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NCT05059301 · ClinicalTrials.gov registry record · Phase 3
A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above
A Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 770
- Enrollment target
- 19
- Study locations
NCT05059301 is a Phase 3 study of Respiratory Syncytial Virus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 770 participants, below the 1,055-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (27% lower). The trial reports 19 study locations across 14 states.
The verdict
NCT05059301, a Phase 3 study of Respiratory Syncytial Virus Infections, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 770 participants
- Enrollment target
- 19
- Study locations
Study Summary
The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).
Conditions Studied
Interventions
- BIOLOGICAL RSVPreF3 OA investigational vaccine
Study Locations (19)
Quebec
- GSK Investigational Site - Québec
- GSK Investigational Site - Saint-Charles-Borromée
- GSK Investigational Site - Sherbrooke
Other
- GSK Investigational Site - Eskilstuna
- GSK Investigational Site - Karlskrona
- GSK Investigational Site - Uppsala
Florida
- GSK Investigational Site - Brooksville
- GSK Investigational Site - Immokalee
Connecticut
- GSK Investigational Site - Waterbury
Georgia
- GSK Investigational Site - Buford
Minnesota
- GSK Investigational Site - Minneapolis
Mississippi
- GSK Investigational Site - Petal
Nebraska
- GSK Investigational Site - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 770 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2022-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05059301
The ClinicalTrials.gov registry entry for NCT05059301 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 770 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,055-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (27% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 1 intervention - of which RSVPreF3 OA investigational vaccine is the first listed.
NCT05059301 reports 19 study locations spanning 14 distinct geographic areas - top geographies include Quebec, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT05059301 about?
NCT05059301 is a clinical study titled "A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above". The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).
What is the current status of trial NCT05059301?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 770 participants. The study started on 2021-10-01. Estimated completion is 2022-06-30.
What conditions does trial NCT05059301 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT05059301?
The interventions under investigation include: RSVPreF3 OA investigational vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05059301?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05059301 being conducted?
This trial has 19 study locations across Connecticut, Florida, Georgia, Minnesota, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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