A Phase 3 interventional study of Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd and Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd in Varicella, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Enrolling by invitation at 1 site in China. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 3, Interventional, and Prevention
Among 17 studies in Chickenpox by Sinovac (Dalian) Vaccine Technology Co., Ltd. — 7 open to participants now, 7 under way, 3 of them phase 3. Chickenpox · Sinovac (Dalian) Vaccine Technology Co., Ltd..
Among the 17 studies in Chickenpox by Sinovac (Dalian) Vaccine Technology Co., Ltd., this one is the 4th largest by planned enrollment of the 16 interventional ones, is one of 3 that started in 2021, is one of 7 in phase 3, and was the 4th registered.
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 475 across 149 interventional studies indexed under Chickenpox.
Browse Chickenpox studies →7 of the 17 studies in Chickenpox by Sinovac (Dalian) Vaccine Technology Co., Ltd. are open now, in 3 countries. Each count lists the studies.
Of the 16 Chickenpox studies recruiting now, 3 (19%) set no upper age limit and 13 (81%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 13 Years and older · all sexes · healthy volunteers too.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2021.
Median enrollment 712 across the 16 interventional studies, 400 across the 1 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
1 of the studies in Chickenpox by Sinovac (Dalian) Vaccine Technology Co., Ltd. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06482216Sinovac (Dalian) Vaccine Technology Co., Ltd.Correlation of Protection Against Varicella in an Exploratory Study | 2027-05-10 |
Among the 17 studies in Chickenpox by Sinovac (Dalian) Vaccine Technology Co., Ltd., from their registry updates:
Nothing recorded among them since 2026-09-25.
This a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunogenicity of a two doses vaccination of investigational vaccine with 0,28 day, 0,42 day and 0,56 day immunization schedule in population aged ≥13 years old.
This study is a randomized, blind, controlled phase # clinical trial in population aged ≥13 years old. The experimental vaccine will be manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 2400 subjects aged 13 years and older will be enrolled with1200 subjects in 13 \~ 17 years old group and1200 subjects in 18 years and older group.960 subjects in each age group will 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, 0,42 days or 0,56 days. An additional 240 subjects in each age group will be randomly divided into experimental group and control group according to 2:1 ratio to receive two doses of the experimental vaccine or placebo with the immunization course of 0, 70 days.In addition,400 subjects including 320 people of experimental group in different immunization course according to the difference of age and 80 people of placebo group according to the difference of age will be selected to collect blood about 3ml each time to evaluate immunity persistence of live attenuated varicella vaccines at 3 and 5 years after the whole immunization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of experimental vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Biological: Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
960 subjects (including 480 children aged 13-17 years and 480 adults aged 18 years and older) will receive two doses of control vaccine with the immunization course of 0,28 days, 0,42 days or 0,56 days.
Biological: Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd
320 subjects (including 160 children aged 13-17 years and 160 adults aged 18 years and older) will receive two doses of the experimental vaccine with the immunization course of 0, 70 days.
Biological: Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd
160 subjects (including 80children aged 13-17 years and 80 adults aged 18 years and older) will receive two doses of the placebo with the immunization course of 0, 70 days.
Biological: Placebo
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection
live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
Sodium chloride and distilled water
Seroconversion rate of the antibody
The seroconversion rate of the antibody 28 days among all subjects after the second vaccination.
Time frame: Day 28 after the whole schedule
GMT of the antibody
The GMT of the antibody 28 days among all subjects after the second vaccination.
Time frame: Day 28 after the whole schedule
GMI of the antibody
GMI of the antibody 28 days among all subjects after the second vaccination.
Time frame: Day 28 after the whole schedule
Seroconversion rate, positive rate, GMT and GMI of the antibody
Seroconversion rate, positive rate, GMT and GMI of the antibody among all subjects on day 28,day 42 and day 56 after the first vaccination.
Time frame: Day 28,Day 42 and day 56 after the first vaccination
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 ,0,42 days and 0,56 days.
Time frame: Within 0~28 days after each dose
Incidence of adverse reactions within 0~14 days after each dose vaccination
Incidence of adverse reactions within 0\~14 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days
Time frame: Within 0~14 days after each dose
Incidence of grade 3 and above adverse reactions
Incidence of grade 3 and above adverse reactions within 0\~28 days after each dose vaccination with immunization course of 0,28 days ,0,42 days and 0,56 days.
Time frame: 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 ,0,42 days and 0,56 days
Time frame: From vaccination to 6 months after the second vaccination
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Sinovac (Dalian) Vaccine Technology Co., Ltd. →