RIVET: Re-inventing Influenza Vaccine Efficacy Trials

• Research type

  Research Study

• Full title

  A pilot study to determine the feasibility and acceptability of the recruitment and follow up procedures planned for a phase IIb study of a novel influenza vaccine.

• IRAS ID

  211715

• Contact name

  Christopher Butler

• Sponsor organisation

  Vaccitech

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  RIVET is a pilot study to test the trial processes for a larger trial, INVICTUS, that will take place in two winter’s time. INVICTUS is hoping to test a new vaccine that is given alongside the usual annual flu vaccine. RIVET aims to test how feasible the first visit processes and the follow up processes are. We will recruit participants who are 65 years old and over to one of two phases of RIVET: Phase 1 will be focused on the first visit procedures at a GP practice although they will not receive any vaccines. Afterwards we will invite all phase 1 participants to discuss their experiences in a focus group. Phase 2 participants will have a recruitment visit at their home prior to getting their annual flu vaccine. After they have been vaccinated they will start the follow up processes designed for INVICTUS which includes either electronic or paper diaries to monitor participants post-vaccination and until the of the flu season. At the end of the follow up period all participants in phase 2 will be invited to take part in a qualitative interview over the phone to share their experiences of taking part in this study.

• REC name

  South East Scotland REC 01

• REC reference

  16/SS/0160

• Date of REC Opinion

  9 Sep 2016

• REC opinion

  Favourable Opinion