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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT04126213 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 534 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (302% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
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 |
What the finished NCT04126213 record still lists
NCT04126213 is an interventional study that assigns participants to a tested intervention. The registered 534 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 (302% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04126213 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04126213's enrollment target sits among peer trials
534 63rd of 2000 higher than 1,937 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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