ID

38314

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 (2)
  1. 08/10/2019 08/10/2019 -
  2. 09/10/2019 09/10/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

9 de outubro 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)

Inglês

Visit 3 - Laboratory Tests; Phone Contact Month 5; Visit 4 - Pre-Vacciantion Assessment; Vaccine Administration

1 Formulários  
Administrative
Descrição

Administrative

Alias
UMLS CUI-1
C1320722
Date of visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descrição

Subject number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Laboratory Tests
Descrição

Laboratory Tests

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

Has a blood sample been taken?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005834
Month 5 - Phone Contact
Descrição

Month 5 - Phone Contact

Alias
UMLS CUI-1
C0337611
UMLS CUI-2
C0039457
UMLS CUI-3
C0439231
Has the information been obtained?
Descrição

Please contact the subject by phone to query about the occurrence of any SAE's using the scripted provided.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3244127
Pre-Vaccination Assessment
Descrição

Pre-Vaccination Assessment

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

Pre- vaccination temperature

Tipo de dados

float

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

Temperature Route

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Vaccine Administration (Engerix-B- Vaccine)
Descrição

Vaccine Administration (Engerix-B- Vaccine)

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0116078
Vaccine Administration
Descrição

(only one box must be checked)

Tipo de dados

integer

Alias
UMLS CUI [1]
C2368628
Vaccination Side/ Site Route
Descrição

Vaccination Side/ Site Route

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Has the study vaccine been administered according to the Protocol?
Descrição

Has the study vaccine been administered according to the Protocol?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If study vaccine has not been administered according to the Protocol, please check all items that apply
Descrição

Please check all items

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Comments
Descrição

Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Vaccine Administration (Infanrix Vaccine)
Descrição

Vaccine Administration (Infanrix Vaccine)

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C1964896
Vaccine Administration
Descrição

(only one box must be checked)

Tipo de dados

integer

Alias
UMLS CUI [1]
C2368628
Vaccination Side/ Site Route
Descrição

Vaccination Side/ Site Route

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Has the study vaccine been administered according to the Protocol?
Descrição

Has the study vaccine been administered according to the Protocol?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If study vaccine has not been administered according to the Protocol, please check all items that apply
Descrição

Please check all items

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C234856
Comments
Descrição

Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Vaccine Administration (Prevnar Vaccine)
Descrição

Vaccine Administration (Prevnar Vaccine)

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0876134
Vaccine Administration
Descrição

(only one box must be checked)

Tipo de dados

integer

Alias
UMLS CUI [1]
C2368628
Vaccination Side/ Site Route
Descrição

Vaccination Side/ Site Route

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Has the study vaccine been administered according to the Protocol?
Descrição

Has the study vaccine been administered according to the Protocol?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If study vaccine has not been administered according to the Protocol, please check all items that apply
Descrição

Please check all items

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C234856
Comments
Descrição

Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Vaccine Administration (HibTITER Vaccine)
Descrição

Vaccine Administration (HibTITER Vaccine)

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C1524027
Vaccine Administration
Descrição

(only one box must be checked)

Tipo de dados

integer

Alias
UMLS CUI [1]
C2368628
Vaccination Side/ Site Route
Descrição

Vaccination Side/ Site Route

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Comments
Descrição

Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
Vaccine Administration (Comvax Vaccine)
Descrição

Vaccine Administration (Comvax Vaccine)

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0535643
Vaccine Administration
Descrição

(only one box must be checked)

Tipo de dados

integer

Alias
UMLS CUI [1]
C2368628
Vaccination Side/ Site Route
Descrição

Vaccination Side/ Site Route

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
UMLS CUI [1,4]
C0441987
Has the study vaccine been administered according to the Protocol?
Descrição

Has the study vaccine been administered according to the Protocol?

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
If study vaccine has not been administered according to the Protocol, please check all items that apply
Descrição

Please check all items

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C234856
Comments
Descrição

Comments

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Visit 3 - Laboratory Tests; Phone Contact Month 5; Visit 4 - Pre-Vacciantion Assessment; Vaccine Administration

