ID

38173

Descripción

Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B

Palabras clave

Versiones (1)
  1. 24/9/19 24/9/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de septiembre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)

Inglés

Visit 1 - Demographics; General medical history/ Physical examination; Pre-Vaccination Assessment; Laboratory Tests

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Center
Descripción

Center

Tipo de datos

text

Alias
UMLS CUI [1]
C1301943
Subject identification - First Name
Descripción

Subject identification - First Name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1443235
UMLS CUI [1,2]
C0600091
Subject identification - Family Name
Descripción

Subject identification - Family Name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1301584
UMLS CUI [1,2]
C0600091
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit 1 - Administrative
Descripción

Visit 1 - Administrative

Alias
UMLS CUI-1
C0545082
UMLS CUI-2
C1320722
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Subject Number

Tipo de datos

text

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 [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Is the subject eligible for the study, according to the criteria listed hereby?
Descripción

Is the subject eligible for the study, according to the criteria listed hereby?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0243161
If subject is not eligible, please give the corresponding criterion number(s)
Descripción

If subject is not eligible, please give the corresponding criterion number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548635
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C0237753
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]
C2986440
UMLS CUI [1,2]
C1443235
Subject initials - Family name
Descripción

Subject initials - Family name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1301584
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

text

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

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

Alias
UMLS CUI [1]
C0005890
Height unit
Descripción

Height unit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C1519795
Weight
Descripción

Weight

Tipo de datos

float

Alias
UMLS CUI [1]
C0005910
Weight unit
Descripción

Weight unit

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
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 pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Descripción

If yes, please check appropriate box(es) and give diagnosis.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0521987
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C0332152
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C2603343
UMLS CUI [2,3]
C0332152
Diagnosis
Descripción

Diagnosis

Alias
UMLS CUI-1
C0011900
Examination
Descripción

Examination

Tipo de datos

integer

Alias
UMLS CUI [1]
C0031809
Other examination
Descripción

Please specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205394
Diagnosis status
Descripción

Diagnosis status

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449438
UMLS CUI [1,2]
C0011900
Diagnosis
Descripción

Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1]
C0011900
Pre-Vaccination Assessment
Descripción

Pre-Vaccination Assessment

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0220825
UMLS CUI-3
C0332152
Pre- vaccination temperature
Descripción

Pre- vaccination temperature

Tipo de datos

float

Unidades de medida
  • °F
Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0332152
UMLS CUI [2]
C0005903
°F
Temperature Route
Descripción

Temperature Route

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
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
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Similar models

Visit 1 - Demographics; General medical history/ Physical examination; Pre-Vaccination Assessment; Laboratory Tests

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center
Item
Center
text
C1301943 (UMLS CUI [1])
Subject identification - First Name
Item
Subject identification - First Name
text
C1443235 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject identification - Family Name
Item
Subject identification - Family Name
text
C1301584 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Visit 1 - Administrative
C0545082 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2])
If subject is not eligible, please give the corresponding criterion number
Item
If subject is not eligible, please give the corresponding criterion number(s)
text
C0681850 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Subject initials - First name
Item
Subject initials - First name
text
C2986440 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
Subject initials - Family name
Item
Subject initials - Family name
text
C2986440 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
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
Other, please specify (OT)
Other race, please specify
Item
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])
Item
Height unit
integer
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Height unit
Code List
Height unit
CL Item
feet (1)
CL Item
inches (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Weight unit
integer
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Weight unit
Code List
Weight unit
CL Item
pounds (1)
CL Item
ounces (2)
Item Group
General medical history/ Physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0521987 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
Item Group
Diagnosis
C0011900 (UMLS CUI-1)
Item
Examination
integer
C0031809 (UMLS CUI [1])
Examination
Code List
Examination
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
Musculoskeletal  (7)
CL Item
Neurological  (8)
CL Item
Genitourinary  (12)
CL Item
Haematology  (11)
CL Item
Allergies  (4)
CL Item
Endocrine  (9)
CL Item
Other (specify) (99)
Other examination
Item
Other examination
text
C0031809 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Diagnosis status
integer
C0449438 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diagnosis status
Code List
Diagnosis status
CL Item
Past (1)
CL Item
Current (2)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item Group
Pre-Vaccination Assessment
C0042196 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Pre- vaccination temperature
Item
Pre- vaccination temperature
float
C0042196 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
Item
Temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Temperature Route
Code List
Temperature Route
CL Item
Rectal (1)
CL Item
Axillary (2)
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
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])
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