ID
34920
Descripción
Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus
Link
https://clinicaltrials.gov/ct2/show/NCT00290277
Palabras clave
Versiones (1)
- 4/2/19 4/2/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
4 de febrero de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277
Medical History / Physical Examination / Birth Control
- StudyEvent: ODM
Descripción
Pre-existing conditions, signs or symptoms
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1457887
Descripción
If YES, specify diagnosis and timeline below. Please report medication(s) as specified in the protocol and fill in the Medication section
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0037088
Descripción
General Medical History / General Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Descripción
Tick each affected organ system one after the other and indicate the diagnosis and the time current/past below.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2347091
Descripción
Specify diagnosis of affected organ system ticked above.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C2347091
Descripción
Timeline of pre-existing condition, sign or symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0521987
- UMLS CUI [1,2]
- C2348792
- UMLS CUI [2,1]
- C0037088
- UMLS CUI [2,2]
- C2347662
- UMLS CUI [2,3]
- C2348792
Descripción
Counselling on birth control
Alias
- UMLS CUI-1
- C0700589
- UMLS CUI-2
- C0474141
Descripción
Current menarcheal status of the subject
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2609149
- UMLS CUI [2,1]
- C0025274
- UMLS CUI [2,2]
- C0687676
Descripción
This counselling can be conducted in private or with the parent or legally acceptable representative, according to the judgement of the investigator or study staff and to applicable local law/regulations.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0474141
- UMLS CUI [1,2]
- C0700589
- UMLS CUI [1,3]
- C0332257
- UMLS CUI [1,4]
- C0036899
- UMLS CUI [2,1]
- C0474141
- UMLS CUI [2,2]
- C0035648
- UMLS CUI [2,3]
- C0547047
- UMLS CUI [2,4]
- C0036916
Descripción
Physical examination
Alias
- UMLS CUI-1
- C0031809
Similar models
Medical History / Physical Examination / Birth Control
- StudyEvent: ODM
C1457887 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
C0031809 (UMLS CUI-2)
C2347091 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C2348792 (UMLS CUI [2,3])
C0474141 (UMLS CUI-2)
C0025274 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0700589 (UMLS CUI [1,2])
C0332257 (UMLS CUI [1,3])
C0036899 (UMLS CUI [1,4])
C0474141 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
C0547047 (UMLS CUI [2,3])
C0036916 (UMLS CUI [2,4])
C1720148 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])