ID
34848
Beschrijving
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
Trefwoorden
Versies (2)
- 31-01-19 31-01-19 -
- 31-01-19 31-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
31 januari 2019
DOI
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Licentie
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
Laboratory Tests (Blood Sample)
- StudyEvent: ODM
Beschrijving
Results of biochemical analysis
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0205474
Beschrijving
Fill in results of creatinine testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0201976
Beschrijving
Fill in results of alanine amino-transferase testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0201836
Beschrijving
Results of haematology analysis
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0474523
Beschrijving
Fill in results of lymphocytes testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0200635
Beschrijving
Fill in results of eosinophils testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0200638
Beschrijving
Fill in results of neutrophils testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0948762
Beschrijving
Fill in results of monocytes testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0200637
Beschrijving
Fill in results of basophils testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0200641
Beschrijving
Fill in results of red blood cells testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0014772
Beschrijving
Fill in results of haematocrit testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0018935
Beschrijving
Fill in results of platelets testing. Answer 'ND' for not done, 'BSI' for blood sample inadequate for testing.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0005821
Beschrijving
Antibody determination
Alias
- UMLS CUI-1
- C3833453
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C3833453
Beschrijving
Please fill in, only if the date of blood sample taking for antibody determination is different from visit date.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C3833453
- UMLS CUI [1,3]
- C0011008
Similar models
Laboratory Tests (Blood Sample)
- StudyEvent: ODM
C0205474 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0018941 (UMLS CUI [2,2])
C0205474 (UMLS CUI-2)
C0201976 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0200635 (UMLS CUI [1,2])
C0200638 (UMLS CUI [1,2])
C0948762 (UMLS CUI [1,2])
C0200637 (UMLS CUI [1,2])
C0200641 (UMLS CUI [1,2])
C0014772 (UMLS CUI [1,2])
C0018935 (UMLS CUI [1,2])
C0005821 (UMLS CUI [1,2])
C3833453 (UMLS CUI [1,2])
C3833453 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])