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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003715-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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The aim of the present dose ranging study is to evaluate the safety, tolerability and immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.75_0%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 0% of MF59 three weeks apart. |
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| 3.75_25%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 25% of MF59 three weeks apart. |
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| 3.75_50%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 50% of MF59 three weeks apart. |
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| 3.75_100%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 3.75µg subunit influenza vaccine containing 100% of MF59 three weeks apart. |
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| 7.5_0%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 0% of MF59 three weeks apart. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59. |
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity, safety and reactogenicity of cell culture-derived H5N1 subunit influenza virus vaccines containing different amounts of antigen and adjuvant. | 52 weeks | |
| identification of the optimal adjuvant-antigen dose combination considering antibody titers against the H5N1 strain observed three weeks after two intramuscular doses. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| immunogenicity against heterologous strains of a cell culture-derived H5N1 subunit influenza virus vaccine containing different amounts of antigen and adjuvant. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Scientist | Seqirus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States | ||
| Universitätsklinikum Gießen und Marburg GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19835829 | Background | Keitel W, Groth N, Lattanzi M, Praus M, Hilbert AK, Borkowski A, Tsai TF. Dose ranging of adjuvant and antigen in a cell culture H5N1 influenza vaccine: safety and immunogenicity of a phase 1/2 clinical trial. Vaccine. 2010 Jan 8;28(3):840-8. doi: 10.1016/j.vaccine.2009.10.019. Epub 2009 Oct 14. |
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| 7.5_25%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 25% of MF59 three weeks apart. |
|
| 7.5_50%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 50% of MF59 three weeks apart. |
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| 7.5_100%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 7.5µg subunit influenza vaccine containing 100% of MF59 three weeks apart. |
|
| 15_0%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 0% of MF59 three weeks apart. |
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| 15_25%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 25% of MF59 three weeks apart. |
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| 15_50%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 50% of MF59 three weeks apart. |
|
| 15_100%MF59 | Experimental | Subjects received two 0.5mL vaccinations of cell culture derived H5N1 15µg subunit influenza vaccine containing 100% of MF59 three weeks apart. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59. |
|
| Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59 | Biological | Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59. |
|
| Giessen |
| 35392 |
| 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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