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Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus. The vaccines contain different antigen doses. For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H5N1 Formulation 1 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval |
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| H5N1 Formulation 2 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval |
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| H5N1 Formulation 3 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval |
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| H5N1 Formulation 4 Group | Experimental | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval |
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| H5N1 Formulation 5 Group | Active Comparator | Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine | Biological | 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers | Geometric mean titers (GMTs) of serum antibodies | At Days 0, 21, 42 and 180 |
| To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus | At days 21, 42 and 180 | |
| Occurrence of solicited local and general adverse events | During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall | |
| Occurrence of unsolicited adverse events | During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination | |
| Occurrence of serious adverse events | During the entire study (Days 0 to 180) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers | Geometric mean titers (GMTs) of serum antibodies | At Days 0, 21, 42 and 180 |
| To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes |
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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 | Finsterwalde | Brandenburg | 03238 | Germany | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Results for study 106378 can be found on the GSK Clinical Study Register | View source |
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| H5N1 Formulation 6 Group | Active Comparator | Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval |
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| H5N1 Formulation 7 Group | Active Comparator | Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval |
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| H5N1 Formulation 8 Group | Active Comparator | Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval |
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| Influenza Monovalent Whole virus (H5N1) | Biological | 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 |
|
| At days 0, 21, 42 and 180 |
| To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers | At Days 21, 42 and 180 |
| Tostedt |
| Lower Saxony |
| 21255 |
| Germany |
| GSK Investigational Site | Dresden | Saxony | 01129 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Freiberg | Saxony | 09599 | Germany |
| GSK Investigational Site | Geringswalde | Saxony | 09326 | Germany |
| GSK Investigational Site | Schmiedeberg | Saxony | 01762 | Germany |
| GSK Investigational Site | Bad Segeberg | Schleswig-Holstein | 23795 | Germany |
| GSK Investigational Site | Elmshorn | Schleswig-Holstein | 25335 | Germany |
| 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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