ID

33189

Descripción

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

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Versiones (1)
  1. 30/11/18 30/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

30 de noviembre de 2018

DOI

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Licencia

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

Inglés

Concomitant Medication Form

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

text

Concomitant Medications
Descripción

Concomitant Medications

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

Have any medications/treatment been administered during study period?

Tipo de datos

boolean

If Yes, please record the concomitant medication details below
Descripción

If Yes, please record the concomitant medication details below

Tipo de datos

text

Medication
Descripción

Medication

Trade/Generic Name
Descripción

Trade/Generic Name

Tipo de datos

text

Medical Indication
Descripción

Medical Indication

Tipo de datos

text

If Other, specify
Descripción

If Other, specify

Tipo de datos

text

Total Daily Dose
Descripción

Total Daily Dose

Tipo de datos

text

Route
Descripción

Route

Tipo de datos

text

Start Date of Medication
Descripción

Start Date of Medication

Tipo de datos

date

End Date of Medication
Descripción

End Date of Medication

Tipo de datos

date

Ongoing at the end of study?
Descripción

Ongoing at the end of study?

Tipo de datos

boolean

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Concomitant Medication Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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