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