ID
35327
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)
- 25-02-19 25-02-19 -
- 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
- StudyEvent: ODM
Beschrijving
ELIMINATION CRITERIA
Beschrijving
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
Datatype
boolean
Beschrijving
EliminationCriteriaConcomitantMedication
Datatype
boolean
Beschrijving
EliminationCriteriaImmunosuppressants
Datatype
boolean
Beschrijving
EliminationCriteriaPriorVaccination
Datatype
boolean
Beschrijving
EliminationCriteriaBacilleCalmette-Guérin
Datatype
boolean
Beschrijving
EliminationCriteriaPreviousVaccination
Datatype
boolean
Beschrijving
EliminationCriteriaHistoryDiphteria
Datatype
boolean
Beschrijving
EliminationCriteriaImmunodeficientCondition
Datatype
boolean
Beschrijving
EliminationCriteriaAllergies
Datatype
boolean
Beschrijving
EliminationCriteriaImmunoglobulinsAdministration
Datatype
boolean
Beschrijving
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.
Datatype
boolean
Beschrijving
EliminationCriteriaChronicImmunosuppressantsAdministration
Datatype
boolean
Beschrijving
EliminationCriteriaPlannedConcomitantVaccineAdministration
Datatype
boolean
Beschrijving
EliminationCriteriaImmunoglobulinsAdministration
Datatype
boolean
Beschrijving
EliminationCriteriaImmunodeficientCondition
Datatype
boolean
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
ContraindicationsHypersensitivity
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
ContraindicationsTemperature
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
PrecautionsShock
Datatype
boolean
Beschrijving
PrecautionsCrying
Datatype
boolean
Beschrijving
PrecautionsConvulsions
Datatype
boolean
Beschrijving
AdditionalPrecautions
Datatype
text
Beschrijving
INFORMED CONSENT
Beschrijving
DEMOGRAPHICS
Beschrijving
CenterNumber
Datatype
integer
Beschrijving
BirthDate
Datatype
date
Beschrijving
Gender :
Datatype
text
Beschrijving
Race
Datatype
text
Beschrijving
OtherRace
Datatype
text
Beschrijving
ELIGIBILITY CHECK
Beschrijving
INCLUSION CRITERIA
Beschrijving
InclusionCriteriaFailed
Datatype
text
Beschrijving
EXCLUSION CRITERIA
Beschrijving
RANDOMISATION / TREATMENT ALLOCATION
Beschrijving
GROUP HBV AT BIRTH
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Visit 1
- StudyEvent: ODM