This was a phase 4 clinical trial was to evaluate the safety of 1 new 6:2 influenza virus reassortant in adults. The study enrolled 300 healthy adults 18 through 49 years of age at 2 study sites, each site randomizing 150 subjects. Each patient received in a 4:1 fashion either a single dose of the monovalent vaccine or placebo by nasal spray and was followed for 180 days.
All study procedures and medication were provided at no cost and financial compensation was available for time and travel to the study site.
All information provided was stored in a secure site, and cannot be released to any third party without the subject’s written and signed authorization.
Influenza is a viral infection that attacks your respiratory system. Your nose, throat and lungs. Influenza, commonly called the flu, is not the same as stomach “flu” viruses that cause diarrhea and vomiting. For most people, influenza resolves on its own. But sometimes, influenza and its complications can be deadly. People at higher risk of developing flu complications include:
- Young children under 5, and especially those under 2 years
- Adults older than 65
- Residents of nursing homes and other long-term care facilities
- Pregnant women and women up to two weeks postpartum
- People with weakened immune systems
- People who have chronic illnesses, such as asthma, heart disease, kidney disease and diabetes
- People who are very obese, with a body mass index (BMI) of 40 or higher
Your best defense against influenza is to receive an annual vaccination.