Single-dose trials of monovalent A/New Jersey/76 (Hsw1N1) influenza virus vaccine in children in Durham, North Carolina.

Ninety-two children received single doses of one of 13 monovalent vaccines derived from influenza virus strain A/New Jersey/8/76 (A/NJ), and 18 children received placebo. Five influenza virus vaccines were whole-virus vaccines, and eight were split-product vaccines. Samples of sera were taken once three weeks after vaccination. All of the 29 children receiving whole-virus vaccines developed a titer of antibody to A/NJ virus of greater than or equal to 1:20, and the geometric mean titers were 1:14-1:45. One of the 60 children who received split-product vaccines developed a titer of antibody to A/NJ of greater than or equal to 1:20, and geometric mean titers were all less than 1:10. There was a trend toward correlation between titers of hemagglutination-inhibiting (HAI) antibody to A/NJ and titers of HAI antibody to A/Victoria/3/75 viruses, with a correlation coefficient of 0.40 for children who received whole-virus vaccines. Three of 60 recipients of split-product vaccines and two of 20 recipients of whole virus developed a fever of greater than or equal to 38 C. One of the two febrile children who had received whole-virus vaccine had otitis media. Therefore, reactogenicity of whole-virus vaccines and split-product vaccines appeared to be similar in these children.