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

Launched by SINOVAC (DALIAN) VACCINE TECHNOLOGY CO., LTD. · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a vaccine called the live attenuated varicella vaccine, which helps protect against chickenpox. The researchers want to find out how well this vaccine works when given at the same time as two other vaccines: the MMR vaccine (which protects against measles, mumps, and rubella) and the DTaP vaccine (which protects against diphtheria, tetanus, and pertussis). They are also checking to see if giving these vaccines together is safe for young children.

To participate in this trial, children must be between 18 and 24 months old and should have received their first doses of the MMR and DTaP vaccines but not the full series yet. Parents or guardians must be able to understand the study and give consent. During the trial, children will receive the vaccines, and the researchers will monitor them for any side effects or reactions. It’s important to know that certain health conditions or previous vaccinations may make a child ineligible to join the study. If you have questions about your child's participation, it's best to talk with a healthcare provider.

Gender

ALL

Eligibility criteria

• 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;
• • 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.