Quadri meningo follow up of previous study (Eudract 2010-022505-18)

• Research type

  Research Study

• Full title

  An observational follow up study of a phase II/III, open label, randomised study of the safety, reactogenicity and immunogenicity of a single dose of meningococcal ACWY conjugate vaccine (Menveo, Glaxosmithkline or Nimenrix, Pfizer) in adolescents who were primed with Meningitec, Menjugate or Neisvac-C during preschool vaccination.

• IRAS ID

  209802

• Contact name

  Paul Turner

• Contact email

  p.turner@imperial.ac.uk

• Sponsor organisation

  Public Health England

• Eudract number

  2016-002381-31

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  A previous cohort of 93 clinical trial participants received quadrivalent meningococcal conjugate vaccine, which includes strains ACW and Y, in their teenage years. The vaccine also contains components of diphtheria and tetanus which are linked to the meningitis components, in a process called conjugation, to improve their effectiveness.

  Participants are now aged 19-25 and will be invited to take part in this study, which will assess antibody persistence over time. This will provide information about the duration of protection by relating current antibody levels to those measured in the previous study, and will underpin the national immunisation schedule in providing optimal immunisation schedule. As well as the meningitis antibodies we will assess diphtheria and tetanus antibody levels.

  The study will involve a single blood test of up to 8mL. Participants will be informed of their results and any with an antibody level that does not infer protection against strain W will be offered an extra dose of vaccine as part of a duty of care.
  The study will involve a single blood test of up to 8mL. Participants will be informed of their results and any with an antibody level that does not infer protection against strain W will be offered an extra dose of vaccine.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  16/LO/1228

• Date of REC Opinion

  21 Jul 2016

• REC opinion

  Favourable Opinion