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NCT05045144 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,586
- Enrollment target
- 20
- Study locations
NCT05045144 is a Phase 3 study of Respiratory Syncytial Virus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,586 participants, above the 1,016-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT05045144, a Phase 3 study of Respiratory Syncytial Virus Infections, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,586 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT RSVPreF3(120 μg)
- COMBINATION_PRODUCT Flu Quadrivalent influenza vaccine (15 μg HA)
Study Locations (20)
Quebec
- GSK Investigational Site - Mirabel
- GSK Investigational Site - Pointe-Claire
- GSK Investigational Site - Québec
- GSK Investigational Site - Saint-Charles-Borromée
- GSK Investigational Site - Sherbrooke
Other
- GSK Investigational Site - Espoo
- GSK Investigational Site - Helsinki
- GSK Investigational Site - Helsinki
- GSK Investigational Site - Jarvenpaa
Ontario
- GSK Investigational Site - London
- GSK Investigational Site - Sarnia
- GSK Investigational Site - Toronto
British Columbia
- GSK Investigational Site - Surrey
- GSK Investigational Site - Vancouver
Florida
- GSK Investigational Site - West Palm Beach
Georgia
- GSK Investigational Site - Stockbridge
Illinois
- GSK Investigational Site - Peoria
Missouri
- GSK Investigational Site - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,586 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2022-06-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05045144
The ClinicalTrials.gov registry entry for NCT05045144 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,586 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,016-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (56% higher). 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 3 interventions - of which Placebo is the first listed.
NCT05045144 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Quebec, Other, Ontario.
Frequently Asked Questions
What is clinical trial NCT05045144 about?
NCT05045144 is a clinical study titled "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.". The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from c...
What is the current status of trial NCT05045144?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,586 participants. The study started on 2021-10-26. Estimated completion is 2022-06-06.
What conditions does trial NCT05045144 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.
What interventions are being tested in trial NCT05045144?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), RSVPreF3(120 μg) (COMBINATION_PRODUCT), Flu Quadrivalent influenza vaccine (15 μg HA) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05045144?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05045144 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, Missouri, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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