Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
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|ClinicalTrials.gov Identifier: NCT00778895|
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : July 9, 2013
Last Update Posted : August 17, 2018
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention|
Biological: GSK Biologicals' influenza vaccine GSK1557482A
|Recruitment Details||Subjects were differentiated according to priming status. Primed Subjects – subjects who had a prior 2-dose priming influenza immunization received a 1-dose vaccination course in the study. Unprimed Subjects – subjects who had not previously received a complete 2-dose priming influenza immunization received a 2-dose vaccination course in the study.|
Study comprised an Active phase of approximately 2 months and a post-vaccination 180 day extended safety follow-up period (ESFU phase).
374 subjects out of the 390 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria.