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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.

To describe the design considerations of a large clinical trial of high-dose compared to standard-dose influenza vaccine in nursing homes and baseline characteristics of participating nursing homes and long-stay (more than 90 days) residents over 65 years of age.

The high …