Chickenpox VaccinesPhase 3NCT06614816
Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years
A Phase 3 study testing Oka strain varicella attenuated live vaccine in people with Chickenpox Vaccines, run by Southeast University, China at 1 site in China.
Trial summary
Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Chickenpox Vaccines
- What is being tested?
- Oka strain varicella attenuated live vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2019to 20 Jun 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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages ranging from 1 to 12 years for the general healthy population ;
- Obtain informed consent from the volunteer and/or their legal guardian, and sign the informed consent form;
- The volunteer and/or their legal guardian is able to comply with the requirements of the clinical trial protocol;
- Axillary body temperature ≤37.0℃.
Who cannot join
- Those who have previously been vaccinated against varicella, have a history of varicella or herpes zoster infection;
- Allergy to known components of the study vaccine, or a history of severe allergic reactions to any vaccination;
- A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders;
- Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or HIV-related immunocompromised individuals, or those with family members closely exposed to congenital immune diseases;
- Those with congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome);
- Known or suspected concurrent diseases, including respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors;
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- Diagnosed with coagulation dysfunction (e.g., deficiency of coagulation factors, coagulation disorders, platelet abnormalities) or significant bruising or coagulation disorders;
- Receipt of blood products within the past 3 months;
- Receipt of attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days;
- Acute illnesses or acute exacerbations of chronic diseases in the past 7 days;
- A history of high fever (axillary body temperature ≥38.0℃) within the past 3 days;
- Any other factors deemed by the investigator as unsuitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Huaiyin District Center for Disease Control and Prevention
Huaian, Jiangsu, 223399
About this study
Official title: Phase III Clinical Trial of Lyophilized Live Attenuated Varicella Vaccine for Children Aged 1-12 Years
Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study
- Conditions
- Chickenpox Vaccines
- Being tested
- Oka strain varicella attenuated live vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oka strain varicella attenuated live vaccineBiological
lyophilized powder, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Live Attenuated Varicella vaccine candidates | Experimental | The test group received the freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co., LTD., which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cells inoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers. Receives: Biological: Oka strain varicella attenuated live vaccine |
| Marketed Live Attenuated Varicella vaccine | Active comparator | the active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers. Receives: Biological: Oka strain varicella attenuated live vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion rate
The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies
Measured: 42 days after completing the full course of vaccination.
Secondary outcomes (2)
geometric mean titer (GMT)
geometric mean titer (GMT) of VZV antibodies 42 days after vaccination
Measured: 42 days after completing the full course of vaccination.
geometric mean fold increase (GMFI)
geometric mean fold increase (GMFI) of VZV antibodies 42 days after vaccination
Measured: 42 days after completing the full course of vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start10 Feb 2019
- Primary completion15 Jul 2021
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chickenpox VaccinesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu CDC
- Responsible party
- Principal investigator, Shiyuan Wang, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614816
- Sponsor's protocol ID
- JSVCT057
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 26 Sep 2024
- 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 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial of Lyophilized Live Attenuated Varicella Vaccine for Children Aged 1-12 Years
- ClinicalTrials.gov ID
- NCT06614816
- Acronym / sponsor ID
- JSVCT057
- Conditions
- Chickenpox Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Jiangsu CDC
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 26 Sep 2024 (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.
Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Live Attenuated Varicella vaccine candidates | Experimental | Biological: Oka strain varicella attenuated live vaccineThe test group received the freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co., LTD., which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cells inoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers. |
| Marketed Live Attenuated Varicella vaccine | Active comparator | Biological: Oka strain varicella attenuated live vaccinethe active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages ranging from 1 to 12 years for the general healthy population ;
- Obtain informed consent from the volunteer and/or their legal guardian, and sign the informed consent form;
- The volunteer and/or their legal guardian is able to comply with the requirements of the clinical trial protocol;
- Axillary body temperature ≤37.0℃.
Key exclusion criteria (12 listed)
- Those who have previously been vaccinated against varicella, have a history of varicella or herpes zoster infection;
- Allergy to known components of the study vaccine, or a history of severe allergic reactions to any vaccination;
- A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders;
- Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or HIV-related immunocompromised individuals, or those with family members closely exposed to congenital immune diseases;
- Those with congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome);
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 |
|---|---|---|
| Oka strain varicella attenuated live vaccinelyophilized powder, subcutaneous injection | Biological | Live Attenuated Varicella vaccine candidates, Marketed Live Attenuated Varicella vaccine |
Primary outcome
seroconversion rate
Time frame: 42 days after completing the full course of vaccination.
The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies
2 secondary outcomes
geometric mean titer (GMT)
Time frame: 42 days after completing the full course of vaccination.
geometric mean fold increase (GMFI)
Time frame: 42 days after completing the full course of 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 26 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oka strain varicella attenuated live vaccine in people with Chickenpox Vaccines, run by Southeast University, China 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 4 inclusion and 12 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 Sep 2024. 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 (time frame: 42 days after completing the full course of 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 26 Sep 2024.