Status:
COMPLETED
Simultaneous Administration Study of Varicella Attenuated Live Vaccine and Trivalent Inactivated Influenza Vaccine (Split Virion)
Lead Sponsor:
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Conditions:
Varicella
Influenza Vaccine
Eligibility:
All Genders
7-12 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate the immunogenicity of simultaneous administration of varicella live attenuated vaccine (varicella vaccine hereafter) and trivalent inactivated influenza ...
Eligibility Criteria
Inclusion
- Healthy children aged 7-12 years;
- 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
- Vaccination history of varicella vaccine;
- Had received a single dose of influenza vaccine for 2024-2025 season;
- 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 15 2024
Estimated Enrollment :
899 Patients enrolled
Trial Details
Trial ID
NCT06987942
Start Date
September 21 2024
End Date
November 15 2024
Last Update
May 23 2025
Active Locations (1)
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1
Jiangsu Provincial Center for Disease control and Prevention
Nanjing, Jiangsu, China, 210009