ID

34869

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 the subjects general medical history and the physical examination performed at visit 1. Please report medication(s) as specified in the protocol and fill in the Medication section. 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. 1/31/19 1/31/19 -
  2. 2/1/19 2/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 1, 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

General Medical History/Physical Examination

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
General Medical History, Phyiscal Examination
Description

General Medical History, Phyiscal Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Description

If yes, please give diagnosis and tick appropriate Past/Current box(es).

Data type

boolean

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2]
C1457887
General Medical History, Phyiscal Examination Record
Description

General Medical History, Phyiscal Examination Record

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Past
Description

Past

Data type

boolean

Alias
UMLS CUI [1]
C0455458
Current
Description

Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0521116
UMLS CUI [1,2]
C0011900
MedDRA System Organ Class
Description

MedDRA System Organ Class

Data type

integer

Alias
UMLS CUI [1]
C2347091

Similar models

General Medical History/Physical Examination

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])
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
General Medical History, Phyiscal Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Pre-existing Conditions, Signs or Symptoms
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
C1457887 (UMLS CUI [2])
Item Group
General Medical History, Phyiscal Examination Record
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Past
Item
Past
boolean
C0455458 (UMLS CUI [1])
Current
Item
Current
boolean
C0521116 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Ear and labyrinth (11)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasms benign, malignantand unspecified (incl cysts. polyps) (17)
CL Item
Surgical and medicalprocedures (18)
CL Item
Other (99)

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