ID

33321

Description

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

Versions (2)
  1. 12/5/18 12/5/18 -
  2. 12/5/18 12/5/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 5, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

English

Visit 1: General Medical History

1 forms  
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

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Similar models

Visit 1: General Medical History

1 forms
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
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
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
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Eyes
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Ears-Nose-Throat
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Cardiovascular
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Respiratory
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Gastrointestinal
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Muskuloskeletal
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Neurological
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Genitourinary
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Haematology
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Allergies
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Endocrine
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Persistent crying
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
Item Group
Other, specify
Diagnosis
Item
Diagnosis
text
Item
Status
text
Status
Code List
Status
CL Item
Past (1)
CL Item
Current (2)
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