ID

35743

Description

Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the general medical history/ physical examination form. It has to be filled in for screening.

Link

https://clinicaltrials.gov/ct2/show/NCT00510874

Keywords

  1. 3/20/19 3/20/19 -
  2. 3/21/19 3/21/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 20, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

General medical history/ physical examination

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0011008
General Medical History/ Physical Examination
Description

General Medical History/ Physical 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 you tick yes, please give diagnosis and tick appropriate Past/Current box(es).

Data type

text

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0037088
MedDRA SYSTEM ORGAN CLASS
Description

MedDRA SYSTEM ORGAN CLASS

Data type

integer

Alias
UMLS CUI [1]
C2347091
General Medical History/ Physical examination, diagnosis
Description

Please report medication(s) as specified in the protocol and fill in the Medication section.

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0011900
Disease, signs and symptoms
Description

Disease, signs and symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0449438

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
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C0011008 (UMLS CUI [1])
Item Group
General Medical History/ Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
text
C0012634 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Code List
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
CL Item
Yes (Y)
CL Item
No (N)
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, malignant and unspecified (incl cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
CL Item
Other (99)
General Medical History/ Physical examination, diagnosis
Item
General Medical History/ Physical examination, diagnosis
text
C0262926 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Item
Disease, signs and symptoms
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
Code List
Disease, signs and symptoms
CL Item
Past (1)
CL Item
Current (2)

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