ID
26123
Description
Study ID: 111028 Clinical Study ID: 111028 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, 0-12 months after visit 12
Link
https://clinicaltrials.gov/ct2/show/NCT00289757
Keywords
Versions (2)
- 10/9/17 10/9/17 -
- 10/9/17 10/9/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 9, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Additional Vaccination 111028
Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111028
Description
Laboratory tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0700881
Description
Blood sample
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
CMI response determination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020966
- UMLS CUI [1,2]
- C0005834
Description
urine sample
Data type
boolean
Alias
- UMLS CUI [1]
- C0200354
Description
Result Urine Pregnancy test
Data type
integer
Alias
- UMLS CUI [1,1]
- C0427777
- UMLS CUI [1,2]
- C0430056
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0700881
Description
Subject Number
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
Vaccine Administration
Data type
integer
Alias
- UMLS CUI [1]
- C2368628
Description
Non-dominant arm
Data type
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Description
Deltoid
Data type
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Description
I.M.
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Study vaccine Administration
Data type
boolean
Alias
- UMLS CUI [1]
- C2368628
Description
Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Description
Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Description
Has the study vaccine been administered according to the Protocol? If No, please tick all items that apply
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0700881
Description
symptoms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C2700396
Description
Redness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Description
If Yes, please specify
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness on Day 0
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness on Day 1
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness on Day 2
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness on Day 3
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Redness ongoing after day 3
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Description
Redness ongoing after day 3? If Yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Description
Swelling
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Description
If Yes, please specify
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Swelling on Day 0
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Swelling on Day 1
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Swelling on Day 2
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Swelling on Day 3
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Description
Swelling ongoing after day 3
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C2700396
Description
Swelling ongoing after day 3? If Yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Description
Pain
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C2700396
Description
If Yes, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Description
Pain on Day 0
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Description
Pain on Day 1
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Description
Pain on Day 2
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Description
Pain on Day 3
Data type
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Description
Pain ongoing after day 3
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C2700396
Description
Pain ongoing after day 3? If Yes, please specify
Data type
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
- UMLS CUI-4
- C0700881
Description
Axillary > 37.5°C Oral > 37.5°C
Data type
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
If Yes, please specify
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0015967
Description
Site of measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Description
Fever on Day 0
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
Fever on Day 1
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
Fever on Day 2
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
Fever on Day 3
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
Fever ongoing after day 3
Data type
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
Fever ongoing after day 3? If Yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0015967
Description
Causality
Data type
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0015967
Description
Fatigue
Data type
boolean
Alias
- UMLS CUI [1]
- C0015672
Description
If Yes, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0522510
Description
Fatigue on Day 0
Data type
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue on Day 1
Data type
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue on Day 2
Data type
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue on Day 3
Data type
integer
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue ongoing after day 3
Data type
boolean
Alias
- UMLS CUI [1]
- C0015672
Description
Fatigue ongoing after day 3? If Yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0011008
Description
Causality
Data type
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0015672
Description
Headache
Data type
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
If Yes, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
Description
Headache on Day 0
Data type
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache on Day 1
Data type
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache on Day 2
Data type
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache on Day 3
Data type
integer
Alias
- UMLS CUI [1]
- C0018681
Description
Headache ongoing after day 3
Data type
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
Headache ongoing after day 3? If Yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0011008
Description
Causality
Data type
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0018681
Description
Gastrointestinal symptoms
Data type
boolean
Alias
- UMLS CUI [1]
- C0426576
Description
If Yes, please specify
Data type
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0522510
Description
Gastrointestinal symptoms on Day 0
Data type
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms on Day 1
Data type
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms on Day 2
Data type
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms on Day 3
Data type
integer
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms ongoing after day 3
Data type
boolean
Alias
- UMLS CUI [1]
- C0426576
Description
Gastrointestinal symptoms ongoing after day 3? If Yes, please specify
Data type
date
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0011008
Description
Causality
Data type
boolean
Alias
- UMLS CUI [1]
- C0015127
- UMLS CUI [2]
- C0426576
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Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111028
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C2700396 (UMLS CUI [1,2])
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C2700396 (UMLS CUI [1,2])
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C2700396 (UMLS CUI [1,2])
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