ID

33109

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

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Versions (1)
  1. 11/28/18 11/28/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 28, 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

Visit 1: Demographic Data

1 forms  
Administrative data
Description

Administrative data

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Demographics
Description

Demographics

Center Number
Description

Center Number

Data type

integer

Date of Birth
Description

Date of Birth

Data type

date

Gender
Description

Gender

Data type

text

Race
Description

Race

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

Height
Description

Height

Data type

integer

Measurement units
  • cm
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
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Visit 1: Demographic Data

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Demographics
Center Number
Item
Center Number
integer
Date of Birth
Item
Date of Birth
date
Item
Gender
text
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
text
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East&South East Asia (4)
CL Item
South Asia (5)
CL Item
American Hispanic (6)
CL Item
Japanese (7)
CL Item
Other (8)
If Other, please specify
Item
If Other, please specify
text
Height
Item
Height
integer
Weight
Item
Weight
float
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