Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects
|ClinicalTrials.gov Identifier: NCT00329927|
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : September 14, 2006
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2006-2007, When Administered to Elderly Subjects.|
|Study Start Date :||June 2006|
- CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
- Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
- Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
- Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329927
|Dipartimento di Medicina e Scienze dell’Invecchiamento, Università G. D'Annunzio|
|Via dei Vestini, Chieti, Italy, 66100|
|Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37|
|Study Chair:||Novartis Vaccines - Drug Information Services||Novartis Vaccines & Diagnostics|