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About:
Safety and Immunogenicity of MF59-Adjuvanted Cell Culture–Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly
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An Entity of Type :
schema:ScholarlyArticle
, within Data Space :
wasabi.inria.fr
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Type:
Academic Article
research paper
schema:ScholarlyArticle
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type
Academic Article
research paper
schema:ScholarlyArticle
isDefinedBy
Covid-on-the-Web dataset
has title
Safety and Immunogenicity of MF59-Adjuvanted Cell Culture–Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly
Creator
Tantawichien, Terapong
Richmond, Peter
Frey, Sharon
Chanthavanich, Pornthep
Hohenboken, Matthew
Jaehnig, Peter
Kittel, Claudia
Mojares, Zenaida
Shakib, Sepehr
Smith, Timothy
Verma, Bikash
Kanesa-Thasan, Niranjan
Source
PMC
abstract
BACKGROUND: A/H5N1 influenza viruses have high pandemic potential; consequently, vaccines need to be produced rapidly. MF59® adjuvant reduces the antigen required per dose, allowing for dose sparing and more rapid vaccine availability. METHODS: Two multicenter, phase II trials were conducted to evaluate the safety and immunogenicity of an MF59-adjuvanted, cell culture–derived, A/H5N1 vaccine (aH5N1c) among 979 adult (18–64 years old) and 1393 elderly (≥65 years old) subjects. Participants were equally randomized to receive 2 full-dose (7.5 μg of hemagglutinin antigen per dose) or 2 half-dose aH5N1c vaccinations 3 weeks apart. Outcomes were based on Center for Biologics Evaluation Research and Review (CBER) and Committee for Medicinal Products for Human Use (CHMP) licensure criteria (titers ≥1:40 and seroconversions on day 43). Solicited reactions and adverse events were assessed (www.clinicaltrials.gov: NCT01776541 and NCT01766921). RESULTS: CBER and CHMP criteria were met by both age groups. CBER criteria for hemagglutination titers were met for the full-dose formulation. Solicited reaction frequencies tended to be higher in the full-dose group and were of mild to moderate intensity. No vaccine-related serious adverse events occurred. CONCLUSIONS: In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines.
has issue date
2019-03-01
(
xsd:dateTime
)
bibo:doi
10.1093/ofid/ofz107
bibo:pmid
30968056
has license
cc-by
sha1sum (hex)
ef201de652f16f09e5a52c4d38fb4ec3b617d07f
schema:url
https://doi.org/10.1093/ofid/ofz107
resource representing a document's title
Safety and Immunogenicity of MF59-Adjuvanted Cell Culture–Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly
has PubMed Central identifier
PMC6446137
has PubMed identifier
30968056
schema:publication
Open Forum Infect Dis
resource representing a document's body
covid:ef201de652f16f09e5a52c4d38fb4ec3b617d07f#body_text
is
schema:about
of
named entity 'dose'
named entity 'Elderly'
named entity 'H5N1'
named entity 'Safety'
named entity 'PANDEMIC'
named entity 'rapidly'
named entity 'vaccines'
named entity 'adjuvant'
named entity 'vaccine'
named entity 'Subunit'
named entity 'Adjuvanted'
named entity 'H5N1'
named entity 'Seqirus'
named entity 'A/H3N2'
named entity 'H5N1'
named entity 'H5N1'
named entity 'confidence interval'
named entity 'reactogenicity'
named entity 'CHMP'
named entity 'seroconversion'
named entity 'vaccine'
named entity 'phase II studies'
named entity 'seroconversion'
named entity 'virus'
named entity 'vaccine'
named entity 'Biologics'
named entity 'antibody'
named entity 'lung adenocarcinoma'
named entity 'atrial fibrillation'
named entity 'AEs'
named entity 'antigen'
named entity 'cell culture'
named entity 'vaccine'
named entity 'fever'
named entity 'World Health Organization'
named entity 'MF59'
named entity 'monovalent'
named entity 'loss of appetite'
named entity 'FAS'
named entity '95% CI'
named entity 'CHMP'
named entity 'AEs'
named entity '7.5'
named entity 'seasonal influenza'
named entity 'cell culture'
named entity 'Thailand'
named entity 'titer'
named entity 'cell culture'
named entity 'titer'
named entity 'H5N1'
named entity 'follow-up'
named entity 'MF59'
named entity 'fatigue'
named entity '2.0'
named entity 'immunogenic'
named entity '7.5'
named entity 'immunogenicity'
named entity 'titer'
named entity 'headache'
named entity 'titer'
named entity 'human disease'
named entity 'Declaration of Helsinki'
named entity 'vaccination'
named entity 'immunogenicity'
named entity 'CHMP'
named entity '7.5'
named entity 'poultry'
named entity 'immunogenicity'
named entity 'adjuvanted'
named entity 'placebo-controlled trial'
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