ID

34952

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

  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 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

Concomitant Vaccination

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Assessment Date
Description

Assessment Date

Data type

text

Alias
UMLS CUI [1]
C2985720
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Description

If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant Vaccination Record
Description

Concomitant Vaccination Record

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade/Generic Name
Description

Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Route
Description

Route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Description

Administration date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210

Similar models

Concomitant Vaccination

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Assessment Date
text
C2985720 (UMLS CUI [1])
Code List
Assessment Date
CL Item
Visit 1 (Visit 1)
CL Item
Visit 2 (Visit 2)
CL Item
Telephone Contact (Telephone Contact)
CL Item
Visit 3 (Visit 3)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes (2)
Item Group
Concomitant Vaccination Record
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

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