ID

35528

Description

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

Keywords

Versions (1)
  1. 3/7/19 3/7/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 7, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652

English

Lab Reference Ranges, Consent Form

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

LABORATORY REFERENCE RANGES
Description

LABORATORY REFERENCE RANGES

LABORATORY NAME:
Description

LABORATORY NAME:

Data type

text

LAB CODE
Description

For internal use only

Data type

text

Date these reference ranges became effective:
Description

Enter the reference range for each test. If the reference ranges for any test differ by age range, age units or sex, complete a separate form for each variation (e.g., males 0-16, males 17-99, females 0- 16, females 17-99 years).

Data type

date

Age range
Description

Age range

Data type

integer

Low age range
Description

Low age range

Data type

integer

High age range
Description

High age range

Data type

integer

Age units
Description

tick one box

Data type

text

Sex
Description

Sex

Data type

text

Hematology
Description

Hematology

[HB] Hemoglobin
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[RBC] Red Blood Cells
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[PLA] Platelets
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[WBC] White Blood Cells
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[NEU] Neutrophils
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[LYM] Lymphocytes
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[MON] Monocytes
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[EOS] Eosinophils
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[BAS] Basophils
Description

Basophils

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[RET] Reticulocytes
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

Blood Chemistry
Description

Blood Chemistry

[BUN] BUN
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[CREA] Creatinine
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[AST] AST/SGOT
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[ALT] ALT/SGPT
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[LDH] Lactate Dehydrogenase (LDH)
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

LD1
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

LD2
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

LD3
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

LD4
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

LD5
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[CHOL] Cholesterol
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[CPK] Creatine phosphokinase
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

[HAP] Serum Haptoglobin
Description

Unit

Data type

text

Low Reference Value
Description

Low Reference Value

Data type

text

High Reference value
Description

High Reference value

Data type

text

USE OF HUMAN SAMPLES BY GSK
Description

USE OF HUMAN SAMPLES BY GSK

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.
Description

Use of Human Samples by GSK

Data type

text

1. Quality Assurance of tests described in the protocol
Description

This may include the management of the quality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably.

Data type

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.
Description

These investigations excludes genetics and HIV testing.

Data type

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.
Description

These investigations excludes genetic and HIV testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed.

Data type

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).
Description

This research excludes genetic and HIV testing and does not affect subject participation in the study.

Data type

boolean

Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
Description

a 15 years GSK storage period

Data type

text

Specify Other
Description

Specify Other

Data type

text

ICF Effective date:
Description

Complete and submit a new form for each change during the study.

Data type

date

INVESTIGATOR'S SIGNATURE
Description

INVESTIGATOR'S SIGNATURE

Investigator's signature:
Description

Investigator's signature

Data type

text

Printed Investigator's name:
Description

Printed Investigator's name

Data type

text

Date
Description

Date

Data type

date

Back to the top of the page

Similar models

Lab Reference Ranges, Consent Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
LABORATORY REFERENCE RANGES
LABORATORY NAME:
Item
LABORATORY NAME:
text
LAB CODE
Item
LAB CODE
text
Date
Item
Date these reference ranges became effective:
date
Item
Age range
integer
Age range
Code List
Age range
CL Item
low (1)
CL Item
high (2)
Low age range
Item
Low age range
integer
High age range
Item
High age range
integer
Item
Age units
text
Age units
Code List
Age units
CL Item
years (1)
CL Item
months (2)
CL Item
weeks (3)
CL Item
days (4)
Item
Sex
text
Sex
Code List
Sex
CL Item
Male reference range (1)
CL Item
Female reference range (2)
CL Item
Male and Female reference range (3)
Item Group
Hematology
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
Item Group
Blood Chemistry
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
Item Group
USE OF HUMAN SAMPLES BY GSK
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
a 15 years GSK storage period
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
Item Group
INVESTIGATOR'S SIGNATURE
Investigator's signature
Item
Investigator's signature:
text
Printed Investigator's name
Item
Printed Investigator's name:
text
Date
Item
Date
date
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial