ID

33246

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

Palabras clave

  1. 3/12/18 3/12/18 -
  2. 30/10/19 30/10/19 - Sarah Riepenhausen
Titular de derechos de autor

GSK group of companies

Subido en

3 de diciembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

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

Diary Card 3: Concomitant Medications

Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Dose
Descripción

Dose

Tipo de datos

text

Medication
Descripción

Medication

Trade Name/Generic Name
Descripción

Trade Name/Generic Name

Tipo de datos

text

Reason
Descripción

Reason

Tipo de datos

text

Total Daily Dose?
Descripción

Total Daily Dose?

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

End Date
Descripción

End Date

Tipo de datos

date

Ongoing?
Descripción

Ongoing?

Tipo de datos

boolean

Reminder
Descripción

Reminder

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

fill the date below

Tipo de datos

date

In case of hospitalisation, please inform
Descripción

fill the name below

Tipo de datos

text

Similar models

Diary Card 3: Concomitant Medications

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