Status:
COMPLETED
Phase IV Clinical Trial of an Inactivated Influenza Split Vaccine
Lead Sponsor:
Hualan Biological Engineering, Inc.
Conditions:
Human Influenza
Eligibility:
All Genders
3+ years
Phase:
PHASE4
Brief Summary
Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to the influenza immun...
Detailed Description
Select three sites to conduct this study in Henan, china. In the principle of informed consent and voluntary participation, adopt randomized and control design and include 6000 healthy subjects, among...
Eligibility Criteria
Inclusion
- Healthy male or female aged 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
- Be able to abide by the requirement of clinical trial protocol to participate in follow up;
- Be willing to supply blood sample during clinical trial of vaccine and able to assist with filling out study data;
- Healthy male or female by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product;
- Be able to comply with the requirement of clinical trial protocol;
- Have no history of vaccination and vaccination with other product in latest 1 week;
- Axillary temperature ≤37℃.
Exclusion
- Any history of severe illness, such as tumor, autoimmune disease, etc.;
- Subject that was allergic to any component of the vaccine (any history of vaccination allergy), especially eggs;
- History of neurological symptom or physical signs;
- Known or suspected (or high possibility of occurrence) damage of or abnormal immune function;
- Bleeding physique or prolonged bleeding;
- History of influenza infection or vaccination at least once within the past 6 months;
- History of administration of other vaccine or injection of immunoglobulin, or any research drug within the past 1 week;
- Any acute disease that needs usage of antibiotics or antiviral therapy on the whole body within the past 7 days;
- Fever (axillary temperature≥38℃) within the past 3 days;
- Participating in another clinical trial;
- History of Guillain-Barre Syndrome, severe birth defect or severe disease, allergy, eclampsia, epilepsy, encephalopathy or psychosis or family disease;
- Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection;
- Known or suspected other diseases at the same time, including respiratory system disease, acute infection or active period of chronic disease, HIV infection of infant or mother, cardiovascular disease, during of treatment of cancer and skin disease;
- Any condition that, in the judgment of investigator, may affect trial assessment.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT01511744
Start Date
November 1 2011
End Date
March 1 2012
Last Update
August 14 2012
Active Locations (1)
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1
Henan Province Center for Disease Preventionand Control
Zhengzhou, Henan, China