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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying medical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: aH5N1 adult | Experimental | aH5N1 healthy and non-healthy adults |
|
| Arm 2: aH5N1 elderly | Experimental | aH5N1 healthy and non-healthy elderly |
|
| Arm 3: aTIV adult | Active Comparator | aTIV healthy and non-healthy adults |
|
| Arm 4: aTIV elderly | Active Comparator | aTIV healthy and non-healthy elderly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novartis Investigational H5N1 vaccine | Biological | 2 doses of 0.5 ml, 3 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving seroconversion | Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10]) | day 43 |
| Geometric mean ratios (GMRs) as determined by HI assay | day 43 | |
| Percentage of subjects with an HI titer ≥1:40 | day 43 | |
| Solicited and unsolicited adverse events | In pooled age groups 18 years of age and older subjects who are healthy or with underlying medical condition who have received aTIV or aH5N1 vaccine. | day 202 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) as determined by HI | HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition | day 1 |
| Geometric mean ratios (GMRs) as determined by SRH |
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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 |
|---|---|---|---|---|---|---|
| 001, Novartis Investigational Site | Berlin | 10117 | Germany | |||
| 003, Novartis Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17029131 | Background | Atmar RL, Keitel WA, Patel SM, Katz JM, She D, El Sahly H, Pompey J, Cate TR, Couch RB. Safety and immunogenicity of nonadjuvanted and MF59-adjuvanted influenza A/H9N2 vaccine preparations. Clin Infect Dis. 2006 Nov 1;43(9):1135-42. doi: 10.1086/508174. Epub 2006 Sep 25. | |
| 19197383 | Background | Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6. |
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| Novartis Investigational H5N1 vaccine | Biological | 2 doses of 0.5 ml, 3 weeks apart |
|
| Novartis Seasonal Influenza Vaccine | Biological | 2 doses of 0.5 ml, 3 weeks apart |
|
| Novartis Seasonal Influenza Vaccine | Biological | 2 doses of 0.5 ml, 3 weeks apart |
|
| day 22 |
| Percentage of subjects with an HI titer ≥1:40 | day 22 |
| Percentage of subjects achieving seroconversion | Seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) | day 22 |
| Percentage of subjects with geometric mean area ≥25 mm2 | day 43 |
| Percentage of subjects achieving seroconversion | Seroconversion is defined as HI ≥1:40 for subjects who were seronegative at baseline [day 1 HI titer <1:10] or a minimum 4-fold increase in HI titer for subjects who were seropositive at baseline [day 1 HI titer ≥1:10]) | day 22 |
| GMTs as determined by SRH | Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition | day 43 (3 weeks after the second vaccination) |
| GMRs as determined by HI | day 22 |
| Geometric mean titers (GMTs) as determined by HI | HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition | day 43 (3 weeks after the second vaccination) |
| Geometric mean titers (GMTs) as determined by HI | HI assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first vaccination (day 22) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition | day 22 (3 weeks after the first vaccination) |
| GMRs as determined by SRH | day 43 |
| Percentage of subjects with an HI titer ≥1:40 | day 1 |
| Percentage of subjects with geometric mean area ≥25 mm2 | day 1 |
| Percentage of subjects with geometric mean area ≥25 mm2 | day 22 |
| Percentage of subjects achieving seroconversion | Seroconversion is defined as SRH area ≥25 mm2 for subjects who were seronegative at baseline [day 1 SRH area ≤3.997 mm2] or a significant increase [at least 50% increase] in SRH area for subjects who were seropositive at baseline [SRH area >3.997 mm2]) | day 43 |
| GMTs as determined by SRH | Serial radial haemolysis (SRH) assay: homologous antibody responses to aH5N1 vaccine 3 weeks after first and second vaccinations (day 22 and day 43) according to CHMP immunogenicity criteria in adult and elderly subjects who are healthy or with underlying medical condition | day 1 |
| Geometric mean ratios (GMRs) as determined by SRH | day 43 (3 weeks after the second vaccination) |
| Dresden |
| 01307 |
| Germany |
| 005, Novartis Investigational Site | Hamburg | 20359 | Germany |
| 006, Novartis Investigational Site | Magdeburg | 39120 | Germany |
| 004, Novartis Investigational Site | Rostock | 18055 | Germany |
| 002, Novartis Investigational Site | Würzburg | 97070 | Germany |
| 11257408 | Background | Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine. 2001 Mar 21;19(17-19):2673-80. doi: 10.1016/s0264-410x(00)00499-0. |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
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