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 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

Link:

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

Keywords:
Versions (1) ▾
  1. 2/5/19
Copyright Holder:
GlaxoSmithKline
Uploaded on:

February 5, 2019

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY-NC 3.0
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Telephone Contact

  1. StudyEvent: ODM
    1. Telephone Contact
Administrative Data
Telephone Contact
Has the information been obtained?