Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine
NCT ID: NCT06891872
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
720 participants
INTERVENTIONAL
2025-05-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A (Varicella vaccine and DTaP co-administration group )
Participants will receive a single dose of varicella vaccine and DTaP vaccine on Day 0 and a single dose of MMR on Day 30.
Vaicella Vaccine+DTaP on Day 0, MMR on Day 30
Varicella vaccine: lyophilized powder, subcutaneous injection
DTaP: intramuscular injection
MMR: lyophilized powder, subcutaneous injection
Group B (Varicella vaccine and MMR co-administration group )
Participants will receive a single dose of varicella vaccine and MMR on Day 0 and DTaP vaccine on Day 30.
Varicella vaccine+MMR on Day 0，DTaP on Day 30
Varicella vaccine: lyophilized powder, subcutaneous injection
MMR: lyophilized powder, subcutaneous injection
DTaP: intramuscular injection
Group C (Varicella vaccine group )
Participants will receive a single dose of varicella vaccine on Day 0.
Varicella Vaccine
lyophilized powder, subcutaneous injection
Interventions
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Vaicella Vaccine+DTaP on Day 0, MMR on Day 30
Varicella vaccine: lyophilized powder, subcutaneous injection
DTaP: intramuscular injection
MMR: lyophilized powder, subcutaneous injection
Varicella vaccine+MMR on Day 0，DTaP on Day 30
Varicella vaccine: lyophilized powder, subcutaneous injection
MMR: lyophilized powder, subcutaneous injection
DTaP: intramuscular injection
Varicella Vaccine
lyophilized powder, subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* 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.
18 Months
24 Months
ALL
Yes
Sponsors
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Sinovac (Dalian) Vaccine Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chongqing Center for Disease Control and Prevention
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO-VZV-4008
Identifier Type: -
Identifier Source: org_study_id
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