Information:
Fel:
ID
33473
Beskrivning
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
Nyckelord
Versioner (1)
- 2018-12-10 2018-12-10 -
Rättsinnehavare
GSK group of companies
Uppladdad den
10 december 2018
DOI
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Licens
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
Diary Card: Local Symptoms (DTPwHBV Kft + HiberixTM)
- StudyEvent: ODM
Similar models
Diary Card: Local Symptoms (DTPwHBV Kft + HiberixTM)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject Number
Item
Subject Number
integer
CL Item
Vaccination 1 (1)
Protocol Number
Item
Protocol Number
integer
Item Group
Local Symptoms - Redness (at injection site) DTPw-HBV Kft Vaccine
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medicalyl attended visit?
Item
Medically attended visit?
boolean
Item Group
Local Symptoms - Swelling (at injection site)
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Description
Item
Description
text
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
Local Symptoms - Redness (at injection site) HiberixTM Vaccine
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
Local Symptoms - Swelling (at injection site) HiberixTM Vaccine
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
Local Symptoms - Pain (at injection site) HiberixTM Vaccine
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Description
Item
Description
text
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
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