ID

36925

Description

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Keywords

Versions (1)
  1. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 21, 2019

DOI

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

English

Visit 4

1 forms  
  1. StudyEvent: ODM
    1. Visit 4
Administrative Data
Description

Administrative Data

Date of Visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

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

Check for Study Continuation

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

Continuation Status, Clinical Trials

Data type

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Description

Continuation Status, Clinical Trials, Reason

Data type

text

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

Continuation Status, Clinical Trials, Reason

Data type

text

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

Continuation Status, Clinical Trials, Decision

Data type

text

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

Laboratory Tests - Blood Sample

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

Collection of blood specimen for laboratory procedure

Data type

text

Alias
UMLS CUI [1]
C0005834
Please complete only if different from visit date
Description

Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Visit 4

1 forms
  1. StudyEvent: ODM
    1. Visit 4
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
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
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
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (3)
Continuation Status, Clinical Trials, Reason
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation Status, Clinical Trials, Decision
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Laboratory Tests - Blood Sample
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken ?
text
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure
Code List
Has a blood sample been taken ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (other half of the subjects of each group) (3)
Collection of blood specimen for laboratory procedure, Date in time
Item
Please complete only if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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