VaricellaPhase 4NCT06987942
Simultaneous Administration Study of Varicella Attenuated Live Vaccine and Trivalent Inactivated Influenza Vaccine (Split Virion)
A Phase 4 study testing Varicella vaccine+TIV, Varicella vaccine and TIV in people with Varicella and Influenza Vaccine, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the immunogenicity of simultaneous administration of varicella live attenuated vaccine (varicella vaccine hereafter) and trivalent inactivated influenza vaccine (TIV hereafter). It will also evaluate the safety of simultaneous administration of the two vaccines. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella, Influenza Vaccine
- What is being tested?
- Varicella vaccine+TIV, Varicella vaccine and TIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 899 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2024to 15 Nov 2024
- Phase
- Phase 4
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 7-12 years;
- The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old);
- Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures;
- Provide legal identity proof;
Who cannot join
- Vaccination history of varicella vaccine;
- Had received a single dose of influenza vaccine for 2024-2025 season;
- History of varicella;
- History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.);
- Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease;
- With any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy);
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- With a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases;
- With encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of Guillain-Barre syndrome;
- Body temperature >37℃ at the time of vaccination;
- Receipt of blood products within 3 months before receiving investigational vaccine;
- Receipt of another study drug within 30 days before receipt of the investigational vaccine;
- Receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine;
- Receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine;
- Participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months;
- The participant had any other factors that were ineligible for vaccination by in the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Randomized, Controlled, Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Administered Concomitantly With Trivalent Inactivated Influenza Vaccine (Split Virion) in Children Aged 7-12 Years
The goal of this clinical trial is to evaluate the immunogenicity of simultaneous administration of varicella live attenuated vaccine (varicella vaccine hereafter) and trivalent inactivated influenza vaccine (TIV hereafter). It will also evaluate the safety of simultaneous administration of the two vaccines. The main questions it aims to answer are:
- If geometric mean titer (GMT) of varicella zoster vrius (VZV) antibody in the simultaneous administration group is non-inferior to that in the varicella vaccine separate group.
- If GMT of hemagglutination inhibition (HI hereafter) antibody in the simultaneous administration group is non-inferior to that in the TIV separate group.
Participants in the simultaneous administration group received a single dose of varicella vaccine and TIV simultaneously on day 0. Participants in the separate groups received a single dose of varicella vaccine or TIV on day 0, respectively.
- Conditions
- Varicella, Influenza Vaccine
- Being tested
- Varicella vaccine+TIV, Varicella vaccine, TIV
- Medical subject headings
- Chickenpox, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella vaccine+TIVBiological
- Varicella vaccine: lyophilized powder, subcutaneous injection
- TIV: Inactived, split virion, containing H1N1, H3N2 and BV strains.
Varicella vaccineBiological
lyophilized powder, subcutaneous
TIVBiological
Inactived, split virion, containing H1N1, H3N2 and BV strains.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous vaccination group | Experimental | Participants received a single dose of varicella vaccine and TIV on Day 0. Receives: Biological: Varicella vaccine+TIV |
| Varicella vaccine separate group | Active comparator | Participants received a single dose of varicella vaccine on Day 0. Receives: Biological: Varicella vaccine |
| TIV separate group | Active comparator | Participants received a single dose of TIV on Day 0. Receives: Biological: TIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT of VZV antibody
GMT of VZV antibody on Day 30 after the vaccination.
Measured: Day 30 after the vaccination
GMT of HI antibody
GMT of HI antibody on Day 30 after vaccination.
Measured: Day 30 after vaccination
Secondary outcomes (6)
Geometric mean increase (GMI) of VZV antibody
GMI of VZV antibody on Day 30 after the vaccination.
Measured: Day 30 after the vaccination
Seroconversion rate of VZV antibody
Seroconversion rate of VZV antibody on Day 30 after the vaccination.
Measured: Day 30 after the vaccination
Seropositive rate of VZV antibody
Seropositive rate of VZV antibody on Day 30 after the vaccination.
