ID
36159
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-04-22 2019-04-22 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
22 april 2019
DOI
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Licens
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
Beskrivning
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Pharmaceutical Preparations
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Human Papilloma Virus Vaccine
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1512511
Beskrivning
Immunosuppressive Agents, chronic
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
Beskrivning
Immunoglobulins; Blood Product
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0456388
Beskrivning
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beskrivning
I certify that Informed Consent has been obtained prior to any study procedure.
Datatyp
date
Alias
- UMLS CUI [1]
- C2985782
Beskrivning
Informed Consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Autoantibody measurement, Informed Consent
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1272321
Beskrivning
Demographics
Alias
- UMLS CUI-1
- C1704791
Beskrivning
Institution name, Identifier
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beskrivning
Patient date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Body Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Body Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
Protocol Compliance
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0525058
Beskrivning
Human Papilloma Virus Vaccine, Vaccine Clinical Trial
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1512511
- UMLS CUI [1,2]
- C1519888
Beskrivning
Informed Consent
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Pharmaceutical Preparations
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beskrivning
Subject Unblinding Event Record, Clinical Trial Period
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C2347804
Beskrivning
Human Papilloma Virus Vaccine, Other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1512511
- UMLS CUI [1,2]
- C0205394
Beskrivning
Occurrence of Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Yes, please fill in Non-Serious Adverse Event section or the Serious Adverse Event report as necessary.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0012634
Beskrivning
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])