Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.
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|ClinicalTrials.gov Identifier: NCT00316628|
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : September 14, 2006
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: influenza vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 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, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2005-2006, When Administered to 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).
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): NCT00316628
|G. D'Annunzio University|
|Chieti, Italy, 66100|
|Office of Hygiene and Public Health, ASL Lanciano|
|Study Director:||Novartis Vaccines - Drug Information Services||Novartis|