ID
36159
Descripción
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
Palabras clave
Versiones (1)
- 22/4/19 22/4/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
22 de abril de 2019
DOI
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Licencia
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
Descripción
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
Descripción
Pharmaceutical Preparations
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0013227
Descripción
Human Papilloma Virus Vaccine
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1512511
Descripción
Immunosuppressive Agents, chronic
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
Descripción
Immunoglobulins; Blood Product
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0456388
Descripción
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Descripción
I certify that Informed Consent has been obtained prior to any study procedure.
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985782
Descripción
Informed Consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
Autoantibody measurement, Informed Consent
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C1272321
Descripción
Demographics
Alias
- UMLS CUI-1
- C1704791
Descripción
Institution name, Identifier
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Descripción
Patient date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Body Height
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Body Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Descripción
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Descripción
Protocol Compliance
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0525058
Descripción
Human Papilloma Virus Vaccine, Vaccine Clinical Trial
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1512511
- UMLS CUI [1,2]
- C1519888
Descripción
Informed Consent
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0021430
Descripción
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Pharmaceutical Preparations
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0013227
Descripción
Subject Unblinding Event Record, Clinical Trial Period
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C2347804
Descripción
Human Papilloma Virus Vaccine, Other
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1512511
- UMLS CUI [1,2]
- C0205394
Descripción
Occurrence of Adverse Event
Alias
- UMLS CUI-1
- C0877248
Descripción
Yes, please fill in Non-Serious Adverse Event section or the Serious Adverse Event report as necessary.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
- UMLS CUI [2]
- C0012634
Descripción
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])