Vaccinations 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 a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received a Three-Dose Series of the Novartis Vaccine as Infants in Study V72P9

• IRAS ID

  27758

• Contact name

  AJ Pollard

• Sponsor organisation

  Novartis Vaccines and Diagnostic, S.r.l.

• Eudract number

  2009-013075-21

• ISRCTN Number

  n/a

• Research summary

  Meningococcal type B (MenB) disease is the most common cause of childhood meningitis in the UK. There is currently no vaccine available providing 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, V72P9, participants received three 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 (??MenB OMV NZ?). In this study, children who completed the parent trial will receive one dose of rMenB with and without OMV NZ depending on 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. This extension study V72P9E1 is designed to evaluate bactericidal antibody persistence at approximately 40 months of age in subjects who received three doses of rMenB with or without OMV NZ (rMenBñOMV NZ) in the parent study V72P9. Furthermore, subjects in this extension study will be boosted at approximately 40 months of age with one dose of the same vaccine received in V72P9. Antibody persistence will be subsequently measured at 20 months after the booster dose when the subjects are 60 months of age. Two groups of naive subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. Both groups of naive subjects will also receive two doses of rMenB㣅 NZ starting at 40 and 60 months of age and, as such, will provide catch-up vaccination data for the pre-school age group. In addition, the doses administered to naive subjects starting at 40 months of age will serve as a control for assessing booster responses and immunological memory in the subjects enrolled from parent study V72P9.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/90

• Date of REC Opinion

  18 Aug 2009

• REC opinion

  Favourable Opinion