GSK Zoster2-Observer blind study to evaluate efficacy, safety, and immunogenictiy of GSK Biologicals Herpes Zoster

A prednisone dose of < 20 mg/day is allowed. - Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. - Concurrently participating in another clinical study, at the time of enrolment or planned participation up to the 30 days post second dose, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine/product. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment. Observational studies conducted to expand our understanding of the underlying epidemiology of shingles are attempting to look at the role that age, immunity, and other related factors play on its developing. Disclosures. The varicella vaccine was developed in 1974 by Michiaki Takahashi. It occurs once (rarely twice), essentially in adults >60 years of age [3, 4]. The ZOE-50 trial also allowed us to determine regional HZ incidence based on a thorough and globally consistent disease confirmation method (NCT01165177). The safety profile of both vaccines was also assessed despite the process change. Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination. Standard safety testing for adventitious agents, however, was performed on primates and other laboratory animals. The underlying quality of GlaxoSmithKline’s business kept Neil Woodford holding on through the firm’s troubled period and it also ensured the company’s inclusion on the Motley Fool’s top investment report called 5 Shares To Retire On.


Although a one-dose vaccination strategy prevented fewer varicella cases, its prevention of severe cases (i.e., with complications) was comparable to two-dose strategies. Vaccination strategies can be implemented differently in each country depending on their needs, infrastructure and healthcare budget. The virus is usually acquired during childhood as chickenpox [1]. Since 2013, Edith has been a board member of the Manchester Collaborative Centre for Inflammation Research, and within GSK, Edith co-chairs the Scientific Advisory Forum and is chair of the DPU head community. – Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo. – Current participation in or planned concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.

– Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. In recent years, increasing numbers of scientists have begun to question if mice and/or guinea pigs are really a good model for evaluating the effectiveness of new HSV-2 vaccine candidates. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. This is most serious in women who have their first symptoms of herpes just before giving birth. Written informed consent obtained from the subject prior to study entry. 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).

This protocol posting also deals with the outcome measures related to the pooled analysis. Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. The recombinant herpes zoster (HZ) subunit vaccine candidate (HZ/su) had >90% efficacy (VE) against HZ in older adults in two phase 3 clinical trials (ZOE-50, ZOE-70 [NCT01165177, NCT01165229]). Previous vaccination against VZV, administration of HZ/su vaccine or any other investigational or non-registered HZ vaccine (except Zostavax for the Prev-Zvax group). – A male or female aged 50 years or older at the time of the first vaccination with the study vaccine(s). – A male or female aged 70 years or older at the time of the first vaccination. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.

UK pharma giant GlaxoSmithKline (GSK; L) says that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix. 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. – The PreChemo group receives their first HZ/su vaccination at least 10 days before the start of a chemotherapy cycle. Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first study visit (Day -29 to Day 0), or planned use during the study period.