ID

36178

Beschrijving

Study ID: 109616 (Y7), 109624 Clinical Study ID: 109616 (Y7) Study Title: A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi- center primary study HPV-001 and having participated in the follow-up study HPV-007 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00518336 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: HPV Vaccine Trade Name: Cervarix Study Indication: Infections, Papillomavirus

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  1. 22-04-19 22-04-19 -
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GlaxoSmithKline

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22 april 2019

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Creative Commons BY-NC 3.0
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Candidate HPV-16/18 L1 VLP A04 Vaccine in Young Adult Women Vaccinated in Phase IIb, NCT00518336

Engels

Study Conclusion of Year 8

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Occurrence of Serious Adverse Event
Beschrijving

Occurrence of Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event since Visit 3 of HPV-023?
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Specify total number of SAE's since Visit 3 of HPV-023
Beschrijving

Serious Adverse Event, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Pregnancy Information
Beschrijving

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant since Visit 3 of HPV-023?
Beschrijving

Pregnancy, Clinical Trials

Datatype

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Status of Treatment Blind
Beschrijving

Status of Treatment Blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken since Visit 3 of HPV-023?
Beschrijving

Subject Unblinding Event Record

Datatype

boolean

Alias
UMLS CUI [1]
C3897431
If Yes, complete Date
Beschrijving

Subject Unblinding Event Record, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If Yes, tick one reason below
Beschrijving

Subject Unblinding Event Record, Reason

Datatype

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0566251
Elimination Criteria
Beschrijving

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable since Visit 3 of HPV-023?
Beschrijving

Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
Specify
Beschrijving

Exclusion Criteria

Datatype

text

Alias
UMLS CUI [1]
C0680251
Withdrawal
Beschrijving

Withdrawal

Alias
UMLS CUI-1
C2349954
Was the subject withdrawn from the study since Visit 3 of HPV-023?
Beschrijving

Withdraw

Datatype

boolean

Alias
UMLS CUI [1]
C2349954
Major reason for withdrawal (tick one box only)
Beschrijving

Withdraw, Reason

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
Who made the decision?
Beschrijving

Withdraw, Decision

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0679006
Date of last contact
Beschrijving

Withdraw Date last contact

Datatype

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0805839
Was the subject in good condition at date of last contact?
Beschrijving

Withdraw, Date last contact, General physical condition

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0805839
UMLS CUI [1,3]
C1142435
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschrijving

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Investigator Signature, Date in time

Datatype

date

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

Investigator Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Cervical Colposcopy Diagram
Beschrijving

Cervical Colposcopy Diagram

Alias
UMLS CUI-1
C0009417
UMLS CUI-2
C0681494
Please indicate in the diagram the precise type(s) and location(s) of lesion(s) according to the abbreviated list below.
Beschrijving

L Leukoplakia W White Epithelium P Punctation M Mosaic V Atypical Vessels C Condyloma Po Polyp E Erosion/ Ulceration X Biopsy Sites I Invasive Carcinoma

Datatype

text

Alias
UMLS CUI [1,1]
C0009417
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0450429
UMLS CUI [1,4]
C0332307
Use of Human Samples by GSK
Beschrijving

Use of Human Samples by GSK

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0457083
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
Beschrijving

Laboratory Procedures, Usage

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0457083
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
Beschrijving

Laboratory Procedures, Storage, Duration

Datatype

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C0449238
ICF Effective date
Beschrijving

Date in time, Consent Forms

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschrijving

Investigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Investigator Signature, Date in time

Datatype

date

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

Investigator Name

Datatype

text

Alias
UMLS CUI [1]
C2826892
Reason for Non-Participation
Beschrijving

Reason for Non-Participation

Alias
UMLS CUI-1
C0558080
UMLS CUI-2
C0679823
UMLS CUI-3
C0392360
Previous Subject Number
Beschrijving

Clinical Trial Subject Unique Identifier, Previous

Datatype

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of Birth
Beschrijving

Patient date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Reason for non participation
Beschrijving

Unwilling, participation, Indication

Datatype

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Reason for non participation - Specifications
Beschrijving

