110390 (Zoster 006) Herpes Zoster Vaccine Study

• Research type

  Research Study

• Full title

  A phase III, randomized, observer-blind, placebo-controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety, and immunogenicity of GSK Biologicals’ gE/AS01B vaccine when administered intramuscularly on a 0, 2-month schedule in adults aged 50 years and older.

• IRAS ID

  60104

• Contact name

  Alex Thompson

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2008-000367-42

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The main purpose of this study is to assess whether the Herpes Zoster vaccine is effective in preventing Herpes Zoster, commonly known as Shingles, compared to placebo in adults aged 50 years and over. Herpes Zoster (HZ occurs when the Varicella Zoster Virus (which causes chickenpox)is reactivated and usually appears as a localised skin rash.The rash normally lasts 2 to 4 weeks usually with a pain that is often described as burning, shooting, or stabbing and some patients experience increased sensitivity to pain in the affected area. The most common complication of shingles (HZ) is postherpetic neuralgia (PHN). This is a pain that continues after the rash has cleared. Affected patients typically report constant burning, throbbing, intermittent sharp or electric shocklike pain. Older people are more likely to develop PHN. If PHN develops it tends to improve over a period of months and about 70 to 80% of cases resolve within a year, however in some people it can persist for many years. Age is also the most common risk factor for developing shingles : at 50 to 59 yrs the incidence is about 5 cases in 1000 persons per year, & in those 60 yrs and over this increases to 10 cases in 1000 persons per year. Half of all cases of shingles occur in people 60 yrs & over. In the study eligible subjects will either receive 2 doses of the study vaccine or a placebo. One dose will be given at the first visit and the second dose at the second visit. these doses will be given two months apart. All subjects will be followed up for at least 30 months with annual visits and monthly contacts (phone and /or email) after visit 3. The exact length of the study for individual subjects will vary, the maximum total being 4 to 5 years.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/46

• Date of REC Opinion

  9 Sep 2010

• REC opinion

  Further Information Favourable Opinion