ID

33246

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

  1. 2018-12-03 2018-12-03 -
  2. 2019-10-30 2019-10-30 - Sarah Riepenhausen
Rättsinnehavare

GSK group of companies

Uppladdad den

3 december 2018

DOI

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Licens

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

Diary Card 3: Concomitant Medications

Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Dose
Beskrivning

Dose

Datatyp

text

Medication
Beskrivning

Medication

Trade Name/Generic Name
Beskrivning

Trade Name/Generic Name

Datatyp

text

Reason
Beskrivning

Reason

Datatyp

text

Total Daily Dose?
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Total Daily Dose?

Datatyp

text

Start Date
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Start Date

Datatyp

date

End Date
Beskrivning

End Date

Datatyp

date

Ongoing?
Beskrivning

Ongoing?

Datatyp

boolean

Reminder
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Reminder

Please do not forget to bring back the diary card on
Beskrivning

fill the date below

Datatyp

date

In case of hospitalisation, please inform
Beskrivning

fill the name below

Datatyp

text

Similar models

Diary Card 3: Concomitant Medications

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Dose
text
Code List
Dose
CL Item
Dose 3 (1)
Item Group
Medication
Trade Name/Generic Name
Item
Trade Name/Generic Name
text
Item
Reason
text
Code List
Reason
Total Daily Dose?
Item
Total Daily Dose?
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Ongoing?
boolean
Item Group
Reminder
Please do not forget to bring back the diary card on
Item
Please do not forget to bring back the diary card on
date
In case of hospitalisation, please inform
Item
In case of hospitalisation, please inform
text

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