Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.
|ClinicalTrials.gov Identifier: NCT00316615|
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : September 14, 2006
|Condition or disease||Intervention/treatment||Phase|
|Influenza Disease||Biological: influenza vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, When Administered to Non-Elderly Adult and Elderly Subjects|
|Study Start Date :||June 2005|
- 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): NCT00316615
|G. D'Annunzio University|
|Chieti, Italy, 66100|
|Office of Hygiene and Public Health, ASL Lanciano|
|Study Chair:||Novartis Vaccines - Drug Information Services||Novartis|