ID
42732
Description
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella
Mots-clés
Versions (2)
- 19/08/2017 19/08/2017 -
- 17/09/2021 17/09/2021 -
Détendeur de droits
glaxoSmithKline
Téléchargé le
17 septembre 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Center number
Type de données
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Type de données
text
Alias
- UMLS CUI [1]
- C0034510
Description
If you chose 'Other Race', please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C3845569
Description
Eligibility check
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion criteria
Alias
- UMLS CUI-1
- C1512693
Description
Compliance
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1321605
Description
age at first vaccination
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C0042196
Description
healthy subject
Type de données
boolean
Alias
- UMLS CUI [1]
- C1708335
Description
Informed consent
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
access to telephone
Type de données
boolean
Alias
- UMLS CUI [1]
- C1822200
Description
contact to varicella
Type de données
boolean
Alias
- UMLS CUI [1]
- C1455968
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Previous vaccination against measles, mumps, rubella and/or varicella.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0042201
- UMLS CUI [2]
- C0042202
- UMLS CUI [3]
- C0042206
- UMLS CUI [4]
- C4302743
Description
History of previous measles, mumps, rubella and/or varicella/zoster diseases
Type de données
boolean
Alias
- UMLS CUI [1]
- C0455465
- UMLS CUI [2]
- C0455466
- UMLS CUI [3]
- C0455467
- UMLS CUI [4]
- C0455469
- UMLS CUI [5]
- C0740380
Description
exposure to measles, mumps, rubella and/or varicella/zoster
Type de données
boolean
Alias
- UMLS CUI [1]
- C2732622
- UMLS CUI [2]
- C0920247
- UMLS CUI [3]
- C2720520
- UMLS CUI [4]
- C0262619
- UMLS CUI [5]
- C0750129
Description
Chronic administration of immunosuppressants or other immune-modifying drugs
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0279021
Description
Administration of immunoglobulins and/or any blood products
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Description
immunosuppressive or immunodeficient condition
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021079
- UMLS CUI [1,2]
- C0021051
Description
Family history of congenital or hereditary immunodeficiency.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C0853602
- UMLS CUI [2,1]
- C0439660
- UMLS CUI [2,2]
- C0021051
Description
History of allergic diseases or reactions
Type de données
boolean
Alias
- UMLS CUI [1]
- C2106654
- UMLS CUI [2]
- C0567447
- UMLS CUI [3]
- C0571380
Description
Major congenital defects or serious chronic illness.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C0205164
- UMLS CUI [2,1]
- C0008679
- UMLS CUI [2,2]
- C0205404
Description
(At any point in time when such exclusion criterion becomes not applicable, potential study participants may come back at a later stage for study inclusion)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0682072
- UMLS CUI [1,2]
- C0021051
- UMLS CUI [2]
- C1855205
Description
History of any neurologic disorders or seizures.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0027765
- UMLS CUI [1,2]
- C0036572
Description
Use of any investigational or non-registered product
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0013230
Description
Administration of a licensed vaccine
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1960631
- UMLS CUI [1,2]
- C1705847
- UMLS CUI [1,3]
- C0032375
Description
Randomisation / Treatment allocation
Alias
- UMLS CUI-1
- C0034656
Description
General medical history / physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
General medical history / physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
anatomic site of symptoms
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0037088
Description
diagnosis 1
Type de données
text
Alias
- UMLS CUI [1]
- C0011900
Description
diagnosis 2
Type de données
text
Alias
- UMLS CUI [1]
- C0011900
Description
diagnosis past
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
Description
diagnosis present
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C0150312
Description
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
Description
Category of exposure
Alias
- UMLS CUI-1
- C2220266
- UMLS CUI-2
- C0683312
Description
Vaccine administration
Alias
- UMLS CUI-1
- C2368628
Description
Pre-Vaccination temperature
Type de données
float
Unités de mesure
- degree Celsius
Alias
- UMLS CUI [1]
- C0005903
Description
anatomic site Temperature taken
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1515974
Description
Vaccine administration
Type de données
text
Alias
- UMLS CUI [1]
- C2368628
Description
Replacement vial
Type de données
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0600091
Description
Wrong vial number
Type de données
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C3827420
Description
Protocol: Side: Left Site: Upper arm (Deltoid) Route: S.C.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
Description
Only answer if vaccine wasn't administered according to protocol.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0444532
- UMLS CUI [1,3]
- C0443246
Description
Only answer if vaccine wasn't administered according to protocol.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
Description
Only answer if vaccine wasn't administered according to protocol.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0013153
Description
Comments on vaccine administration
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0947611
Description
fill in only if different from visit date
Type de données
date
Alias
- UMLS CUI [1]
- C4301990
Description
Please tick the ONE most appropriate category for non administration
Type de données
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0392360
Description
Please specify number of SAE if that is the reason, why vaccine wasn't administered.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Description
number of unsolicited adverse event
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449788
Description
e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
- UMLS CUI [1,3]
- C2368628
Description
Unsolicited adverse event
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0042196
Description
Solicited adverse events - Local symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Description
