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)
- 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
Visit 1
- StudyEvent: ODM
Description
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
Description
Pharmaceutical Preparations
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
Human Papilloma Virus Vaccine
Data type
boolean
Alias
- UMLS CUI [1]
- C1512511
Description
Immunosuppressive Agents, chronic
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
Description
Immunoglobulins; Blood Product
Data type
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0456388
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
I certify that Informed Consent has been obtained prior to any study procedure.
Data type
date
Alias
- UMLS CUI [1]
- C2985782
Description
Informed Consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Autoantibody measurement, Informed Consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1272321
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Institution name, Identifier
Data type
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Protocol Compliance
Data type
boolean
Alias
- UMLS CUI [1]
- C0525058
Description
Human Papilloma Virus Vaccine, Vaccine Clinical Trial
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1512511
- UMLS CUI [1,2]
- C1519888
Description
Informed Consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Pharmaceutical Preparations
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
Subject Unblinding Event Record, Clinical Trial Period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C2347804
Description
Human Papilloma Virus Vaccine, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1512511
- UMLS CUI [1,2]
- C0205394
Description
Occurrence of Adverse Event
Alias
- UMLS CUI-1
- C0877248
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
Description
Colposcopy Information
Alias
- UMLS CUI-1
- C0009417
Similar models
Visit 1
- StudyEvent: ODM
C0205191 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2])
C1272321 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C1519888 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2])