title: A randomized controlled trial of cold-adapted and inactivated vaccines for the prevention of influenza A disease.
abstract: 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.
authors.affiliation: Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, Tennessee 37232-2581.
authors.forename: K M
authors.initials: KM
authors.lastname: Edwards
authors.forename: W D
authors.initials: WD
authors.lastname: Dupont
authors.forename: M K
authors.initials: MK
authors.lastname: Westrich
authors.forename: W D
authors.initials: WD
authors.lastname: Plummer
authors.forename: P S
authors.initials: PS
authors.lastname: Palmer
authors.forename: P F
authors.initials: PF
authors.lastname: Wright
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006386:Hemagglutination Tests; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D009980:Influenza A virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control*; D007273:Injections, Intramuscular; D008253:Macaca mulatta; D008297:Male; D008875:Middle Aged; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated; D015164:Vaccines, Inactivated