ID

35265

Descrizione

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

Keywords

versioni (2)
  1. 25/02/19 25/02/19 -
  2. 28/02/19 28/02/19 -
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GSK group of companies

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25 febbraio 2019

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Creative Commons BY-NC 3.0
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Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants

Inglese

Visit 1

1 moduli  
  1. StudyEvent: ODM
    1. Visit 1
Administrative data
Descrizione

Administrative data

Visit Number
Descrizione

Visit Number

Tipo di dati

integer

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

ELIMINATION CRITERIA
Descrizione

ELIMINATION CRITERIA

Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the combined DTPw-HepB vaccine or DTPw-HepB/Hib vaccine, with the exception of oral poliovirus vaccine (OPV).
Descrizione

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

Tipo di dati

boolean

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Descrizione

EliminationCriteriaConcomitantMedication

Tipo di dati

boolean

Chronic administration (defined as more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period. (For corticostreoids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Descrizione

EliminationCriteriaImmunosuppressants

Tipo di dati

boolean

Hepatitis B vaccine received after the first 72 hours of life.
Descrizione

EliminationCriteriaPriorVaccination

Tipo di dati

boolean

Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.
Descrizione

EliminationCriteriaBacilleCalmette-Guérin

Tipo di dati

boolean

Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae or hepatitis B (except if indicated in the group allocation).
Descrizione

EliminationCriteriaPreviousVaccination

Tipo di dati

boolean

History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B or Hib diseases.
Descrizione

EliminationCriteriaHistoryDiphteria

Tipo di dati

boolean

Any confirmed immunodeficient condition, based on medical history and physical examination (no laboratory testing is required at study entry).
Descrizione

EliminationCriteriaImmunodeficientCondition

Tipo di dati

boolean

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Descrizione

EliminationCriteriaAllergies

Tipo di dati

boolean

Administration of immunoglobulins and/ or any blood products during the study period.
Descrizione

EliminationCriteriaImmunoglobulinsAdministration

Tipo di dati

boolean

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Descrizione

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.

Tipo di dati

boolean

Chronic administration (defined as more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period. (For corticostreoids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Descrizione

EliminationCriteriaChronicImmunosuppressantsAdministration

Tipo di dati

boolean

Planned administration/ administration of a vaccine not foreseen by the study protocol during the period from 30 days before each dose of vaccine and ending 30 after the last dose of vaccine, with the exception of OPV.
Descrizione

EliminationCriteriaPlannedConcomitantVaccineAdministration

Tipo di dati

boolean

Administration of immunoglobulins and/or any blood products during the study period.
Descrizione

EliminationCriteriaImmunoglobulinsAdministration

Tipo di dati

boolean

Any confirmed immunodeficient condition, based on medical history and physical examination (no laboratory testing required at study entry).
Descrizione

EliminationCriteriaImmunodeficientCondition

Tipo di dati

boolean

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Descrizione

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

Anaphylactic reaction following the administration of vaccines.
Descrizione

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 di dati

boolean

Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B or Hib vaccines
Descrizione

ContraindicationsHypersensitivity

Tipo di dati

boolean

Encephalopathy (not due to another identifiable cause).
Descrizione

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 di dati

boolean

Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5 °C or rectal temperature < 38 °C.
Descrizione

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 di dati

boolean

Axillary or oral temperature = 37.5 °C or Rectal temperature = 38 °C at the time of vaccination.
Descrizione

ContraindicationsTemperature

Tipo di dati

boolean

Precautions:
Descrizione

Precautions:

Fever = 40.0 °C (preferable axillary temperature or oral temperature) within 48 hours of vaccination, not due to another identifiable cause.
Descrizione

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 di dati

boolean

Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
Descrizione

PrecautionsShock

Tipo di dati

boolean

Persistent crying lasting = 3 hours, occurring within 48 hours of vaccination
Descrizione

PrecautionsCrying

Tipo di dati

boolean

Convulsions with or without fever, occurring within 3 days of vaccination.
Descrizione

PrecautionsConvulsions

Tipo di dati

boolean

Additional Precautions:
Descrizione

AdditionalPrecautions

Tipo di dati

text

INFORMED CONSENT
Descrizione

INFORMED CONSENT

I certify that Informed Consent has been obtained prior to any study procedure.
Descrizione

I certify that Informed Consent has been obtained prior to any study procedure.

