ID
26124
Beskrivning
Study ID: 111029 Clinical Study ID: 111029 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Additional Vaccination, Year 17, 0-12 months after visit 22
Länk
https://clinicaltrials.gov/ct2/show/NCT00289757
Nyckelord
Versioner (2)
- 2017-10-09 2017-10-09 -
- 2017-10-09 2017-10-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 oktober 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Additional Vaccination 111029
Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029
Beskrivning
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0700881
Beskrivning
Blood sample
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beskrivning
CMI response determination
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020966
- UMLS CUI [1,2]
- C0005834
Beskrivning
urine sample
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0200354
Beskrivning
Result Urine Pregnancy test
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0427777
- UMLS CUI [1,2]
- C0430056
Beskrivning
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0700881
Beskrivning
Subject Number
Datatyp
text
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
Vaccine Administration
Datatyp
integer
Alias
- UMLS CUI [1]
- C2368628
Beskrivning
Non-dominant arm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beskrivning
Deltoid
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beskrivning
I.M.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beskrivning
Study vaccine Administration
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2368628
Beskrivning
Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beskrivning
Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beskrivning
Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beskrivning
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0700881
Beskrivning
symptoms
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2700396
Beskrivning
Redness
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Beskrivning
If Yes, please specify
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Redness on Day 0
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Redness on Day 1
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Redness on Day 2
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Redness on Day 3
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Redness ongoing after day 3
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Beskrivning
Redness ongoing after day 3? If Yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beskrivning
Swelling
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Beskrivning
If Yes, please specify
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Swelling on Day 0
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Swelling on Day 1
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Swelling on Day 2
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Swelling on Day 3
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Swelling ongoing after day 3
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Beskrivning
Swelling ongoing after day 3? If Yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C2700396
Beskrivning
If Yes, please specify
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain on Day 0
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain on Day 1
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain on Day 2
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain on Day 3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain ongoing after day 3
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C2700396
Beskrivning
Pain ongoing after day 3? If Yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beskrivning
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0700881
Beskrivning
Axillary > 37.5°C Oral > 37.5°C
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
If Yes, please specify
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Site of measurement
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Beskrivning
Fever on Day 0
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
if taken, please specify
Datatyp
float
Måttenheter
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Beskrivning
Fever on Day 1
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
if taken, please specify
Datatyp
float
Måttenheter
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Beskrivning
Fever on Day 2
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
if taken, please specify
Datatyp
float
Måttenheter
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Beskrivning
Fever on Day 3
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
if taken, please specify
Datatyp
float
Måttenheter
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Beskrivning
Fever ongoing after day 3
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever ongoing after day 3? If Yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015967
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0015967
Beskrivning
Fatigue
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
If Yes, please specify
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0522510
Beskrivning
Fatigue on Day 0
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
Fatigue on Day 1
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
Fatigue on Day 2
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
Fatigue on Day 3
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
Fatigue ongoing after day 3
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
Fatigue ongoing after day 3? If Yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0011008
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0015672
Beskrivning
Headache
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
If Yes, please specify
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
Beskrivning
Headache on Day 0
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
Headache on Day 1
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
Headache on Day 2
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
Headache on Day 3
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
Headache ongoing after day 3
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
Headache ongoing after day 3? If Yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0011008
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0018681
Beskrivning
Gastrointestinal symptoms
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
If Yes, please specify
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0522510
Beskrivning
Gastrointestinal symptoms on Day 0
Datatyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
Gastrointestinal symptoms on Day 1
Datatyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
Gastrointestinal symptoms on Day 2
Datatyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
Gastrointestinal symptoms on Day 3
Datatyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
Gastrointestinal symptoms ongoing after day 3
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
Gastrointestinal symptoms ongoing after day 3? If Yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0426576
Similar models
Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029
C0042196 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
C0170300 (UMLS CUI-4)
C0005834 (UMLS CUI [1,2])
C0430056 (UMLS CUI [1,2])
C0700881 (UMLS CUI-2)
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C1457887 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
C2700396 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0700881 (UMLS CUI-4)
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0018681 (UMLS CUI [2])
C0522510 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0426576 (UMLS CUI [2])