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  • 1.
    López-Fauqued, M.
    et al.
    GSK, Wavre, BEL.
    Campora, L.
    GSK, Wavre, BEL.
    Delannois, F.
    GSK, Wavre, BEL.
    El Idrissi, M.
    GSK, Rixensart, BEL.
    Oostvogels, L.
    GSK, Wavre, BEL.
    De Looze, F. J.
    University of Queensland, AUS.
    Diez-Domingo, J.
    Fundación para el Fomento de la Investigación Sanitaria y Biomédica, ESP.
    Heineman, T. C.
    GSK, King of Prussia, USA.
    Lal, H.
    GSK, King of Prussia, USA.
    McElhaney, J. E.
    ealth Sciences North Research Institute, CAN.
    McNeil, S. A.
    Dalhousie University, CAN.
    Yeo, W.
    University of Wollongong, AUS.
    Tavares-Da-Silva, F.
    GSK, Wavre, BEL.
    Ahonen, A.
    University of Tampere, FIN.
    Avelino-Silva, T. J.
    University of São Paulo, BRA.
    Barba-Gomez, J. F.
    Instituto Dermatológico de Jalisco, MEX.
    Sanmartin Berglund, Johan
    Blekinge Tekniska Högskola, Fakulteten för teknikvetenskaper, Institutionen för hälsa.
    Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials2019Inngår i: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 37, nr 18, s. 2482-2493Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    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

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  • 2. Ostergaard, Lars
    et al.
    Silfverdal, Sven-Arne
    Berglund, Johan
    Blekinge Tekniska Högskola, Sektionen för hälsa.
    Flodmark, Carl-Erik
    West, Christina
    Bianco, Veronique
    Baine, Yaela
    Miller, Jacqueline M.
    A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix2012Inngår i: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, nr 4, s. 774-783Artikkel i tidsskrift (Fagfellevurdert)
    Abstract [en]

    The co-administration of the tetravalent meningococcal conjugate vaccine, MenACWY-TT, with a licensed hepatitis A and B vaccine, HepA/B (Twinrix (R)), was compared to their separate administration in this open, randomised, controlled study. Healthy subjects 11-17 years of age (n = 611) were randomised (3:1:1) to receive both vaccines, MenACWY-TT alone or HepA/B alone. The co-administration of both vaccines was shown to be non-inferior to their individual administration. At seven months after the first vaccination, 99.4-100% of the subjects who received both vaccines co-administered showed seroprotection against all meningococcal serogroups and at least 99.1% of them were seropositive for hepatitis A and seroprotected against hepatitis B. This study suggests that MenACWY-TT vaccine could be co-administered with HepA/B without adversely impacting the immunogenicity, safety and reactogenicity of either of the vaccines.

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