ID
33348
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)
- 2018-12-06 2018-12-06 -
Rättsinnehavare
GSK group of companies
Uppladdad den
6 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
Large Swelling Reaction
- StudyEvent: ODM
Beskrivning
Report of Physical Examination
Beskrivning
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.
Datatyp
date
Beskrivning
Was the examination performed by a member of study personnel during the large swelling reaction period?
Datatyp
boolean
Beskrivning
Date when the swelling was first considered to be a large swelling reaction
Datatyp
date
Beskrivning
If occurring within 24 hrs after vaccination, please specify how long after vaccination
Datatyp
integer
Måttenheter
- hrs
Beskrivning
measurement of the greatest diameter
Datatyp
integer
Måttenheter
- mm
Beskrivning
please specify in section "clinical case description"
Datatyp
text
Beskrivning
Circumference of swollen limb (at the site of maximum swelling)
Datatyp
integer
Måttenheter
- mm
Beskrivning
Circumference of the opposite limb (at the same level)
Datatyp
integer
Måttenheter
- mm
Beskrivning
Associated signs
Beskrivning
Please report t°; if the t° has been taken more than once a day, please report the highest value.
Datatyp
integer
Måttenheter
- °C
Beskrivning
Route
Datatyp
text
Beskrivning
Redness
Datatyp
boolean
Beskrivning
Redness - largest diameter
Datatyp
integer
Måttenheter
- mm
Beskrivning
Induration
Datatyp
boolean
Beskrivning
Induration - largest diameter
Datatyp
integer
Måttenheter
- mm
Beskrivning
at administration site
Datatyp
boolean
Beskrivning
Pain intensity
Datatyp
text
Beskrivning
Functional impairment
Datatyp
boolean
Beskrivning
Functional impairment intensity
Datatyp
text
Beskrivning
If hospitalisation is required, please also complete a Serious Adverse Event Form
Beskrivning
Clinical Case Description
Beskrivning
Includes a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
Datatyp
text
Beskrivning
Last date when the swelling was still considered to be a large swelling reaction
Datatyp
date
Beskrivning
Outcome of the large swelling reaction
Datatyp
text
Beskrivning
Follow-up information
Datatyp
text
Beskrivning
e.g., allergy, infection, trauma, underlying conditions
Datatyp
boolean
Beskrivning
If Yes, please specify below
Datatyp
text
Similar models
Large Swelling Reaction
- StudyEvent: ODM