Influenza
Conditions
Keywords
influenza, vaccine, immunogenicity
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 (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
Interventions
BIOLOGICALnon-elderly aged between 18 and 60
one dose of 0.5mL AdimFlu-S
BIOLOGICALelderly aged over 60
one dose of 0.5mL AdimFlu-S
Sponsors
Adimmune Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40. | 3 weeks post vaccination | Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI). |
Countries
Taiwan
Outcome results
None listed