ID

33140

Beskrivning

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. 2018-11-29 2018-11-29 -
Rättsinnehavare

GSK group of companies

Uppladdad den

29 november 2018

DOI

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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

Visit 1: Unsolicited Adverse Events (Dose 1)

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Unsolicited Adverse Events
Beskrivning

Unsolicited Adverse Events

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

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

Datatyp

text

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Similar models

Visit 1: Unsolicited Adverse Events (Dose 1)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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