Important underlying illness that in the opinion of the investigator would be expected to interfere significantly during the study. – Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe. – Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study. In previous phase 1–2 clinical trials involving older adults, a subunit vaccine containing varicella–zoster virus glycoprotein E and the AS01B adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response. Bio CSL: Scientific Advisor, Consulting fee; O. R. This means that all consider that repeated contacts with varicella reduces the risk of zoster to be equivalent to the unproven assumption that the absence of contact with varicella causes an increased risk of zoster [10–14].
Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively. Stage 2. This study found that shortening the dosing interval increased the number of cases prevented, although the effect was less important than increasing coverage rate. The high infection rates and associated economic burden of varicella result in a significant public health burden . The Shingles Prevention Study showed that immunization of adults ≥60 years of age with a high-dose (median, 24 600 pfu/dose) of a live attenuated Oka VZV vaccine (Zostavax, Merck & Co., Inc) reduced the incidence of HZ by 51% and the incidence of PHN by 67% . Currently he has oversight of both the early and late stage clinical groups in respiratory and chairs/sits on numerous internal scientific strategic committees. The recommended route for recording temperature in this study will be oral.
Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. Clinical evaluation to confirm the manufacturing consistency of three lots of an adjuvanted glycoprotein D genital herpes vaccine in healthy seronegative pre-teen and adolescent girls: A phase III multi-center double-blind randomized trial. However, the investigational use of a registered product to treat the subject’s underlying disease, is allowed. History of allergy to any component of the vaccine. Seoul, Korea, 31 August 2013. VE against HZ in ZOE-50 was 97.6% (95% confidence interval: 92.7–99.6) in adults ≥60 YOA. Inhaled, topical and intra-articular corticosteroids are allowed.
– Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period. Assuming the vaccine eventually comes to market, it will compete with Merck & Coâs Zostavax (zoster vaccine, live). It has been established in accordance with Directive 2001/20/EC. *E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines. Het Rijksvaccinatieprogramma (RVP) is één van de meest succesvolle en kosteneffectieve interventies van de volksgezondheid. This portal provides a single entry point to search for industry sponsored clinical trials which are on existing registers and databases. Or subjects’ Legally Acceptable Representative(s) [LAR(s)]/caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g.
IFPMA.org is a search portal provided by the International Federation of Pharamceutical Manufacturers & Associations (IFPMA). IFPMA.org is a search portal provided by the International Federation of Pharamceutical Manufacturers & Associations (IFPMA). ClinicalTrial.gov is a database that provides summary protocol information for ongoing clinical trials. – Written informed consent obtained from the subject prior to performance of any study specific procedure. GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party. GlaxoSmithKline (GSK) has commenced late-stage clinical trials of its herpes zoster vaccine currently being developed for the prevention of shingles. Below we present our open studies for which the follow-up visits are still ongoing.
•To evaluate VE in reducing the total duration of ‘worst’ HZ-associated pain over the entire pain reporting period in autologous HCT recipients 18 years of age and older with confirmed HZ; •To evaluate VE in the reduction of confirmed HZ-associated complications in autologous HCT recipients 18 years of age and older; •To evaluate VE in the prevention of Postherpetic Neuralgia (PHN) in autologous HCT recipients 18 years of age and older; •To evaluate humoral immune responses to the study vaccine, when administered according to a 2-dose schedule in a sub-cohort of subjects; •To evaluate vaccine safety and reactogenicity in autologous HCT recipients 18 years of age and older. Subjects receiving only newer, more targeted therapies if not taken together with a classical chemotherapy. GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.