ID

33246

Description

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

Keywords

  1. 12/3/18 12/3/18 -
  2. 10/30/19 10/30/19 - Sarah Riepenhausen
Copyright Holder

GSK group of companies

Uploaded on

December 3, 2018

DOI

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License

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
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Dose
Description

Dose

Data type

text

Medication
Description

Medication

Trade Name/Generic Name
Description

Trade Name/Generic Name

Data type

text

Reason
Description

Reason

Data type

text

Total Daily Dose?
Description

Total Daily Dose?

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Reminder
Description

Reminder

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

fill the date below

Data type

date

In case of hospitalisation, please inform
Description

fill the name below

Data type

text

Similar models

Diary Card 3: Concomitant Medications

Name
Type
Description | Question | Decode (Coded Value)
Data type
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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