At a glance
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An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients
In Brief
A Phase 2 clinical trial evaluating NTHi Mcat investigational vaccine (GSK3277511A) and Placebo for Respiratory Disorders. Completed, enrolled 606 participants across 67 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.
Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.