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NCT04138056 · ClinicalTrials.gov registry record · Phase 2
A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 509
- Enrollment target
NCT04138056: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT04138056 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 509 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (283% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04138056, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 509 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix \[Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine\] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.
Primary Outcome
Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the
Interventions
- DRUG Placebo
- BIOLOGICAL RSVPreF3 formulation 3
- BIOLOGICAL RSVPreF3 formulation 2
- BIOLOGICAL Boostrix-ex-US
- BIOLOGICAL Boostrix-US
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 509 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 2 |
What the finished NCT04138056 record still lists
NCT04138056 is an interventional study that assigns participants to a tested intervention. The registered 509 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (283% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04138056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04138056 about?
NCT04138056 is a clinical study titled "A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women". The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-...
What is the current status of trial NCT04138056?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 509 participants. The study started on 2019-11-05. Estimated completion is 2021-11-22.
What interventions are being tested in trial NCT04138056?
The interventions under investigation include: Placebo (DRUG), RSVPreF3 formulation 3 (BIOLOGICAL), RSVPreF3 formulation 2 (BIOLOGICAL), Boostrix-ex-US (BIOLOGICAL), Boostrix-US (BIOLOGICAL).
Who is sponsoring clinical trial NCT04138056?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04138056's enrollment target sits among peer trials
509 69th of 2000 higher than 1,932 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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