Status:
COMPLETED
Study on Booster Immunization With Varicella Vaccine at Different Intervals
Lead Sponsor:
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Conditions:
VZV
Varicella Immunisation
Eligibility:
All Genders
7-12 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT06994052
Start Date
September 21 2024
End Date
November 30 2024
Last Update
May 29 2025
Active Locations (1)
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1
Jiangsu Provincial Center for Disease control and Prevention
Nanjing, Jiangsu, China, 210009