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