ID

33188

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

  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

Concomitant Vaccination Form

Administrative data
Descrição

Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

text

Concomitant Vaccination
Descrição

Concomitant Vaccination

Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Descrição

Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?

Tipo de dados

boolean

If Yes, please record the concomitant vaccination details below
Descrição

If Yes, please record the concomitant vaccination details below

Tipo de dados

text

Vaccination details
Descrição

Vaccination details

Trade/Generic Name
Descrição

Trade/Generic Name

Tipo de dados

text

Route
Descrição

Route

Tipo de dados

text

Administration Date
Descrição

Administration Date

Tipo de dados

date

Similar models

Concomitant Vaccination Form

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
text
Item Group
Concomitant Vaccination
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
If Yes, please record the concomitant vaccination details below
Item
If Yes, please record the concomitant vaccination details below
text
Item Group
Vaccination details
Trade/Generic Name
Item
Trade/Generic Name
text
Item
Route
text
Code List
Route
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Other (6)
CL Item
Parenteral (7)
CL Item
Oral (8)
CL Item
Subcutaneous (9)
CL Item
Sublingual (10)
CL Item
Transdermal (11)
CL Item
Unknown (12)
Administration Date
Item
Administration Date
date

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