116023 (FLU D-QIV-009 EXT 004)

• Research type

  Research Study

• Full title

  A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU D-QIV-004 PRI).

• IRAS ID

  109180

• Contact name

  Saul Faust

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2012-001230-34

• Research summary

  flunza or flu is a disease caused by different types ofluviruses (germs). It causes an infection of the airways and is passed from person-to-person by coughing, sneezing or through direct contact with an infected person. Vaccination is an effective way of helping to prevenfluby stimulating the bodies?? own immune system to fight thfluby making substances called antibodies. Current seasonafluvaccines contain the 3 main circulatinfluviruses each season (two A strains and one B strain). However in the last 10-15 years, two B strains have been spreading around the world. <fluD-QIV is a vaccine developed with two A strains and two B strains (4 altogether). This GSK 116023 study is a follow on study from thfluD-QIV vaccine study 115345 (which took place at GP practices, NHS and University sites). Globally, the plan is to recruit about 452 children, including approximately 50-70 children in UK. The study aims to assess how strong the immune response (antibody production) is to the quadrivalenfluD-QIV vaccine in children who already received a previous dose in study 115345 compared to children who did not receive it. We will also assess the safety of the study vaccine in children. In the UK, children between 12 and 35 months of age when they took part in the previous study, who are in stable health and received two doses ofluvaccination, will receive one dose of thfluD-QIV vaccine. Children who received nofluvaccines in the previous study will be given two doses ofluD-QIV vaccine. Two blood samples will be collected to assess the immune response at the first visit and 7 days after one dose ofluD-QIV vaccine. The study will last for approximately 6 months.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0237

• Date of REC Opinion

  26 Sep 2012

• REC opinion

  Further Information Favourable Opinion