Tipo di dati

boolean

Informed Consent Date :
Descrizione

Informed Consent Date :

Tipo di dati

date

DEMOGRAPHICS
Descrizione

DEMOGRAPHICS

Center number :
Descrizione

CenterNumber

Tipo di dati

integer

Date of birth :
Descrizione

BirthDate

Tipo di dati

date

Gender :
Descrizione

Gender :

Tipo di dati

text

Race :
Descrizione

Race

Tipo di dati

text

If Other, please specify
Descrizione

OtherRace

Tipo di dati

text

ELIGIBILITY CHECK
Descrizione

ELIGIBILITY CHECK

Did the subject meet all the entry criteria?
Descrizione

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Tipo di dati

boolean

INCLUSION CRITERIA
Descrizione

INCLUSION CRITERIA

Tick the boxes corresponding to any of the inclusion criteria the subject failed
Descrizione

InclusionCriteriaFailed

Tipo di dati

text

EXCLUSION CRITERIA
Descrizione

EXCLUSION CRITERIA

Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
Descrizione

ExclusionCriteria

Tipo di dati

text

RANDOMISATION / TREATMENT ALLOCATION
Descrizione

RANDOMISATION / TREATMENT ALLOCATION

Record treatment number
Descrizione

TreatmentNumber

Tipo di dati

integer

GROUP HBV AT BIRTH
Descrizione

GROUP HBV AT BIRTH

Has the Engerix™-B vaccine been administered at birth ?
Descrizione

ENGERIX™-B VACCINE Only for subjects in the HBV+DTPw-HBV/Hib Kft group

Tipo di dati

boolean

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Similar models

Visit 1

1 moduli
  1. StudyEvent: ODM
    1. Visit 1
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
Visit Number
Item
Visit Number
integer
Subject Number
Item
Subject Number
integer
Item Group
ELIMINATION CRITERIA
Planned administration/administration of a vaccine not foreseen by the study protocol
Item
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the combined DTPw-HepB vaccine or DTPw-HepB/Hib vaccine, with the exception of oral poliovirus vaccine (OPV).
boolean
EliminationCriteriaConcomitantMedication
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
EliminationCriteriaImmunosuppressants
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period. (For corticostreoids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
EliminationCriteriaPriorVaccination
Item
Hepatitis B vaccine received after the first 72 hours of life.
boolean
EliminationCriteriaBacilleCalmette-Guérin
Item
Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.
boolean
EliminationCriteriaPreviousVaccination
Item
Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae or hepatitis B (except if indicated in the group allocation).
boolean
EliminationCriteriaHistoryDiphteria
Item
History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B or Hib diseases.
boolean
EliminationCriteriaImmunodeficientCondition
Item
Any confirmed immunodeficient condition, based on medical history and physical examination (no laboratory testing is required at study entry).
boolean
EliminationCriteriaAllergies
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
EliminationCriteriaImmunoglobulinsAdministration
Item
Administration of immunoglobulins and/ or any blood products during the study period.
boolean
EliminationCriteriaConcomitantVaccines
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
EliminationCriteriaChronicImmunosuppressantsAdministration
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immunomodifying drugs during the study period. (For corticostreoids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
EliminationCriteriaPlannedConcomitantVaccineAdministration
Item
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period from 30 days before each dose of vaccine and ending 30 after the last dose of vaccine, with the exception of OPV.
boolean
EliminationCriteriaImmunoglobulinsAdministration
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
EliminationCriteriaImmunodeficientCondition
Item
Any confirmed immunodeficient condition, based on medical history and physical examination (no laboratory testing required at study entry).
boolean
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
ContraindicationsAnaphylacticReaction
Item
Anaphylactic reaction following the administration of vaccines.
boolean
ContraindicationsHypersensitivity
Item
Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B or Hib vaccines
boolean
ContraindicationsEncephalopathy
Item
Encephalopathy (not due to another identifiable cause).
boolean
ContraindicationsDisease
Item
Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature < 37.5 °C or rectal temperature < 38 °C.
boolean
ContraindicationsTemperature
Item
Axillary or oral temperature = 37.5 °C or Rectal temperature = 38 °C at the time of vaccination.
boolean
Item Group
Precautions:
PrecautionsFever
Item
Fever = 40.0 °C (preferable axillary temperature or oral temperature) within 48 hours of vaccination, not due to another identifiable cause.
boolean
PrecautionsShock
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
boolean
PrecautionsCrying
Item
Persistent crying lasting = 3 hours, occurring within 48 hours of vaccination
boolean
PrecautionsConvulsions
Item
Convulsions with or without fever, occurring within 3 days of vaccination.
boolean
Item
Additional Precautions:
text