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (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
Month 5 - Phone Contact
C0337611 (UMLS CUI-1)
C0039457 (UMLS CUI-2)
C0439231 (UMLS CUI-3)
Has the information been obtained?
Item
Has the information been obtained?
boolean
C3244127 (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
Vaccine Administration (Engerix-B- Vaccine)
C2368628 (UMLS CUI-1)
C0116078 (UMLS CUI-2)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Engerix-B Vaccine (1)
CL Item
Replacement vial (comment) (2)
CL Item
Wrong vial number (comment) (3)
CL Item
Not administered (comment) (4)
Item
Vaccination Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Vaccination Side/ Site Route
Code List
Vaccination Side/ Site Route
CL Item
Upper left Anterolateral thigh I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If study vaccine has not been administered according to the Protocol, please check all items that apply
integer
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
If study vaccine has not been administered according to the Protocol, please check all items that apply
Code List
If study vaccine has not been administered according to the Protocol, please check all items that apply
CL Item
Upper Left (1)
CL Item
Lower Left (2)
CL Item
Upper Right (3)
CL Item
Lower Right (4)
CL Item
Deltoid (5)
CL Item
Thigh (6)
CL Item
s.c. (7)
CL Item
i.m. (8)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Vaccine Administration (Infanrix Vaccine)
C2368628 (UMLS CUI-1)
C1964896 (UMLS CUI-2)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Infanrix® Vaccine (1)
CL Item
Replacement vial (comment)  (2)
CL Item
Wrong vial number (comment)  (3)
CL Item
Not administered (comment) (4)
Item
Vaccination Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Vaccination Side/ Site Route
Code List
Vaccination Side/ Site Route
CL Item
Upper left Anterolateral thigh I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If study vaccine has not been administered according to the Protocol, please check all items that apply
integer
C2368628 (UMLS CUI [1,1])
C234856 (UMLS CUI [1,2])
If study vaccine has not been administered according to the Protocol, please check all items that apply
Code List
If study vaccine has not been administered according to the Protocol, please check all items that apply
CL Item
Upper Left  (1)
CL Item
Lower Left  (2)
CL Item
Upper Right  (3)
CL Item
Lower Right  (4)
CL Item
Deltoid  (5)
CL Item
Thigh  (6)
CL Item
s.c.  (7)
CL Item
i.m. (8)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Vaccine Administration (Prevnar Vaccine)
C2368628 (UMLS CUI-1)
C0876134 (UMLS CUI-2)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Prevnar® Vaccine (1)
CL Item
Replacement vial (comment)  (2)
CL Item
Wrong vial number (comment)  (3)
CL Item
Not administered (comment) (4)
Item
Vaccination Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Vaccination Side/ Site Route
Code List
Vaccination Side/ Site Route
CL Item
Upper left Anterolateral thigh I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If study vaccine has not been administered according to the Protocol, please check all items that apply
integer
C2368628 (UMLS CUI [1,1])
C234856 (UMLS CUI [1,2])
If study vaccine has not been administered according to the Protocol, please check all items that apply
Code List
If study vaccine has not been administered according to the Protocol, please check all items that apply
CL Item
Upper Left  (1)
CL Item
Lower Left  (2)
CL Item
Upper Right  (3)
CL Item
Lower Right  (4)
CL Item
Deltoid  (5)
CL Item
Thigh  (6)
CL Item
s.c.  (7)
CL Item
i.m. (8)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Vaccine Administration (HibTITER Vaccine)
C2368628 (UMLS CUI-1)
C1524027 (UMLS CUI-2)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Liquid PedvaxHIB Vaccine (1)
CL Item
Replacement vial (comment)  (2)
CL Item
Wrong vial number (comment) (3)
CL Item
Not administered (comment) (4)
Item
Vaccination Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Vaccination Side/ Site Route
Code List
Vaccination Side/ Site Route
CL Item
Oral (1)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Vaccine Administration (Comvax Vaccine)
C2368628 (UMLS CUI-1)
C0535643 (UMLS CUI-2)
Item
Vaccine Administration
integer
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
Comvax Vaccine (1)
CL Item
Replacement vial (comment)  (2)
CL Item
Wrong vial number (comment)  (3)
CL Item
Not administered (comment) (4)
Item
Vaccination Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
Vaccination Side/ Site Route
Code List
Vaccination Side/ Site Route
CL Item
Upper left Anterolateral thigh I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
If study vaccine has not been administered according to the Protocol, please check all items that apply
integer
C2368628 (UMLS CUI [1,1])
C234856 (UMLS CUI [1,2])
If study vaccine has not been administered according to the Protocol, please check all items that apply
Code List
If study vaccine has not been administered according to the Protocol, please check all items that apply
CL Item
Upper Left  (1)
CL Item
Lower Left  (2)
CL Item
Upper Right  (3)
CL Item
Lower Right  (4)
CL Item
Deltoid  (5)
CL Item
Thigh  (6)
CL Item
s.c.  (7)
CL Item
i.m. (8)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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