ID

33135

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. 11/29/18 11/29/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 29, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Visit 1: Laboratory Tests - Blood

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Blood Sample
Description

Blood Sample

Has a blood sample been taken?
Description

Has a blood sample been taken?

Data type

boolean

If Yes, record the date of sample taken
Description

If Yes, record the date of sample taken

Data type

date

Hepatitis B Vaccine
Description

Hepatitis B Vaccine

Has the hepatitis B vaccine been administered at birth?
Description

Has the hepatitis B vaccine been administered at birth?

Data type

boolean

Back to the top of the page

Similar models

Visit 1: Laboratory Tests - Blood

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Blood Sample
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
If Yes, record the date of sample taken
Item
If Yes, record the date of sample taken
date
Item Group
Hepatitis B Vaccine
Has the hepatitis B vaccine been administered at birth?
Item
Has the hepatitis B vaccine been administered at birth?
boolean
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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