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Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE4

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

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

NCT06891872•Sinovac (Dalian) Vaccine Technology Co., Ltd.

View on ClinicalTrials.gov

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. The secondary objective is to evaluate the safety of the vaccines when administered simultaneously.

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.

Eligibility

Age

1 - 2 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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;
•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;
+5 more criteria

Locations (1)

Chongqing Center for Disease Control and Prevention

Chongqing, China

Key Dates

Start Date

May 1, 2025

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

March 24, 2025

Enrollment

720

ESTIMATED participants

Conditions

Varicella (chickenpox)MMR VaccineDTaP Vaccine

Interventions

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

BIOLOGICAL

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

BIOLOGICAL

Varicella Vaccine

BIOLOGICAL

Contacts

XU Jiawei

CONTACT

023-68813088 452712782@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Second Dose of Varicella Vaccine in Healthy Children

Pertussis Vaccination Among HIV-infected and HIV-uninfected Pregnant Women

Safety & Immunogenicity of MMR Vaccine by DSJI to That by Needle-Syringe in 15-18 Months Old Children

The Effectiveness of Varicella Vaccination in Children in Germany