| Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study. | |
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MedLine Citation:
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PMID: 19934787 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Janet A Englund; Emmanuel Walter; Steven Black; Mark Blatter; Jack Nyberg; Frederick L Ruben; Michael D Decker; |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Pediatric infectious disease journal Volume: 29 ISSN: 1532-0987 ISO Abbreviation: Pediatr. Infect. Dis. J. Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-02-01 Completed Date: 2010-03-30 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8701858 Medline TA: Pediatr Infect Dis J Country: United States |
Other Details:
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Languages: eng Pagination: 105-10 Citation Subset: IM |
Affiliation:
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Department of Pediatrics, Division of Infectious Diseases, Children's Hospital Research Institute, University of Washington, Seattle, WA, USA. Janet.Englund@seattlechildrens.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Antibodies, Viral
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blood Double-Blind Method Drug Toxicity Hemagglutination Inhibition Tests Humans Immunization, Secondary / methods Infant Influenza Vaccines / adverse effects*, immunology* Influenza, Human / prevention & control* Placebos / administration & dosage United States Vaccination / methods Vaccines, Inactivated / adverse effects, immunology |
| Chemical | |
Reg. No./Substance:
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0/Antibodies, Viral; 0/Influenza Vaccines; 0/Placebos; 0/Vaccines, Inactivated |
| Investigator | |
Investigator/Affiliation:
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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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