ID

33245

Descripción

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

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Versiones (1)
  1. 3/12/18 3/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

3 de diciembre de 2018

DOI

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Licencia

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

Inglés

Diary Card 3: Other Symptoms

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Dose
Descripción

Dose

Tipo de datos

text

Other Symptoms
Descripción

Other Symptoms

Description
Descripción

Description

Tipo de datos

text

Intensity
Descripción

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)

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

End Date
Descripción

End Date

Tipo de datos

date

Ongoing?
Descripción

Ongoing?

Tipo de datos

boolean

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

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Diary Card 3: Other Symptoms

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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