ID

33466

Beskrivning

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Nyckelord

Versioner (1)
  1. 2018-12-10 2018-12-10 -
Rättsinnehavare

GSK group of companies

Uppladdad den

10 december 2018

DOI

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Creative Commons BY-NC 3.0
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Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

Engelsk

Visit 4: Non-Serious Adverse Events Form

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Non-Serious Adverse Events
Beskrivning

Non-Serious Adverse Events

Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
Beskrivning

Please report all SAE only on the SAE-form.

Datatyp

boolean

If Yes, please complete the section below
Beskrivning

If Yes, please complete the section below

Datatyp

text

Non-Serious Adverse Events Data
Beskrivning

Non-Serious Adverse Events Data

AE Number
Beskrivning

AE Number

Datatyp

integer

Description
Beskrivning

Description

Datatyp

text

Administration sites
Beskrivning

Administration sites

Datatyp

text

Date Started
Beskrivning

Date Started

Datatyp

date

Date Stopped
Beskrivning

Date Stopped

Datatyp

date

Intensity
Beskrivning

Intensity

Datatyp

text

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Datatyp

boolean

Outcome
Beskrivning

Outcome

Datatyp

text

Medically attended visit
Beskrivning

Medically attended visit

Datatyp

boolean

If Yes, record the type of visit
Beskrivning

If Yes, record the type of visit

Datatyp

text

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Similar models

Visit 4: Non-Serious Adverse Events Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
Non-Serious Adverse Events
Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
Item
Has any non-serious adverse event occurred within one month post-vaccination, excluding those recorded on the Solicited AE forms?
boolean
If Yes, please complete the section below
Item
If Yes, please complete the section below
text
Item Group
Non-Serious Adverse Events Data
Item
AE Number
integer
AE Number
Code List
AE Number
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
Description
Item
Description
text
Item
Administration sites
text
Administration sites
Code List
Administration sites
CL Item
DTPw-HBV/Hib Kft vaccine (1)
CL Item
DTPw-HBV Kft vaccine (2)
CL Item
HiberixTM vaccine (3)
CL Item
Non-administration site (4)
Date Started
Item
Date Started
date
Date Stopped
Item
Date Stopped
date
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item
Outcome
text
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
Item
If Yes, record the type of visit
text
If Yes, record the type of visit
Code List
If Yes, record the type of visit
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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