Trials / Completed
CompletedNCT02075541
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.
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | NTHi-10-AS01E | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| DRUG | NaCl Placebo | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
Timeline
- Start date
- 2014-07-08
- Primary completion
- 2017-04-19
- Completion
- 2017-04-19
- First posted
- 2014-03-03
- Last updated
- 2018-08-01
- Results posted
- 2018-08-01
Locations
14 sites across 2 countries: Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT02075541. Inclusion in this directory is not an endorsement.