ID

33108

Beschrijving

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

Trefwoorden

  1. 28-11-18 28-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

28 november 2018

DOI

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Licentie

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
Beschrijving

Administrative data

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Subject Number
Beschrijving

Subject Number

Datatype

integer

Informed Consent
Beschrijving

Informed Consent

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

record the Informed Consent Date

Datatype

date

Similar models

Visit 1: Consent Form

  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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