Document Detail

Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study.
MedLine Citation:
PMID:  19934787     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Infants less than 6 months of age are at high risk for influenza disease and influenza-related complications, but no vaccine is licensed for this population. METHODS: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6 to 12 weeks of age. Subjects received 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone, sanofi pasteur; N = 915) or placebo (N = 460) 1 month apart in combination with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following vaccination, and unsolicited adverse events for 28 days. Hemagglutination-inhibition antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose. RESULTS: No significant differences were seen between TIV and placebo groups for any safety outcome. Fever > or =38 degrees C within 3 days of vaccination was seen in 11.2% versus 11.7% of TIV versus placebo recipients. Serious adverse events within 28 days were reported in 1.9% of TIV and 1.5% of placebo recipients. Antibody responses to childhood vaccines were similar in both groups. Increased influenza-specific antibody responses in TIV recipients compared with placebo recipients were seen against all 3 strains in TIV recipients (P < 0.001), with better responses to influenza A strains noted. Reciprocal geometrical mean titer to H1N1, H3N2, and B were 33, 95, and 11 in TIV recipients versus 7, 9, and 5 for placebo recipients. Over 90% of TIV recipients had antibody > or =1:40 for at least 1 vaccine strain and 49.6% for 2 strains, versus 16.4% and 0.9% in placebo-recipients. CONCLUSIONS: TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.
Janet A Englund; Emmanuel Walter; Steven Black; Mark Blatter; Jack Nyberg; Frederick L Ruben; Michael D Decker;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  29     ISSN:  1532-0987     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  2010 Feb 
Date Detail:
Created Date:  2010-02-01     Completed Date:  2010-03-30     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  105-10     Citation Subset:  IM    
Department of Pediatrics, Division of Infectious Diseases, Children's Hospital Research Institute, University of Washington, Seattle, WA, USA.
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MeSH Terms
Antibodies, Viral / blood
Double-Blind Method
Drug Toxicity
Hemagglutination Inhibition Tests
Immunization, Secondary / methods
Influenza Vaccines / adverse effects*,  immunology*
Influenza, Human / prevention & control*
Placebos / administration & dosage
United States
Vaccination / methods
Vaccines, Inactivated / adverse effects,  immunology
Reg. No./Substance:
0/Antibodies, Viral; 0/Influenza Vaccines; 0/Placebos; 0/Vaccines, Inactivated
Wilson Andrews / ; Marshall Benbow / ; Dean Blumberg / ; John Buttler / ; Kathie Coopersmith / ; Matthew Cox / ; Anton Duke / ; Alvin Gabrielsen / ; Stanley Grogg / ; Edward Goldblatt / ; David Hurley / ; David Johnson / ; Nicola Klein / ; Richard Kratz / ; Paul Lei / ; Stephen Luber / ; Michael Lauret / ; Andrea McCoy / ; David Matson / ; Alfred Phillips / ; Robert Roskin / ; Joan Roberts / ; Shelly Sender / ; Jane Sneed / ; Tracy Stewart / ; David Weed / ; Leonard Weiner / ; Kenneth Zollo /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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