Safety and Immunogenicity of an Adjuvanted Influenza Vaccine in Subjects Aged 65 Years and Over.
This study has been completed.
Information provided by:
First received: April 19, 2006
Last updated: September 13, 2006
Last verified: September 2006
The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary Outcome Measures:
- 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).
|Study Start Date:||June 2005|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316628
|G. D'Annunzio University|
|Chieti, Italy, 66100|
|Office of Hygiene and Public Health, ASL Lanciano|
Sponsors and Collaborators
|Study Director:||Novartis Vaccines - Drug Information Services||Novartis|