Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT07050732
Brief Summary:
This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems. The main questions it aims to answer are:
* Does 1 or 2 doses of Arexvy work better in people with weakened immune systems?
* What medical problems do participants have after receiving Arexvy?
Participants with weakened immune systems will:
* Receive 3 study vaccines over the course of 1 year
* Keep a diary of symptoms for 7 days after each vaccine
* Have 3 in-person follow up study visits for checkups and tests over the course of 1.5 years
* Have 6 phone follow up study visits over the course of 1.5 years
Detailed Description:
People with weakened immune systems will be randomized to either:
1. Receive one dose of Arexvy followed by a placebo vaccine (sterile saline) 60 days later, or
2. Receive one dose of Arexvy followed by another dose of Arexvy 60 days later
Both groups will also receive another dose of Arexvy 1 year after the first dose.
A small group of people without weakened immune systems will also be enrolled in the study. This group will receive one dose of Arexvy.
Study:
NCT07050732
Study Brief:
Protocol Section:
NCT07050732