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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03275389 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 470 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (683% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.
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 |
What the finished NCT03275389 record still lists
NCT03275389 is an interventional study that assigns participants to a tested intervention. The registered 470 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 (683% higher).
The record links to 0 conditions, and to 5 interventions - of which D-SUIV cH8/1N1+AS03 is the first listed.
NCT03275389 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03275389's enrollment target sits among peer trials
470 52nd of 2000 higher than 1,949 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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