ID

33189

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

Versions (1)
  1. 11/30/18 11/30/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 30, 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

English

Concomitant Medication Form

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

text

Concomitant Medications
Description

Concomitant Medications

Have any medications/treatment been administered during study period?
Description

Have any medications/treatment been administered during study period?

Data type

boolean

If Yes, please record the concomitant medication details below
Description

If Yes, please record the concomitant medication details below

Data type

text

Medication
Description

Medication

Trade/Generic Name
Description

Trade/Generic Name

Data type

text

Medical Indication
Description

Medical Indication

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Total Daily Dose
Description

Total Daily Dose

Data type

text

Route
Description

Route

Data type

text

Start Date of Medication
Description

Start Date of Medication

Data type

date

End Date of Medication
Description

End Date of Medication

Data type

date

Ongoing at the end of study?
Description

Ongoing at the end of study?

Data type

boolean

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Similar models

Concomitant Medication Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
text
Item Group
Concomitant Medications
Have any medications/treatment been administered during study period?
Item
Have any medications/treatment been administered during study period?
boolean
If Yes, please record the concomitant medication details below
Item
If Yes, please record the concomitant medication details below
text
Item Group
Medication
Trade/Generic Name
Item
Trade/Generic Name
text
Item
Medical Indication
text
Medical Indication
Code List
Medical Indication
CL Item
Prophylactic (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
Total Daily Dose
Item
Total Daily Dose
text
Item
Route
text
Route
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)
Start Date of Medication
Item
Start Date of Medication
date
End Date of Medication
Item
End Date of Medication
date
Ongoing at the end of study?
Item
Ongoing at the end of study?
boolean
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