The reactogenicity and immunogenicity of whole-virus and split-product influenza vaccines were studied in 77 children between the ages of 6 and 36 months. Subjects initially received monovalent vaccine containing either A/USSR/77 (H1N1) antigen in 1978 or A/Brazil/78 (H1N1) antigen in 1979. One month later a trivalent preparation was given which contained the respective H1N1 antigen plus A/Texas/77 (H3N2) and B/Hong Kong/72 antigens. Temperatures of ≥37.8 C (≥100 F) were observed more commonly after initial vaccination with whole-virus vaccine (35%) than after split-product vaccine (14%). No child had a temperature of ≥39.4 C (103 F) or a febrile convulsion. The trivalent vaccines were more reactogenic than the monovalent vaccines although none of the reaction indices exceeded 0.9. The whole-virus vaccine appeared to be more immunogenic, especially in those children who were initially seronegative (preimmunization hemagglutination-inhibiting antibody titer 5). Only 50% of children vaccinated with split-product vaccines with initial hemagglutination-inhibiting titers of 5 achieved titers of ≥20 to the H1N1 antigen after two doses of vaccine compared with 97% in similar whole-virus vaccine recipients. The degree of antibody response to the A/Texas/77 component of the vaccines was greater than the response to the A/Brazil/78 or A/USSR/77 antigens.
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