ID

35064

Descripción

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

Palabras clave

Versiones (1)
  1. 13/2/19 13/2/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

13 de febrero de 2019

DOI

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Licencia

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

Inglés

Study conclusion

1 formularios  
  1. StudyEvent: ODM
    1. Study conclusion
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Protocol number
Descripción

Protocol number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008971
UMLS CUI [1,2]
C0600091
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Follow-up studies
Descripción

Follow-up studies

Alias
UMLS CUI-1
C0016441
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
Descripción

If NO, please specify the most appropriate reason below.

Tipo de datos

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
If NO, Please tick the most appropriate reason:
Descripción

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.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0016884
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C0566251
Specify the most appropriate reason choosen above:
Descripción

Specify the most appropriate reason for non-participation in future studies

Tipo de datos

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
Study conclusion
Descripción

Study conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Did the subject experience any Serious Adverse Event during the study period?
Descripción

If YES, specify total numbers of SAEs below.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519255
If the subject experienced SAEs, please specify the total number of SAEs:
Descripción

Total number of SAEs

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did the subject become pregnant during the study?
Descripción

If YES, please complete the Pregnancy notification form.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1533716
Was the treatment blind broken during the study?
Descripción

If YES, complete date and tick one reason below.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
If the treatment blind was broken during the study, please complete the date:
Descripción

Date of Unblinding

Tipo de datos

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Tick the reason, why the treatment blind was broken during the study:
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C3897431
Specify 'Other' reason for unblinding:
Descripción

Complete, if you ticked 'Other' as reason for unblinding.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1521902
Did any elimination criteria become applicable during the study?
Descripción

If YES, specify below.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
If any elimination criteria became applicable during the study, please specify:
Descripción

Specify applicable elimination criteria

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Withdrawal from the study
Descripción

Withdrawal from the study

Alias
UMLS CUI-1
C0422727
Was the subject withdrawn from the study?
Descripción

If yes, specify reason, decision, date of last contact and condition at date of last contact below.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0422727
Please tick ONE major reason for withdrawal:
Descripción

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.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
If SAE was the major reason for withdrawal, please complete SAE number:
Descripción

SAE number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If Non-Serious adverse event was the major reason for withdrawal, please complete AE Number:
Descripción

Complete AE number OR the following solicited AE code.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If Non-Serious adverse event was the major reason for withdrawal, please complete solicited AE code:
Descripción

Complete solicited AE code OR the previously asked AE number.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0805701
If Protocol violation was the major reason for withdrawal from the study, please specify:
Descripción

Protocol violation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
If 'Other' was the major reason for withdrawal from the study, please specify:
Descripción

Specify other reason for withdrawal from the study

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Investigator's signature
Descripción

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Descripción

Date of signature

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Descripción

Printed Investigator's name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study conclusion

1 formularios
  1. StudyEvent: ODM
    1. Study conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Protocol number
Item
Protocol number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
Future studies
Item
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
C0020975 (UMLS CUI [1,1])
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])
Item
If NO, Please tick the most appropriate reason:
text
C0008976 (UMLS CUI [1,1])
C0016884 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Reason for non-participation in future studies
Code List
If NO, Please tick the most appropriate reason:
CL Item
adverse events or serious adverse events (a)
CL Item
other (b)
Specify the most appropriate reason for non-participation in future studies
Item
Specify the most appropriate reason choosen above:
text
C0008976 (UMLS CUI [1,1])
C0016884 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Occurrence of serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
Total number of SAEs
Item
If the subject experienced SAEs, please specify the total number of SAEs:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Pregnancy information
Item
Did the subject become pregnant during the study?
boolean
C0032961 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
Status of treatment blind
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Date of Unblinding
Item
If the treatment blind was broken during the study, please complete the date:
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Tick the reason, why the treatment blind was broken during the study:
text
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Reason for unblinding
Code List
Tick the reason, why the treatment blind was broken during the study:
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
Specify 'Other' reason for unblinding
Item
Specify 'Other' reason for unblinding:
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Elimination Criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Specify applicable elimination criteria
Item
If any elimination criteria became applicable during the study, please specify:
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Withdrawal from the study
C0422727 (UMLS CUI-1)
Withdrawal
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Please tick ONE major reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Major reason for withdrawal
Code List
Please tick ONE major reason for withdrawal:
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other (OTH)
SAE number
Item
If SAE was the major reason for withdrawal, please complete SAE number:
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE number
Item
If Non-Serious adverse event was the major reason for withdrawal, please complete AE Number:
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE code
Item
If Non-Serious adverse event was the major reason for withdrawal, please complete solicited AE code:
text
C1518404 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Protocol violation
Item
If Protocol violation was the major reason for withdrawal from the study, please specify:
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify other reason for withdrawal from the study
Item
If 'Other' was the major reason for withdrawal from the study, please specify:
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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