ID
33464
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)
- 12/10/18 12/10/18 -
Copyright Holder
GSK group of companies
Uploaded on
December 10, 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 4: Large Swelling Reaction
- StudyEvent: ODM
Description
Report of Physical Examination
Description
Please complete this section for: any local swelling with diameter >50mm, any noticeable diffuse injection site swelling (diameter not measurable), any noticeable increased circumference of the injected limb.
Data type
date
Description
Was the examination performed by a member of study personnel during the large swelling reaction period?
Data type
boolean
Description
Date when the swelling was first considered to be a large swelling reaction
Data type
date
Description
If occurring within 24 hrs after vaccination, please specify how long after vaccination
Data type
integer
Measurement units
- hrs
Description
measurement of the greatest diameter
Data type
integer
Measurement units
- mm
Description
please specify in section "clinical case description"
Data type
text
Description
Circumference of swollen limb (at the site of maximum swelling)
Data type
integer
Measurement units
- mm
Description
Circumference of the opposite limb (at the same level)
Data type
integer
Measurement units
- mm
Description
Associated signs
Description
Please report t°; if the t° has been taken more than once a day, please report the highest value.
Data type
integer
Measurement units
- °C
Description
Route
Data type
text
Description
Redness
Data type
boolean
Description
Redness - largest diameter
Data type
integer
Measurement units
- mm
Description
Induration
Data type
boolean
Description
Induration - largest diameter
Data type
integer
Measurement units
- mm
Description
at administration site
Data type
boolean
Description
Pain intensity
Data type
text
Description
Functional impairment
Data type
boolean
Description
Functional impairment intensity
Data type
text
Description
If hospitalisation is required, please also complete a Serious Adverse Event Form
Description
Clinical Case Description
Description
Includes a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
Data type
text
Description
Last date when the swelling was still considered to be a large swelling reaction
Data type
date
Description
Outcome of the large swelling reaction
Data type
text
Description
Follow-up information
Data type
text
Description
e.g., allergy, infection, trauma, underlying conditions
Data type
boolean
Description
If Yes, please specify below
Data type
text
Similar models
Visit 4: Large Swelling Reaction
- StudyEvent: ODM