ID
33348
Beschreibung
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
Stichworte
Versionen (1)
- 06.12.18 06.12.18 -
Rechteinhaber
GSK group of companies
Hochgeladen am
6. Dezember 2018
DOI
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Lizenz
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
Beschreibung
Report of Physical Examination
Beschreibung
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.
Datentyp
date
Beschreibung
Was the examination performed by a member of study personnel during the large swelling reaction period?
Datentyp
boolean
Beschreibung
Date when the swelling was first considered to be a large swelling reaction
Datentyp
date
Beschreibung
If occurring within 24 hrs after vaccination, please specify how long after vaccination
Datentyp
integer
Maßeinheiten
- hrs
Beschreibung
measurement of the greatest diameter
Datentyp
integer
Maßeinheiten
- mm
Beschreibung
please specify in section "clinical case description"
Datentyp
text
Beschreibung
Circumference of swollen limb (at the site of maximum swelling)
Datentyp
integer
Maßeinheiten
- mm
Beschreibung
Circumference of the opposite limb (at the same level)
Datentyp
integer
Maßeinheiten
- mm
Beschreibung
Associated signs
Beschreibung
Please report t°; if the t° has been taken more than once a day, please report the highest value.
Datentyp
integer
Maßeinheiten
- °C
Beschreibung
Route
Datentyp
text
Beschreibung
Redness
Datentyp
boolean
Beschreibung
Redness - largest diameter
Datentyp
integer
Maßeinheiten
- mm
Beschreibung
Induration
Datentyp
boolean
Beschreibung
Induration - largest diameter
Datentyp
integer
Maßeinheiten
- mm
Beschreibung
at administration site
Datentyp
boolean
Beschreibung
Pain intensity
Datentyp
text
Beschreibung
Functional impairment
Datentyp
boolean
Beschreibung
Functional impairment intensity
Datentyp
text
Beschreibung
If hospitalisation is required, please also complete a Serious Adverse Event Form
Beschreibung
Clinical Case Description
Beschreibung
Includes a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.
Datentyp
text
Beschreibung
Last date when the swelling was still considered to be a large swelling reaction
Datentyp
date
Beschreibung
Outcome of the large swelling reaction
Datentyp
text
Beschreibung
Follow-up information
Datentyp
text
Beschreibung
e.g., allergy, infection, trauma, underlying conditions
Datentyp
boolean
Beschreibung
If Yes, please specify below
Datentyp
text
Ähnliche Modelle
Large Swelling Reaction
- StudyEvent: ODM