AdditionalPrecautions
Code List
Additional Precautions:
CL Item
A history of febrile convulsions, a family history of convulsions, a family history of Sudden Infant Death (1)
CL Item
Syndrome (SIDS) and a family history of an adverse event following Tritanrix™-HepB vaccination do not (Syndrome (SIDS) and a family history of an adverse event following Tritanrix™-HepB vaccination do not)
CL Item
constitute contraindications. (constitute contraindications.)
CL Item
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of (2)
CL Item
anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should (anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee should)
CL Item
remain under medical supervision for 30 minutes after vaccination. (remain under medical supervision for 30 minutes after vaccination.)
CL Item
DTPw-HBV should be administered with caution to subjects with thrombocytopenia or a bleeding disorder (3)
CL Item
since bleeding may occur following an intramuscular administration to these subjects. (since bleeding may occur following an intramuscular administration to these subjects.)
CL Item
DTPw-HBV should under no circumstances be administered intravenously. (DTPw-HBV should under no circumstances be administered intravenously.)
Item Group
INFORMED CONSENT
I certify that Informed Consent has been obtained prior to any study procedure.
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
Informed Consent Date :
Item
Informed Consent Date :
date
Item Group
DEMOGRAPHICS
CenterNumber
Item
Center number :
integer
BirthDate
Item
Date of birth :
date
Item
Gender :
text
Gender :
Code List
Gender :
CL Item
Male (1)
CL Item
Female (2)
Item
Race :
text
Race
Code List
Race :
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
American Hispanic (6)
CL Item
Japanese (7)
CL Item
Other (8)
OtherRace
Item
If Other, please specify
text
Item Group
ELIGIBILITY CHECK
EligibilityCheckQuestion
Item
Did the subject meet all the entry criteria?
boolean
Item Group
INCLUSION CRITERIA
Item
Tick the boxes corresponding to any of the inclusion criteria the subject failed
text
InclusionCriteriaFailed
Code List
Tick the boxes corresponding to any of the inclusion criteria the subject failed
CL Item
Born to a mother known to be seronegative for HBsAg (documented laboratory result of HBsAgassay from a maternal blood sample is available). (1)
CL Item
Written informed consent obtained from the parent or guardian of the subject. (2)
CL Item
Free of obvious health problems as established by medical history and clinical examination (3)
CL Item
before entering into the study. (before entering into the study.)
CL Item
Born after a normal gestation period (between 36 and 42 weeks). (4)
CL Item
A male or female less than or equal to 3 days (72 hours) of age at the time of the birth dose of (5)
CL Item
Hepatitis B vaccination, if indicated for the group. (Hepatitis B vaccination, if indicated for the group.)
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) since birth, or planned use during the study period. (6)
Item Group
EXCLUSION CRITERIA
Item
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
text
ExclusionCriteria
Code List
Tick the box corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study (1)
CL Item
vaccine(s) since birth, or planned use during the study period. (vaccine(s) since birth, or planned use during the study period.)
CL Item
Any confirmed immunodeficient condition, based on medical history and physical (2)
CL Item
examination (no laboratory testing is required at study entry). (examination (no laboratory testing is required at study entry).)
CL Item
A family history of congenital or hereditary immunodeficiency. (3)
CL Item
Major congenital defects or serious chronic illness. (4)
CL Item
History of any neurologic disorders or seizures. (5)
CL Item
Administration of immunoglobulins and/or any blood products since birth or planned (6)
CL Item
administration during the study period. (administration during the study period.)
CL Item
Acute disease at the time of enrolment. (Acute disease is defined as the presence of a (7)
CL Item
moderate or severe illness with or without fever. All vaccines can be administered to (moderate or severe illness with or without fever. All vaccines can be administered to)
CL Item
persons with a minor illness such as diarrhea, mild upper respiratory infection with or without (persons with a minor illness such as diarrhea, mild upper respiratory infection with or without)
CL Item
low-grade febrile illness, i.e., axillary temperature < 37.5 °C or rectal temperature < 38 °C). (low-grade febrile illness, i.e., axillary temperature < 37.5 °C or rectal temperature < 38 °C).)
CL Item
Other conditions which in the opinion of the investigator may potentially interfere with (8)
CL Item
interpretation of study outcomes. (interpretation of study outcomes.)
CL Item
Hepatitis B vaccination given at birth outside the study. (9)
Item Group
RANDOMISATION / TREATMENT ALLOCATION
TreatmentNumber
Item
Record treatment number
integer
Item Group
GROUP HBV AT BIRTH
VaccinationAtBirth
Item
Has the Engerix™-B vaccine been administered at birth ?
boolean
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