A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD? Surface Antigen, Inactivated, (Adjuvanted with MF59C.1) Influenza Vaccine, Formulation 2005-2006, when Administered to Elderly Subjects
- Conditions
- Active influenza immunizationMedDRA version: 9.1Level: LLTClassification code 10022000Term: Influenza
- Registration Number
- EUCTR2005-000621-38-IT
- Lead Sponsor
- CHIRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Valutazione della tollerabilita' e immunogenicita' della formulazione 2005/2006 del vaccino FLUAD secondo quanto richiesto dalle raccomandazioni dell?Unione Europea.;Secondary Objective: ;Primary end point(s): Rispondenza ai criteri CPMP per i vaccini influenzali della formulazione 2005/2006 del vaccino FLUAD <br>
- Secondary Outcome Measures
Name Time Method