ID
33192
Description
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
Keywords
Versions (1)
- 11/30/18 11/30/18 -
Copyright Holder
GSK group of companies
Uploaded on
November 30, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
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
Description
Occurrence of Serious Adverse Event
Description
Elimination Criteria
Description
Withdrawal from Study
Description
Was the subject withdrawn from study?
Data type
boolean
Description
If Yes, please tick the ONE most appropriate category for withdrawal
Data type
text
Description
If Other, please specify
Data type
text
Description
Who took the decision to withdraw?
Data type
text
Description
Date of last contact
Data type
date
Description
If No, please give details within the Adverse Events section
Data type
boolean
Description
Investigator's signature
Description
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.
Data type
date
Description
Investigator's signature
Data type
text
Description
Investigator's name (in print)
Data type
text
Similar models
Study Conclusion
- StudyEvent: ODM