Varicella (Chickenpox)Phase 3NCT07473427
Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children
A Phase 3 study testing Varicella Vaccine in people with Varicella (Chickenpox) and Varicella Immunisation, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in Vietnam.
Trial summary
This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac. 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 (Chickenpox), Varicella Immunisation
- What is being tested?
- Varicella Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jun 2026to 1 Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 children aged 1-12 years;
- Vaccination history:
- Participants aged 1 year old: no vaccination history with any varicella containing vaccine;
- Participants aged 2~12 years old: no vaccination history with any varicella containing vaccine, or have received 1 dose of varicella vaccine at least 3 months before enrollment;
- Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily;
- Participants are able to comply with the study procedures based on the assessment of the investigator;
- Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
Who cannot join
- Prior history of VZV infection;
- Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;
- Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
- Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
Show all 16Show fewer
- Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
- Current or history of severe neurological diseases (epilepsy, convulsions or seizures [excluding history of febrile seizures]) or psychiatric disorders, or presence of a family history of psychiatric disorders;
- Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;
- Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
- Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
- Receipt of attenuated live vaccines or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
- Fever on vaccination day, with axillary temperature >37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
- Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;
- Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
- Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Hanoi Medical University
Hanoi, 100000
Pham Thi Van Anh, +84- 915 595 690, phamthivananh.hmu@gmail.com
About this study
Official title: Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children Aged 1~12 Years: A Single-armed Bridging Clinical Trial
This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.
- Conditions
- Varicella (Chickenpox), Varicella Immunisation
- Being tested
- Varicella Vaccine
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella VaccineBiological
Varicella vaccine manufactured by Sinovac
| Study group | Role | What they receive |
|---|---|---|
| No vaccination history group | Experimental | Participants aged 1-12 years with no vaccination history of varicella-containing vaccine Receives: Biological: Varicella Vaccine |
| Vaccination history group | Experimental | Participants aged 2-12 years have received 1 dose of varicella vaccine Receives: Biological: Varicella Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history
Measured: 42 days after vaccination
Secondary outcomes (7)
The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history
Measured: 42 days after vaccination
The Geometric Mean Concentration(GMC) of VZV antibodies in total population
Measured: 42 days after vaccination
The seropositive rate of VZV antibodies in total population
Measured: 42 days after vaccination
The geometric mean fold rise (GMFR) of VZV antibodies in total population
Measured: 42 days after vaccination
The geometric mean fold rise (GMFR) of VZV antibodies among population with varicella immunization history
Measured: 42 days after vaccination
The geometric mean concentration (GMC) of VZV antibodies among population with varicella immunization history
Measured: 42 days after vaccination
The seropositive rate of VZV antibodies among population with varicella immunization history
Measured: 42 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella (Chickenpox)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473427
- Sponsor's protocol ID
- PRO-VZV-4009
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 12 Jun 2026
- Results posted
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children Aged 1~12 Years: A Single-armed Bridging Clinical Trial
- ClinicalTrials.gov ID
- NCT07473427
- Acronym / sponsor ID
- PRO-VZV-4009
- Conditions
- Varicella (Chickenpox), Varicella Immunisation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Mar 2026 (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 single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No vaccination history group | Experimental | Biological: Varicella VaccineParticipants aged 1-12 years with no vaccination history of varicella-containing vaccine |
| Vaccination history group | Experimental | Biological: Varicella VaccineParticipants aged 2-12 years have received 1 dose of varicella vaccine |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy children aged 1-12 years;
- Vaccination history:
- Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily;
- Participants are able to comply with the study procedures based on the assessment of the investigator;
- Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
Key exclusion criteria (16 listed)
- Prior history of VZV infection;
- Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;
- Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
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 |
|---|---|---|
| Varicella VaccineVaricella vaccine manufactured by Sinovac | Biological | No vaccination history group, Vaccination history group |
Primary outcome
The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history
Time frame: 42 days after vaccination
7 secondary outcomes
The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history
Time frame: 42 days after vaccination
The Geometric Mean Concentration(GMC) of VZV antibodies in total population
Time frame: 42 days after vaccination
The seropositive rate of VZV antibodies in total population
Time frame: 42 days after vaccination
The geometric mean fold rise (GMFR) of VZV antibodies in total population
Time frame: 42 days after vaccination
The geometric mean fold rise (GMFR) of VZV antibodies among population with varicella immunization history
Time frame: 42 days after vaccination
The geometric mean concentration (GMC) of VZV antibodies among population with varicella immunization history
Time frame: 42 days after vaccination
The seropositive rate of VZV antibodies among population with varicella immunization history
Time frame: 42 days after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Varicella (Chickenpox)
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
Active, not recruitingPhase 2
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
Herpes Zoster
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.
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 Varicella Vaccine in people with Varicella (Chickenpox) and Varicella Immunisation, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in Vietnam.
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 12 Jun 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pham Thi Van Anh (+84- 915 595 690, phamthivananh.hmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history (time frame: 42 days after vaccination). 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 12 Jun 2026.