ID
35064
Beschreibung
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
Stichworte
Versionen (1)
- 13.02.19 13.02.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
13. Februar 2019
DOI
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Lizenz
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
Beschreibung
Follow-up studies
Alias
- UMLS CUI-1
- C0016441
Beschreibung
If NO, please specify the most appropriate reason below.
Datentyp
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
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C0016884
- UMLS CUI [1,3]
- C2348568
- UMLS CUI [1,4]
- C0566251
Beschreibung
Specify the most appropriate reason for non-participation in future studies
Datentyp
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
Beschreibung
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschreibung
If YES, specify total numbers of SAEs below.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Total number of SAEs
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beschreibung
If YES, please complete the Pregnancy notification form.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C1533716
Beschreibung
If YES, complete date and tick one reason below.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0749659
- UMLS CUI [1,2]
- C2347038
Beschreibung
Date of Unblinding
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C3897431
Beschreibung
Complete, if you ticked 'Other' as reason for unblinding.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beschreibung
If YES, specify below.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0680251
Beschreibung
Specify applicable elimination criteria
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Beschreibung
Withdrawal from the study
Alias
- UMLS CUI-1
- C0422727
Beschreibung
If yes, specify reason, decision, date of last contact and condition at date of last contact below.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0566251
Beschreibung
SAE number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschreibung
Complete AE number OR the following solicited AE code.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschreibung
Complete solicited AE code OR the previously asked AE number.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1517001
- UMLS CUI [1,3]
- C0805701
Beschreibung
Protocol violation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C1521902
Beschreibung
Specify other reason for withdrawal from the study
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschreibung
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date of signature
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Printed Investigator's name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Ähnliche Modelle
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])