Trivalent Inactivated Influenza Virus Vaccine Given to Two-Month-Old Children An Off-Season Pilot Study

Background: Although children less than 6 months of age have the highest risk for hospitalization related to influenza infection, influenza vaccine is not approved for these children. Methods: In an open-label, off-season study, healthy 6 to 12 week and 6-month-old children received 2 doses of the 2004 to 2005 trivalent inactivated influenza vaccine (TIV) administered I month apart along with other routine pediatric vaccines. Safety was assessed by parental diaries (n = 393). Immunogenicity analyses (n = 293) were performed on sera obtained before vaccination and I month after the second dose of TIV. Outcomes included the frequencies of subjects with injection site and systemic reactions and seroprotection rates to TIV antigens. Results: Injection site reactions and fevers were generally mild and resolved within 3 days. Postvaccination seroprotection rates (titer 1:40) in the 6- to 12-week-old and 6-month-old groups were 46% and 69% to A/New Caledonia (H1N1), 59% and 79% to A/Wyoming (H3N2), and 5% and 22% to B/Jiangsu (P < 0.001, all comparisons). For seronegative 6- to 12-week-olds whose mothers had not received TIV during pregnancy, postvaccination seroprotective titers to A/New Caledonia (H1N1) were achieved in 70% (38/54) and to A/Wyoming (H3N2) in 68% (23/34) of infants. Conclusions: TIV was well tolerated and safe when administered to children at both 6 to 12 weeks and 6 months of age. The antibody response was lower in the younger children, probably related to antibody suppression from passively acquired antibodies from mothers. In 6- to 12-weekolds without preexisting antibody, seroresponses to influenza A antigens approached those of 6-month-old children.