ID
35332
Beschrijving
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
Trefwoorden
Versies (2)
- 27-02-19 27-02-19 -
- 28-02-19 28-02-19 -
Houder van rechten
GSK group of companies
Geüploaded op
28 februari 2019
DOI
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Licentie
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
Beschrijving
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beschrijving
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 :
Datatype
boolean
Beschrijving
hypersensitivity to vaccine
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
Temperature
Datatype
boolean
Beschrijving
PRECAUTIONS
Beschrijving
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.
Datatype
boolean
Beschrijving
Collapse or Shock
Datatype
boolean
Beschrijving
Crying
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
Reminder
Datatype
text
Beschrijving
INFORMED CONSENT
Beschrijving
DEMOGRAPHICS
Beschrijving
Center number
Datatype
integer
Beschrijving
Date of birth
Datatype
date
Beschrijving
Gender
Datatype
text
Beschrijving
Race
Datatype
text
Beschrijving
ELIGIBILITY CHECK
Beschrijving
INCLUSION CRITERIA
Beschrijving
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatype
boolean
Beschrijving
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatype
boolean
Beschrijving
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatype
boolean
Beschrijving
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatype
boolean
Beschrijving
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatype
boolean
Beschrijving
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datatype
boolean
Beschrijving
EXCLUSION CRITERIA
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datatype
boolean
Beschrijving
RANDOMISATION / TREATMENT ALLOCATION
Beschrijving
GROUP HBV AT BIRTH
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VISIT 1 (Day 0 Birth)
- StudyEvent: ODM