ID

33189

Descrizione

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. 30/11/18 30/11/18 -
Titolare del copyright

GSK group of companies

Caricato su

30 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

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
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

text

Concomitant Medications
Descrizione

Concomitant Medications

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

Have any medications/treatment been administered during study period?

Tipo di dati

boolean

If Yes, please record the concomitant medication details below
Descrizione

If Yes, please record the concomitant medication details below

Tipo di dati

text

Medication
Descrizione

Medication

Trade/Generic Name
Descrizione

Trade/Generic Name

Tipo di dati

text

Medical Indication
Descrizione

Medical Indication

Tipo di dati

text

If Other, specify
Descrizione

If Other, specify

Tipo di dati

text

Total Daily Dose
Descrizione

Total Daily Dose

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

text

Start Date of Medication
Descrizione

Start Date of Medication

Tipo di dati

date

End Date of Medication
Descrizione

End Date of Medication

Tipo di dati

date

Ongoing at the end of study?
Descrizione

Ongoing at the end of study?

Tipo di dati

boolean

Similar models

Concomitant Medication Form

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial