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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 509 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04138056
The ClinicalTrials.gov registry entry for NCT04138056 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 509 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04138056 reports 0 study locations.
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.
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