ID
33189
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
Concomitant Medication Form
- StudyEvent: ODM
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Concomitant Medications
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Have any medications/treatment been administered during study period?
Datatyp
boolean
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If Yes, please record the concomitant medication details below
Datatyp
text
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Medication
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Trade/Generic Name
Datatyp
text
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Medical Indication
Datatyp
text
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If Other, specify
Datatyp
text
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Total Daily Dose
Datatyp
text
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Route
Datatyp
text
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Start Date of Medication
Datatyp
date
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End Date of Medication
Datatyp
date
Beskrivning
Ongoing at the end of study?
Datatyp
boolean
Similar models
Concomitant Medication Form
- StudyEvent: ODM