ID
33192
Descripción
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
Palabras clave
Versiones (1)
- 30/11/18 30/11/18 -
Titular de derechos de autor
GSK group of companies
Subido en
30 de noviembre de 2018
DOI
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Licencia
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
Descripción
Occurrence of Serious Adverse Event
Descripción
Elimination Criteria
Descripción
Withdrawal from Study
Descripción
Was the subject withdrawn from study?
Tipo de datos
boolean
Descripción
If Yes, please tick the ONE most appropriate category for withdrawal
Tipo de datos
text
Descripción
If Other, please specify
Tipo de datos
text
Descripción
Who took the decision to withdraw?
Tipo de datos
text
Descripción
Date of last contact
Tipo de datos
date
Descripción
If No, please give details within the Adverse Events section
Tipo de datos
boolean
Descripción
Investigator's signature
Descripción
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.
Tipo de datos
date
Descripción
Investigator's signature
Tipo de datos
text
Descripción
Investigator's name (in print)
Tipo de datos
text
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Study Conclusion
- StudyEvent: ODM