Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000964-26 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | FLUAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted influenza vaccine | Biological | Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc | ||
| To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria USL 7 di Siena | Siena | 53100 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided