ID
33192
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
Versies (1)
- 30-11-18 30-11-18 -
Houder van rechten
GSK group of companies
Geüploaded op
30 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
Study Conclusion
- StudyEvent: ODM
Beschrijving
Occurrence of Serious Adverse Event
Beschrijving
Elimination Criteria
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Withdrawal from Study
Beschrijving
Was the subject withdrawn from study?
Datatype
boolean
Beschrijving
If Yes, please tick the ONE most appropriate category for withdrawal
Datatype
text
Beschrijving
If Other, please specify
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text
Beschrijving
Who took the decision to withdraw?
Datatype
text
Beschrijving
Date of last contact
Datatype
date
Beschrijving
If No, please give details within the Adverse Events section
Datatype
boolean
Beschrijving
Investigator's signature
Beschrijving
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
Beschrijving
Investigator's signature
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text
Beschrijving
Investigator's name (in print)
Datatype
text
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Study Conclusion
- StudyEvent: ODM