Novartis Vaccine N. menigitidis Carriage Trial

• Research type

  Research Study

• Full title

  A Phase 3 Observer blind Randomised, Multi-centre, Controlled study to evaluate the effect of Novartis Vaccine’s Meningococcal B recombinant and MenACWY Conjugate vaccines on Pharyngeal Carriage of N. meningitidis in Young Adults

• IRAS ID

  57873

• Contact name

  Robert Read

• Eudract number

  2010-019592-29

• ISRCTN Number

  N/A

• Research summary

  This is a Phase 3, observer-blind, randomised, multi-centre controlled trial that will enroll university students in the UK. All participants will receive 2 vaccinations one month apart and will be followed for a total of 12 months. Participants will be randomised at Visit 1 to 1 of 3 treatment arms to receive either 2 doses of Men B vaccine, 1 dose MenACWY vaccine plus 1 dose Placebo vaccine or 2 doses of Japanese encephalitis vaccine. At the conclusion of the study all participants in Groups 1 and 3 will receive 1 dose of MenACWY vaccine. All participants will have pharyngeal swabs performed at every study visit to determine carriage rates and serogroup of N. meningitidis strains occurring in the study population over the trial period. A subset of participants in each arm will also provide blood specimens to assess the immunogenicity of MenB vaccine in a young adult population. Exploratory analyses may be performed to assess the relationship between immune response to the study vaccines and carriage rates in the study population.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/61

• Date of REC Opinion

  24 Aug 2010

• REC opinion

  Further Information Favourable Opinion