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Varicella (chickenpox)Phase 4NCT06891872

Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine

A Phase 4 study testing Vaicella Vaccine+DTaP on Day 0, MMR on Day 30, Varicella vaccine+MMR on Day 0，DTaP on Day 30 and Varicella Vaccine in people with Varicella (chickenpox) and MMR Vaccine, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The primary objective of this study is to evaluate the immunogenicity of live attenuated varicella vaccine co-administered with MMR vaccine or DTaP vaccine. Read more about this study

Who is it for?
Ages 18 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Varicella (chickenpox), MMR Vaccine, DTaP Vaccine
What is being tested?
Vaicella Vaccine+DTaP on Day 0, MMR on Day 30, Varicella vaccine+MMR on Day 0，DTaP on Day 30 and Varicella Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
1 siteChina
Study dates
May 2025to Dec 2025
Phase
Phase 4
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 18 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants aged 18-24 months;
  • have completed 3 doses of DTaP for primary immunization in their first year of life without the fourth dose of Dtap-containing vaccine;
  • have completed the first dose of MMR in their first year of life without a second dose of MMR;
  • Guardians of participants who are able to understand and voluntarily sign informed consent;
  • Provision of legal proof of identity.

Who cannot join

  • Having a history of previous varicella vaccination;
  • Having a history of chickenpox, pertussis, diphtheria, tetanus, measles, mumps, and rubella;
  • Having a history of uncontrolled chronic or serious diseases, including but not limited to cardiovascular diseases, hematological diseases, liver and kidney diseases, digestive diseases, respiratory diseases, malignant tumors, major functional organ transplantation, etc.;
  • Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
  • Presence of abnormal coagulation function (e.g. coagulation factor deficiency, platelet abnormality);
  • Having/Previous having a severe neurological disorder (epilepsy, seizures, or convulsions) or psychosis, or have a family history of psychosis;
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  • Acute onset of various acute or chronic illnesses within the last 7 days, or known or suspected active infection;
  • Receipt of > 14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2 mg/kg/ day or its equivalent, except topical or inhaled corticosteroids), cytotoxic therapy within the past 6 months, or planned to receive such therapy during the trial;
  • Having received immune globulin or other blood products within the past 3 months or plan to receive such treatment during the trial;
  • Receipt of another study drug or vaccine within the past 30 days or plans to receive such drug or vaccine during the trial;
  • Administration of live attenuated vaccine within the past 28 days or subunit, inactivated, or other process vaccine within the past 7 days;
  • Known allergies to the vaccine or vaccine components, such as urticaria after vaccination, dyspnea, angioedema;
  • Having fever on the day of scheduled vaccination (axillary temperature > 37.0 ° C);
  • Failure of medical examination on the planned vaccination day;
  • Participants have any other factors that, in the judgment of the investigator, make them ineligible to participate in a clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

XU Jiawei contact

023-68813088

452712782@qq.com

China1 site

  • Chongqing Center for Disease Control and Prevention

    Chongqing, 400042

    XU Jiawei, 023-68813088, 452712782@qq.com

Other trials in China

About this study

Official title: Immunogenicity and Safety of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine in Healthy Children Aged 18~24 Months: an Open-label, Randomized, Phase Ⅳ Study Clinical Trial

This is a phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The primary objective of this study is to evaluate the immunogenicity of live attenuated varicella vaccine co-administered with MMR vaccine or DTaP vaccine. The secondary objective is to evaluate the safety of the vaccines when administered simultaneously.

Read the detailed description

A total of 720 children aged 18~24 months who have not received varicella vaccine, the second dose of MMR and the fourth dose of DTaP (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group A, Group B and Group C. Participants in Group A will receive varicella vaccine and DTaP simultaneously on Day 0 and receive MMR on Day 30. Participants in Group B will varicella vaccine and MMR simultaneously on Day 0 and receive DTaP on Day 30. Participants in Group C will receive varicella vaccine only.

