A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.

Last updated: September 5, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Respiratory Syncytial Virus (Rsv)

Treatment

RSVpreF SDV

RSVpreF MDV

Clinical Study ID

NCT06473519
C4841001
  • Ages 18-49
  • Female
  • Accepts Healthy Volunteers

Study Summary

Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness, where medical help is needed. RSV can lead to airway diseases in all ages. Vaccines help your body make antibodies. These antibodies help fight against diseases. This is called an immune response.

The purpose of this study is to learn about the safety, tolerability, and immunogenicity of a RSV vaccine called RSVpreF. RSVpreF comes either as:

  • a single dose in a container (called a vial),

  • or in a vial that holds multiple doses. A multidose vial contains more than one dose of RSVpreF.

    2-Phenoxyethanol (2-PE) is a preservative to help prevent the growth of bacteria (germs). This study will compare RSVpreF with an added preservative called 2-phenoxyethanol (2-PE) from a multidose vial, to RSVpreF without an added preservative, from a single-dose vial.

This study is looking to enroll nonpregnant, nonbreastfeeding, healthy female participants.

Participants will need to visit the study clinic two times during the study. Participants will also have a final safety telephone call at the end of the study. All participants will receive a single shot of the study vaccine either from:

  • a multidose vial (with the preservative), or

  • from a single-dose vial (without the preservative) at the first study clinic visit.

Blood samples will be taken at the two study clinic visits. Each participant will take part in the study for around 6 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 (Day 1).

  2. Willing and able to comply with all scheduled visits, investigational plan,lifestyle considerations, and other study procedures.

  3. Available for the duration of the study and can be contacted by telephone duringstudy participation.

  4. Capable of giving signed informed consent as described in the protocol whichincludes compliance with the requirements and restrictions listed in the ICD and inthe protocol.

Exclusion

Exclusion Criteria:

  1. Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.

  2. History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) to any component of the vaccines being administered inthe study.

  3. Immunocompromised participants with known or suspected immunodeficiency, asdetermined by history, laboratory tests, and/or physical examination.

  4. History or active autoimmune disease, including but not limited to systemic orcutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis,Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathicthrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cellarteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).

  5. Bleeding diathesis or any condition that would, in the opinion of the investigator,contraindicate intramuscular injection.

  6. Previous vaccination with any licensed or investigational RSV vaccine, or plannedreceipt of a nonstudy RSV vaccine throughout the study.

  7. Receipt of chronic systemic treatment with immunosuppressant medications (includingcytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 daysbefore enrollment through conclusion of the study.

  8. Receipt of blood/plasma products or immunoglobulin within 60 days before studyintervention administration or planned receipt throughout the study.

  9. Current alcohol abuse or illicit drug use.

  10. Individuals who are pregnant or breastfeeding.

  11. Participation in other studies involving an investigational product within 28 daysprior to study entry and/or during study participation. Participation in purelyobservational studies is acceptable.

  12. Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.

Study Design

Total Participants: 453
Treatment Group(s): 2
Primary Treatment: RSVpreF SDV
Phase: 3
Study Start date:
June 24, 2024
Estimated Completion Date:
September 20, 2024

Connect with a study center

  • Qps-Mra, Llc

    South Miami, Florida 33143
    United States

    Site Not Available

  • Qps-Mra, Llc

    South Miami 4173495, Florida 4155751 33143
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge 4224681, Georgia 4197000 30281
    United States

    Site Not Available

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Clinical Research Prime Rexburg

    Rexburg, Idaho 83440
    United States

    Site Not Available

  • Clinical Research Prime

    Idaho Falls 5596475, Idaho 5596512 83404
    United States

    Site Not Available

  • Clinical Research Prime Rexburg

    Rexburg 5605242, Idaho 5596512 83440
    United States

    Site Not Available

  • Headlands Research - Detroit

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Headlands Research - Detroit

    Southfield 5010636, Michigan 5001836 48034
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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