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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: Completed Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the 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 |
What the finished NCT05045144 record still lists
NCT05045144 is an interventional study that assigns participants to a tested intervention. Its 1,586 participants enrollment target places it among the larger protocols in the corpus, above the 1,016-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (56% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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Where NCT05045144's enrollment target sits among peer trials
1,586 4th of 21 higher than 18 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.
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