ID

36159

Description

Study ID: 109616 (Y7) 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

Keywords

Versions (1)
  1. 4/22/19 4/22/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 22, 2019

DOI

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License

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

English

Visit 1

1 forms  
  1. StudyEvent: ODM
    1. Visit 1
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria During the Study
Description

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) during the study period.
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Administration of any HPV vaccine other than that used in HPV-001 (This will result in withdrawal from the study).
Description

Human Papilloma Virus Vaccine

Data type

boolean

Alias
UMLS CUI [1]
C1512511
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Administration of inhaled and/or topical steroids is not considered a criterion that will influence a subject’s evaluability in the ATP cohorts.).
Description

Immunosuppressive Agents, chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
Administration of immunoglobulins and/or any blood products less than three months prior to blood sampling.
Description

Immunoglobulins; Blood Product

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1]
C2985782
Did the subject agree that if she needs to undergo gynaecological treatment with a physician not involved in this study, she allows her records and samples to be sent to the same laboratories used in this study for histology evaluation and HPV testing?
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Did the subject agree that if an autoimmune disorder is detected during this study, she allows for autoantibody testing on samples taken during studies HPV-001, HPV-007 and HPV-023?
Description

Autoantibody measurement, Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1272321
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Institution name, Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility Check
Description

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

If No, tick (!) all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow–up visits) should be enrolled in the study.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Subjects who participated in study HPV-007.
Description

Human Papilloma Virus Vaccine, Vaccine Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C1512511
UMLS CUI [1,2]
C1519888
Written informed consent obtained from the subject prior to enrolment.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use or planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccine.
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Decoding of the subject’s HPV-001 treatment allocation to either the subject or the investigator (or designee).
Description

Subject Unblinding Event Record, Clinical Trial Period

Data type

boolean

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C2347804
Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study HPV-001.
Description

Human Papilloma Virus Vaccine, Other

Data type

text

Alias
UMLS CUI [1,1]
C1512511
UMLS CUI [1,2]
C0205394
Occurrence of Adverse Event
Description

Occurrence of Adverse Event

Alias
UMLS CUI-1
C0877248
Did the subject experience any serious adverse events or NOCDs or other medically significant conditions between the last visit of HPV-007 and first visit of HPV-023?
Description

Yes, please fill in Non-Serious Adverse Event section or the Serious Adverse Event report as necessary.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0012634
Colposcopy Information
Description

Colposcopy Information

Alias
UMLS CUI-1
C0009417
Has a colposcopy been performed between the last visit of HPV-007 and first visit of HPV-023?
Description

Yes, please complete the Colposcopysection

Data type

boolean

Alias
UMLS CUI [1]
C0009417
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Similar models

Visit 1

1 forms
  1. StudyEvent: ODM
    1. Visit 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) during the study period.
boolean
C0013227 (UMLS CUI [1])
Human Papilloma Virus Vaccine
Item
Administration of any HPV vaccine other than that used in HPV-001 (This will result in withdrawal from the study).
boolean
C1512511 (UMLS CUI [1])
Immunosuppressive Agents, chronic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying drugs during the study period. (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Administration of inhaled and/or topical steroids is not considered a criterion that will influence a subject’s evaluability in the ATP cohorts.).
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Immunoglobulins; Blood Product
Item
Administration of immunoglobulins and/or any blood products less than three months prior to blood sampling.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Informed Consent
Item
Did the subject agree that if she needs to undergo gynaecological treatment with a physician not involved in this study, she allows her records and samples to be sent to the same laboratories used in this study for histology evaluation and HPV testing?
boolean
C0021430 (UMLS CUI [1])
Autoantibody measurement, Informed Consent
Item
Did the subject agree that if an autoimmune disorder is detected during this study, she allows for autoantibody testing on samples taken during studies HPV-001, HPV-007 and HPV-023?
boolean
C0021430 (UMLS CUI [1,1])
C1272321 (UMLS CUI [1,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Protocol Compliance
Item
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow–up visits) should be enrolled in the study.
boolean
C0525058 (UMLS CUI [1])
Human Papilloma Virus Vaccine, Vaccine Clinical Trial
Item
Subjects who participated in study HPV-007.
boolean
C1512511 (UMLS CUI [1,1])
C1519888 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent obtained from the subject prior to enrolment.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pharmaceutical Preparations
Item
Use or planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccine.
boolean
C0013227 (UMLS CUI [1])
Subject Unblinding Event Record, Clinical Trial Period
Item
Decoding of the subject’s HPV-001 treatment allocation to either the subject or the investigator (or designee).
boolean
C3897431 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
Human Papilloma Virus Vaccine, Other
Item
Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study HPV-001.
text
C1512511 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Occurrence of Adverse Event
C0877248 (UMLS CUI-1)
Serious Adverse Event; Disease
Item
Did the subject experience any serious adverse events or NOCDs or other medically significant conditions between the last visit of HPV-007 and first visit of HPV-023?
boolean
C1519255 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
Item Group
Colposcopy Information
C0009417 (UMLS CUI-1)
Colposcopy
Item
Has a colposcopy been performed between the last visit of HPV-007 and first visit of HPV-023?
boolean
C0009417 (UMLS CUI [1])
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