Trials / Completed
CompletedNCT01657526
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A) | Administered intramuscularly (IM) in the deltoid region of non-dominant arm |
| BIOLOGICAL | GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A) | 2 doses administered IM in the deltoid region of non-dominant arm |
| BIOLOGICAL | Saline placebo | 2 doses administered IM in the deltoid region of non-dominant arm |
Timeline
- Start date
- 2012-08-08
- Primary completion
- 2013-11-25
- Completion
- 2013-11-25
- First posted
- 2012-08-06
- Last updated
- 2017-05-15
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT01657526. Inclusion in this directory is not an endorsement.