ID

34950

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

  1. 2/5/19 2/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 5, 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 NCT00321373

Telephone Contact

  1. StudyEvent: ODM
    1. Telephone Contact
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Telephone Contact
Description

Telephone Contact

Alias
UMLS CUI-1
C0420309
Has the information been obtained?
Description

Information Obtained

Data type

boolean

Alias
UMLS CUI [1]
C3244127
Please complete the date
Description

If information has been obtained

Data type

date

Alias
UMLS CUI [1,1]
C3244127
UMLS CUI [1,2]
C0011008

Similar models

Telephone Contact

  1. StudyEvent: ODM
    1. Telephone Contact
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Telephone Contact
C0420309 (UMLS CUI-1)
Information Obtained
Item
Has the information been obtained?
boolean
C3244127 (UMLS CUI [1])
Date Information Obtained
Item
Please complete the date
date
C3244127 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

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