Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
|ClinicalTrials.gov Identifier: NCT00342940|
Recruitment Status : Withdrawn (Lack of Vaccine Supplies)
First Posted : June 21, 2006
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: influenza surface antigen inactivated vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label, Uncontrolled, Single 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 :||October 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): NCT00342940
|Chiltern International Limited , Chiltern Place, Upton Road|
|Slough, United Kingdom, SL1 2AD|
|Study Chair:||Novartis Vaccines Drug Information Services||Novartis|