Study on Booster Immunization With Varicella Vaccine at Different Intervals
- Registration Number
- NCT06994052
- Lead Sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 412
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Varicella vaccine Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination. Group B Varicella vaccine Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination. Group C Varicella vaccine Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination. Group D Varicella vaccine Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Jiangsu Provincial Center for Disease control and Prevention
🇨🇳Nanjing, Jiangsu, China