ID
35332
Beschreibung
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
Stichworte
Versionen (2)
- 27.02.19 27.02.19 -
- 28.02.19 28.02.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
28. Februar 2019
DOI
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Lizenz
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
Beschreibung
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beschreibung
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 :
Datentyp
boolean
Beschreibung
hypersensitivity to vaccine
Datentyp
boolean
Beschreibung
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.
Datentyp
boolean
Beschreibung
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.
Datentyp
boolean
Beschreibung
Temperature
Datentyp
boolean
Beschreibung
PRECAUTIONS
Beschreibung
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.
Datentyp
boolean
Beschreibung
Collapse or Shock
Datentyp
boolean
Beschreibung
Crying
Datentyp
boolean
Beschreibung
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.
Datentyp
boolean
Beschreibung
Reminder
Datentyp
text
Beschreibung
INFORMED CONSENT
Beschreibung
DEMOGRAPHICS
Beschreibung
Center number
Datentyp
integer
Beschreibung
Date of birth
Datentyp
date
Beschreibung
Gender
Datentyp
text
Beschreibung
Race
Datentyp
text
Beschreibung
ELIGIBILITY CHECK
Beschreibung
INCLUSION CRITERIA
Beschreibung
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datentyp
boolean
Beschreibung
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datentyp
boolean
Beschreibung
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datentyp
boolean
Beschreibung
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datentyp
boolean
Beschreibung
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datentyp
boolean
Beschreibung
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Datentyp
boolean
Beschreibung
EXCLUSION CRITERIA
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Datentyp
boolean
Beschreibung
RANDOMISATION / TREATMENT ALLOCATION
Beschreibung
GROUP HBV AT BIRTH
Ähnliche Modelle
VISIT 1 (Day 0 Birth)
- StudyEvent: ODM