However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine. To evaluate the safety, in terms of unsolicited adverse events (AE), Serious Adverse Events (SAE) and potential Immune Mediated Disease (pIMD) in all subjects, following administration of each dose of the HZ/su vaccine. J. Supplement sponsorship. In the United States, childhood varicella vaccination has been generalized since 1995. A male or female between, and including, 13 and 15 months of age at the time of the first vaccination. The efficacy of the vaccine was shown to be 85% in preventing chickenpox [11, 12].
In Sicily, which was the first Italian region to implement varicella vaccination, there was a 95 % reduction in cases over 10 years, with coverage rates increasing to 85 % . Several practical aspects that need consideration include how to reach and sustain high coverage levels in order to optimise protection against varicella disease. In a study in mice, recombinant gE-induced potent CD4+ T-cell responses when adjuvanted with AS01 . John is the former SVP, Infectious Diseases Medicine Development Centre for GSK. – Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata). Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Use of rituximab (MabThera) more than 60 days after transplant. HZ/su vaccine was more reactogenic than placebo, but reactions were mostly mild or moderate and transient (Figure 2). – Concurrently participating 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 vaccine/product (pharmaceutical product or device). – Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Primary end point(s): 1. Onderzoek naar werkzaamheid en veiligheid van vaccins is hierdoor noodzakelijk. • Female subjects of non-childbearing potential may be enrolled in the study.
This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of =20 mg/day [or equivalent]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). EU Clinical Trials Register is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. Herpes zoster is commonly known as shingles. •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. Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/ placebo. This portal provides a single entry point to search for industry sponsored clinical trials which are on existing registers and databases. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, 1, 5, 7F, 3, 6A, 19A, 22F,…
The protocol summary has been updated following Protocol Amendment 2, August 2014, leading to the increase of the enrolment. • Previous vaccination against VZV or HZ. The study is designed as a randomized, double-blind study with three parallel groups. Information is provided for original product approvals, new indications, and the current package insert. Methods: Vaccine-induced immune response data from healthy older adults (≥60 years of age) who had received 2 doses (2 months apart) of HZ/su in a previous trial conducted in the Czech Republic, Germany, Sweden and the Netherlands were recorded for up to 6 years post-dose 1 (NCT00434577 and NCT01295320). Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ) Vaccine When Administered Under the Skin (Subcutaneously) vs. 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.
has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Background. Singles (herpes zoster) is a blistering and painful skin rash that results from the re-activation of the dormant chicken-pox (varicella zoster) virus. Background: A trial involving adults 50 years of age or older (ZOE-50) showed that the herpes zoster subunit vaccine (HZ/su) containing recombinant varicella-zoster virus glycoprotein E and the AS01B adjuvant system was associated with a risk of herpes zoster that was 97.2% lower than that associated with placebo.