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Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
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This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK's candidate influenza vaccine 1562902A | Biological | Intramuscular dose on Day 0 and Day 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum HI antibody titres | Day -30, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum HI antibody titres | Day -30, Day 42, Month 6, Month 12 | |
| Serum neutralising antibody titres | Day -30, Day 42, Month 6, Month 12 | |
| Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms |
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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 | Curitiba/ParanĂ¡ | ParanĂ¡ | 80810-050 | Brazil |
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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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| FluarixTM | Biological | Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule |
|
| Placebo | Biological | Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule |
|
| Day 0 - Day 6 after each vaccination |
| Occurrence, intensity and relationship to vaccination of unsolicited adverse events | Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination |
| Occurrence and relationship to vaccination of serious adverse events | Day 0 - Month 6 |
| Occurrence of adverse events of specific interest | Day 0 - Month 12 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |