ID

33140

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

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Versões (1)
  1. 29/11/2018 29/11/2018 -
Titular dos direitos

GSK group of companies

Transferido a

29 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

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Visit 1: Unsolicited Adverse Events (Dose 1)

1 Formulários  
Administrative data
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Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Unsolicited Adverse Events
Descrição

Unsolicited Adverse Events

Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
Descrição

Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?

Tipo de dados

text

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Visit 1: Unsolicited Adverse Events (Dose 1)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Unsolicited Adverse Events
Item
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
text
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
Code List
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form (4)
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