ID
33192
Descrição
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
Palavras-chave
Versões (1)
- 30/11/2018 30/11/2018 -
Titular dos direitos
GSK group of companies
Transferido a
30 de novembro de 2018
DOI
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Licença
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
Descrição
Occurrence of Serious Adverse Event
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Elimination Criteria
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Withdrawal from Study
Descrição
Was the subject withdrawn from study?
Tipo de dados
boolean
Descrição
If Yes, please tick the ONE most appropriate category for withdrawal
Tipo de dados
text
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If Other, please specify
Tipo de dados
text
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Who took the decision to withdraw?
Tipo de dados
text
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Date of last contact
Tipo de dados
date
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If No, please give details within the Adverse Events section
Tipo de dados
boolean
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Investigator's signature
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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 dados
date
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Investigator's signature
Tipo de dados
text
Descrição
Investigator's name (in print)
Tipo de dados
text
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Study Conclusion
- StudyEvent: ODM