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NCT03674177 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 502
- Enrollment target
NCT03674177: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03674177 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 502 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (737% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03674177, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 502 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.
Primary Outcome
Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters.
Interventions
- DRUG Placebo (Normal Saline)
- BIOLOGICAL GSK3888550A RSV Maternal vaccine formulation 1
- BIOLOGICAL GSK3888550A RSV Maternal vaccine formulation 2
- BIOLOGICAL GSK3888550A RSV Maternal vaccine formulation 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2018-10-30 |
| Est. Completion | 2019-09-02 |
| Phase | Phase 1 |
What the finished NCT03674177 record still lists
NCT03674177 is an interventional study that assigns participants to a tested intervention. The registered 502 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (737% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo (Normal Saline) is the first listed.
NCT03674177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03674177 about?
NCT03674177 is a clinical study titled "A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women". The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data. As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study...
What is the current status of trial NCT03674177?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 502 participants. The study started on 2018-10-30. Estimated completion is 2019-09-02.
What interventions are being tested in trial NCT03674177?
The interventions under investigation include: Placebo (Normal Saline) (DRUG), GSK3888550A RSV Maternal vaccine formulation 1 (BIOLOGICAL), GSK3888550A RSV Maternal vaccine formulation 2 (BIOLOGICAL), GSK3888550A RSV Maternal vaccine formulation 3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03674177?
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 NCT03674177's enrollment target sits among peer trials
502 44th of 2000 higher than 1,957 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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