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Previous Volume 338:1405-1412 May 14, 1998 Number 20 Next

	Full Text PDF Editorial by Barnett, E. D. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Influenzavirus vaccine is used infrequently in healthy children, even though the rates of influenza in this group are high. We conducted a multicenter, double-blind, placebo-controlled trial of a live attenuated, cold-adapted, trivalent influenzavirus vaccine in children 15 to 71 months old.

Methods Two hundred eighty-eight children were assigned to receive one dose of vaccine or placebo given by intranasal spray, and 1314 were assigned to receive two doses approximately 60 days apart. The strains included in the vaccine were antigenically equivalent to those in the inactivated influenzavirus vaccine in use at the time. The subjects were monitored with viral cultures for influenza during the subsequent influenza season. A case of influenza was defined as an illness associated with the isolation of wild-type influenzavirus from respiratory secretions.

Results The intranasal vaccine was accepted and well tolerated. Among children who were initially seronegative, antibody titers increased by a factor of four in 61 to 96 percent, depending on the influenza strain. Culture-positive influenza was significantly less common in the vaccine group (14 cases among 1070 subjects) than the placebo group (95 cases among 532 subjects). The vaccine efficacy was 93 percent (95 percent confidence interval, 88 to 96 percent) against culture-confirmed influenza. Both the one-dose regimen (89 percent efficacy) and the two-dose regimen (94 percent efficacy) were efficacious, and the vaccine was efficacious against both strains of influenza circulating in 1996–1997, A(H3N2) and B. The vaccinated children had significantly fewer febrile illnesses, including 30 percent fewer episodes of febrile otitis media (95 percent confidence interval, 18 to 45 percent; P<0.001).

Conclusions A live attenuated, cold-adapted influenzavirus vaccine was safe, immunogenic, and effective against influenza A(H3N2) and B in healthy children.

Source Information

From the Department of Medicine, Saint Louis University, St. Louis (R.B.B.); Aviron, Mountain View, Calif. (P.M.M.); the Department of Medicine, University of Rochester, Rochester, N.Y. (J.T.); the Department of Pediatrics, University of Maryland at Baltimore, Baltimore (J.K., K.K.); the Department of Pediatrics, Vanderbilt University, Nashville (W.C.G.); the Department of Microbiology and Immunology, Baylor College of Medicine, Houston (P.P.); the Department of Pediatrics, Children's Hospital Medical Center, Cincinnati (D.I.B.); the Departments of Internal Medicine and Pathology, University of Virginia, Charlottesville (F.G.H.); Kaiser–UCLA Vaccine Program and the Department of Pediatrics, Harbor–UCLA Medical Center, Los Angeles (K.Z.); the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md. (D.I.); and Emmes Corporation, Potomac, Md. (M.W.). Other authors were Keith Reisinger, M.D. (Pittsburgh Pediatric Research, Pittsburgh), Stan L. Block, M.D. (Kentucky Pediatric Research, Bardstown), Janet Wittes, Ph.D. (Statistics Collaborative, Washington, D.C.), and Regina Rabinovich, M.D. (Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.).

Address reprint requests to Dr. Belshe at Saint Louis University Health Sciences Center, Division of Infectious Diseases, 3635 Vista Ave., FDT-8N, St. Louis, MO 63110.

Full Text of this Article

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Intranasal Influenzavirus Vaccine in Children
Edwards K. M., Dupont W. D., Dumois J., Belshe R. B., Gruber W. C., Mendelman P. M.
Extract | Full Text  
N Engl J Med 1998; 339:922-923, Sep 24, 1998. Correspondence

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