NCT06473519

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

A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE FORMULATED IN MULTIDOSE VIALS IN HEALTHY FEMALE ADULTS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	RSVpreF MDV	RSVpreF with 2-PE formulated in an MDV
BIOLOGICAL	RSVpreF SDV	RSVpreF without 2-PE formulated in an SDV

Timeline

• Start date: 2024-06-24
• Primary completion: 2024-09-20
• Completion: 2024-09-20
• First posted: 2024-06-25
• Last updated: 2025-09-25
• Results posted: 2025-09-25

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study