ID

33188

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

  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

Concomitant Vaccination Form

Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

text

Concomitant Vaccination
Descripción

Concomitant Vaccination

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

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

Tipo de datos

boolean

If Yes, please record the concomitant vaccination details below
Descripción

If Yes, please record the concomitant vaccination details below

Tipo de datos

text

Vaccination details
Descripción

Vaccination details

Trade/Generic Name
Descripción

Trade/Generic Name

Tipo de datos

text

Route
Descripción

Route

Tipo de datos

text

Administration Date
Descripción

Administration Date

Tipo de datos

date

Similar models

Concomitant Vaccination Form

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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