Clinical trials : journal of the Society for Clinical Trials
-
Randomized Controlled Trial Comparative Study
A cluster randomized controlled trial comparing relative effectiveness of two licensed influenza vaccines in US nursing homes: Design and rationale.
Influenza, the most important viral infection affecting older adults, produces a substantial burden in health care costs, morbidity, and mortality. Influenza vaccination remains the mainstay in prevention and is associated with reduced rates of hospitalization, stroke, heart attack, and death in non-institutional older adult populations. Influenza vaccination produces considerably lower antibody response in the elderly compared to young adults. Four-fold higher vaccine antigen (high-dose) than in the standard adult vaccine (standard-dose) elicits higher serum antibody levels and antibody response in ambulatory elderly. ⋯ This high-dose influenza vaccine trial uniquely offers a paradigm for future studies of clinical and programmatic interventions within the framework of efforts designed to test the impact of changes in usual treatment practices adopted by health care systems.