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NCT04126213 · ClinicalTrials.gov registry record · Phase 2
Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 534
- Enrollment target
NCT04126213 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 534 participants.
The verdict
NCT04126213, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 534 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.
Interventions
- DRUG Placebo
- BIOLOGICAL RSV MAT 60 µg
- BIOLOGICAL RSV MAT 120 µg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 534 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2021-05-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04126213
The ClinicalTrials.gov registry entry for NCT04126213 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 534 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 3 interventions - of which Placebo is the first listed.
NCT04126213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04126213 about?
NCT04126213 is a clinical study titled "Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants". The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.
What is the current status of trial NCT04126213?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 534 participants. The study started on 2019-11-05. Estimated completion is 2021-05-14.
What interventions are being tested in trial NCT04126213?
The interventions under investigation include: Placebo (DRUG), RSV MAT 60 µg (BIOLOGICAL), RSV MAT 120 µg (BIOLOGICAL).
Who is sponsoring clinical trial NCT04126213?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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