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This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval. |
|
| Group B | Experimental | Subjects will receive 2 doses of a formulation of GSK2592984A vaccine at a 21-day interval. |
|
| Group C | Placebo Comparator | Subjects will receive 2 doses of a placebo at a 21-day interval. |
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| Group D | Experimental | Subjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval. |
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| Group E | Experimental | Subjects will receive 2 doses of a formulation of GSK2340274A vaccine at a 21-day interval. |
|
| Group F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' investigational vaccine GSK2590066A | Biological | Intramuscular injection, two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity with respect to components of the investigational vaccine Day 0 | Day 0 | |
| Immunogenicity with respect to components of the investigational vaccine Day 42 | Day 42 | |
| Occurrence of Grade 3 injection site pain | During a 7-day follow-up period (Day 0 to 6) after any vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of each solicited local symptom | During a 7-day follow-up period (Day 0 to 6) after any vaccination | |
| Occurrence of each solicited general symptom | During a 7-day follow-up period (Day 0 to 6) after any vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anaheim | California | 92801 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25722291 | Derived | Schuind A, Segall N, Drame M, Innis BL. Immunogenicity and Safety of an EB66 Cell-Culture-Derived Influenza A/Indonesia/5/2005(H5N1) AS03-Adjuvanted Vaccine: A Phase 1 Randomized Trial. J Infect Dis. 2015 Aug 15;212(4):531-41. doi: 10.1093/infdis/jiv091. Epub 2015 Feb 25. |
| Label | URL |
|---|---|
| Results for study 114371 can be found on the GSK Clinical Study Register | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114371 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Experimental |
Subjects will receive 2 doses of a formulation of GSK2340273A vaccine at a 21-day interval. |
|
| GSK Biologicals' investigational vaccine GSK2592984A | Biological | Intramuscular injection, two doses |
|
| GSK Biologicals' investigational vaccine GSK2340274A | Biological | Intramuscular injection, two doses |
|
| GSK Biologicals' investigational vaccine GSK2340273A | Biological | Intramuscular injection, two doses |
|
| Placebo | Other | Intramuscular injection, two doses |
|
|
| Occurrence of unsolicited adverse events (AEs) | Within 21 days (Day 0 to 20) after any vaccination |
| Occurrence of AEs with medically attended visits (MAEs) | During the entire study period (from Day 0 to Month 12) |
| Occurrence and relationship to vaccination of (potential) immune mediated diseases (pIMDs) | During the entire study period (from Day 0 to Month 12) |
| Occurrence and relationship to vaccination of serious adverse events (SAEs) | During the entire study period (from Screening to Month 12) |
| Occurrence of adverse pregnancy outcomes | During the entire study period (from Day 0 to Month 12) |
| Clinical safety laboratory abnormalities | At Days 7, 28 and at Month 6. |
| Immunogenicity with respect to components of the investigational vaccine in terms of hemagglutinin Inhibition (HI) antibodies | At Days 0, 21, and 42 and Months 6 and 12 |
| Immunogenicity with respect to components of the investigational vaccine in terms of microneutralization (MN) antibodies | Days 0, 21, and 42 and Months 6 and 12 |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| GSK Investigational Site | Lenexa | Kansas | 66219 | United States |
| GSK Investigational Site | Austin | Texas | 78705 | United States |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114371 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114371 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114371 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114371 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114371 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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