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
Mots-clés
Versions (1)
- 30/11/2018 30/11/2018 -
Détendeur de droits
GSK group of companies
Téléchargé le
30 novembre 2018
DOI
Pour une demande vous connecter.
Licence
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
Description
Occurrence of Serious Adverse Event
Description
Did the subject experience any Serious Adverse Event during the study period?
Type de données
boolean
Description
If Yes, specify total number of SAE's
Type de données
integer
Description
Elimination Criteria
Description
Withdrawal from Study
Description
Was the subject withdrawn from study?
Type de données
boolean
Description
If Yes, please tick the ONE most appropriate category for withdrawal
Type de données
text
Description
If Other, please specify
Type de données
text
Description
Who took the decision to withdraw?
Type de données
text
Description
Date of last contact
Type de données
date
Description
If No, please give details within the Adverse Events section
Type de données
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.
Type de données
date
Description
Investigator's signature
Type de données
text
Description
Investigator's name (in print)
Type de données
text
Similar models
Study Conclusion
- StudyEvent: ODM