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OpenTrials
Completed

NCT Number: NCT06890416

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

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Puerto Rico, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE

Biological

Intramuscular injection

Other names: ABRYSVO, RSVpreF, PF-06928316

HZ/su vaccine

Biological

intramuscular injection

Other names: SHINGRIX, RZV, HZ/su

Primary outcomes

  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

    Time frame: 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

    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

  3. Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination

    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).

  4. Percentage of Participants with Systemic Events Within 7 Days after Vaccination

    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).

  5. Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination

    Time frame: Within 1 Month after last vaccination

    Describe AEs occurring through 1 month after each study intervention administration

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

    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.

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: 1 month after vaccination with RSVpreF

  4. Anti-gE antibody concentrations expressed as GMCs

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

  5. Anti-gE antibody concentrations expressed as GMFRs

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

  6. Anti-gE antibody concentrations expressed as seroresponse rate

    Time frame: 1 month after the second dose of HZ/su

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: PISSARRO

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Nov 6, 2025

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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