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NCT03814590 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,053
- Enrollment target
NCT03814590 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,053 participants.
The verdict
NCT03814590, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,053 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).
Interventions
- BIOLOGICAL RSV Vaccine (GSK3844766A) unadjuvanted low dose
- BIOLOGICAL RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E
- BIOLOGICAL RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
- BIOLOGICAL RSV Vaccine (GSK3844766A) unadjuvanted medium dose
- BIOLOGICAL RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,053 participants |
| Start Date | 2019-01-21 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03814590
The ClinicalTrials.gov registry entry for NCT03814590 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,053 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 RSV Vaccine (GSK3844766A) unadjuvanted low dose is the first listed.
NCT03814590 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03814590 about?
NCT03814590 is a clinical study titled "A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults". The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. As the investigation...
What is the current status of trial NCT03814590?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,053 participants. The study started on 2019-01-21. Estimated completion is 2020-11-30.
What interventions are being tested in trial NCT03814590?
The interventions under investigation include: RSV Vaccine (GSK3844766A) unadjuvanted low dose (BIOLOGICAL), RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E (BIOLOGICAL), RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B (BIOLOGICAL), RSV Vaccine (GSK3844766A) unadjuvanted medium dose (BIOLOGICAL), RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E (BIOLOGICAL).
Who is sponsoring clinical trial NCT03814590?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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