ID
33191
Beskrivning
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
Nyckelord
Versioner (1)
- 2018-11-30 2018-11-30 -
Rättsinnehavare
GSK group of companies
Uppladdad den
30 november 2018
DOI
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Licens
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
Non-Serious Adverse Events Form
- StudyEvent: ODM
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Non-Serious Adverse Events
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Non-Serious Adverse Events Data
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AE Number
Datatyp
integer
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Description
Datatyp
text
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Administration sites
Datatyp
text
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Date Started
Datatyp
date
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Date Stopped
Datatyp
date
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Intensity
Datatyp
text
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Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
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Outcome
Datatyp
text
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Medically attended visit
Datatyp
boolean
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If Yes, record the type of visit
Datatyp
text
Similar models
Non-Serious Adverse Events Form
- StudyEvent: ODM