ID

33135

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. 29/11/2018 29/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

29 novembre 2018

DOI

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Licence

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

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Visit 1: Laboratory Tests - Blood

1 Formulaires  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Type de données

integer

Blood Sample
Description

Blood Sample

Has a blood sample been taken?
Description

Has a blood sample been taken?

Type de données

boolean

If Yes, record the date of sample taken
Description

If Yes, record the date of sample taken

Type de données

date

Hepatitis B Vaccine
Description

Hepatitis B Vaccine

Has the hepatitis B vaccine been administered at birth?
Description

Has the hepatitis B vaccine been administered at birth?

Type de données

boolean

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Visit 1: Laboratory Tests - Blood

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Blood Sample
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
If Yes, record the date of sample taken
Item
If Yes, record the date of sample taken
date
Item Group
Hepatitis B Vaccine
Has the hepatitis B vaccine been administered at birth?
Item
Has the hepatitis B vaccine been administered at birth?
boolean
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