Status:
COMPLETED
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Seasonal Influenza
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged over 3 years
Detailed Description
This study is a phase I\& III clinical trial. Phase I is open-labelled, and phase III is randomized, double-blind, active-controlled. The purpose of this study is to evaluate the safety and immunogeni...
Eligibility Criteria
Inclusion
- Healthy volunteers aged ≥3 years;
- Proven legal identity;
- Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
Exclusion
- Prior vaccination with influenza vaccine of the current year;
- History of influenza within 6 months prior to study entry;
- Axillary temperature \> 37.0 °C;
- History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;
- Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;
- Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
- History of asthma, thyroidectomy, angioedema, diabetes or malignancy;
- No spleen, or functional no spleen, or splenectomy.
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2018
Estimated Enrollment :
2380 Patients enrolled
Trial Details
Trial ID
NCT03853993
Start Date
January 23 2018
End Date
October 8 2018
Last Update
February 27 2019
Active Locations (2)
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1
Guanyun Center for Disease Control and Prevention
Lianyungang, Jiangsu, China, 222200
2
Pizhou Center for Disease Control and Prevention
Pizhou, Jiangsu, China, 221300