A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults
- Conditions
- Respiratory Syncytial Virus (RSV)
- Interventions
- Biological: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINEBiological: HZ/su VACCINE
- Registration Number
- NCT06890416
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 525
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coadministration Group RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE * Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2 Coadministration Group HZ/su VACCINE * Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2 Sequential Administration Group RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE * Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2 Sequential Administration Group HZ/su VACCINE * Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2
- Primary Outcome Measures
Name Time Method 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 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 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 Within 7 Days after each vaccination (Vaccination on Day 1) 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).
Percentage of Participants with Systemic Events Within 7 Days after Vaccination Within 7 Days after each vaccination (Vaccination on Day 1) 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).
Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination Within 1 Month after last vaccination Describe AEs occurring through 1 month after each study intervention administration
Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study Within 4 Months after first study vaccination (Vaccination on Day 1) Describe SAEs occurring through 4 months after the first study intervention administration.
- Secondary Outcome Measures
Name Time Method NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT) Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR) Before vaccination and 1 month after vaccination with RSVpreF NTs for RSV A and RSV B expressed as seroresponse rate 1 month after vaccination with RSVpreF Anti-gE antibody concentrations expressed as GMCs Before vaccination and 1 month after the second dose of HZ/su Anti-gE antibody concentrations expressed as GMFRs Before vaccination and 1 month after the second dose of HZ/su Anti-gE antibody concentrations expressed as seroresponse rate 1 month after the second dose of HZ/su
Related Research Topics
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Trial Locations
- Locations (25)
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Alliance for Multispecialty Research, LLC
🇺🇸Coral Gables, Florida, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, 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
Synexus Clinical Research US, Inc.
🇺🇸Chicago, Illinois, United States
Optimal Research
🇺🇸Peoria, Illinois, United States
Jadestone Clinical Research
🇺🇸Silver Spring, Maryland, United States
Oakland Medical Research
🇺🇸Troy, Michigan, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
IMA Clinical Research Warren
🇺🇸Warren, New Jersey, United States
NYU Langone Health
🇺🇸New York, New York, United States
Centricity Research Columbus Ohio Multispecialty
🇺🇸Columbus, Ohio, United States
DM Clinical Research - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
DM Clinical Research - Bellaire
🇺🇸Houston, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
IMA Clinical Research San Antonio
🇺🇸San Antonio, Texas, United States
DM Clinical Research - Sugar Land
🇺🇸Sugar Land, Texas, United States