The placebo-controlled trial will enroll 240 children ages 18 months to six years. Traditionally, the elderly and people with chronic health problems that put them at high risk for severe illness or complications from the flu have been the major targets of influenza vaccine campaigns. School-age children, however, are major carriers of the flu virus and thus help fuel epidemic spread of the illness.
Children pass the virus among themselves at school, and then bring it home to their parents.
The experimental vaccine is made from a live but weakened influenza virus that cannot cause the flu but stimulates anti-influenza antibodies in the respiratory tract. In prior clinical tests, the nose drop form of the vaccine has been shown to be safe and effective in children and adults. Influenza affects up to one-quarter of the U.S. population each year. Epidemics usually occur from late fall to early spring. About 30,000 people in the United States die from influenza and its complications each year.