ID
33245
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)
- 03/12/2018 03/12/2018 -
Titular dos direitos
GSK group of companies
Transferido a
3 de dezembro 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
Diary Card 3: Other Symptoms
- StudyEvent: ODM
Descrição
Other Symptoms
Descrição
Description
Tipo de dados
text
Descrição
Mild (an adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities); Moderate (An adverse event which is sufficiently discomforting to interfere with normal everyday activities); Severe (An adverse event which prevents normal, everyday activities: e.g attendance at school/kindergarten/a day-care centre and would cause parents/guardians to seek medical advice)
Tipo de dados
text
Descrição
Start Date
Tipo de dados
date
Descrição
End Date
Tipo de dados
date
Descrição
Ongoing?
Tipo de dados
boolean
Descrição
Medically attended visit?
Tipo de dados
boolean
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Diary Card 3: Other Symptoms
- StudyEvent: ODM