Influenza Clinical Trial
Official title:
An Open-Label Exploratory Clinical Study to Evaluate the Antibody and Cell Mediated Immunity of One Intramuscular Dose of MF59-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 to 60 Years
The purpose of this study is explore the antibody and cell mediated immune responses to one injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.
This will be a Phase IV open-label clinical profiling study. The population to be enrolled
will consist of healthy adults aged 18-60 years. A total of approximately 60 subjects are
planned for enrolment into this study.
Subjects enrolled in this study will receive 7.5 µg of vaccine + MF59 (9.75 mg/dose). Each
subject will receive one 0.5 mL IM dose (deltoid muscle, non-dominant arm) of H1N1sw vaccine
at Visit 1, after the blood draw. Up to 70 mL of blood will be drawn for CMI and antibody
assessment from all subjects at all study visits.
Subjects will be requested to declare occurrence of influenza-related symptoms during the
study period. Whenever appropriate, subjects might be asked to provide throat swab for viral
typing. Subjects with laboratory confirmed H1N1sw influenza might be asked to provide one
blood sample (70 mL) within 4 weeks after influenza resolution.
Although this study is not designed nor powered to draw conclusions regarding safety and
tolerability, all subjects will be followed, but not analyzed, for safety throughout the
study. After vaccination, all subjects will remain under medical supervision at the study
site for 30 minutes to be monitored and evaluated for possible immediate hypersensitivity
reactions. All study subjects will be instructed on the completion of diary cards to record
local and systemic reactions for seven days, starting on the day of vaccination and
continuing during the 6 following days. The same diary cards will additionally be used to
collect any vaccine-related reactions and any changes in the subject's health (including any
serious medical problems such as hospitalizations or any life-threatening medical problems)
and any medications taken by the subject throughout the study. All serious adverse events
and all adverse events will be recorded throughout the entire trial.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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