ID
35332
Descripción
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
Palabras clave
Versiones (2)
- 27/2/19 27/2/19 -
- 28/2/19 28/2/19 -
Titular de derechos de autor
GSK group of companies
Subido en
28 de febrero de 2019
DOI
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Licencia
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
Descripción
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Descripción
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 :
Tipo de datos
boolean
Descripción
hypersensitivity to vaccine
Tipo de datos
boolean
Descripción
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.
Tipo de datos
boolean
Descripción
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.
Tipo de datos
boolean
Descripción
Temperature
Tipo de datos
boolean
Descripción
PRECAUTIONS
Descripción
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.
Tipo de datos
boolean
Descripción
Collapse or Shock
Tipo de datos
boolean
Descripción
Crying
Tipo de datos
boolean
Descripción
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.
Tipo de datos
boolean
Descripción
Reminder
Tipo de datos
text
Descripción
INFORMED CONSENT
Descripción
DEMOGRAPHICS
Descripción
Center number
Tipo de datos
integer
Descripción
Date of birth
Tipo de datos
date
Descripción
Gender
Tipo de datos
text
Descripción
Race
Tipo de datos
text
Descripción
ELIGIBILITY CHECK
Descripción
INCLUSION CRITERIA
Descripción
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Tipo de datos
boolean
Descripción
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Tipo de datos
boolean
Descripción
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Tipo de datos
boolean
Descripción
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Tipo de datos
boolean
Descripción
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Tipo de datos
boolean
Descripción
Tick the boxes corresponding to any of the inclusion criteria the subject failed
Tipo de datos
boolean
Descripción
EXCLUSION CRITERIA
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Tipo de datos
boolean
Descripción
RANDOMISATION / TREATMENT ALLOCATION
Descripción
GROUP HBV AT BIRTH
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VISIT 1 (Day 0 Birth)
- StudyEvent: ODM