ClinicalTrials.gg
CompletedNCT06987942Updated May 23, 2025

Simultaneous Administration Study of Varicella Attenuated Live Vaccine and Trivalent Inactivated Influenza Vaccine (Split Virion)

A Phase 4 interventional study of Varicella vaccine+TIV and Varicella vaccine in Varicella and Influenza Vaccine, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2024, registered May 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
899
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Varicella
  • Influenza Vaccine
03

In context

Chickenpox

180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.

This study's enrollment of 899 is above the median of 475 across 149 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Healthy children aged 7-12 years;
  • The subject or legal guardian can understand and sign the 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;

Exclusion criteria

Exclusion Criteria:

  • 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, or receiving immunosuppressive therapy (including systemic therapy);
  • 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 vaccine;
  • Receipt of another study drug within 30 days before receipt of the investigational vaccine;
  • Receipt of 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.
Terms in these criteria, in plain language(5)

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.

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.

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.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
899 participants (actual)

Study arms

  • Experimental
    Simultaneous vaccination group

    Participants received a single dose of varicella vaccine and TIV on Day 0.

    Biological: Varicella vaccine+TIV

  • Active comparator
    Varicella vaccine separate group

    Participants received a single dose of varicella vaccine on Day 0.

    Biological: Varicella vaccine

  • Active comparator
    TIV separate group

    Participants received a single dose of TIV on Day 0.

    Biological: TIV

Interventions

  • BiologicalVaricella vaccine+TIV

    Drug page: Chickenpox Vaccine

    * Varicella vaccine: lyophilized powder, subcutaneous injection * TIV: Inactived, split virion, containing H1N1, H3N2 and BV strains.

  • lyophilized powder, subcutaneous

  • BiologicalTIV

    Inactived, split virion, containing H1N1, H3N2 and BV strains.

06

What researchers measure

Primary outcomes

  1. GMT of VZV antibody

    GMT of VZV antibody on Day 30 after the vaccination.

    Time frame: Day 30 after the vaccination

  2. GMT of HI antibody

    GMT of HI antibody on Day 30 after vaccination.

    Time frame: Day 30 after vaccination

Secondary outcomes

  1. Geometric mean increase (GMI) of VZV antibody

    GMI of VZV antibody on Day 30 after the vaccination.

    Time frame: Day 30 after the vaccination

  2. Seroconversion rate of VZV antibody

    Seroconversion rate of VZV antibody on Day 30 after the vaccination.

    Time frame: Day 30 after the vaccination

  3. Seropositive rate of VZV antibody

    Seropositive rate of VZV antibody on Day 30 after the vaccination.

    Time frame: Day 30 after the vaccination

  4. GMI of HI antibody

    GMI of HI antibody on Day 30 after the vaccination.

    Time frame: Day 30 after the vaccination

  5. Seroconversion rate of HI antibody

    Seroconversion rate of HI antibody on Day 30 after the vaccination.

    Time frame: Day 30 after the vaccination

  6. Seroprotection rate of HI antibody

    Seroprotection rate of HI antibody on Day 30 after the vaccination.

    Time frame: Day 30 after the vaccination

07

Study locations

1 site
  • Jiangsu Provincial Center for Disease control and Prevention
    Nanjing, Jiangsu 210009, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06987942
Responsible party
Sponsor
First posted
May 23, 2025
Start date
Sep 21, 2024
Primary completion
Nov 15, 2024
Completion
Nov 15, 2024
Last update
May 23, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Chickenpox Vaccine

Start the discussion