[A trial to study the effect of influenza vaccination in the elderly: ethical, feasible and badly needed].

Based on current research, there are no valid reasons to assume that influenza vaccination of people aged 60 and over without any other medical indications, in the context of the national programme of influenza prevention, leads to significant, relevant and cost-effective health benefits. In view of the pressure on health care budgets and the decreasing social willingness to vaccinate, it is of great and urgent importance that the actual effect of influenza vaccination is quantified in a double-blind placebo-controlled randomized trial (RCT) with relevant outcome measures, which does not suffer from the methodological shortcomings of the few previous studies. In order to demonstrate a 10% reduction in hospitalisation for respiratory infections, this RCT should include approximately 100,000 subjects and follow these participants for three years. We consider such a trial feasible in the Dutch situation.