Clinical Trials Logo

Clinical Trial Summary

The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a 0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. No vaccinations will be administered in this trial.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03201211
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date June 22, 2017
Completion date March 19, 2020

See also
  Status Clinical Trial Phase
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Withdrawn NCT00844935 - Electrocardiographic Autonomic Function Measures in Mechanically Ventilated Patients N/A
Completed NCT01395849 - Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol) N/A
Completed NCT03557645 - Ventilator Hyperinflation and Hemodynamics N/A
Completed NCT03281876 - 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. Phase 2
Completed NCT01395862 - Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol) N/A
Completed NCT01476046 - Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects. Phase 1
Completed NCT01587807 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057 Phase 1
Completed NCT00835003 - Timing of Planned Caesarean Section and Morbidity of the Newborn N/A
Completed NCT03443427 - A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine Phase 2
Completed NCT01360398 - Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly N/A
Completed NCT02075541 - A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction. Phase 2
Completed NCT00455767 - Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients Phase 2
Withdrawn NCT01505556 - Proprioceptive Postural Control and Diaphragm Paresis
Completed NCT01505582 - Inspiratory Muscle Training and Low Back Pain N/A
Completed NCT02322671 - Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects Phase 1
Completed NCT01818024 - A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers Phase 1
Recruiting NCT02316379 - Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration Phase 1/Phase 2
Completed NCT01516437 - A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable COPD N/A
Recruiting NCT02272049 - Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults Phase 1/Phase 2