ID

33134

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

  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.

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

Visit 1: General Medical History

Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Physical Examination
Description

Physical Examination

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Description

Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?

Data type

text

Cutaneous
Description

Cutaneous

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Eyes
Description

Eyes

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Ears-Nose-Throat
Description

Ears-Nose-Throat

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Cardiovascular
Description

Cardiovascular

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Respiratory
Description

Respiratory

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Gastrointestinal
Description

Gastrointestinal

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Muskuloskeletal
Description

Muskuloskeletal

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Neurological
Description

Neurological

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Genitourinary
Description

Genitourinary

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Haematology
Description

Haematology

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Allergies
Description

Allergies

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Endocrine
Description

Endocrine

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Persistent crying
Description

Persistent crying

Diagnosis
Description

crying continuous (i.e., not episodic, not interrupted within the time period of 3 hours by e.g. naps) and unaltered for >=3 hours

Data type

text

Status
Description

Status

Data type

text

Other, specify
Description

Other, specify

Diagnosis
Description

Diagnosis

Data type

text

Status
Description

Status

Data type

text

Similar models

Visit 1: General Medical History

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Physical Examination
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
text
Code List
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
Yes (please tick appropriate box(es) and give diagnosis (1)
CL Item
No (2)
Item Group
Cutaneous
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Eyes
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Ears-Nose-Throat
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Cardiovascular
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Respiratory
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Gastrointestinal
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Muskuloskeletal
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Neurological
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Genitourinary
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Haematology
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Allergies
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Endocrine
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Persistent crying
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Other, specify
Diagnosis
Item
Diagnosis
text
Item
Status
text
Code List
Status
CL Item
Past (1)
CL Item
Current (2)

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

Fields marked with * are required.

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