ID

33189

Descrição

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

Palavras-chave

  1. 30/11/2018 30/11/2018 -
Titular dos direitos

GSK group of companies

Transferido a

30 de novembro de 2018

DOI

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Licença

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

Concomitant Medication Form

Administrative data
Descrição

Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

text

Concomitant Medications
Descrição

Concomitant Medications

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

Have any medications/treatment been administered during study period?

Tipo de dados

boolean

If Yes, please record the concomitant medication details below
Descrição

If Yes, please record the concomitant medication details below

Tipo de dados

text

Medication
Descrição

Medication

Trade/Generic Name
Descrição

Trade/Generic Name

Tipo de dados

text

Medical Indication
Descrição

Medical Indication

Tipo de dados

text

If Other, specify
Descrição

If Other, specify

Tipo de dados

text

Total Daily Dose
Descrição

Total Daily Dose

Tipo de dados

text

Route
Descrição

Route

Tipo de dados

text

Start Date of Medication
Descrição

Start Date of Medication

Tipo de dados

date

End Date of Medication
Descrição

End Date of Medication

Tipo de dados

date

Ongoing at the end of study?
Descrição

Ongoing at the end of study?

Tipo de dados

boolean

Similar models

Concomitant Medication Form

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
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
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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