Information:
Fel:
ID
35528
Beskrivning
Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal
Nyckelord
Versioner (1)
- 2019-03-07 2019-03-07 -
Rättsinnehavare
GSK group of companies
Uppladdad den
7 mars 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652
Lab Reference Ranges, Consent Form
- StudyEvent: ODM
Similar models
Lab Reference Ranges, Consent Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Number
Item
Subject Number
integer
LABORATORY NAME:
Item
LABORATORY NAME:
text
LAB CODE
Item
LAB CODE
text
Date
Item
Date these reference ranges became effective:
date
CL Item
low (1)
CL Item
high (2)
Low age range
Item
Low age range
integer
High age range
Item
High age range
integer
CL Item
years (1)
CL Item
months (2)
CL Item
weeks (3)
CL Item
days (4)
CL Item
Male reference range (1)
CL Item
Female reference range (2)
CL Item
Male and Female reference range (3)
Hemoglobin
Item
[HB] Hemoglobin
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Red Blood Cells
Item
[RBC] Red Blood Cells
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Platelets
Item
[PLA] Platelets
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
White Blood Cells
Item
[WBC] White Blood Cells
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Neutrophils
Item
[NEU] Neutrophils
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Lymphocytes
Item
[LYM] Lymphocytes
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Monocytes
Item
[MON] Monocytes
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Eosinophils
Item
[EOS] Eosinophils
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Basophils
Item
[BAS] Basophils
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Reticulocytes
Item
[RET] Reticulocytes
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
BUN
Item
[BUN] BUN
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Creatinine
Item
[CREA] Creatinine
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
AST/SGOT
Item
[AST] AST/SGOT
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
ALT/SGPT
Item
[ALT] ALT/SGPT
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Lactate Dehydrogenase (LDH)
Item
[LDH] Lactate Dehydrogenase (LDH)
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
LD1
Item
LD1
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
LD2
Item
LD2
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
LD3
Item
LD3
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
LD4
Item
LD4
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
LD5
Item
LD5
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Cholesterol
Item
[CHOL] Cholesterol
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Creatine phosphokinase
Item
[CPK] Creatine phosphokinase
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Serum Haptoglobin
Item
[HAP] Serum Haptoglobin
text
Low Reference Value
Item
Low Reference Value
text
High Reference value
Item
High Reference value
text
Use of Human Samples by GSK
Item
In addition to the use of samples for the tests described in the protocol, samples might be used for other research by GSK (see protocol). Please tick "Yes" for what is also covered by the subject Informed Consent form of your center.
text
1. Quality Assurance of tests described in the protocol
Item
1. Quality Assurance of tests described in the protocol
boolean
2. Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases caused by S. pneumoniae or Haemophilus influenzae under study.
Item
2. Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases caused by S. pneumoniae or Haemophilus influenzae under study.
boolean
3. Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases caused by S. pneumoniae or Haemophilus influenzae under study.
Item
3. Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases caused by S. pneumoniae or Haemophilus influenzae under study.
boolean
4.Further research by GSK Biologicals that is NOT RELATED to the vaccines or the diseases caused by S. pneumoniae or Haemophilus influenzae under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed).
Item
4.Further research by GSK Biologicals that is NOT RELATED to the vaccines or the diseases caused by S. pneumoniae or Haemophilus influenzae under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed).
boolean
Item
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
text
Code List
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals (1)
CL Item
Other (2)
Specify Other
Item
Specify Other
text
ICF Effective date
Item
ICF Effective date:
date
Investigator's signature
Item
Investigator's signature:
text
Printed Investigator's name
Item
Printed Investigator's name:
text
Date
Item
Date
date