Background: The need for up-to-date flu vaccines is always present, especially since some populations are at risk. Taking into consideration all peculiarities of the group of elderly subjects, Smooth Drug Development organized the conduct of a clinical study of a flu vaccine on people of over 60, the study was initiated by a leading vaccine company.
About the trial: Our responsibilities in the trial included developing essential documentation, selecting and approving sites, data management, monitoring, and final report preparation. Our task was to intake into account all the peculiarities of the elderly population. The study included 320 subjects at 2 centers.
Challenges: The recruitment of subjects fell at the beginning of the COVID-19 pandemic, so we faced the problem of lockdowns. Older people were found to be at risk, so they did not have the opportunity to come to the sites for visits. Some sites refused to participate in the study so we ended up with 2 enrolling sites. In order to meet the project deadlines, we organized field teams of doctors and nurses together with the centers. Medical teams visited patients at home to administer the vaccine, collect bio-samples for immunogenicity, and monitor patient well-being. Coordinated work with the sites and the central laboratory allowed us to stay within the time frame stated by the Sponsor and ensure the safety of the subjects.
The study proved the efficacy and safety of the drug.