A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Surface Antigen, Inactivated, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
| Registry | NCT00518726 |
|---|---|
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional; non randomized, single group, masking: none, prevention |
| Enrollment | 125 (Actual) |
| Sponsor | Novartis Vaccines (Industry) |
| Conditions | Influenza |
| Interventions | Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008 (Biological) |
| Dates | start 2007-06-01, primary completion 2007-07-01, completion 2007-07-01, first posted 2007-08-21, last updated 2016-12-01 |
| Locations | 3 sites in Italy |
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All trials for Influenza All trials of Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged > 18 years
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1 | Experimental | Biological: Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008 |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * > 18 years of age or older Exclusion Criteria: * any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.
| Facility | City | Country | Status |
|---|---|---|---|
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio | Via Dei Vestini, Chieti | Italy | |
| Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale | Via S. Spaventa, 37, Lanciano, Chieti | Italy | |
| Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena | Siena | Italy |