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NCT06473519 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
NCT06473519 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 453 participants.
The verdict
NCT06473519, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
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.
Interventions
- BIOLOGICAL RSVpreF MDV
- BIOLOGICAL RSVpreF SDV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2024-06-24 |
| Est. Completion | 2024-09-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06473519
The ClinicalTrials.gov registry entry for NCT06473519 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 453 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RSVpreF MDV is the first listed.
NCT06473519 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06473519 about?
NCT06473519 is a clinical study titled "A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.". 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 ...
What is the current status of trial NCT06473519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2024-06-24. Estimated completion is 2024-09-20.
What interventions are being tested in trial NCT06473519?
The interventions under investigation include: RSVpreF MDV (BIOLOGICAL), RSVpreF SDV (BIOLOGICAL).
Who is sponsoring clinical trial NCT06473519?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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