Trials / Completed
CompletedNCT01777295
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Development of Read-outs to Detect and Characterise the Early and Adaptive Immune Responses in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen in Combination With a GSK Biologicals' Adjuvant System
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines. This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.
Detailed description
This study will be conducted in 2 steps with 2 study groups in each step. The entire study period for Step 1 is from Day -30 to Day 210 (240 days) The entire study period for Step 2 is from Day 0 to Day 180 for Group C and from Day 0 to Day 330 for Group D. Subjects will be blinded up to Day 60 in Step 1 and will be unblinded at the end of their Day 60 visit. Step 2 will be conducted in an open-label manner.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A. | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| BIOLOGICAL | EngerixTM-B | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| BIOLOGICAL | Placebo | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
Timeline
- Start date
- 2013-02-25
- Primary completion
- 2016-05-17
- Completion
- 2016-09-13
- First posted
- 2013-01-28
- Last updated
- 2019-01-04
- Results posted
- 2019-01-04
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01777295. Inclusion in this directory is not an endorsement.