201190 (Zoster-049)
Research type
Research Study
Full title
A phase IIIb, open-label, multi-country, multi-centre, long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077 (ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine and assessment of 1 or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults.
IRAS ID
184577
Contact name
Janice Patrick
Contact email
Sponsor organisation
GSK UK Ltd
Eudract number
2015-001778-17
Clinicaltrials.gov Identifier
BB-IND 13857, Investigational New Drug (IND) number
Duration of Study in the UK
6 years, 7 months, 25 days
Research summary
Shingles is an infection that is caused by the same virus that causes chickenpox. After getting chickenpox during childhood, the virus remains in the body. Shingles occurs when the virus becomes active again after many years, mostly when people are older than 50 years. The chance of getting shingles is higher as people get older. \n\nThis study will enrol people who previously participated in either Zoster 006 or Zoster 022 clinical study, sponsored by GlaxoSmithKline (GSK) Biologicals.\n\nThe purpose of this study is to follow up those individuals, who received the study vaccine when they took part in the previous Zoster studies; for approximately 6 more years. This study will help doctors know how long the study vaccine protects patients from getting shingles and more about how safe this vaccine is. Up to 14,450 people globally, will be asked to take part in this study. In the UK, approximately 414 people from 7 GP practices will be invited to take part. \n\nIn certain countries, people may be randomly selected to receive 1 or 2 additional booster doses of the shingles study vaccine; in these countries, there will also be a Control group of people that will not be vaccinated, but will have scheduled blood sampling similar to those getting the vaccinations. The UK will not be participating in this part of the study; instead people will be invited to take part in the Long-Term Follow-Up (LTFU) group, where nobody gets the additional booster vaccination.\n\nPeople participating will have a blood sample taken once a year and explained the information they need to provide during the monthly phone calls. If the doctor feels that the participant has experienced a shingles episode, they will be asked to visit the doctor, where another blood sample will be taken.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0146
Date of REC Opinion
22 Mar 2016
REC opinion
Favourable Opinion