RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE
BiologicalIntramuscular injection
Other names: ABRYSVO, RSVpreF, PF-06928316
NCT Number: NCT06890416
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.
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Notify Me50 year and older
All sexes
Interventional
Phase 3
Clinical Research Puerto Rico, San Juan, Puerto Rico
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intramuscular injection
Other names: ABRYSVO, RSVpreF, PF-06928316
intramuscular injection
Other names: SHINGRIX, RZV, HZ/su
Time frame: 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
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
Time frame: 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).
Time frame: 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).
Time frame: Within 1 Month after last vaccination
Describe AEs occurring through 1 month after each study intervention administration
Time frame: Within 4 Months after first study vaccination (Vaccination on Day 1)
Describe SAEs occurring through 4 months after the first study intervention administration.
Time frame: Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF
Time frame: Before vaccination and 1 month after vaccination with RSVpreF
Time frame: 1 month after vaccination with RSVpreF
Time frame: Before vaccination and 1 month after the second dose of HZ/su
Time frame: Before vaccination and 1 month after the second dose of HZ/su
Time frame: 1 month after the second dose of HZ/su
Pfizer
Industry
A PHASE 3, MULTICENTER, PARALLEL-GROUP, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH HERPES ZOSTER SUBUNIT VACCINE IN ADULTS ≥50 YEARS OF AGE
Acronym: PISSARRO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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