A new vaccine against meningitis group B: A follow-on study

• Research type

  Research Study

• Full title

  A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12

• IRAS ID

  16397

• Contact name

  A J Pollard

• Sponsor organisation

  Novartis Vaccines and Diagnostic, S.r.l.

• Eudract number

  2009-011676-30

• 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, V72P12, participants were enrolled to receive three doses of rMenB㣅 NZ routine immunisations, together with or staggered from routine vaccines by approximately one month. Participants in the control group received routine immunisations only. This extension study V72P12E1 is designed to investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB㣅 NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB㣅 NZ in the parent study according to the two different three-dose immunisation schedules in infancy (2, 3, 4 and 2, 4, 6 months of age) and for the 2, 4, 6 rMenB㣅 NZ schedule, according to two different immunisation schedules for routine vaccines (together with rMenB㣅 NZ and staggered). This study will also explore bactericidal antibody persistence in subjects at 12, 18 and 24 months of age following the two different immunisation schedules in infants in Study V72P12.Finally, this study will investigate catch-up regimens in naive toddlers. Two rMenB㣅 NZ doses will be given, 2 months apart, to unprimed, naive toddlers at 12 months (subjects enrolled in the control group of V72P12), 18 months or 24 months of age (two new cohorts of subjects to be enrolled). These participants will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, and will serve as controls for the assessment of antibody persistence and booster responses for the other groups.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/61

• Date of REC Opinion

  12 May 2009

• REC opinion

  Favourable Opinion