ID
33343
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 (1)
- 12/6/18 12/6/18 -
Copyright Holder
GSK group of companies
Uploaded on
December 6, 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
Visit 3: Solicited Adverse Events - General Symptoms
- StudyEvent: ODM
Description
Solicited Adverse Events
Description
Fever
Description
Day
Data type
integer
Description
Fever
Data type
boolean
Description
If Yes, record t°
Data type
float
Measurement units
- °C
Description
record route
Data type
text
Description
Ongoing after days 7?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Visit type
Data type
text
Description
Irritability/Fussiness
Description
Day
Data type
integer
Description
Irritability/Fussiness
Data type
boolean
Description
If Yes, record intensity
Data type
text
Description
Ongoing after days 7?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Visit type
Data type
text
Description
Drowsiness
Description
Day
Data type
integer
Description
Drowsiness
Data type
boolean
Description
If Yes, record intensity
Data type
text
Description
Ongoing after days 7?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Visit type
Data type
text
Description
Loss of Appetite
Description
Day
Data type
integer
Description
Loss of Appetite
Data type
boolean
Description
If Yes, record intensity
Data type
text
Description
Ongoing after days 7?
Data type
boolean
Description
Date of last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
boolean
Description
Visit type
Data type
text
Description
In case of "Severe" Intensity of Crying:
Description
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Data type
boolean
Description
Was the crying unaltered >=3 hours?
Data type
boolean
Similar models
Visit 3: Solicited Adverse Events - General Symptoms
- StudyEvent: ODM