Trials / Completed
CompletedNCT02547974
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.
An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
| BIOLOGICAL | Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
| BIOLOGICAL | Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
| DRUG | Placebo | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
Timeline
- Start date
- 2015-08-31
- Primary completion
- 2017-03-31
- Completion
- 2017-03-31
- First posted
- 2015-09-14
- Last updated
- 2018-08-31
- Results posted
- 2018-07-23
Locations
3 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02547974. Inclusion in this directory is not an endorsement.