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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002625-36 |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
| |
| 4 | Active Comparator |
| |
| 5 | Active Comparator |
| |
| 6 | Active Comparator |
| |
| 7 | Active Comparator |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent Influenza Vaccine | Biological | 1 dose of Trivalent Influenza Vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Strain-specific influenza antibody titers will be used to assess Immunogenicity | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Vaccinology | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24732325 | Derived | Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli C, Groth N, Levin Y, Del Giudice G. A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59(R)-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration. Hum Vaccin Immunother. 2014;10(6):1701-10. doi: 10.4161/hv.28618. Epub 2014 Apr 14. | |
| 22426371 |
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| 8 |
| Active Comparator |
|
| 9 | Active Comparator |
|
| 10 | Active Comparator |
|
| Trivalent Influenza Vaccine + high A |
| Biological |
1 dose of Trivalent Influenza Vaccine with high A content |
|
| Trivalent Influenza Vaccine + ¼ dose adjuvant | Biological | 1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant |
|
| Trivalent Influenza Vaccine + high A + ¼ dose adjuvant | Biological | 1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant |
|
| Trivalent Influenza Vaccine + ½ dose adjuvant | Biological | 1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant |
|
| Trivalent Influenza Vaccine + high A + ½ dose adjuvant | Biological | 1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant |
|
| Trivalent Influenza Vaccine + adjuvant | Biological | 1 dose of Trivalent Influenza Vaccine plus adjuvant |
|
| Trivalent Influenza Vaccine + high A + adjuvant | Biological | 1 dose of Trivalent Influenza Vaccine with high A plus adjuvant |
|
| Trivalent Influenza Vaccine intradermal dose | Biological | 1 dose of Trivalent Influenza Vaccine intradermal dose |
|
| Trivalent Influenza Vaccine + high A intradermal dose | Biological | 1 intradermal dose of Trivalent Influenza Vaccine + high A |
|
| Derived |
| Della Cioppa G, Nicolay U, Lindert K, Leroux-Roels G, Clement F, Castellino F, Galli G, Groth N, Del Giudice G. Superior immunogenicity of seasonal influenza vaccines containing full dose of MF59 ((R)) adjuvant: results from a dose-finding clinical trial in older adults. Hum Vaccin Immunother. 2012 Feb;8(2):216-27. doi: 10.4161/hv.18445. Epub 2012 Feb 1. |
| 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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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