccination Course in Healthy Population Aged ≥13 Years Old
This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.
Read the detailed description
This study is a randomized, blind, controlled phase III clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Shanghai Institute of Biological Products Co.,Ltd.. A total of 2480 subjects aged 13 years and older will be enrolled with 1240 subjects in 13~17 years old group and1240 subjects in 18 years and older group. 1240 subjects in each age group would be randomly divided into experimental group and control group according to 1:1 ratio, and subjects will receive two doses of vaccine with the immunization course of 0,28 days or 0,56 days. In addition, 400 subjects from experimental group (100 subjects per subgroup) would be selected to collect blood at 3 and 5 years after immunization to evaluate immune persistence of live attenuated varicella vaccines.
- Conditions
- Varicella
- Being tested
- Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd., Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
- 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 vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.Biological
live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection
Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,LtdBiological
live varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group with the immunization course of 0,28 days or 0,56 days | Experimental | 1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days. Receives: Biological: Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. |
| Control Group | Active comparator | 1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days. Receives: Biological: Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of HI antibody
The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.
Measured: Day 42 after the whole schedule
GMT of HI antibody
The GMT of the antibody 42 days among all subjects after the second vaccination.
Measured: Day 42 after the whole schedule
Secondary outcomes (4)
Seroprotection rate of HI antibody
The seroprotection rate of the antibody 42 days among all subjects after the second vaccination.
Measured: Day 42 after the whole schedule
Incidence of adverse reactions within 30 minutes after each dose
Incidence of adverse reactions within 30 minutes after each dose vaccination with immunization course of 0,28 days and 0,56 days.
Measured: Within 30 minutes after each dose
Incidence of adverse reactions within 0~28 days after each dose
Incidence of adverse reactions within 0~28 days after each dose vaccination with immunization course of 0,28 days and 0,56 days.
Measured: Within 0~28 days after each dose
Incidence of serious adverse events
Incidence of serious adverse events from vaccination to 6 months after the second vaccination with immunization course of 0,28 days and 0,56 days
Measured: From vaccination to 6 months after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start13 Feb 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
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.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- 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
- 2,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanxia Wang, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158777
- Sponsor's protocol ID
- 2020LP00094-III
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Controlled Clinical Trial to Evaluate Safety and Immunogenicity of Live Attenuated Varicella Vaccine After a Two-dose Vaccination Course in Healthy Population Aged ≥13 Years Old
- ClinicalTrials.gov ID
- NCT05158777
- Acronym / sponsor ID
- 2020LP00094-III
- Conditions
- Varicella
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,480 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 15 Dec 2021 (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 a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.
Detailed description
This study is a randomized, blind, controlled phase III clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Shanghai Institute of Biological Products Co.,Ltd.. A total of 2480 subjects aged 13 years and older will be enrolled with 1240 subjects in 13~17 years old group and1240 subjects in 18 years and older group. 1240 subjects in each age group would be randomly divided into experimental group and control group according to 1:1 ratio, and subjects will receive two doses of vaccine with the immunization course of 0,28 days or 0,56 days. In addition, 400 subjects from experimental group (100 subjects per subgroup) would be selected to collect blood at 3 and 5 years after immunization to evaluate immune persistence of live attenuated varicella vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group with the immunization course of 0,28 days or 0,56 days | Experimental | Biological: Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days or 0,56 days. |
| Control Group | Active comparator | Biological: Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd1240 subjects (including 620 children aged 13-17 years and 620 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days or 0,56 days. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy population aged 13 years and above;
- Proven legal identity;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form).
Key exclusion criteria (18 listed)
- Disease history or vaccine history of chickenpox or shingles;
- Have fever before vaccination, axillary temperature >37.0°C;
- Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
- History of severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
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 vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd.live varicella-zoster virus in 0.5 mL of sucrose, sodium chloride, potassium chloride, sodium glutamate, phosphate and injection water per injection | Biological | Experimental Group with the immunization course of 0,28 days or 0,56 days |
| Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltdlive varicella-zoster virus in 0.5 mL of mannitol, dextrose tincture, sucrose, trehalose, human serum albumin and injection water per injection | Biological | Control Group |
Primary outcome
Seroconversion rate of HI antibody
Time frame: Day 42 after the whole schedule
The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.
GMT of HI antibody
Time frame: Day 42 after the whole schedule
The GMT of the antibody 42 days among all subjects after the second vaccination.
4 secondary outcomes
Seroprotection rate of HI antibody
Time frame: Day 42 after the whole schedule
Incidence of adverse reactions within 30 minutes after each dose
Time frame: Within 30 minutes after each dose
Incidence of adverse reactions within 0~28 days after each dose
Time frame: Within 0~28 days after each dose
Incidence of serious adverse events
Time frame: From vaccination to 6 months after the second vaccination
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 29 Dec 2023.
- 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.
Yanxia Wang 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 3 study testing Live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. and Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd in people with Varicella, run by Shanghai Institute Of Biological Products 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 29 Dec 2023. 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. 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?
Seroconversion rate of HI antibody (time frame: Day 42 after the whole schedule). 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 29 Dec 2023.