Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects
Phase 2
Completed
- Conditions
- Influenza
- Interventions
- Biological: Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008
- Registration Number
- NCT00518726
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged \> 18 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008 -
- Primary Outcome Measures
Name Time Method Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale
🇮🇹Via S. Spaventa, 37, Lanciano, Chieti, Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
🇮🇹Via dei Vestini, Chieti, Italy
Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena
🇮🇹Siena, Italy