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ID
36159
Beschrijving
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
Trefwoorden
Versies (1)
- 22-04-19 22-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 april 2019
DOI
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Licentie
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
Similar models
Visit 1
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
C0456388 (UMLS CUI [2])
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])
C1272321 (UMLS CUI [1,2])
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
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])
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (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])
C1519888 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent obtained from the subject prior to enrolment.
boolean
C0021430 (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])
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])
C0205394 (UMLS CUI [1,2])
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])
C0012634 (UMLS CUI [2])
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])