A randomized controlled trial of cold-adapted and inactivated vaccines for the prevention of influenza A disease.

Edwards KM, Dupont WD, Westrich MK, Plummer WD, Palmer PS, Wright PF
J Infect Dis. 1994 169 (1): 68-76

PMID: 8277200 · DOI:10.1093/infdis/169.1.68

A double-blind, randomized controlled trial over 5 years compared the safety, immunogenicity, and efficacy of cold-adapted and inactivated influenza A vaccines in 5210 normal subjects. Both vaccines were well tolerated. Inactivated vaccine significantly increased hemagglutination inhibition antibody titers. Significant titer rises were also noted after cold-adapted vaccine but of lesser magnitude than with inactivated vaccine. The efficacy of inactivated vaccine in preventing culture-positive influenza was 76% (95% confidence interval [CI], 58%-87%) for H1N1 disease and 74% (95% CI, 52%-86%) for H3N2; for cold-adapted vaccine, 85% (95% CI, 70%-92%) and 58% (95% CI, 29%-75%), respectively. The efficacy of inactivated vaccine in preventing a four-fold rise in antibody titer over the influenza season was 69% (95% CI, 61%-76%) for H1N1 and 73% (95% CI, 65%-79%) for H3N2; for cold-adapted vaccine, 54% (95% CI, 44%-62%) and 32% (95% CI, 17%-44%), respectively. Cold-adapted and inactivated influenza vaccines are safe and effective for preventing influenza A disease.

MeSH Terms (23)

Administration, Intranasal Adolescent Adult Analysis of Variance Animals Antibodies, Viral Child Child, Preschool Double-Blind Method Female Hemagglutination Tests Humans Immunization, Secondary Infant Influenza, Human Influenza A virus Influenza Vaccines Injections, Intramuscular Macaca mulatta Male Middle Aged Vaccines, Attenuated Vaccines, Inactivated

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