A new vaccine against meningitis type B: An extension study

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Novartis Vaccine as Infants in Study V72P6

• IRAS ID

  27755

• Contact name

  AJ Pollard

• Sponsor organisation

  Novartis Vaccines and Diagnostic, S.r.l.

• Eudract number

  2009-013054-33

• ISRCTN Number

  n/a

• Research summary

  Meningococcal group B (MenB) disease is the most common cause of childhood meningitis in the UK. There is currently no vaccine available that provides broad protection against MenB disease. A new vaccine, made from a combination of proteins from the surface of the MenB bacteria, has been combined with a vaccine previously used against MenB in New Zealand (OMV) to make the rMenB㣅 vaccine. In the parent study, V72P6, participants received one or four doses of either rMenB or rMenB㣅 NZ, together with routine immunisations. This study will assess the Investigational Vaccines designed by Novartis to prevent MenB disease: Meningococcal B Recombinant Vaccine (??rMenB?) and Meningococcal B Recombinant with Outer Membrane Vesicles New Zealand (OMV NZ) Vaccine (??rMenB OMV NZ?). In this study children who completed the parent trial will receive one or two doses of rMenB with and without OMV NZ at different points depending on the schedule and the vaccine they received in the parent trial. Two additional groups of children will be enrolled in this extension trial to receive two doses of rMenB㣅 NZ, two months apart, starting between the ages of 40-44 or 60-62 months of age. The aim of this extension study, V72P6E1, is to assess the safety and tolerability of rMenB㣅 NZ vaccine and look at how the immune system responds to the vaccine. We also aim to assess the vaccine??s long-term effect. To do this we will take blood samples before and after vaccination. These blood samples will be tested to measure, in children who received rMenB with and without OMV NZ vaccine in the parent trial, the level of antibodies against type B bacteria and compare these with the antibody levels in blood taken from children who received the vaccination only in the course of this extension study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/89

• Date of REC Opinion

  18 Aug 2009

• REC opinion

  Favourable Opinion