ID
34920
Beschrijving
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
Trefwoorden
Versies (1)
- 04-02-19 04-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 februari 2019
DOI
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Licentie
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
Beschrijving
Pre-existing conditions, signs or symptoms
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C1457887
Beschrijving
If YES, specify diagnosis and timeline below. Please report medication(s) as specified in the protocol and fill in the Medication section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0037088
Beschrijving
General Medical History / General Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschrijving
Tick each affected organ system one after the other and indicate the diagnosis and the time current/past below.
Datatype
text
Alias
- UMLS CUI [1]
- C2347091
Beschrijving
Specify diagnosis of affected organ system ticked above.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C2347091
Beschrijving
Timeline of pre-existing condition, sign or symptom
Datatype
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
Beschrijving
Counselling on birth control
Alias
- UMLS CUI-1
- C0700589
- UMLS CUI-2
- C0474141
Beschrijving
Current menarcheal status of the subject
Datatype
text
Alias
- UMLS CUI [1]
- C2609149
- UMLS CUI [2,1]
- C0025274
- UMLS CUI [2,2]
- C0687676
Beschrijving
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.
Datatype
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
Beschrijving
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])