Being tested
Vaicella Vaccine+DTaP on Day 0, MMR on Day 30, Varicella vaccine+MMR on Day 0，DTaP on Day 30, Varicella Vaccine
Keywords
Co-administered, VZV
Medical subject headings
Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaicella Vaccine+DTaP on Day 0, MMR on Day 30Biological

    Varicella vaccine: lyophilized powder, subcutaneous injection

    DTaP: intramuscular injection

    MMR: lyophilized powder, subcutaneous injection

  • Varicella vaccine+MMR on Day 0，DTaP on Day 30Biological

    Varicella vaccine: lyophilized powder, subcutaneous injection

    MMR: lyophilized powder, subcutaneous injection

    DTaP: intramuscular injection

  • Varicella VaccineBiological

    lyophilized powder, subcutaneous injection

Study groups in NCT06891872
Study groupRoleWhat they receive
Group A (Varicella vaccine and DTaP co-administration group )ExperimentalParticipants will receive a single dose of varicella vaccine and DTaP vaccine on Day 0 and a single dose of MMR on Day 30.
Receives: Biological: Vaicella Vaccine+DTaP on Day 0, MMR on Day 30
Group B (Varicella vaccine and MMR co-administration group )ExperimentalParticipants will receive a single dose of varicella vaccine and MMR on Day 0 and DTaP vaccine on Day 30.
Receives: Biological: Varicella vaccine+MMR on Day 0，DTaP on Day 30
Group C (Varicella vaccine group )Active comparatorParticipants will receive a single dose of varicella vaccine on Day 0.
Receives: Biological: Varicella Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Varicella zoster virus (VZV) antibody seroconversion rate

    Seroconversion rate of VZV antibody on Day 30 after the administration of varicella vaccine.

    Measured: Day 30 after the administration of varicella vaccine

Secondary outcomes (14)

  1. Seropositive rate of VZV antibody

    Seropositive rate of VZV antibody on Day 30 after the administration of varicella vaccine.

    Measured: Day 30 after the administration of varicella vaccine

  2. Geometric mean titer (GMT) of VZV antibody

    GMT of VZV antibody on Day 30 after the administration of varicella vaccine.

    Measured: Day 30 after the administration of varicella vaccine

  3. Geometric mean fold increase (GMI) of VZV antibody

    GMI of VZV antibody on Day 30 after the administration of varicella vaccine.

    Measured: Day 30 after the administration of varicella vaccine

  4. Seroconversion rate of measles antibody, mumps antibody and rubella antibody

    Seroconversion rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR

    Measured: Day 30 after the administration of MMR

  5. Seropositive rate of measles antibody, mumps antibody and rubella antibody

    Seropositive rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR

    Measured: Day 30 after the administration of MMR

  6. Geometric mean concentration (GMC) of measles antibody, mumps antibody and rubella antibody

    GMC of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR

    Measured: Day 30 after the administration of MMR

  7. GMI of measles antibody, mumps antibody and rubella antibody

    GMI of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR

    Measured: Day 30 after the administration of MMR

  8. Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody

    Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP

    Measured: Day 30 after the administration of DTaP

  9. Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody

    Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP

    Measured: Day 30 after the administration of DTaP

  10. GMC of pertussis antibody, diphtheria antibody and tetanus antibody

    GMC of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP

    Measured: Day 30 after the administration of DTaP

  11. GMI of pertussis antibody, diphtheria antibody and tetanus antibody

    GMI of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP

    Measured: Day 30 after the administration of DTaP

  12. The incidence of adverse reactions within 0~14 days

    The incidence of adverse reactions within 0~14 days after each dose vaccination.

    Measured: 0~14 days after each dose vaccination

  13. The incidence of adverse reactions within 0~30 days

    The incidence of adverse reactions within 0~30 days after each dose vaccination.

    Measured: 0~30 days after each dose vaccination

  14. The incidence of serious adverse events (SAEs) within 0~30 days

    The incidence of SAEs within 0~30 days after each dose vaccination.

    Measured: 0~30 days after each dose vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06891872
Sponsor's protocol ID
PRO-VZV-4008
Status last verified
Mar 2025
First submitted
2 Mar 2025
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vaicella Vaccine+DTaP on Day 0, MMR on Day 30, Varicella vaccine+MMR on Day 0，DTaP on Day 30 and Varicella Vaccine in people with Varicella (chickenpox) and MMR 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 5 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: opening soon, as of the sponsor's last update on 24 Mar 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?

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 XU Jiawei (023-68813088, 452712782@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Varicella zoster virus (VZV) antibody seroconversion rate (time frame: Day 30 after the administration of varicella vaccine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06891872.

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 24 Mar 2025.

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