Status:
COMPLETED
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Seasonal Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.
Detailed Description
The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two dose...
Eligibility Criteria
Inclusion
- Healthy volunteer between 6 - 35 months old; Term birth; Birth weight \>2500g;
- Proven legal identity;
- Written consent of the guardian(s) of the volunteer;
Exclusion
- Received seasonal influenza vaccine in the current year;
- Suffering from seasonal influenza in the past 6 moths;
- Axillaty temperature \> 37.0 °C;
- History of allergy to any vaccine or vaccine ingredient;
- History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Autoimmune disease or immunodeficiency;
- Congenital malformation, developmental disorders;
- Severe malnutrition;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- History of epilepsy (except febrile seizures occurred \< 2 years of age or pure epilepsy occurred within the past 3 years that does not need treatment)
- Chronic diseases (e.g., viral hepatitis, tuberculosis, diabetes, blood diseases, or neurological disorders)
- Acute disease or acute stage of chronic disease;
- Receipt of any of the following products:
- Any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry;
- Any live attenuated vaccine within 30 days prior to study entry;
- Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
- Blood product within 3 months prior to study entry;
- Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
- Participate or will participate in other clinical trial(s) during this study;
- Based on the judgment of investigator(s) or the Ethic Committee, there was any condition indicating that the subject should be excluded;
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2018
Estimated Enrollment :
2340 Patients enrolled
Trial Details
Trial ID
NCT03859141
Start Date
February 6 2018
End Date
November 2 2018
Last Update
March 1 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Guanyun Center for Disease Prevention and Control
Lianyungang, Jiangsu, China, 222200
2
Pizhou Center for Disease Prevention and Control
Pizhou, Jiangsu, China, 221300