ID
35064
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 study conclusion and should be filled in at the end of the study (visit 4).
Link
https://clinicaltrials.gov/ct2/show/NCT00290277
Trefwoorden
Versies (1)
- 13-02-19 13-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
13 februari 2019
DOI
Voor een aanvraag inloggen.
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
Study conclusion
- StudyEvent: ODM
Beschrijving
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
Beschrijving
If NO, please specify the most appropriate reason below.
Datatype
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
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0016884
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [1,4]
- C0566251
Beschrijving
Specify the most appropriate reason for non-participation in future studies
Datatype
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
Beschrijving
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschrijving
If YES, specify total numbers of SAEs below.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Total number of SAEs
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beschrijving
If YES, please complete the Pregnancy notification form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1533716
Beschrijving
If YES, complete date and tick one reason below.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0749659
- UMLS CUI [1,2]
- C2347038
Beschrijving
Date of Unblinding
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3897431
Beschrijving
Complete, if you ticked 'Other' as reason for unblinding.
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschrijving
If YES, specify below.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
Specify applicable elimination criteria
Datatype
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Beschrijving
Withdrawal from the study
Alias
- UMLS CUI-1
- C0422727
Beschrijving
If yes, specify reason, decision, date of last contact and condition at date of last contact below.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
Beschrijving
SAE number
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
Complete AE number OR the following solicited AE code.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Complete solicited AE code OR the previously asked AE number.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1517001
- UMLS CUI [1,3]
- C0805701
Beschrijving
Protocol violation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beschrijving
Specify other reason for withdrawal from the study
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschrijving
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date of signature
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Printed Investigator's name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Study conclusion
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0337611 (UMLS CUI [1,3])
C1955348 (UMLS CUI [1,4])
C0016441 (UMLS CUI [2,1])
C0337611 (UMLS CUI [2,2])
C1955348 (UMLS CUI [2,3])
C0016884 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0016884 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C1519255 (UMLS CUI [1,2])
C1533716 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C3897431 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])