OKAH-193 - Varicella vaccine study in the second year of life
Research type
Research Study
Full title
A Phase III, double blind, randomised, comparative study of the safety and immunogenicity of GSK Biologicals’ Varilrix HSA-free varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life
IRAS ID
185354
Contact name
Saul Faust
Contact email
Eudract number
2013-003535-30
Duration of Study in the UK
0 years, 9 months, 15 days
Research summary
The GSK Biologicals’ varicella (chickenpox) vaccine, Varilrix™ has been licensed since 1994 and is currently available in 96 countries worldwide. Human Serum Albumin (also called HSA) is used in the process of making the chickenpox vaccine, Varilrix™.
However, to limit as much as possible the use of animal or human derived products in the production of vaccines, HSA was removed from the production of vaccines at GSK Biologicals. The Varilrix vaccine made without HSA was first approved in 2013 and it is now licensed in a few countries, Canada, New Zealand, Australia, France and Spain.
This is a phase III; randomised, comparative study in healthy children aged 12 to 23 months. The study is being conducted to investigate the safety of the Varilrix vaccine without HSA compared with the Varilrix vaccine with HSA and understand how well the Varilrix vaccine without HSA is tolerated. This study is being conducted in 4 countries worldwide and will enrol 1220 children in total. In the UK, 400 subjects will be enrolled across four sites.
The participant’s parent / legal guardian will be asked to review and sign the study informed consent form in order for his/her child to participate.
This study will last about 3 months and participants would need to have 3 study visits, either at their home or in the clinic. Two vaccinations will be given by injection around 6 weeks apart in the study at Visit 1 and 2. All participants will have a physical examination at visit 1 (some also at visit 2 and 3 if applicable). A proportion of participants will have blood samples taken three times during the study. Skin rash samples will be collected from any child who develops chicken-pox like rash. The participant’s parent / legal guardian will also need to complete diary cards 42 days after each injection on how their child is feeling and any medications they are taking.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0631
Date of REC Opinion
21 Sep 2015
REC opinion
Further Information Favourable Opinion