Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to document the telephone contact with the subect, 30 days after administration of the study vaccine. Please contact the subject by phone 30 days after administration of the study vaccine dose to follow up on: - Check of elimination criteria - Recording of any non-serious adverse events occurring within 30 days (days 0-29) post-vaccination, by investigator. - Recording of concomitant medication /vaccination. - Recording and reporting of any serious adverse events. - Study Conclusion Day 30. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1
February 5, 2019
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