RSV OA=ADJ-012

• Research type

  Research Study

• Full title

  A phase 3b, randomized, open label, multi-country, multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV OA=ADJ-006 study

• IRAS ID

  1009460

• Contact name

  Marie Van Der Wielen

• Contact email

  marie.x.van-der-wielen@gsk.com

• Sponsor organisation

  GlaxoSmithKline Biologicals SA

• Clinicaltrials.gov Identifier

  NCT06534892

• Research summary

  Respiratory Syncytial Virus (RSV) is a highly contagious virus that causes respiratory infections in people of all ages. Mild cases present like a common cold. RSV can lead to serious complications such as pneumonia in older adults. RSV may also worsen some existing conditions such as chronic respiratory or heart diseases.
  This clinical study will involve patients who previously participated in the RSV OA=ADJ-006 (RSV 006) and received either a placebo vaccine or a single dose of the RSV vaccine, to investigate when patients should have a further dose to continue receiving protection from RSV; to give patients that previously received a placebo vaccine in RSV 006 the opportunity to receive the RSV vaccine for the first time; and to collect further safety information on the vaccine.
  Participants in the study, following provision of their consent, will undergo initial screening to understand if they are eligible for participation in the study. All patients that previously received a placebo vaccine will be offered the approved RSV vaccine, returning 30 days after the vaccination was administered for assessment, and will have a follow-up call 6 months after the first visit.
  Patients that previously received a single dose of the RSV vaccine will be separated randomly into three equal groups. Two of the groups will receive the RSV vaccine either in the first or second year of the study. They will return 30 days after the vaccination was administered, and will have a follow-up call 6 months after the vaccination visit. They will also have a further single visit annually on years where they do not receive a vaccine, until 2026 when they will leave the study. The last group will not receive a vaccine but will have a visit annually until 2026, when they will leave the study.

• REC name

  Wales REC 1

• REC reference

  24/WA/0036

• Date of REC Opinion

  2 Apr 2024

• REC opinion

  Further Information Favourable Opinion