Informações:
Falhas:
ID
38173
Descrição
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
Palavras-chave
Versões (1)
- 24/09/2019 24/09/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
24 de setembro de 2019
DOI
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Licença
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)
Visit 1 - Demographics; General medical history/ Physical examination; Pre-Vaccination Assessment; Laboratory Tests
Similar models
Visit 1 - Demographics; General medical history/ Physical examination; Pre-Vaccination Assessment; Laboratory Tests
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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)
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])
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])
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])
C1548635 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Subject initials - First name
Item
Subject initials - First name
text
C2986440 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
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])
C1301584 (UMLS CUI [1,2])
CL Item
Male (M)
CL Item
Female (F)
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])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
CL Item
feet (1)
CL Item
inches (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
CL Item
pounds (1)
CL Item
ounces (2)
Item Group
General medical history/ Physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
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])
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])
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])
C0205394 (UMLS CUI [1,2])
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)
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])
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
Item
Temperature Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,2])
CL Item
Rectal (1)
CL Item
Axillary (2)
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])