ID

33134

Beskrivning

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

Nyckelord

  1. 2018-11-29 2018-11-29 -
Rättsinnehavare

GSK group of companies

Uppladdad den

29 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Physical Examination
Beskrivning

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?
Beskrivning

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

Datatyp

text

Cutaneous
Beskrivning

Cutaneous

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Eyes
Beskrivning

Eyes

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Ears-Nose-Throat
Beskrivning

Ears-Nose-Throat

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Cardiovascular
Beskrivning

Cardiovascular

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Respiratory
Beskrivning

Respiratory

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Gastrointestinal
Beskrivning

Gastrointestinal

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Muskuloskeletal
Beskrivning

Muskuloskeletal

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Neurological
Beskrivning

Neurological

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Genitourinary
Beskrivning

Genitourinary

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Haematology
Beskrivning

Haematology

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Allergies
Beskrivning

Allergies

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Endocrine
Beskrivning

Endocrine

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Persistent crying
Beskrivning

Persistent crying

Diagnosis
Beskrivning

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

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Other, specify
Beskrivning

Other, specify

Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Similar models

Visit 1: General Medical History

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

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