ID
33348
Beschrijving
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
Trefwoorden
Versies (1)
- 06-12-18 06-12-18 -
Houder van rechten
GSK group of companies
Geüploaded op
6 december 2018
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Report of Physical Examination
Beschrijving
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.
Datatype
date
Beschrijving
Was the examination performed by a member of study personnel during the large swelling reaction period?
Datatype
boolean
Beschrijving
Date when the swelling was first considered to be a large swelling reaction
Datatype
date
Beschrijving
If occurring within 24 hrs after vaccination, please specify how long after vaccination
Datatype
integer
Maateenheden
- hrs
Beschrijving
measurement of the greatest diameter
Datatype
integer
Maateenheden
- mm
Beschrijving
please specify in section "clinical case description"
Datatype
text
Beschrijving
Circumference of swollen limb (at the site of maximum swelling)
Datatype
integer
Maateenheden
- mm
Beschrijving
Circumference of the opposite limb (at the same level)
Datatype
integer
Maateenheden
- mm
Beschrijving
Associated signs
Beschrijving
Please report t°; if the t° has been taken more than once a day, please report the highest value.
Datatype
integer
Maateenheden
- °C
Beschrijving
Route
Datatype
text
Beschrijving
Redness
Datatype
boolean
Beschrijving
Redness - largest diameter
Datatype
integer
Maateenheden
- mm
Beschrijving
Induration
Datatype
boolean
Beschrijving
Induration - largest diameter
Datatype
integer
Maateenheden
- mm
Beschrijving
at administration site
Datatype
boolean
Beschrijving
Pain intensity
Datatype
text
Beschrijving
Functional impairment
Datatype
boolean
Beschrijving
Functional impairment intensity
Datatype
text
Beschrijving
If hospitalisation is required, please also complete a Serious Adverse Event Form
Beschrijving
Clinical Case Description
Beschrijving
Includes a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
Datatype
text
Beschrijving
Last date when the swelling was still considered to be a large swelling reaction
Datatype
date
Beschrijving
Outcome of the large swelling reaction
Datatype
text
Beschrijving
Follow-up information
Datatype
text
Beschrijving
e.g., allergy, infection, trauma, underlying conditions
Datatype
boolean
Beschrijving
If Yes, please specify below
Datatype
text
Similar models
Large Swelling Reaction
- StudyEvent: ODM