Linked Life Data

21219987

Source:http://linkedlifedata.com/resource/pubmed/id/21219987

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
10
pubmed:dateCreated
2011-2-22
pubmed:abstractText
A randomized placebo-controlled double-blind trial of a nasally administered inactivated trivalent influenza vaccine formulated with partially purified meningococcal outer membrane proteins (OMP-TIV) was conducted in 1349 healthy adults aged 18-64 years. Subjects received either vaccine containing 15 ?g of haemagglutinin (HA) of each of three influenza strains for the 2003-2004 season on days 0 and 14, or 30 ?g on day 0 and saline placebo on day 14, or placebo on days 0 and 14. Vaccination was well tolerated, with similar reactogenicity as placebo. Compared to placebo, statistically significant increases in mean serum haemagglutinin inhibition reciprocal titers and salivary secretory IgA to all 3 antigens were seen on day 28 for both vaccine dose groups. The incidence of culture-positive influenza and fever >37.8°C and cough and one or more of sore throat, runny nose or nasal congestion, muscle or joint ache, headache, fatigue, or chills or culture positive influenza and at least two of these symptoms was low (16/1349; 1.2%). In the intent-to-immunize population too few febrile culture-confirmed illness events (n=4) occurred to perform analysis. Fever occurred infrequently, even in the presence of positive cultures and disabling multi-symptom disease. In participants receiving all doses of either vaccine regimen the incidence of culture-confirmed influenza with respiratory symptoms and with or without fever was 0.77% (7/904) vs. 2.03% (9/443) in placebo recipients (p=0.045, Fisher's exact test; relative risk reduction 62%), despite circulation of a drift variant A/H3N2 that was poorly matched to vaccine. An OMP-TIV vaccine was well tolerated and reduced risk of symptomatic culture confirmed influenza. Vaccine efficacy will need to be validated in a season with a higher attack rate.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Feb
pubmed:issn
1873-2518
pubmed:author
pubmed:copyrightInfo
Copyright © 2011 Elsevier Ltd. All rights reserved.
pubmed:issnType
Electronic
pubmed:day
24
pubmed:volume
29
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1921-8
pubmed:meshHeading
pubmed-meshheading:21219987-Adjuvants, Immunologic, pubmed-meshheading:21219987-Adolescent, pubmed-meshheading:21219987-Adult, pubmed-meshheading:21219987-Antibodies, Viral, pubmed-meshheading:21219987-Bacterial Outer Membrane Proteins, pubmed-meshheading:21219987-Double-Blind Method, pubmed-meshheading:21219987-Female, pubmed-meshheading:21219987-Hemagglutination Inhibition Tests, pubmed-meshheading:21219987-Humans, pubmed-meshheading:21219987-Immunity, Mucosal, pubmed-meshheading:21219987-Immunization, Secondary, pubmed-meshheading:21219987-Immunoglobulin A, Secretory, pubmed-meshheading:21219987-Influenza, Human, pubmed-meshheading:21219987-Influenza Vaccines, pubmed-meshheading:21219987-Male, pubmed-meshheading:21219987-Middle Aged, pubmed-meshheading:21219987-Neisseria meningitidis, pubmed-meshheading:21219987-Placebos, pubmed-meshheading:21219987-Saliva, pubmed-meshheading:21219987-Time Factors, pubmed-meshheading:21219987-Vaccination, pubmed-meshheading:21219987-Vaccines, Inactivated, pubmed-meshheading:21219987-Young Adult
pubmed:year
2011
pubmed:articleTitle
A nasally administered trivalent inactivated influenza vaccine is well tolerated, stimulates both mucosal and systemic immunity, and potentially protects against influenza illness.
pubmed:affiliation
Canadian Centre for Vaccinology, Dalhousie University and IWK Health Centre, Halifax, Canada. joanne.langley@dal.ca
pubmed:publicationType
Journal Article, Randomized Controlled Trial