Status:
COMPLETED
A Phase I Clinical Trial for Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Adults in China
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Jiangsu Jindike Biotechnology Co., Ltd.
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract...
Detailed Description
Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract...
Eligibility Criteria
Inclusion
- Aged from 18 to 49 years old
- Healthy adults judged from medical history and clinical examination
- Subjects able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature \<=37.0°C on axillary setting
Exclusion
- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
- Any prior administration of influenza vaccine in last 6 month
- Subject who is allergic to any ingredient of the vaccine
- Female subject with a positive result after urine pregnancy test or during pregnancy or baby nursing period
- Subject with damaged or low immune function which has already been known
- Subject who had a seasonal influenza medical history in last 6 months
- Subject with acute febrile illness or infectious disease
- Major congenital defects or serious chronic illness, including perinatal brain damage
- Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
- Subject who has serious allergic history
- Subject with other medical history not suitable for vaccination such as fainting during injection or acupuncture treatment
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of other research medicine/vaccine in last 30 days
- Any prior administration of any attenuated live vaccine in last 30 days
- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02269007
Start Date
May 1 2015
End Date
September 1 2015
Last Update
October 14 2015
Active Locations (1)
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1
Guanyun County Center for Disease Control and Prevention
Liangyungang, Jiangsu, China