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NCT03275389 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 470
- Enrollment target
NCT03275389 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 470 participants.
The verdict
NCT03275389, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 470 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will be enrolled and vaccinated with one or 2 primary dose(s) followed by a booster dose one year later.
Interventions
- BIOLOGICAL D-SUIV cH8/1N1+AS03
- BIOLOGICAL D-SUIV cH5/1N1+AS03
- BIOLOGICAL D-SUIV cH11/1N1+AS03
- BIOLOGICAL D-SUIV cH8/1N1+AS01
- BIOLOGICAL D-SUIV cH5/1N1+AS01
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2017-09-08 |
| Est. Completion | 2020-03-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03275389
The ClinicalTrials.gov registry entry for NCT03275389 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 470 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 D-SUIV cH8/1N1+AS03 is the first listed.
NCT03275389 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03275389 about?
NCT03275389 is a clinical study titled "A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years". The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted) in 18 to 39 year-old healthy subjects. Subjects will b...
What is the current status of trial NCT03275389?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 470 participants. The study started on 2017-09-08. Estimated completion is 2020-03-26.
What interventions are being tested in trial NCT03275389?
The interventions under investigation include: D-SUIV cH8/1N1+AS03 (BIOLOGICAL), D-SUIV cH5/1N1+AS03 (BIOLOGICAL), D-SUIV cH11/1N1+AS03 (BIOLOGICAL), D-SUIV cH8/1N1+AS01 (BIOLOGICAL), D-SUIV cH5/1N1+AS01 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03275389?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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