At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older on day of inclusion
- ✓Able to attend scheduled visits and comply with study procedures
- ✓In reasonably good health as assessed by investigator
- ✓Willing and able to give informed consent
- ✕Allergy to egg proteins, chicken proteins, or vaccine constituents (thimerosal, formaldehyde)
- ✕Acute illness with or without fever (≥99.5°F oral) within 72 hours before enrollment
- ✕History of severe adverse event to any influenza vaccine
- ✕Laboratory-confirmed influenza infection or vaccination against influenza within 6 months before enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Annual Study of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2005-2006 Formulation)
In Brief
A Phase 4 clinical trial evaluating Fluzone®: Influenza Virus Vaccine for Influenza. Completed, enrolled 120 participants across 1 site.
Detailed Summary
To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged ≥ 60 years. To describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone, in subjects aged 18-59 years and subjects aged ≥ 60 years. To submit remaining available sera to the Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular
0.5 mL, Intramuscular