ID

30023

Beschrijving

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Non-Serious Adverse Events

Trefwoorden

Versies (2)
  1. 10-07-17 10-07-17 -
  2. 04-05-18 04-05-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

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4 mei 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Non-Serious Adverse Events 759346/004

Engels

Non-Serious Adverse Events Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

1 Formulieren  
Non-serious Adverse Events
Beschrijving

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0042210
Subject Number
Beschrijving

Subject Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschrijving

If YES, please complete the following table.

Datatype

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Beschrijving

Adverse Event Number

Datatype

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-serious adverse events: Description
Beschrijving

Description

Datatype

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Non-serious adverse events: Description
Beschrijving

Description

Datatype

integer

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Type of vaccine
Beschrijving

Description of Non-Serious Adverse Event

Datatype

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0678257
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start: during immediate post-vaccination period (30 minutes)
Beschrijving

Start

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C1518404
End Date
Beschrijving

End Date

Datatype

date

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

Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Beschrijving

Relationship to investigational product(s)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschrijving

Outcome

Datatype

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Medically attended visit?
Beschrijving

Medically attended visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C1518404
Medically attended visit type
Beschrijving

Did the subject seek medical advice? If yes, please specify type

Datatype

text

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

Non-Serious Adverse Events Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Description
Code List
Non-serious adverse events: Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Item
Type of vaccine
integer
C0042210 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
undefined item
Code List
Type of vaccine
CL Item
Tritanrix-HepB/Hib-MenAC vaccine (1)
CL Item
Tritanrix-HepB/Hiberix vaccine (2)
CL Item
Meningitec vaccine (3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Modearte (2)
CL Item
Severe (3)
Relationship to investigational product(s)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
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)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
Medical advice type
Code List
Medically attended visit type
CL Item
Hospitalisation (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
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