Status:
COMPLETED
Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects
Lead Sponsor:
Adimmune Corporation
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition ...
Eligibility Criteria
Inclusion
- Males or non-pregnant females and aged ≥ 18 years;
- Willing and able to adhere to visit schedules and all study requirements;
- Subjects read and signed the study-specific informed consent.
Exclusion
- Subject or his/her family is employed by the participated hospital;
- Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
- History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication
- Personal or family history of Guillain-Barré Syndrome
- An acute febrile illness within 1 week prior to vaccination;
- Current upper respiratory illness, including the common cold or nasal congestion within 72 hours
- Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough
- Female subjects who are pregnant during the study
- Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent
- Immunodeficiency, or under immunosuppressive treatment
- Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
- Receipt of any blood products, including immunoglobulin in the prior 3 months;
- Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT01411358
Start Date
August 1 2011
End Date
March 1 2012
Last Update
July 12 2012
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan