Efficacy study of a quadrivalent flu vaccine in children (FLU D-QIV)

• Research type

  Research Study

• Full title

  A phase III, observer-blind, randomized, multi-country, non-influenza vaccine comparator-controlled study to demonstrate the efficacy of GlaxoSmithKline Biologicals’ quadrivalent seasonal influenza candidate vaccine GSK2321138A (FLU D-QIV), administered intramuscularly in children 6 to 35 months of age.

• IRAS ID

  84736

• Contact name

  Saul Faust

• Sponsor organisation

  GlaxoSmithKline UK Ltd on behalf of GSK Biologicals Ltd

• Eudract number

  2011-000758-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Influenza or 'flu' is a disease caused by different types of flu viruses (germs). It causes an infection of the airways and is passed from person-to-person by coughing and sneezing or through direct contact with an infected person. Vaccination is an effective way of preventing the flu and its complications by stimulating the body to developing an immune response to fight the flu by making substances called antibodies.Current seasonal flu vaccines contain the 3 main circulating flu viruses 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. Therefore a vaccine with two A strains and two B strains (4 altogether - Quadrivalent Influenza Vaccine) is being developed (FLU D-QIV vaccine). These viruses are not live which means that it is not possible to get the flu from having the vaccine. The purpose of this research study is to test the immune response in children who received the quadrivalent flu vaccine(s) and in children who received other non-flu vaccines. We will also compare the safety and effectiveness of the quadrivalent study vaccine to children receiving the non-flu (control) vaccines.In the UK, children aged between 12 and 35 months of age who are healthy and who have not received a dose of varicella vaccine and/or hepatitis A vaccine will be randomised to receive a different number of vaccines depending on whether or not they have previously received a full course (two doses) of the seasonal flu vaccine. The study will last for approximately 6-8 months.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/SC/0313

• Date of REC Opinion

  28 Sep 2011

• REC opinion

  Further Information Favourable Opinion