ID
35265
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)
- 25.02.19 25.02.19 -
- 28.02.19 28.02.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
25. 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
Visit 1
- StudyEvent: ODM
Beschreibung
ELIMINATION CRITERIA
Beschreibung
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
Datentyp
boolean
Beschreibung
EliminationCriteriaConcomitantMedication
Datentyp
boolean
Beschreibung
EliminationCriteriaImmunosuppressants
Datentyp
boolean
Beschreibung
EliminationCriteriaPriorVaccination
Datentyp
boolean
Beschreibung
EliminationCriteriaBacilleCalmette-Guérin
Datentyp
boolean
Beschreibung
EliminationCriteriaPreviousVaccination
Datentyp
boolean
Beschreibung
EliminationCriteriaHistoryDiphteria
Datentyp
boolean
Beschreibung
EliminationCriteriaImmunodeficientCondition
Datentyp
boolean
Beschreibung
EliminationCriteriaAllergies
Datentyp
boolean
Beschreibung
EliminationCriteriaImmunoglobulinsAdministration
Datentyp
boolean
Beschreibung
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.
Datentyp
boolean
Beschreibung
EliminationCriteriaChronicImmunosuppressantsAdministration
Datentyp
boolean
Beschreibung
EliminationCriteriaPlannedConcomitantVaccineAdministration
Datentyp
boolean
Beschreibung
EliminationCriteriaImmunoglobulinsAdministration
Datentyp
boolean
Beschreibung
EliminationCriteriaImmunodeficientCondition
Datentyp
boolean
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
ContraindicationsHypersensitivity
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
ContraindicationsTemperature
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
PrecautionsShock
Datentyp
boolean
Beschreibung
PrecautionsCrying
Datentyp
boolean
Beschreibung
PrecautionsConvulsions
Datentyp
boolean
Beschreibung
AdditionalPrecautions
Datentyp
text
Beschreibung
INFORMED CONSENT
Beschreibung
DEMOGRAPHICS
Beschreibung
CenterNumber
Datentyp
integer
Beschreibung
BirthDate
Datentyp
date
Beschreibung
Gender :
Datentyp
text
Beschreibung
Race
Datentyp
text
Beschreibung
OtherRace
Datentyp
text
Beschreibung
ELIGIBILITY CHECK
Beschreibung
INCLUSION CRITERIA
Beschreibung
InclusionCriteriaFailed
Datentyp
text
Beschreibung
EXCLUSION CRITERIA
Beschreibung
RANDOMISATION / TREATMENT ALLOCATION
Beschreibung
GROUP HBV AT BIRTH
Ähnliche Modelle
Visit 1
- StudyEvent: ODM