ID
34920
Beskrivning
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
Länk
https://clinicaltrials.gov/ct2/show/NCT00290277
Nyckelord
Versioner (1)
- 2019-02-04 2019-02-04 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
4 februari 2019
DOI
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Licens
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
Beskrivning
Pre-existing conditions, signs or symptoms
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1457887
Beskrivning
If YES, specify diagnosis and timeline below. Please report medication(s) as specified in the protocol and fill in the Medication section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0037088
Beskrivning
General Medical History / General Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beskrivning
Tick each affected organ system one after the other and indicate the diagnosis and the time current/past below.
Datatyp
text
Alias
- UMLS CUI [1]
- C2347091
Beskrivning
Specify diagnosis of affected organ system ticked above.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C2347091
Beskrivning
Timeline of pre-existing condition, sign or symptom
Datatyp
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
Beskrivning
Counselling on birth control
Alias
- UMLS CUI-1
- C0700589
- UMLS CUI-2
- C0474141
Beskrivning
Current menarcheal status of the subject
Datatyp
text
Alias
- UMLS CUI [1]
- C2609149
- UMLS CUI [2,1]
- C0025274
- UMLS CUI [2,2]
- C0687676
Beskrivning
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.
Datatyp
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
Beskrivning
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])