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

NCT06473519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2025-09-25

Study results available
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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

BIOLOGICAL

RSVpreF MDV

RSVpreF with 2-PE formulated in an MDV

BIOLOGICAL

RSVpreF SDV

RSVpreF without 2-PE formulated in an SDV

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2024-09-20
Completion
2024-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06473519 on ClinicalTrials.gov