Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novavax
Age
60–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \>38.0°C on the planned day of vaccine administration).
Known disturbance of coagulation.
Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
You may not be if
1. Subjects on stable (no change in ≥ 2 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with current symptoms or disability.
2. Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with asymptomatic mitral valve prolapse).
3. Other clinically insignificant findings, not deemed to be associated with increased risk due to respiratory viral infections as determined by the Investigator.
Free of other illnesses which are believed to increase the risk of influenza or influenza related complications including: diabetes mellitus, congenital or acquired blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.
Willing and able to give informed consent prior to study enrollment.
Able to comply with study requirements.
Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination and/or planned participation at any time during the study.
History of a serious reaction to any prior vaccination or known allergy to constituents of licensed TIV (e.g., egg proteins).
History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
Receipt of any influenza vaccine within the preceding 3 months.
Receipt of any vaccine in the 4 weeks preceding the study vaccination and planned receipt of a licensed vaccine any time prior to Day 56.
Receipt of an RSV vaccine at any time.
Any known or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination.