If Yes is ticked, please complete all following items.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0851536
- UMLS CUI [1,2]
- C0037088
Description
Administration site erythema
Type de données
boolean
Alias
- UMLS CUI [1]
- C3805283
Description
Size of erythema at administration site Day 0
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3805283
- UMLS CUI [1,2]
- C0456389
Description
Size of erythema at administration site Day 1
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3805283
- UMLS CUI [1,2]
- C0456389
Description
Size of erythema at administration site Day 2
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3805283
- UMLS CUI [1,2]
- C0456389
Description
Size of erythema at administration site Day 3
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3805283
- UMLS CUI [1,2]
- C0456389
Description
Erythema ongoing after day 3
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3805283
- UMLS CUI [1,2]
- C0549178
Description
Date of last day of symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Description
Administration site swelling
Type de données
boolean
Alias
- UMLS CUI [1]
- C3854415
Description
Size of swelling at administration site Day 0
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3854415
- UMLS CUI [1,2]
- C0456389
Description
Size of swelling at administration site Day 1
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3854415
- UMLS CUI [1,2]
- C0456389
Description
Size of swelling at administration site Day 2
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3854415
- UMLS CUI [1,2]
- C0456389
Description
Size of swelling at administration site Day 3
Type de données
integer
Unités de mesure
- mm
Alias
- UMLS CUI [1,1]
- C3854415
- UMLS CUI [1,2]
- C0456389
Description
Swelling ongoing after day 3
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3854415
- UMLS CUI [1,2]
- C0549178
Description
Date of last day of symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Administration site pain
Type de données
boolean
Alias
- UMLS CUI [1]
- C0521491
Description
Intensity: 0: None 1: Mild 2: Moderate 3: Severe
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0521491
- UMLS CUI [1,2]
- C1320357
Description
Intensity: 0: None 1: Mild 2: Moderate 3: Severe
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0521491
- UMLS CUI [1,2]
- C1320357
Description
Intensity: 0: None 1: Mild 2: Moderate 3: Severe
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0521491
- UMLS CUI [1,2]
- C1320357
Description
Intensity: 0: None 1: Mild 2: Moderate 3: Severe
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0521491
- UMLS CUI [1,2]
- C1320357
Description
Pain ongoing after day 3
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0521491
- UMLS CUI [1,2]
- C0549178
Description
Date of last day of symptoms
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Description
Solicited adverse events - General symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Description
If Yes is ticked, please complete all following items.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C2368628
Description
≥37.5 °C axillary/≥38.0 °C rectal route If yes, please complete the Temperature section.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C2368628
Description
excluding varicella / zoster If yes, please complete the Rash / Exanthema section.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015230
- UMLS CUI [1,2]
- C2368628
Description
If yes, please complete the Parotid / Salivary Gland Swelling section.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0240925
- UMLS CUI [1,2]
- C2368628
Description
If yes, please complete the Febrile Convulsions – Suspected Signs of Meningism section.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0009952
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [2,1]
- C0025287
- UMLS CUI [2,2]
- C2368628
Description
If yes, please complete the Varicella / Zoster section.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0008049
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [2,1]
- C0740380
- UMLS CUI [2,2]
- C2368628
Description
Temperature
Alias
- UMLS CUI-1
- C0039476
Description
Direct measurement of axillary/ rectal temperature within 15 days post-vaccination 1. Only ONE route of temperature measurement should be used consistently for a given subject. Fever: Axillary: > 37.5°C Rectal: > 38.0°C
Type de données
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1515974
Description
Temperature
Alias
- UMLS CUI-1
- C0039476
Description
Day 1 - 42
Type de données
integer
Description
Temperature
Type de données
float
Unités de mesure
- Degree Celsius
Alias
- UMLS CUI [1]
- C0039476
Description
Temperature not taken
Type de données
boolean
Alias
- UMLS CUI [1]
- C0039476
Description
Only fill in if fever.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C3641099
- UMLS CUI [1,3]
- C2368628
Description
Medically attended Visit?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C0015967
Similar models
GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1
C0600091 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0042202 (UMLS CUI [2])
C0042206 (UMLS CUI [3])
C4302743 (UMLS CUI [4])
C0455466 (UMLS CUI [2])
C0455467 (UMLS CUI [3])
C0455469 (UMLS CUI [4])
C0740380 (UMLS CUI [5])
C0920247 (UMLS CUI [2])
C2720520 (UMLS CUI [3])
C0262619 (UMLS CUI [4])
C0750129 (UMLS CUI [5])
C0279021 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
C0021051 (UMLS CUI [1,2])
C0853602 (UMLS CUI [1,2])
C0439660 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
C0567447 (UMLS CUI [2])
C0571380 (UMLS CUI [3])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0021051 (UMLS CUI [1,2])
C1855205 (UMLS CUI [2])
C0036572 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,2])
C0032375 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
C0037088 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0444532 (UMLS CUI [1,2])
C0443246 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0231291 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0231291 (UMLS CUI [2,2])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0037088 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C1320357 (UMLS CUI [1,2])
C1320357 (UMLS CUI [1,2])
C1320357 (UMLS CUI [1,2])
C1320357 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C0025287 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
C2368628 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
C3641099 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
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