ID

33108

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

Mots-clés

  1. 28/11/2018 28/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

28 novembre 2018

DOI

Pour une demande vous connecter.

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

Visit 1: Consent Form

  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Administrative data
Description

Administrative data

Date of Visit
Description

Date of Visit

Type de données

date

Subject Number
Description

Subject Number

Type de données

integer

Informed Consent
Description

Informed Consent

I certify that Informed Consent has been obtained prior to any study procedure.
Description

record the Informed Consent Date

Type de données

date

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Visit 1: Consent Form

  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Informed Consent
I certify that Informed Consent has been obtained prior to any study procedure.
Item
I certify that Informed Consent has been obtained prior to any study procedure.
date

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