Varicella (Chickenpox), Varicella Immunisation
Conditions
Brief 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.
Interventions
BIOLOGICALVaricella Vaccine
Varicella vaccine manufactured by Sinovac
Sponsors
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy children aged 1-12 years; 2. Vaccination history: * Participants aged 1 year old: no vaccination history with any varicella containing vaccine; * Participants aged 2\~12 years old: no vaccination history with any varicella containing vaccine, or have received 1 dose of varicella vaccine at least 3 months before enrollment; 3. Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily; 4. Participants are able to comply with the study procedures based on the assessment of the investigator; 5. Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
Exclusion criteria
1. Prior history of VZV infection; 2. Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment; 3. Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema; 4. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection); 5. Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture; 6. 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; 7. Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection; 8. 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; 9. Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial; 10. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial; 11. Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period; 12. Receipt of attenuated live vaccines or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening; 13. Fever on vaccination day, with axillary temperature \>37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination; 14. Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions; 15. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections; 16. Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history | 42 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history | 42 days after vaccination |
| The Geometric Mean Concentration(GMC) of VZV antibodies in total population | 42 days after vaccination |
| The seropositive rate of VZV antibodies in total population | 42 days after vaccination |
| The geometric mean fold rise (GMFR) of VZV antibodies in total population | 42 days after vaccination |
| The geometric mean fold rise (GMFR) of VZV antibodies among population with varicella immunization history | 42 days after vaccination |
| The geometric mean concentration (GMC) of VZV antibodies among population with varicella immunization history | 42 days after vaccination |
| The seropositive rate of VZV antibodies among population with varicella immunization history | 42 days after vaccination |
Countries
Vietnam
Contacts
CONTACTPham Thi Van Anh
Outcome results
None listed