A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.

Eligibility criteria

Qualifiers

Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC_1 and Visit 4 for participants in IC_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available.

Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study).

Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.

Female participants of nonchildbearing potential may be enrolled in the study. Non childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.

Disqualifiers

Any history of dementia or any medical condition that moderately or severely impairs cognition.

Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end).

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention

Acute or chronic clinically significant cardiovascular or hepatic functional abnormality, as determined by physical examination or laboratory screening tests.

Trial design

Treatments tested in this trial

  • Adjuvanted RSVPreF3 vaccine

Treatment groups

184 Participants
are divided into 1 treatment group

Sponsors and collaborators