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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: Completed Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Enzyme-linked immunosorbent assay (ELISA) was used to assess the concentrations of IgG antibodies against RSV PreF3 in serum samples.
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 |
What the finished NCT05059301 record still lists
NCT05059301 is an interventional study that assigns participants to a tested intervention. The registered 770 participants enrollment target is mid-sized for trials with a published cap, below the 1,055-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (27% lower).
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 lists 19 locations in 14 states (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.
Learn More About Clinical Trials
Similar trials for Respiratory Syncytial Virus Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05059301's enrollment target sits among peer trials
770 7th of 21 higher than 15 of 21 other Respiratory Syncytial Virus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
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An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study
ACTIVE NOT RECRUITING · Phase 3
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Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
ACTIVE NOT RECRUITING · Phase 3
-
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
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-
A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
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A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
COMPLETED · Phase 3
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