ID

36623

Beschreibung

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Stichworte

Versionen (1)
  1. 26.05.19 26.05.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

26. Mai 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

Englisch

Visit 4

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 4
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Beschreibung

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for visit 4 ?
Beschreibung

Continuation status, Clinical Trials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beschreibung

Continuation status, Clinical Trials, Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Beschreibung

Continuation status, Clinical Trials, Reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who made the decision
Beschreibung

Continuation status, Clinical Trials, Decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Laboratory Tests - Blood Sample
Beschreibung

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken ?
Beschreibung

Collection of blood specimen for laboratory procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date (Please complete only if different from visit date)
Beschreibung

Collection of blood specimen for laboratory procedure, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Visit 4

1 Formulare
  1. StudyEvent: ODM
    1. Visit 4
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Did the subject return for visit 4 ?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE No.) (1)
CL Item
Non-Serious adverse event (Please specify AE No. or solicited AE code) (2)
CL Item
Other, please specify (3)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Specify
Item
Please tick who made the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Please tick who made the decision
CL Item
Investigator  (1)
CL Item
Parents/Guardians (2)
Item Group
Laboratory Tests - Blood Sample
C0005834 (UMLS CUI-1)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken ?
boolean
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure, Date in time
Item
Date (Please complete only if different from visit date)
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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