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 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

  1. 11/30/18 11/30/18 -
Copyright Holder:
GSK group of companies
Uploaded on:

November 30, 2018

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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

  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Occurrence of Serious Adverse Event
Did the subject experience any Serious Adverse Event during the study period?
Elimination Criteria
Did any elimination criteria become applicable during the study?
Withdrawal from Study
Was the subject withdrawn from study?
If Yes, please tick the ONE most appropriate category for withdrawal
Who took the decision to withdraw?
Was the subject in good condition at the date of last contact?
Investigator's signature

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