ID

35893

Beschrijving

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

Trefwoorden

Versies (1)
  1. 02-04-19 02-04-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

2 april 2019

DOI

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Licentie

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

Engels

Non-Serious Adverse Events

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Subject Number
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Non-Serious Adverse Events
Beschrijving

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
AE No.
Beschrijving

Non-Serious Adverse Event, Numbers

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Beschrijving

Non-Serious Adverse Event, Description

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Description
Beschrijving

Non-Serious Adverse Event, Localization

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0475264
If Administrazion site, Vaccine
Beschrijving

Non-Serious Adverse Event, Administration of Vaccine

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2368628
Please check box in case of onset of chronic illness
Beschrijving

Non-Serious Adverse Event, Chronic disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0008679
Date started
Beschrijving

Non-Serious Adverse Event, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Date stopped
Beschrijving

Non-Serious Adverse Event, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Intensity
Beschrijving

Non-Serious Adverse Event, Intensity

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Non-Serious Adverse Event, Relationship, Experimental drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Outcome
Beschrijving

Non-Serious Adverse Event, Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1547647
Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Beschrijving

Non-Serious Adverse Event, Visit, advice, medical

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
Beschrijving

Non-Serious Adverse Event, Visit, advice, medical, Type

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C0332307
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Similar models

Non-Serious Adverse Events

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Item
AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Exanthema, Numbers
Code List
AE No.
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Non-Serious Adverse Event, Description
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Description
text
C1518404 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Exanthema, Description
Code List
Description
CL Item
Administration sites  (1)
CL Item
Non-administration sites (2)
Item
If Administrazion site, Vaccine
text
C1518404 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Exanthema, Description
Code List
If Administrazion site, Vaccine
CL Item
Hib-MenCY-TT vaccine  (1)
CL Item
Infanrix® penta vaccine  (2)
CL Item
Prevenar® vaccine (3)
CL Item
ActHIB® vaccine (4)
CL Item
Meningitec® vaccine (5)
Non-Serious Adverse Event, Chronic disease
Item
Please check box in case of onset of chronic illness
boolean
C1518404 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
Non-Serious Adverse Event, Start Date
Item
Date started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Non-Serious Adverse Event, End Date
Item
Date stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Intensity
text
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Exanthema, Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Non-Serious Adverse Event, Relationship, Experimental drug
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Exanthema, Outcome
Code List
Outcome
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Non-Serious Adverse Event, Visit, advice, medical
Item
Medically attended visit (Refer to protocol for full definition.) If yes please specify type: HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Non-Serious Adverse Event, Visit, advice, medical, Type
Item
Type HO: Hospitalisation ER: Emergency Room MD: MedicalPersonnel
boolean
C1518404 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
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