At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Randomized, Controlled, Open-label Study to Evaluate the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults (>=18 Years of Age) When Administered to Lung and Renal Transplant Recipients Comparing 1 Versus 2 Doses and Compared to Healthy Controls (>=50 Years of Age) Receiving 1 Dose.
In Brief
A Phase 2 clinical trial evaluating RSVPreF3 OA Investigational Vaccine for Respiratory Syncytial Virus Infections. Completed, enrolled 386 participants across 46 sites in 8 countries.
Signals
Detailed Summary
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
Study Details
Timeline
Arms & Interventions
Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Interventions
0.5 mililiter dose was administered intramuscularly as 1 dose to RSV\_IC\_1 and RSV\_HA groups, and 2 doses to RSV\_IC\_2 group.