ID
35265
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)
- 2019-02-25 2019-02-25 -
- 2019-02-28 2019-02-28 -
Rättsinnehavare
GSK group of companies
Uppladdad den
25 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
Visit 1
- StudyEvent: ODM
Beskrivning
ELIMINATION CRITERIA
Beskrivning
The following criteria should be checked at Visit 2. If any become applicable during the study, it will not require withdrawal of the subject from the study but does determine a subject’s evaluability in the according-to-protocol analysis (ATP) analysis
Datatyp
boolean
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EliminationCriteriaConcomitantMedication
Datatyp
boolean
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EliminationCriteriaImmunosuppressants
Datatyp
boolean
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EliminationCriteriaPriorVaccination
Datatyp
boolean
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EliminationCriteriaBacilleCalmette-Guérin
Datatyp
boolean
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EliminationCriteriaPreviousVaccination
Datatyp
boolean
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EliminationCriteriaHistoryDiphteria
Datatyp
boolean
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EliminationCriteriaImmunodeficientCondition
Datatyp
boolean
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EliminationCriteriaAllergies
Datatyp
boolean
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EliminationCriteriaImmunoglobulinsAdministration
Datatyp
boolean
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The following criteria should be checked at Visits 3, 4 and 5. If any become applicable during the study, it will not require withdrawal of the subject from the study but does determine a subject’s evaluability in ATP analysis.
Datatyp
boolean
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EliminationCriteriaChronicImmunosuppressantsAdministration
Datatyp
boolean
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EliminationCriteriaPlannedConcomitantVaccineAdministration
Datatyp
boolean
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EliminationCriteriaImmunoglobulinsAdministration
Datatyp
boolean
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EliminationCriteriaImmunodeficientCondition
Datatyp
boolean
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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
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ContraindicationsHypersensitivity
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
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ContraindicationsTemperature
Datatyp
boolean
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Precautions:
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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
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PrecautionsShock
Datatyp
boolean
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PrecautionsCrying
Datatyp
boolean
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PrecautionsConvulsions
Datatyp
boolean
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AdditionalPrecautions
Datatyp
text
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INFORMED CONSENT
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DEMOGRAPHICS
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CenterNumber
Datatyp
integer
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BirthDate
Datatyp
date
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Gender :
Datatyp
text
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Race
Datatyp
text
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OtherRace
Datatyp
text
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ELIGIBILITY CHECK
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INCLUSION CRITERIA
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InclusionCriteriaFailed
Datatyp
text
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EXCLUSION CRITERIA
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RANDOMISATION / TREATMENT ALLOCATION
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GROUP HBV AT BIRTH
Similar models
Visit 1
- StudyEvent: ODM