Status:
COMPLETED
The Immunogenicity and Safety of 2013-2014 Seasonal Trivalent Influenza Vaccine
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Influenza
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 ...
Eligibility Criteria
Inclusion
- For adults and seniors:
- Healthy adults aged 18-60 years old, and healthy seniors aged \> 60 years old;
- Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- No traveling plan during the study period of this trial;
- Be able to understand and sign the informed consent;
Exclusion
- Allergic to egg products or any ingredient of the study vaccine;
- Fever, influenza or acute illness on the vaccination day;
- Acute stage of chronic illness;
- Malignant tumor;
- Immunodeficiency, includes HIV infection;
- Guillain-Barre syndrome;
- Administration of live attenuated vaccine within the previous 14 days;
- Administration of subunit or inactivated vaccine within the previous 7 days;
- Planned to participate in any other clinical trial of drug or vaccine during this study;
- Received immunesuppressive treatment within the previous month, or planned for such treatment during this study;
- Pregnant, or planning pregnancy;
- Axillary temperature \> 37.0℃;
- Any other factors that, in the judgment of the investigator, is unsuitable for this study;
- For infants:
- Inclusion Criteria:
- Healthy male or female aged between 6 and 35 months;
- Full-term birth, birth weight 2,500 grams or more;
- Provided birth certification or vaccination card
- Parent or legal guardian is able to understand and sign the informed consent;
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT02269852
Start Date
December 1 2013
End Date
June 1 2014
Last Update
September 21 2015
Active Locations (1)
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1
Guzhen Center for Diseases Control and Prevention
Bengbu, Anhui, China