Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children Aged 1~12 Yea… (NCT07473427) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children Aged 1~12 Years: A Single-armed Bridging Clinical Trial
Vietnam300 participantsStarted 2026-05-01
Plain-language summary
This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.
Who can participate
Age range1 Year – 12 Years
SexALL
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Inclusion criteria
✓. Healthy children aged 1-12 years;
✓. Vaccination history:
✓. Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily;
✓. Participants are able to comply with the study procedures based on the assessment of the investigator;
✓. Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
Exclusion criteria
✕. Prior history of VZV infection;
✕. Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;
✕. Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
✕. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
✕. Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
✕. Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
What they're measuring
1
The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history
✕. Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
✕. Current or history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding history of febrile seizures\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;