Unwilling, participation, Indication

Datatype

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Date of Contact
Beschrijving

Date last contact

Datatype

date

Alias
UMLS CUI [1]
C0805839
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Similar models

Study Conclusion of Year 8

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Occurrence of Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event since Visit 3 of HPV-023?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event, Numbers
Item
Specify total number of SAE's since Visit 3 of HPV-023
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant since Visit 3 of HPV-023?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy, Clinical Trials
Code List
Did the subject become pregnant since Visit 3 of HPV-023?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Not Applicable (3)
Item Group
Status of Treatment Blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Subject Unblinding Event Record
Item
Was the treatment blind broken since Visit 3 of HPV-023?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time
Item
If Yes, complete Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If Yes, tick one reason below
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Subject Unblinding Event Record, Reason
Code List
If Yes, tick one reason below
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Exclusion Criteria
Item
Did any elimination criteria become applicable since Visit 3 of HPV-023?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Specify
text
C0680251 (UMLS CUI [1])
Item Group
Withdrawal
C2349954 (UMLS CUI-1)
Withdraw
Item
Was the subject withdrawn from the study since Visit 3 of HPV-023?
boolean
C2349954 (UMLS CUI [1])
Item
Major reason for withdrawal (tick one box only)
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Withdraw, Reason
Code List
Major reason for withdrawal (tick one box only)
CL Item
Serious adverse event (Please complete and submit SAE report, Please specify SAE No.) (1)
CL Item
Non-Serious adverse event (Please complete Non-serious Adverse Event section, Please specify AE No.) (2)
CL Item
Protocol violation (please specify) (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Administration of any HPV vaccine other than that used in study HPV-001 (5)
CL Item
Unblinding to allow the subject to decide if she will consider immunization with a licensed HPV vaccine. (6)
CL Item
Migrated / moved from the study area (7)
CL Item
Lost to follow-up. (8)
CL Item
Other, please specify (9)
Item
Who made the decision?
text
C2349954 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Withdraw, Decision
Code List
Who made the decision?
CL Item
Investigator  (1)
CL Item
Subject (2)
Withdraw Date last contact
Item
Date of last contact
date
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Withdraw, Date last contact, General physical condition
Item
Was the subject in good condition at date of last contact?
boolean
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Item Group
Cervical Colposcopy Diagram
C0009417 (UMLS CUI-1)
C0681494 (UMLS CUI-2)
Colposcopy, Diagram, Lesion, Location, Type
Item
Please indicate in the diagram the precise type(s) and location(s) of lesion(s) according to the abbreviated list below.
text
C0009417 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Item Group
Use of Human Samples by GSK
C0022885 (UMLS CUI-1)
C0457083 (UMLS CUI-2)
Item
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
text
C0022885 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Laboratory Procedures, Usage
Code List
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
CL Item
Quality Assurance of tests described in the protocol. This may include the management of t equality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably. (1)
CL Item
Further investigation by GSK Biologicals into the ability of HPV- vaccine to protect people if any findings from related studies require it and further research in cervical cancer. These investigations excludes genetics and HIV testing. (2)
CL Item
Further investigation by GSK Biologicals into the ability of HPV- vaccine to protect people if any findings from related studies require it and further research in cervical cancer. These investigations excludes genetic and HIV testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed. (3)
Item
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
text
C0022885 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Laboratory Procedures, Storage, Duration
Code List
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals  (1)
CL Item
Other,specify (2)
Date in time, Consent Forms
Item
ICF Effective date
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Item Group
Reason for Non-Participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Clinical Trial Subject Unique Identifier, Previous
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Reason for non participation
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Unwilling, participation, Indication
Code List
Reason for non participation
CL Item
Subject not eligible (Please specify criteria that are not fulfilled) (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to Adverse event(s), or serious adverse event (Please specify), Other (Please specify) (3)
CL Item
Subject died on (4)
Item
Reason for non participation - Specifications
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Unwilling, participation, Indication
Code List
Reason for non participation - Specifications
Date last contact
Item
Date of Contact
date
C0805839 (UMLS CUI [1])
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