ID

34990

Description

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 this form is to document any concimtant vaccination, the subject has received during the study. It should be filled out at each visit/contact. At each study visit/contact, the investigator should question the subject about any vaccination(s) taken. - Any vaccine not foreseen in the study protocol administered in the period beginning 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) preceding the dose of study vaccines and ending 30 days after administration of the study vaccines, and in the period beginning 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) preceding the last study visit at Day 180 is to be recorded with trade name, route of administration and date(s) of administration. - Any Flu vaccine administered during the study period is to be recorded with trade name, route of administration and date(s) of administration. 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

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Keywords

Versions (3)

1. 2/5/19 2/5/19 -
2. 2/5/19 2/5/19 -
3. 2/7/19 2/7/19 -

Copyright Holder

GlaxoSmithKline

Uploaded on

February 7, 2019

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