ID

35168

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 if a blood sample for HI antibody determination has been taken. 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 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373" This study is a LONG-TERM FOLLOW-UP to the PREVIOUS STUDY 107022 (FLU-LD-001).

Link

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

Keywords

  1. 2/13/19 2/13/19 -
  2. 2/20/19 2/20/19 - Sarah Riepenhausen
  3. 2/25/19 2/25/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 20, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97

Laboratory Tests

  1. StudyEvent: ODM
    1. Laboratory Tests
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for HI antibody determination?
Description

Blood Sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2,1]
C0003241
UMLS CUI [2,2]
C0021400
Assessment Date
Description

If yes, please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C2985720

Similar models

Laboratory Tests

  1. StudyEvent: ODM
    1. Laboratory Tests
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood Sample
Item
Has a blood sample been taken for HI antibody determination?
boolean
C0005834 (UMLS CUI [1])
C0003241 (UMLS CUI [2,1])
C0021400 (UMLS CUI [2,2])
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])

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