ID
35064
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 study conclusion and should be filled in at the end of the study (visit 4).
Link
https://clinicaltrials.gov/ct2/show/NCT00290277
Keywords
Versions (1)
- 2/13/19 2/13/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 13, 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
Study conclusion
- StudyEvent: ODM
Description
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
Description
If NO, please specify the most appropriate reason below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020975
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0337611
- UMLS CUI [1,4]
- C1955348
- UMLS CUI [2,1]
- C0016441
- UMLS CUI [2,2]
- C0337611
- UMLS CUI [2,3]
- C1955348
Description
If the subject is not willing to be contacted and learn more about potentially offered booster studies or follow-up studies in the future, please tick the most appropriate reason and specify below.
Data type
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0016884
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [1,4]
- C0566251
Description
Specify the most appropriate reason for non-participation in future studies
Data type
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0016884
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [1,4]
- C0566251
- UMLS CUI [1,5]
- C1521902
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Description
If YES, specify total numbers of SAEs below.
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Total number of SAEs
Data type
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Description
If YES, please complete the Pregnancy notification form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1533716
Description
If YES, complete date and tick one reason below.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0749659
- UMLS CUI [1,2]
- C2347038
Description
Date of Unblinding
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
Complete, if the treatment blind was broken during the study. If you ticked 'Other', please specify below. Complete Non-Serious Adverse Event section or a Serious Adverse Event report as appropriate
Data type
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3897431
Description
Complete, if you ticked 'Other' as reason for unblinding.
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Description
If YES, specify below.
Data type
boolean
Alias
- UMLS CUI [1]
- C0680251
Description
Specify applicable elimination criteria
Data type
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Description
Withdrawal from the study
Alias
- UMLS CUI-1
- C0422727
Description
If yes, specify reason, decision, date of last contact and condition at date of last contact below.
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
Complete, if the subject was withdrawn from the study. If you ticked 'SAE', please complete and submit SAE report and specify SAE number below. If you ticked 'AEX', please complete Non-Serious adverse event section and specify AE number OR solicited AE code below. If you ticked 'PTV', please specify below. If you ticked 'OTH', please specify below.
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
Description
SAE number
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Complete AE number OR the following solicited AE code.
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Complete solicited AE code OR the previously asked AE number.
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1517001
- UMLS CUI [1,3]
- C0805701
Description
Protocol violation
Data type
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Description
Specify other reason for withdrawal from the study
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleaguesis, to the best of my knowledge, complete and accurate, as of the date below
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date of signature
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Printed Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
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Study conclusion
- StudyEvent: ODM
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C0337611 (UMLS CUI [1,3])
C1955348 (UMLS CUI [1,4])
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