This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
526
Intramuscular injection
intramuscular injection
Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone
Time frame: 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone
Time frame: 1 month after the second dose of HZ/su in the RSVpreF + HZ/su coadministration group to HZ/su alone in the sequential administration group
Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination
Describe local reactions (redness, swelling, and pain at the injection site) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
Time frame: Within 7 Days after each vaccination (Vaccination on Day 1)
Percentage of Participants with Systemic Events Within 7 Days after Vaccination
Describe systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
Time frame: Within 7 Days after each vaccination (Vaccination on Day 1)
Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination
Describe AEs occurring through 1 month after each study intervention administration
Time frame: Within 1 Month after last vaccination
Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
Describe SAEs occurring through 4 months after the first study intervention administration.
Time frame: Within 4 Months after first study vaccination (Vaccination on Day 1)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Central Research Associates
Birmingham, Alabama, United States
Medical Affiliated Research Center
Huntsville, Alabama, United States
AMR Clinical
Mobile, Alabama, United States
Kaiser Permanente
Los Angeles, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC
Doral, Florida, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
De La Cruz Research Center, LLC
Miami, Florida, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
...and 16 more locations
NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Time frame: Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Time frame: Before vaccination and 1 month after vaccination with RSVpreF
NTs for RSV A and RSV B expressed as seroresponse rate
Time frame: 1 month after vaccination with RSVpreF
Anti-gE antibody concentrations expressed as GMCs
Time frame: Before vaccination and 1 month after the second dose of HZ/su
Anti-gE antibody concentrations expressed as GMFRs
Time frame: Before vaccination and 1 month after the second dose of HZ/su
Anti-gE antibody concentrations expressed as seroresponse rate
Time frame: 1 month after the second dose of HZ/su