ID

33188

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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

Nyckelord

Versioner (1)
  1. 2018-11-30 2018-11-30 -
Rättsinnehavare

GSK group of companies

Uppladdad den

30 november 2018

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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

Engelsk

Concomitant Vaccination Form

1 Formulär  
Administrative data
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Administrative data

Subject Number
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Subject Number

Datatyp

text

Concomitant Vaccination
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Concomitant Vaccination

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

Datatyp

boolean

If Yes, please record the concomitant vaccination details below
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If Yes, please record the concomitant vaccination details below

Datatyp

text

Vaccination details
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Vaccination details

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Trade/Generic Name

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text

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Route

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text

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date

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Concomitant Vaccination Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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If Yes, please record the concomitant vaccination details below
text
Item Group
Vaccination details
Trade/Generic Name
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Trade/Generic Name
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Route
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Code List
Route
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Intradermal (1)
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Inhalation (2)
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Intramuscular (3)
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Intravenous (4)
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Intranasal (5)
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Other (6)
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Parenteral (7)
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Transdermal (11)
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