RSVpreF + Shingles Vaccine for Respiratory Syncytial Virus
(PISSARRO Trial)
Recruiting at 15 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Adults aged 50 and older can join this study to test the safety and immune response of two vaccines given together: one for shingles (Herpes Zoster) and another for Respiratory Syncytial Virus (RSV).Inclusion Criteria
I am 50 or older and either healthy or have stable chronic conditions.
Exclusion Criteria
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, and medication list
I have not had the Zostavax vaccine in the last 2 years.
I currently have or had shingles within the last year.
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Treatment Details
Interventions
- HZ/su (Virus Therapy)
- RSVpreF (Virus Therapy)
Trial OverviewThe trial is testing RSVpreF, a vaccine aimed at preventing RSV, alongside HZ/su, a shingles vaccine. Participants will receive both vaccines to see how well they work when administered at the same time.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sequential Administration GroupExperimental Treatment2 Interventions
* Visit 1 (Day 1): HZ/su dose 1
* Visit 2 (Month 1): RSVpreF
* Visit 3 (Month 2): HZ/su dose 2
Group II: Coadministration GroupExperimental Treatment2 Interventions
* Visit 1 (Day 1): RSVpreF + HZ/su dose 1
* Visit 3 (Month 2): HZ/su dose 2
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University