A new vaccine against meningitis groupB: A second follow-on study

• Research type

  Research Study

• Full title

  A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1

• IRAS ID

  101133

• Contact name

  Andrew J Pollard

• Sponsor organisation

  Novartis Vaccines & Diagnostics

• Eudract number

  2011-004931-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Meningococcal type B (MenB) disease is the most common cause of childhood meningitis in the UK. Currently no vaccine is 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 NZ (MenB) vaccine. In the parent study V72P12, participants were enrolled to receive 3 doses of MenB routine immunisations, together with or staggered from routine vaccines by approximately one month. 314 participants in the control group received routine immunisations only. An extension study V72P12E1 was completed to investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of MenB at 12, 18 and 24 months of age in subjects primed with MenB in the parent study along with 103 control children receiving MenB doses 2 months apart (18 and 20 or 24 and 26 months). This second follow on study is to explore bactericidal antibody persistence in 4-year-old children after a fourth dose of MenB or after a 2 dose catch-up schedule of MenB administered to children as part of their respective vaccination courses in V72P12E1. This study will characterize the antibody response to a fifth dose in all children who received a three-dose primary series of MenB at 2, 3, 4 months of age and only in a subset of children who received a three-dose primary series of MenB at 2,4,6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of MenB administered at 4 years of age in children immunised at 12,18 and 24 months of age. The safety and immunogenicity of two catch-up doses of MenB administered 2 months apart to healthy naÇîve children at 4 years of age will be assessed.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0384

• Date of REC Opinion

  10 Oct 2012

• REC opinion

  Further Information Favourable Opinion