ID

33240

Description

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

Keywords

Versions (1)
  1. 12/3/18 12/3/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 3, 2018

DOI

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License

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

English

Diary Card 2: Other Symptoms

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Dose
Description

Dose

Data type

text

Other Symptoms
Description

Other Symptoms

Description
Description

Description

Data type

text

Intensity
Description

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)

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

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Similar models

Diary Card 2: Other Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Dose
text
Dose
Code List
Dose
CL Item
Dose 2 (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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