ID
35332
Beskrivning
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed 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 (2)
- 2019-02-27 2019-02-27 -
- 2019-02-28 2019-02-28 -
Rättsinnehavare
GSK group of companies
Uppladdad den
28 februari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222
VISIT 1 (Day 0 Birth)
- StudyEvent: ODM
Beskrivning
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beskrivning
The following adverse events (AEs) constitute absolute contraindications to further administration of the study vaccines; if any of these AEs occur during the study, the subject must not receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE :
Datatyp
boolean
Beskrivning
hypersensitivity to vaccine
Datatyp
boolean
Beskrivning
This is defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination, and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Even though causation by DTP vaccine cannot be established, no subsequent doses of pertussis vaccine should be given. In these circumstances the vaccination course should be continued with DT and HB vaccines.
Datatyp
boolean
Beskrivning
The following AEs constitute contraindications to administration of the study vaccines at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.
Datatyp
boolean
Beskrivning
Temperature
Datatyp
boolean
Beskrivning
PRECAUTIONS
Beskrivning
If any of the following events occur in temporal relation to receipt of study vaccines, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered.
Datatyp
boolean
Beskrivning
Collapse or Shock
Datatyp
boolean
Beskrivning
Crying
Datatyp
boolean
Beskrivning
A history of febrile convulsions, a family history of convulsions, a family history of Sudden Infant Death Syndrome (SIDS) and a family history of an adverse event following TritanrixTM-HepB vaccination do not constitute contraindications.
Datatyp
boolean
Beskrivning
Reminder
Datatyp
text
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INFORMED CONSENT
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DEMOGRAPHICS
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Center number
Datatyp
integer
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Date of birth
Datatyp
date
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Gender
Datatyp
text
Beskrivning
Race
Datatyp
text
Beskrivning
ELIGIBILITY CHECK
Beskrivning
INCLUSION CRITERIA
Beskrivning
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatyp
boolean
Beskrivning
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatyp
boolean
Beskrivning
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatyp
boolean
Beskrivning
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatyp
boolean
Beskrivning
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatyp
boolean
Beskrivning
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatyp
boolean
Beskrivning
EXCLUSION CRITERIA
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatyp
boolean
Beskrivning
RANDOMISATION / TREATMENT ALLOCATION
Beskrivning
GROUP HBV AT BIRTH
Similar models
VISIT 1 (Day 0 Birth)
- StudyEvent: ODM