VZV, Varicella Immunisation
Conditions
Brief summary
The goal of this clinical trial is to evaluate the immunogenicity and safety of booster immunization of varicella live attenuated vaccine (varicella vaccine hereafter) at different intervals.
Interventions
BIOLOGICALVaricella vaccine
lyophilized powder, subcutaneous injection
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
7 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy children aged 7-12 years; * Has previously received a single dose of varicella vaccine, with at least 3 months since the first dose; * The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old); * Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures; * Provide legal identity proof;
Exclusion criteria
* History of varicella; * History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.); * Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease; * With any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy); * With a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases; * With encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of Guillain-Barre syndrome; * Body temperature \>37℃ at the time of vaccination; * Receipt of blood products within 3 months before receiving investigational vaccine; * Receipt of another study drug within 30 days before receipt of the investigational vaccine; * Receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine; * Receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine; * Participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months; * The participant had any other factors that were ineligible for vaccination by in the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titer (GMT) of varicella-zoster virus (VZV) antibodies | 30 days after booster dose immunization | GMT of VZV antibodies 30 days after booster dose immunization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate of varicella-zoster virus (VZV) antibodies | 30 days after booster dose immunization | Seroconversion rate of VZV antibodies 30 days after booster dose immunization |
| Seropositive rate of varicella-zoster virus (VZV) antibodies | 30 days after booster dose immunization | Seropositive rate of VZV antibodies 30 days after booster dose immunization |
| Geometric mean increase (GMI) of varicella-zoster virus (VZV) antibodies | 30 days after booster dose immunization | GMI of VZV antibodies 30 days after booster dose immunization |
Countries
China
Outcome results
None listed