Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00329966|
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, Influenza (form.2006-07)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 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, Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329966
|Dipartimento di Medicina e Scienze dell’Invecchiamento Università G. D’AnnunzioVia dei Vestini|
|Chieti, Italy, 66100|
|Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37|
|Study Chair:||Novartis Vaccines - Drug Information Services||Novartis Vaccines & Diagnostics|