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

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Keywords

Versions (1)
  1. 2/4/19 2/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 4, 2019

DOI

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License

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

English

Medical History / Physical Examination / Birth Control

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit number
Description

The itemgroups 'pre-existing conditions, signs and symptoms' and 'general medical history / general physical examination' have to be filled in only at visit 1. The itemgroups 'Counselling on birth control' and 'physical examination' have to be filled in at every visit.

Data type

text

Alias
UMLS CUI [1]
C1549755
Pre-existing conditions, signs or symptoms
Description

Pre-existing conditions, signs or symptoms

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C1457887
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Description

If YES, specify diagnosis and timeline below. Please report medication(s) as specified in the protocol and fill in the Medication section

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0037088
General Medical History / General Physical Examination
Description

General Medical History / General Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
MedDRA SYSTEM ORGAN CLASS
Description

Tick each affected organ system one after the other and indicate the diagnosis and the time current/past below.

Data type

text

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Specify diagnosis of affected organ system ticked above.

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C2347091
Timeline of pre-existing condition, sign or symptom
Description

Timeline of pre-existing condition, sign or symptom

Data type

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
Counselling on birth control
Description

Counselling on birth control

Alias
UMLS CUI-1
C0700589
UMLS CUI-2
C0474141
What is the current menarcheal status of the subject?
Description

Current menarcheal status of the subject

Data type

text

Alias
UMLS CUI [1]
C2609149
UMLS CUI [2,1]
C0025274
UMLS CUI [2,2]
C0687676
Has an age appropriate counselling on birth control and pregnancy prevention (including abstinence) and on methods to reduce risk of sexually transmitted infections been done?
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.

Data type

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
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
Has a history-directed physical examination been performed?
Description

History-directed physical examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1720148
UMLS CUI [1,3]
C0262926
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Similar models

Medical History / Physical Examination / Birth Control

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (month 0, pre-vacc) (Visit 1)
CL Item
Visit 2 (month 1) (Visit 2)
CL Item
Visit 3 (month 6) (Visit 3)
CL Item
Visit 4 (month 7, post vacc III) (Visit 4)
Item Group
Pre-existing conditions, signs or symptoms
C0262926 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
Pre-existing conditions, signs or symptoms
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Item Group
General Medical History / General Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
MedDRA SYSTEM ORGAN CLASS
text
C2347091 (UMLS CUI [1])
MedDRA SYSTEM ORGAN CLASS
Code List
MedDRA SYSTEM ORGAN CLASS
CL Item
Skin and subcutaneous tissue ([1])
CL Item
Musculoskeletal and connectivetissue ([2])
CL Item
Cardiac ([3])
CL Item
Vascular ([4])
CL Item
Respiratory, thoracic and mediastinal ([5])
CL Item
Gastrointestinal ([6])
CL Item
Hepatobiliary ([7])
CL Item
Renal and unrinary ([8])
CL Item
Nervous System ([9])
CL Item
Eye ([10])
CL Item
Ear and Labyrinth ([11])
CL Item
Endocrine ([12])
CL Item
Metabolism and nutrition ([13])
CL Item
Blood and lymphatic system ([14])
CL Item
Immune system (incl allergies, autoimmune disorders) ([15])
CL Item
Infections and infestations ([16])
CL Item
Neoplasms benign, malignantand unspecified (incl cysts, polyps) ([17])
CL Item
Surgical and medicalprocedures ([18])
CL Item
Other ([99])
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1,1])
C2347091 (UMLS CUI [1,2])
Item
Timeline of pre-existing condition, sign or symptom
text
C0521987 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C2348792 (UMLS CUI [2,3])
Timeline of pre-existing condition, sign or symptom
Code List
Timeline of pre-existing condition, sign or symptom
CL Item
Past (Past)
CL Item
Current (Current)
Item Group
Counselling on birth control
C0700589 (UMLS CUI-1)
C0474141 (UMLS CUI-2)
Item
What is the current menarcheal status of the subject?
text
C2609149 (UMLS CUI [1])
C0025274 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
Current menarcheal status of the subject
Code List
What is the current menarcheal status of the subject?
CL Item
Pre-menarcheal (Pre-menarcheal)
CL Item
Post-menarcheal (Post-menarcheal)
Counselling on birth control, pregnancy and methods to reduce risk of sexually transmitted infections
Item
Has an age appropriate counselling on birth control and pregnancy prevention (including abstinence) and on methods to reduce risk of sexually transmitted infections been done?
boolean
C0474141 (UMLS CUI [1,1])
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])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
History-directed physical examination
Item
Has a history-directed physical examination been performed?
boolean
C0031809 (UMLS CUI [1,1])
C1720148 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
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