Measured: Day 30 after the vaccination
GMI of HI antibody
GMI of HI antibody on Day 30 after the vaccination.
Measured: Day 30 after the vaccination
Seroconversion rate of HI antibody
Seroconversion rate of HI antibody on Day 30 after the vaccination.
Measured: Day 30 after the vaccination
Seroprotection rate of HI antibody
Seroprotection rate of HI antibody on Day 30 after the vaccination.
Measured: Day 30 after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start21 Sep 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 899 participants (actual)
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
- NCT06987942
- Sponsor's protocol ID
- PRO-VAR-MA4004-JS-2
- Status last verified
- Apr 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Administered Concomitantly With Trivalent Inactivated Influenza Vaccine (Split Virion) in Children Aged 7-12 Years
- ClinicalTrials.gov ID
- NCT06987942
- Acronym / sponsor ID
- PRO-VAR-MA4004-JS-2
- Conditions
- Varicella, Influenza Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 899 participants (actual)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 23 May 2025 (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 goal of this clinical trial is to evaluate the immunogenicity of simultaneous administration of varicella live attenuated vaccine (varicella vaccine hereafter) and trivalent inactivated influenza vaccine (TIV hereafter). It will also evaluate the safety of simultaneous administration of the two vaccines. The main questions it aims to answer are:
- If geometric mean titer (GMT) of varicella zoster vrius (VZV) antibody in the simultaneous administration group is non-inferior to that in the varicella vaccine separate group.
- If GMT of hemagglutination inhibition (HI hereafter) antibody in the simultaneous administration group is non-inferior to that in the TIV separate group.
Participants in the simultaneous administration group received a single dose of varicella vaccine and TIV simultaneously on day 0. Participants in the separate groups received a single dose of varicella vaccine or TIV on day 0, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simultaneous vaccination group | Experimental | Biological: Varicella vaccine+TIVParticipants received a single dose of varicella vaccine and TIV on Day 0. |
| Varicella vaccine separate group | Active comparator | Biological: Varicella vaccineParticipants received a single dose of varicella vaccine on Day 0. |
| TIV separate group | Active comparator | Biological: TIVParticipants received a single dose of TIV on Day 0. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 7-12 years;
- The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old);
- Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures;
- Provide legal identity proof;
Key exclusion criteria (15 listed)
- Vaccination history of varicella vaccine;
- Had received a single dose of influenza vaccine for 2024-2025 season;
- History of varicella;
- History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.);
- Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease;
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 vaccine+TIV* Varicella vaccine: lyophilized powder, subcutaneous injection * TIV: Inactived, split virion, containing H1N1, H3N2 and BV strains. | Biological | Simultaneous vaccination group |
| Varicella vaccinelyophilized powder, subcutaneous | Biological | Varicella vaccine separate group |
| TIVInactived, split virion, containing H1N1, H3N2 and BV strains. | Biological | TIV separate group |
Primary outcome
GMT of VZV antibody
Time frame: Day 30 after the vaccination
GMT of VZV antibody on Day 30 after the vaccination.
GMT of HI antibody
Time frame: Day 30 after vaccination
GMT of HI antibody on Day 30 after vaccination.
6 secondary outcomes
Geometric mean increase (GMI) of VZV antibody
Time frame: Day 30 after the vaccination
Seroconversion rate of VZV antibody
Time frame: Day 30 after the vaccination
Seropositive rate of VZV antibody
Time frame: Day 30 after the vaccination
GMI of HI antibody
Time frame: Day 30 after the vaccination
Seroconversion rate of HI antibody
Time frame: Day 30 after the vaccination
Seroprotection rate of HI antibody
Time frame: Day 30 after the 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 23 May 2025.
- 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 4 study testing Varicella vaccine+TIV, Varicella vaccine and TIV in people with Varicella and Influenza Vaccine, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. 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 15 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 23 May 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
GMT of VZV antibody (time frame: Day 30 after the vaccination). 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 23 May 2025.