ID
33192
Beschreibung
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
Stichworte
Versionen (1)
- 30.11.18 30.11.18 -
Rechteinhaber
GSK group of companies
Hochgeladen am
30. November 2018
DOI
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Lizenz
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
Study Conclusion
- StudyEvent: ODM
Beschreibung
Occurrence of Serious Adverse Event
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Elimination Criteria
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Withdrawal from Study
Beschreibung
Was the subject withdrawn from study?
Datentyp
boolean
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If Yes, please tick the ONE most appropriate category for withdrawal
Datentyp
text
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If Other, please specify
Datentyp
text
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Who took the decision to withdraw?
Datentyp
text
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Date of last contact
Datentyp
date
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If No, please give details within the Adverse Events section
Datentyp
boolean
Beschreibung
Investigator's signature
Beschreibung
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
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date
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Investigator's signature
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text
Beschreibung
Investigator's name (in print)
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text
Ähnliche Modelle
Study Conclusion
- StudyEvent: ODM