Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials

L. Oostvogels, TC. Heineman, RW. Johnson, MJ. Levin, JE. McElhaney, P. Van den Steen, T. Zahaf, AF. Dagnew, R. Chlibek, J. Diez-Domingo, IS. Gorfinkel, C. Hervé, SJ. Hwang, H. Ikematsu, G. Kalema, H. Lal, SA. McNeil, T. Mrkvan, K. Pauksens, J....

. 2019 ; 15 (12) : 2865-2872. [pub] 20190628

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc20022941
E-zdroje Online Plný text

NLK Free Medical Journals od 2012 do Před 1 rokem
PubMed Central od 2012 do Před 1 rokem
Europe PubMed Central od 2012 do Před 1 rokem

Odkazy

PubMed 31216205
DOI 10.1080/21645515.2019.1627818
Knihovny.cz E-zdroje

In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc20022941
003      
CZ-PrNML
005      
20201214125014.0
007      
ta
008      
201125s2019 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1080/21645515.2019.1627818 $2 doi
035    __
$a (PubMed)31216205
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Oostvogels, Lidia $u GSK, Wavre, Belgium.
245    10
$a Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials / $c L. Oostvogels, TC. Heineman, RW. Johnson, MJ. Levin, JE. McElhaney, P. Van den Steen, T. Zahaf, AF. Dagnew, R. Chlibek, J. Diez-Domingo, IS. Gorfinkel, C. Hervé, SJ. Hwang, H. Ikematsu, G. Kalema, H. Lal, SA. McNeil, T. Mrkvan, K. Pauksens, J. Smetana, D. Watanabe, LY. Weckx, AL. Cunningham,
520    9_
$a In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ).Adults aged ≥50 or ≥70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment.At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported ≥1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant.As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.
650    _2
$a adjuvancia imunologická $x aplikace a dávkování $7 D000276
650    _2
$a senioři $7 D000368
650    _2
$a chronická nemoc $7 D002908
650    _2
$a komorbidita $7 D015897
650    _2
$a interpretace statistických dat $7 D003627
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a herpes zoster $x prevence a kontrola $7 D006562
650    _2
$a vakcína proti pásovému oparu $x aplikace a dávkování $x imunologie $7 D053061
650    _2
$a lidé $7 D006801
650    _2
$a imunokompromitovaný pacient $7 D016867
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a postherpetická neuralgie $x imunologie $x prevence a kontrola $7 D051474
650    _2
$a rizikové faktory $7 D012307
650    _2
$a vakcinace $7 D014611
650    12
$a potence vakcíny $7 D064166
650    _2
$a syntetické vakcíny $x imunologie $7 D014614
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Heineman, Thomas C $u GSK, King of Prussia, PA, USA.
700    1_
$a Johnson, Robert W $u Faculty of Health Sciences, University of Bristol, Bristol, UK.
700    1_
$a Levin, Myron J $u Departments of Pediatrics and Medicine, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.
700    1_
$a McElhaney, Janet E $u Health Sciences North Research Institute, Sudbury, Ontario, Canada.
700    1_
$a Van den Steen, Peter $u GSK, Wavre, Belgium.
700    1_
$a Zahaf, Toufik $u GSK, Wavre, Belgium.
700    1_
$a Dagnew, Alemnew F $u GSK, Rockville, MD, USA.
700    1_
$a Chlibek, Roman $u Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
700    1_
$a Diez-Domingo, Javier $u Fundación para el Fomento de la Investigación Sanitaria y Biomédica, Valencia, Spain.
700    1_
$a Gorfinkel, Iris S $u PrimeHealth Clinical Research, Toronto, Ontario, Canada.
700    1_
$a Hervé, Caroline $u GSK, Wavre, Belgium.
700    1_
$a Hwang, Shinn-Jang $u Department of Family Medicine, Taipei Veterans General Hospital and National Yang Ming University School of Medicine, Taipei, Taiwan.
700    1_
$a Ikematsu, Hideyuki $u Japan Physicians Association, Tokyo, Japan.
700    1_
$a Kalema, George $u Keyrus Biopharma, Waterloo, Belgium, on behalf of GSK.
700    1_
$a Lal, Himal $u GSK, King of Prussia, PA, USA.
700    1_
$a McNeil, Shelly A $u Canadian Center for Vaccinology, IWK Health Center and Nova Scotia Health Authority, Dalhousie, University, Halifax, Canada.
700    1_
$a Mrkvan, Tomas $u GSK, Wavre, Belgium.
700    1_
$a Pauksens, Karlis $u Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.
700    1_
$a Smetana, Jan $u Faculty of Military Health Sciences, University of Defense, Hradec Kralove, Czech Republic.
700    1_
$a Watanabe, Daisuke $u Department of Dermatology, Aichi Medical University, Nagakute, Japan.
700    1_
$a Weckx, Lily Yin $u Department of Pediatrics, Federal University of Sao Paulo, Sao Paulo, Brazil.
700    1_
$a Cunningham, Anthony L $u The Westmead Institute for Medical Research, Westmead, University of Sydney, Sydney, NSW, Australia.
773    0_
$w MED00181409 $t Human vaccines & immunotherapeutics $x 2164-554X $g Roč. 15, č. 12 (2019), s. 2865-2872
856    41
$u https://pubmed.ncbi.nlm.nih.gov/31216205 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20201125 $b ABA008
991    __
$a 20201214125013 $b ABA008
999    __
$a ok $b bmc $g 1595260 $s 1113617
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2019 $b 15 $c 12 $d 2865-2872 $e 20190628 $i 2164-554X $m Human vaccines & immunotherapeutics $n Hum Vaccin Immunother $x MED00181409
LZP    __
$a Pubmed-20201125

Najít záznam

Citační ukazatele

Možnosti archivace