ID

33166

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

  1. 11/30/18 11/30/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 30, 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

Visit 2: Physical Examination

Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Date of Visit
Description

Date of Visit

Data type

date

Visit
Description

Visit

Data type

text

Physical Examination
Description

Physical Examination

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 2: Physical Examination

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Item
Visit
text
Code List
Visit
CL Item
Visit 2 (1)
Item Group
Physical Examination
Height
Item
Height
integer
Weight
Item
Weight
float

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