ID

35694

Descripción

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Palabras clave

Versiones (2)
  1. 12/3/19 12/3/19 -
  2. 15/3/19 15/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

15 de marzo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

Inglés

Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection

1 formularios  
Administration
Descripción

Administration

Alias
UMLS CUI-1
C1320722
Centre
Descripción

Centre

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit
Descripción

Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent date:
Descripción

I certify that Informed Consent has been obtained prior to any study procedure.

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
Demographics
Descripción

Demographics

Alias
UMLS CUI-1
C1704791
Subject initials - First name
Descripción

Subject initials - First name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
UMLS CUI [2]
C1443235
Subject initials - Family Name
Descripción

Subject initials - Family Name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
UMLS CUI [2]
C1301584
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Race
Descripción

Race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
If other race, please specify
Descripción

If other race, please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility
Descripción

Eligibility

Alias
UMLS CUI-1
C0013893
Is the subject eligible for the study, according to the criteria listed hereby?
Descripción

If no, please give the corresponding criterion number(s)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013893
Corresponding criterion number(s)
Descripción

Corresponding criterion number(s)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0237753
Investigator Signature:
Descripción

Investigator Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
General Medical History / Physical Examination
Descripción

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any relevant medical history/medical condition?
Descripción

Please tick appropriate box and give diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0012634
Medical Condition
Descripción

Medical Condition

Alias
UMLS CUI-1
C0012634
Diagnosis
Descripción

Diagnosis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0011900
Status
Descripción

Status

Tipo de datos

integer

Alias
UMLS CUI [1]
C0449438
Medical Condition
Descripción

Medical Condition

Tipo de datos

text

Alias
UMLS CUI [1]
C0012634
Laboratory Tests
Descripción

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Descripción

Has a blood sample been taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Baseline Temperature
Descripción

Baseline Temperature

Alias
UMLS CUI-1
C0005903
UMLS CUI-2
C1442488
Temperature:
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Descripción

Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Baseline Assessment - General Symptoms
Descripción

Baseline Assessment - General Symptoms

Alias
UMLS CUI-1
C1442488
UMLS CUI-2
C1516048
UMLS CUI-3
C0159028
Does the subject experience any of the following general solicited signs or symptoms just before injection?
Descripción

Does the subject experience any of the following general solicited signs or symptoms just before injection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0332152
General Symptoms Observed Just Before Injection
Descripción

General Symptoms Observed Just Before Injection

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C1533685
UMLS CUI-3
C0332152
Symptom
Descripción

Only for children from 1 to 5 Years old

Tipo de datos

integer

Alias
UMLS CUI [1]
C1457887
Intensity
Descripción

Intensity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518690
General Symptoms Observed Just Before Injection
Descripción

General Symptoms Observed Just Before Injection

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C1533685
UMLS CUI-3
C0332152
Symptom
Descripción

Only for Children from 6 to 11 Years old

Tipo de datos

integer

Alias
UMLS CUI [1]
C1457887
Intensity
Descripción

Intensity

Tipo de datos

integer

Alias
UMLS CUI [1]
C0518690
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Similar models

Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Centre
Item
Centre
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit
Item
Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Informed Consent date
Item
Informed Consent date:
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Subject initials - First name
Item
Subject initials - First name
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C1443235 (UMLS CUI [2])
Subject initials - Family Name
Item
Subject initials - Family Name
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
C1301584 (UMLS CUI [2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
Gender
Code List
Gender
CL Item
Female (F)
CL Item
Male (M)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (WH)
CL Item
Black (BL)
CL Item
Oriental (OR)
CL Item
OT (please specify) (Other)
If other race, please specify
Item
If other race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Eligibility
C0013893 (UMLS CUI-1)
Is the subject eligible for the study, according to the criteria listed hereby
Item
Is the subject eligible for the study, according to the criteria listed hereby?
boolean
C0013893 (UMLS CUI [1])
Corresponding criterion number(s)
Item
Corresponding criterion number(s)
text
C1516637 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature:
text
C2346576 (UMLS CUI [1])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Are you aware of any relevant medical history/medical condition
Item
Are you aware of any relevant medical history/medical condition?
boolean
C0262926 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Item Group
Medical Condition
C0012634 (UMLS CUI-1)
Item
Diagnosis
integer
C0011900 (UMLS CUI [1])
Diagnosis
Code List
Diagnosis
CL Item
Cutaneous (10)
CL Item
Eyes (5)
CL Item
Ears-Nose-Throat (6)
CL Item
Cardiovascular (2)
CL Item
Respiratory (3)
CL Item
Gastrointestinal (1)
CL Item
Musculo-Skeletal (7)
CL Item
Neurological (8)
CL Item
Genito-Urinary (12)
CL Item
Haematology (11)
CL Item
Allergies (4)
CL Item
Endocrine (9)
CL Item
Other (specify) (99)
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Medical Condition
Item
Medical Condition
text
C0012634 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item Group
Baseline Temperature
C0005903 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Temperature
Item
Temperature:
float
C0005903 (UMLS CUI [1])
Item
Route
integer
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Oral (applicable for all ages) (2)
CL Item
Rectal (applicable to 1 to 5 years old) (3)
Item Group
Baseline Assessment - General Symptoms
C1442488 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
Does the subject experience any of the following general solicited signs or symptoms just before injection
Item
Does the subject experience any of the following general solicited signs or symptoms just before injection?
boolean
C0159028 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item Group
General Symptoms Observed Just Before Injection
C0159028 (UMLS CUI-1)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Irritability/ Fussiness (1)
CL Item
Drowsiness (2)
CL Item
Loss of appetite (3)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item Group
General Symptoms Observed Just Before Injection
C0159028 (UMLS CUI-1)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Headache (1)
CL Item
Fatigue (2)
CL Item
Gastrointestinal symptoms (3)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
1  (1)
CL Item
2  (2)
CL Item
3 (3)
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