AzTrials
AzTrials

Respiratory Syncytial Virus (RSV)Phase 3PISSARRONCT06890416

A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults

A Phase 3 study testing RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE and HZ/su VACCINE in people with Respiratory Syncytial Virus (RSV), run by Pfizer at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus (RSV)
What is being tested?
RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE and HZ/su VACCINE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
526 participants
Where
26 sitesin 2 countries
Study dates
4 Apr 2025to 30 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions

Who cannot join

  • Current clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of HZ and/or history of clinically suspected or PCR-confirmed HZ within the past 12 months.
  • Prior history of any subtype of Guillain Barré syndrome of any etiology.
  • Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, and medication list
  • Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt of a nonstudy RSV vaccine during study participation.
  • Previous vaccination with any licensed recombinant adjuvant zoster vaccine (Shingrix) at any time prior to enrollment, or planned receipt of a nonstudy licensed VZV vaccine (Shingrix) during study participation.
Show all 9Show fewer
  • History of previous vaccination with live HZ vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
  • Previous vaccination with any investigational VZV vaccine at any time prior to enrollment, or planned receipt of a nonstudy investigational VZV vaccine during study participation.
  • Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids (defined as ≥20 mg/day of prednisone or equivalent for ≥14 days), eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration, or planned receipt throughout the study.

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States25 sites

  • Central Research Associates

    Birmingham, Alabama, 35205

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Synexus Clinical Research US, Inc.

    Chicago, Illinois, 60602

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia, 31904

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213

  • Alliance for Multispecialty Research, LLC

    Doral, Florida, 33172

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida, 33308

  • DM Clinical Research - Bellaire

    Houston, Texas, 77081

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • De La Cruz Research Center, LLC

    Miami, Florida, 33184

  • AMR Clinical

    Mobile, Alabama, 36608

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • NYU Langone Health

    New York, New York, 10016

  • Optimal Research

    Peoria, Illinois, 61614

  • DM Clinical Research - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229

  • Jadestone Clinical Research

    Silver Spring, Maryland, 20904

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • DM Clinical Research - Sugar Land

    Sugar Land, Texas, 77478

  • Oakland Medical Research

    Troy, Michigan, 48085

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • IMA Clinical Research Warren

    Warren Township, New Jersey, 07059

Other trials in United States

Puerto Rico1 site

  • Clinical Research Puerto Rico

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: 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

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.

Being tested
RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE, HZ/su VACCINE
Keywords
RSV, Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINEBiological

    Also called ABRYSVO, RSVpreF, PF-06928316

    Intramuscular injection

  • HZ/su VACCINEBiological

    Also called SHINGRIX, RZV, HZ/su

    intramuscular injection

Study groups in NCT06890416
Study groupRoleWhat they receive
Coadministration GroupOther* Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2
Receives: Biological: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE; Biological: HZ/su VACCINE
Sequential Administration GroupOther* Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2
Receives: Biological: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE; Biological: HZ/su VACCINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group

  2. Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone

    Measured: 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

  3. 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).

    Measured: Within 7 Days after each vaccination (Vaccination on Day 1)

  4. 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).

    Measured: Within 7 Days after each vaccination (Vaccination on Day 1)

  5. 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

    Measured: Within 1 Month after last vaccination

  6. Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study

    Describe SAEs occurring through 4 months after the first study intervention administration.

    Measured: Within 4 Months after first study vaccination (Vaccination on Day 1)

Secondary outcomes (6)

  1. NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)

    Measured: Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF

  2. NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)

    Measured: Before vaccination and 1 month after vaccination with RSVpreF

  3. NTs for RSV A and RSV B expressed as seroresponse rate

    Measured: 1 month after vaccination with RSVpreF

  4. Anti-gE antibody concentrations expressed as GMCs

    Measured: Before vaccination and 1 month after the second dose of HZ/su

  5. Anti-gE antibody concentrations expressed as GMFRs

    Measured: Before vaccination and 1 month after the second dose of HZ/su

  6. Anti-gE antibody concentrations expressed as seroresponse rate

    Measured: 1 month after the second dose of HZ/su

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start4 Apr 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890416
Sponsor's protocol ID
C3671058
Other IDs
PISSARRO
Acronym
PISSARRO
Status last verified
Nov 2025
First submitted
17 Mar 2025
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE and HZ/su VACCINE in people with Respiratory Syncytial Virus (RSV), run by Pfizer at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06890416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in