ID

35779

Descrição

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

Palavras-chave

Versões (1)
  1. 22/03/2019 22/03/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

22 de março de 2019

DOI

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Licença

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)

Inglês

Visit 15 (one month post vaccination) - Check for Study Continuation; Laboratory Tests

1 Formulários  
Check for Study Continuation
Descrição

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for follow-up concerning the additional vaccination visit?
Descrição

Yes → Please complete the next pages. No → Please complete below.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0332156
UMLS CUI [2,1]
C0042196
UMLS CUI [2,2]
C0940824
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrição

Please tick the ONE most appropriate reason and skip the following pages of this visit.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0392360
If SAE, please specify SAE No
Descrição

If SAE, please specify SAE No

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code
Descrição

If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If other reason, please specify
Descrição

If other reason, please specify

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
Please tick, who took the decision
Descrição

Please tick, who took the decision

Tipo de dados

text

Alias
UMLS CUI [1]
C0679006
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
Date of blood sample been taken
Descrição

Please complete only if different from visit date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Voltar ao início da página

Similar models

Visit 15 (one month post vaccination) - Check for Study Continuation; Laboratory Tests

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Did the subject return for follow-up concerning the additional vaccination visit?
Item
Did the subject return for follow-up concerning the additional vaccination visit?
boolean
C1522577 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2,1])
C0940824 (UMLS CUI [2,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C1522577 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form)  (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section)  (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, Protocol violation, …) (OTH)
If SAE, please specify SAE No
Item
If SAE, please specify SAE No
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code
Item
If Non-serious Adverse Event, please specify unsolicited AE No or solicited AE Code
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
If other reason, please specify
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Please tick, who took the decision
text
C0679006 (UMLS CUI [1])
Please tick, who took the decision
Code List
Please tick, who took the decision
CL Item
Investigator (I)
CL Item
Parents/ Guardians (P)
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])
Date of blood sample been taken
Item
Date of blood sample been taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Voltar ao início da página 

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