ID
35265
Description
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
Mots-clés
Versions (2)
- 25/02/2019 25/02/2019 -
- 28/02/2019 28/02/2019 -
Détendeur de droits
GSK group of companies
Téléchargé le
25 février 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants
Visit 1
- StudyEvent: ODM
Description
ELIMINATION CRITERIA
Description
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
Type de données
boolean
Description
EliminationCriteriaConcomitantMedication
Type de données
boolean
Description
EliminationCriteriaImmunosuppressants
Type de données
boolean
Description
EliminationCriteriaPriorVaccination
Type de données
boolean
Description
EliminationCriteriaBacilleCalmette-Guérin
Type de données
boolean
Description
EliminationCriteriaPreviousVaccination
Type de données
boolean
Description
EliminationCriteriaHistoryDiphteria
Type de données
boolean
Description
EliminationCriteriaImmunodeficientCondition
Type de données
boolean
Description
EliminationCriteriaAllergies
Type de données
boolean
Description
EliminationCriteriaImmunoglobulinsAdministration
Type de données
boolean
Description
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.
Type de données
boolean
Description
EliminationCriteriaChronicImmunosuppressantsAdministration
Type de données
boolean
Description
EliminationCriteriaPlannedConcomitantVaccineAdministration
Type de données
boolean
Description
EliminationCriteriaImmunoglobulinsAdministration
Type de données
boolean
Description
EliminationCriteriaImmunodeficientCondition
Type de données
boolean
Description
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Description
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
Type de données
boolean
Description
ContraindicationsHypersensitivity
Type de données
boolean
Description
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.
Type de données
boolean
Description
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.
Type de données
boolean
Description
ContraindicationsTemperature
Type de données
boolean
Description
Precautions:
Description
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.
Type de données
boolean
Description
PrecautionsShock
Type de données
boolean
Description
PrecautionsCrying
Type de données
boolean
Description
PrecautionsConvulsions
Type de données
boolean
Description
AdditionalPrecautions
Type de données
text
Description
INFORMED CONSENT
Description
DEMOGRAPHICS
Description
CenterNumber
Type de données
integer
Description
BirthDate
Type de données
date
Description
Gender :
Type de données
text
Description
Race
Type de données
text
Description
OtherRace
Type de données
text
Description
ELIGIBILITY CHECK
Description
INCLUSION CRITERIA
Description
InclusionCriteriaFailed
Type de données
text
Description
EXCLUSION CRITERIA
Description
RANDOMISATION / TREATMENT ALLOCATION
Description
GROUP HBV AT BIRTH
Similar models
Visit 1
- StudyEvent: ODM