At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 145 enrolled
Drug / intervention
NTHi-10-AS01E +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients
In Brief
A Phase 2 clinical trial evaluating NTHi-10-AS01E and NaCl Placebo for Respiratory Disorders. Completed, enrolled 145 participants across 14 sites in 2 countries.
Detailed Summary
The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with moderate and severe persistent airflow obstruction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Disorders
CountriesSweden, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartJul 2014
Primary CompletionApr 2017
TodayJul 2026
First PostedMar 3, 2014
Enrollment StartJul 8, 2014
Primary CompletionApr 19, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.3 years ago
Interventions
NTHi-10-AS01Ebiological
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
NaCl Placebodrug
Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.