ID

34848

Description

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This form contains information about labotratory tests and should be filled in at visit 1 and at visit 4.

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Keywords

Versions (2)
  1. 1/31/19 1/31/19 -
  2. 1/31/19 1/31/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 31, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

English

Laboratory Tests (Blood Sample)

1 forms  
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

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit number
Description

This form should be filled in at visit 1 and at visit 4.

Data type

text

Alias
UMLS CUI [1]
C1549755
Laboratory Name
Description

Laboratory Name

Data type

text

Alias
UMLS CUI [1]
C3258037
Has a blood sample been taken for biochemical and haematological analysis?
Description

If YES, complete date of blood sample taking below (if different from visit date) and complete test results below. 5ml for biochemical and haematological analysis. 5 ml for HPV antibody determination.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0205474
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0018941
Results of biochemical analysis
Description

Results of biochemical analysis

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0205474
Creatinine
Description

Fill in results of creatinine testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0201976
Alanine amino-transferase
Description

Fill in results of alanine amino-transferase testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0201836
Results of haematology analysis
Description

Results of haematology analysis

Alias
UMLS CUI-1
C1254595
UMLS CUI-2
C0474523
White blood cells: Lymphocytes
Description

Fill in results of lymphocytes testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0200635
White blood cells: Eosinophils
Description

Fill in results of eosinophils testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0200638
White blood cells: Neurophils
Description

Fill in results of neutrophils testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0948762
White blood cellls: Monocytes
Description

Fill in results of monocytes testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0200637
White blood cells: Basophils
Description

Fill in results of basophils testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0200641
Red blood cells
Description

Fill in results of red blood cells testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0014772
Haematocrit
Description

Fill in results of haematocrit testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0018935
Platelets
Description

Fill in results of platelets testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.

Data type

text

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0005821
Antibody determination
Description

Antibody determination

Alias
UMLS CUI-1
C3833453
Has a blood sample been taken for antibody determination?
Description

If YES, please complete date of blood sample taking below (if different from visit date). 5ml for biochemical and haematological analysis. 5 ml for HPV antibody determination.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C3833453
Date of blood sample taking for antibody determination
Description

Please fill in, only if the date of blood sample taking for antibody determination is different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C3833453
UMLS CUI [1,3]
C0011008
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Similar models

Laboratory Tests (Blood Sample)

1 forms
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
C1320303 (UMLS CUI [1])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (month 0, pre-vacc) (Visit 1)
CL Item
Visit 4 (month 7, post vacc III) (Visit 4)
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Blood sample
Item
Has a blood sample been taken for biochemical and haematological analysis?
boolean
C0005834 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
Item Group
Results of biochemical analysis
C1254595 (UMLS CUI-1)
C0205474 (UMLS CUI-2)
Creatinine
Item
Creatinine
text
C1254595 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
Alanine amino-transferase
Item
Alanine amino-transferase
text
C1254595 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
Item Group
Results of haematology analysis
C1254595 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
White blood cells: Lymphocytes
Item
White blood cells: Lymphocytes
text
C1254595 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
White blood cells: Eosinophils
Item
White blood cells: Eosinophils
text
C1254595 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
White blood cells: Neurophils
Item
White blood cells: Neurophils
text
C1254595 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
White blood cells: Monocytes
Item
White blood cellls: Monocytes
text
C1254595 (UMLS CUI [1,1])
C0200637 (UMLS CUI [1,2])
White blood cells: Basophils
Item
White blood cells: Basophils
text
C1254595 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
Red blood cells
Item
Red blood cells
text
C1254595 (UMLS CUI [1,1])
C0014772 (UMLS CUI [1,2])
Haematocrit
Item
Haematocrit
text
C1254595 (UMLS CUI [1,1])
C0018935 (UMLS CUI [1,2])
Platelets
Item
Platelets
text
C1254595 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
Item Group
Antibody determination
C3833453 (UMLS CUI-1)
Antibody determination
Item
Has a blood sample been taken for antibody determination?
boolean
C0005834 (UMLS CUI [1,1])
C3833453 (UMLS CUI [1,2])
Date of blood sample taking for antibody determination
Item
Date of blood sample taking for antibody determination
date
C0005834 (UMLS CUI [1,1])
C3833453 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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