About: Safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine in elderly Chinese subjects

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About: Safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine in elderly Chinese subjects Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine in elderly Chinese subjects
Creator	Fang, Hanhua Li, Rongcheng Li, Yanping Liu, Youping Pellegrini, Michele Podda, Audino
Source	Medline; PMC
abstract	BACKGROUND: The safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine (Sub/MF59™; FLUAD(®), Novartis Vaccines) was evaluated among elderly Chinese subjects (≥ 60 years of age). After a preliminary Phase I, open-label study (n = 25) to assess safety 1–14 days post-vaccination, a comparative observer-blind, randomised, controlled clinical trial (n = 600) was performed to assess safety and immunogenicity versus a non-adjuvanted subunit influenza vaccine (Subunit; Agrippal(®), Novartis Vaccines). Subjects were randomised (2:1) to receive Sub/MF59™ or Subunit. RESULTS: Both vaccines were well tolerated, with no vaccine-related serious adverse events reported during the Phase I trial. During the observer-blind study, local and systemic reactions were generally similar for both vaccines 1–22 days post-vaccination; however, injection-site induration was more frequent among the Subunit group (P < 0.05), and mild pain at the injection site and fever were more frequent among Sub/MF59™ recipients (P ≤ 0.005). Both vaccines induced a significant (P < 0.001) increase in geometric mean titres (GMTs) for the three strains tested, versus baseline; GMTs against A/H1N1, A/H3N2 and B were significantly higher in the Sub/MF59™ group (P = 0.034, P < 0.001 and P = 0.005, respectively). GMT ratios against A/H1N1, A/H3N2 and B were also significantly higher in the Sub/MF59™ group (P = 0.038, P < 0.001 and P = 0.006, respectively). Similarly, the percentage of subjects achieving seroprotection or seroconversion on Day 22 was greater for Sub/MF59™ recipients, reaching significance for A/H3N2 (P < 0.001). CONCLUSION: MF59™-adjuvanted subunit influenza vaccine is well tolerated by elderly Chinese subjects and induces a higher level of immunogenicity than a non-adjuvanted subunit influenza vaccine in this population that is at high risk of influenza-related complications. CLINICAL TRIAL REGISTRY: , NCT00310648
has issue date	2008-02-20(xsd:dateTime)
bibo:doi	10.1186/1742-4933-5-2
bibo:pmid	18289372
has license	cc-by
sha1sum (hex)	4e951550757b4a9f7b9b5167c9774a1113c787e9
schema:url	https://doi.org/10.1186/1742-4933-5-2
resource representing a document's title	Safety and immunogenicity of an MF59™-adjuvanted subunit influenza vaccine in elderly Chinese subjects
has PubMed Central identifier	PMC2291031
has PubMed identifier	18289372
schema:publication	Immun Ageing
resource representing a document's body	covid:4e951550757b4a9f7b9b5167c9774a1113c787e9#body_text
is schema:about of	named entity 'FLUAD' named entity 'CONTROLLED CLINICAL TRIAL' named entity 'CHINESE' named entity 'SUBJECTS' named entity 'SAFETY' named entity 'SUBUNIT' named entity 'ADJUVANTED' named entity 'DAYS' named entity 'NON-' named entity 'MF59' named entity 'SUBUNIT' named entity 'Phase I' named entity 'assess' named entity 'Novartis' named entity 'influenza vaccine' named entity 'adjuvanted' named entity 'MF59' named entity 'IMMUNITY' named entity 'SUB' named entity 'AGE' named entity '282' named entity 'PHASE I' named entity 'INFLUENZA VACCINE' named entity 'RECEIVE' named entity 'IMMUNOGENICITY' named entity 'VACCINES' named entity 'OBSERVER' named entity 'ELDERLY' named entity 'PERFORMED' named entity 'YEARS' named entity 'ELDERLY' named entity 'AGEING' named entity 'SUBJECTS' named entity 'IMMUNOGENICITY' named entity 'CHINESE' named entity 'INFLUENZA VACCINE' named entity 'SAFETY' named entity 'NOVARTIS' named entity 'ASSESS' named entity 'PRELIMINARY' named entity '600' named entity 'MF59' named entity 'ADJUVANTED' named entity 'BLIND' named entity 'OPEN-LABEL STUDY' named entity 'EVALUATED' covid:arg/4e951550757b4a9f7b9b5167c9774a1113c787e9 named entity 'immunogenicity' named entity 'immunogenicity' named entity 'MF59' named entity 'adjuvanted' named entity 'influenza vaccine' named entity 'open-label study' named entity 'immunogenicity' named entity 'Vaccines' named entity 'Subunit vaccine' named entity 'influenza vaccine' named entity 'China' named entity 'influenza vaccine' named entity 'systemic reactions' named entity 'adjuvanted' named entity '1, 2' named entity 'age-standardised' named entity 'influenza vaccine' named entity 'adjuvanted' named entity 'influenza vaccines' named entity 'serological' named entity 'A/H1N1' named entity 'adjuvanted' named entity 'significant difference' named entity 'influenza vaccine' named entity 'elderly people' named entity 'short duration' named entity 'influenza vaccine' named entity 'oxygen therapy' named entity 'adjuvanted'

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