Startsida
Hjälp
Sök i LIBRIS databas

     

 

Sökning: onr:q10d6903nsw724l7 > Safety profile of t...

Safety profile of the adjuvanted recombinant zoster vaccine [Elektronisk resurs] Pooled analysis of two large randomised phase 3 trials

López-Fauqued, M. (författare)
Campora, L. (författare)
Delannois, F. (författare)
El Idrissi, M. (författare)
Oostvogels, L. (författare)
De Looze, F. J. (författare)
Diez-Domingo, J. (författare)
Heineman, T. C. (författare)
Lal, H. (författare)
McElhaney, J. E. (författare)
McNeil, S. A. (författare)
Yeo, W. (författare)
Tavares-Da-Silva, F. (författare)
Ahonen, A. (författare)
Avelino-Silva, T. J. (författare)
Barba-Gomez, J. F. (författare)
Sanmartin Berglund, Johan (författare)
Blekinge Tekniska Högskola Fakulteten för teknikvetenskaper (utgivare)
Publicerad: Elsevier Ltd, 2019
Engelska.
Ingår i: Vaccine. - 0264-410X. ; 37:18, 2482-2493
Läs hela texten
Läs hela texten
Läs hela texten
  • E-artikel/E-kapitel
Sammanfattning Ämnesord
Stäng  
  • Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. © 2019 GlaxoSmithKline Biologicals SA 

Ämnesord

Medical and Health Sciences  (hsv)
Health Sciences  (hsv)
Public Health, Global Health, Social Medicine and Epidemiology  (hsv)
Medicin och hälsovetenskap  (hsv)
Hälsovetenskaper  (hsv)
Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi  (hsv)

Genre

government publication  (marcgt)

Indexterm och SAB-rubrik

Reactogenicity
Safety
Vaccine
Varicella-zoster virus
placebo
varicella zoster vaccine
acute kidney failure
adult
age distribution
aged
alopecia areata
aortic stenosis
arthralgia
Article
atrial fibrillation
autoimmune pancreatitis
autoimmune thyroiditis
backache
brain infarction
cardiogenic shock
cardiopulmonary insufficiency
celiac disease
cerebrovascular accident
chill
chronic gastritis
chronic obstructive lung disease
clinical evaluation
cohort analysis
controlled study
coughing
Crohn disease
disease course
dizziness
drug efficacy
drug safety
erythema nodosum
facial nerve paralysis
fatigue
female
fever
fibrosing alveolitis
follow up
glomerulonephritis
Graves disease
Guillain Barre syndrome
headache
heart atrium flutter
heart failure
heart infarction
herpes zoster
human
idiopathic thrombocytopenic purpura
immunoglobulin A nephropathy
information processing
injection site erythema
injection site pain
injection site pruritus
injection site swelling
injection site warmth
insulin dependent diabetes mellitus
lichen planus
lung fibrosis
lung tumor
major clinical study
malaise
male
mixed connective tissue disease
multiple organ failure
multiple sclerosis
myalgia
neuritis
oropharynx pain
pancreas carcinoma
paraneoplastic neuropathy
pemphigus
phase 3 clinical trial
pneumonia
polyradiculoneuropathy
population research
priority journal
psoriasis
psoriatic arthritis
race
radiculitis
randomized controlled trial
Raynaud phenomenon
respiratory failure
retina detachment
rheumatic polymyalgia
rheumatoid arthritis
rhinopharyngitis
sepsis
septic shock
sex ratio
single blind procedure
spondyloarthropathy
supraventricular tachycardia
syndrome CREST
systemic juvenile idiopathic arthritis
systemic lupus erythematosus
tachycardia
temporal arteritis
trigeminal nerve disease
trigeminus neuralgia
ulcerative colitis
upper respiratory tract infection
uveitis
vaccination
vitiligo
Inställningar Hjälp

Beståndsinformation saknas

Om LIBRIS
Sekretess
Hjälp
Fel i posten?
Kontakt
Teknik och format
Sök utifrån
Sökrutor
Plug-ins
Bookmarklet
Anpassa
Textstorlek
Kontrast
Vyer
LIBRIS söktjänster
SwePub
Uppsök

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

Copyright © LIBRIS - Nationella bibliotekssystem

 
pil uppåt Stäng

Kopiera och spara länken för att återkomma till aktuell vy