ID

33245

Beskrivning

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Nyckelord

Versioner (1)
  1. 2018-12-03 2018-12-03 -
Rättsinnehavare

GSK group of companies

Uppladdad den

3 december 2018

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

Engelsk

Diary Card 3: Other Symptoms

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Dose
Beskrivning

Dose

Datatyp

text

Other Symptoms
Beskrivning

Other Symptoms

Description
Beskrivning

Description

Datatyp

text

Intensity
Beskrivning

Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities); Moderate (An adverse event which is sufficiently discomforting to interfere with normal everyday activities); Severe (An adverse event which prevents normal, everyday activities: e.g attendance at school/kindergarten/a day-care centre and would cause parents/guardians to seek medical advice)

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

End Date
Beskrivning

End Date

Datatyp

date

Ongoing?
Beskrivning

Ongoing?

Datatyp

boolean

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

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Diary Card 3: Other Symptoms

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Dose
text
Dose
Code List
Dose
CL Item
Dose 3 (1)
Item Group
Other Symptoms
Description
Item
Description
text
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Ongoing?
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
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