Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03281876 · ClinicalTrials.gov registry record · Phase 2
A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.
A Phase 2 study of Respiratory Disorders, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 606
- Enrollment target
- 20
- Study locations
NCT03281876 is a Phase 2 study of Respiratory Disorders that has completed, run by GlaxoSmithKline. The registered enrollment target is 606 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT03281876, a Phase 2 study of Respiratory Disorders, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 606 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response. In the current study, COPD patients with a history of acute exacerbations will receive 2 doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month vaccination schedule, in addition to standard care. The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable Haemophilus influenza \[NTHi\] and Moraxella catarrhalis \[Mcat\]) will be evaluated at pre-defined timepoints (scheduled study visits). In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s) will take place for each acute exacerbation of COPD occurring from first vaccination up to study conclusion.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL NTHi Mcat investigational vaccine (GSK3277511A)
Study Locations (20)
Arizona
- GSK Investigational Site - Mesa
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
Florida
- GSK Investigational Site - Clearwater
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Jacksonville
North Carolina
- GSK Investigational Site - Charlotte
- GSK Investigational Site - Mooresville
- GSK Investigational Site - Winston-Salem
Oregon
- GSK Investigational Site - Corvallis
- GSK Investigational Site - Medford
South Carolina
- GSK Investigational Site - Gaffney
- GSK Investigational Site - Mt. Pleasant
California
- GSK Investigational Site - Palm Springs
Iowa
- GSK Investigational Site - Council Bluffs
Kansas
- GSK Investigational Site - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 606 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2020-03-26 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03281876
The ClinicalTrials.gov registry entry for NCT03281876 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 606 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 1 condition, with Respiratory Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03281876 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Arizona, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03281876 about?
NCT03281876 is a clinical study titled "A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.". The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response. In the current study, COPD patients with a history of acute exacer...
What is the current status of trial NCT03281876?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 606 participants. The study started on 2017-11-27. Estimated completion is 2020-03-26.
What conditions does trial NCT03281876 study?
This clinical trial studies the following conditions: Respiratory Disorders.
What interventions are being tested in trial NCT03281876?
The interventions under investigation include: Placebo (BIOLOGICAL), NTHi Mcat investigational vaccine (GSK3277511A) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03281876?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03281876 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Respiratory Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.