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Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
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This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 18 to 64 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental | Subjects enrolled in this group will be stratified by age (18 to 40 years and 41 to 64 years) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A | Biological | Intramuscular injection, one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response in terms of Hemagglutination Inhibition (HI) antibodies (Vaccine virus-homologous responses) | At Day 21 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response in terms of HI antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains | At Day 0, 21 and 182 after vaccination | |
| Humoral immune response in terms of neutralizing antibodies against A/California/7/2009 (H1N1)v-like antigen and any drifted strains |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| At Day 0, 21 and 182 after vaccination |
| Occurrence of solicited local and general symptoms | During a 7-day (Day 0-6) follow-up period after vaccination. |
| Occurrence of unsolicited adverse events | During a 21-day (Day 0-20) follow-up period after vaccination and from Days 0 to 84. |
| Occurrence of medically attended and/or serious adverse events, and of potentially immune-mediated diseases. | From the beginning up to the end of the study (Day 182) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |