A Phase 3 Master Protocol to Evaluate the Safety, Tolerability, and Immunogenicity of Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults at High Risk of Severe RSV Disease.
Substudy A Design:
This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study that will assess the safety, tolerability, and immunogenicity of Pfizer’s RSVpreF in adults 18 to <60 years of age considered to be at high risk of RSV disease due to certain chronic medical conditions.
Substudy B Design:
This is a Phase 3, single-arm, open-label, multicenter study that will assess the safety, tolerability, and immunogenicity of Pfizer’s RSVpreF in immunocompromised adults.
The George Washington University Vaccine Research Unit is seeking volunteers for an RSV vaccine clinical trial who are:
Substudy A
- Between the ages 18-59
- May be at high-risk for RSV disease
- For example, chronic lung disease, (including asthma or COPD), heart disease, diabetes, or chronic kidney disease
- Have never received an investigational RSV vaccine
Substudy B
- At least 18 years old
- Are immunocompromised, which may include:
- Non-small cell lung cancer (NSCLC) and receiving treatment
- Organ transplant recipient
- On hemodialysis
- On therapy for autoimmune disorders (such as inflammatory bowel disease or type of arthritis)
- Have never received an investigational RSV vaccine
More information will be available at www.clinicaltrials.gov.