ID

35332

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

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Versionen (2)
  1. 27.02.19 27.02.19 -
  2. 28.02.19 28.02.19 -
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28. Februar 2019

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Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222

Englisch

VISIT 1 (Day 0 Birth)

1 Formulare  
  1. StudyEvent: ODM
    1. VISIT 1 (Day 0 Birth)
ELIMINATION CRITERIA DURING THE STUDY
Beschreibung

ELIMINATION CRITERIA DURING THE STUDY

Subject Number
Beschreibung

Subject Number

Datentyp

text

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).
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

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

Elimination Criteria Unplanned Concomitant Medication

Datentyp

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).
Beschreibung

Elimination Criteria Immunodepressants

Datentyp

boolean

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

Elimination Criteria Prior Hepatitis B Vaccine

Datentyp

boolean

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

Elimination Criteria Prior BCG Vaccine

Datentyp

boolean

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

Elimination Criteria Previous Vaccination

Datentyp

boolean

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

Elimination Criteria History of Diphteria

Datentyp

boolean

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

Elimination Criteria Immunodeficient condition

Datentyp

boolean

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

Elimination Criteria Allergies

Datentyp

boolean

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

Elimination Criteria Immuniglobulins

Datentyp

boolean

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

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).
Beschreibung

Elimination Criteria Immunosuppressants

Datentyp

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.
Beschreibung

Elimination Criteria Planned Concomitant Vaccination

Datentyp

boolean

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

Elimination Criteria Immunoglobulins

Datentyp

boolean

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

Elimination Criteria History of Immunodeficiency

Datentyp

boolean

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beschreibung

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

Anaphylactic reaction following the administration of vaccines.
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

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.
Beschreibung

hypersensitivity to vaccine

Datentyp

boolean

Encephalopathy (not due to another identifiable cause).
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

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.)
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

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

Temperature

Datentyp

boolean

PRECAUTIONS
Beschreibung

PRECAUTIONS

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

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

Collapse or Shock

Datentyp

boolean

Persistent crying lasting >= 3 hours, occurring within 48 hours of vaccination.
Beschreibung

Crying

Datentyp

boolean

Convulsions with or without fever, occurring within 3 days of vaccination. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Beschreibung

A history of febrile convulsions, a family history of convulsions, a family history of Sudden Infant Death Syndrome (SIDS) and a family history of an adverse event following TritanrixTM-HepB vaccination do not constitute contraindications.

Datentyp

boolean

Reminder
Beschreibung

Reminder

Datentyp

text

INFORMED CONSENT
Beschreibung

INFORMED CONSENT

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

Informed Consent

Datentyp

boolean

Informed Consent Date:
Beschreibung

Informed Consent Date

Datentyp

date

DEMOGRAPHICS
Beschreibung

DEMOGRAPHICS

Center number:
Beschreibung

Center number

Datentyp

integer

Date of birth:
Beschreibung

Date of birth

Datentyp

date

Gender:
Beschreibung

Gender

Datentyp

text

Race:
Beschreibung

Race

Datentyp

text

ELIGIBILITY CHECK
Beschreibung

ELIGIBILITY CHECK

Did the subject meet all the entry criteria?
Beschreibung

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria; Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Datentyp

boolean

INCLUSION CRITERIA
Beschreibung

INCLUSION CRITERIA

Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Beschreibung

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

Datentyp

boolean

Born to a mother known to be seronegative for HBsAg (documented laboratory result of HBsAg assay from a maternal blood sample is available).
Beschreibung

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

Datentyp

boolean

Written informed consent obtained from the parent or guardian of the subject.
Beschreibung

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

Datentyp

boolean

Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beschreibung

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

Datentyp

boolean

Born after a normal gestation period (between 36 and 42 weeks).
Beschreibung

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

Datentyp

boolean

A male or female less than or equal to 3 days (72 hours) of age at the time of the birth dose of Hepatitis B vaccination, if indicated for the group.
Beschreibung

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

Datentyp

boolean

EXCLUSION CRITERIA
Beschreibung

EXCLUSION CRITERIA

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.
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

boolean

A family history of congenital or hereditary immunodeficiency.
Beschreibung

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

Datentyp

boolean

Major congenital defects or serious chronic illness.
Beschreibung

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

Datentyp

boolean

History of any neurologic disorders or seizures.
Beschreibung

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

Datentyp

boolean

Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Beschreibung

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

Datentyp

boolean

Acute disease at the time of enrolment. (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).
Beschreibung

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

Datentyp

boolean

Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Beschreibung

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

Datentyp

boolean

Hepatitis B vaccination given at birth outside the study.
Beschreibung

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

Datentyp

boolean

RANDOMISATION / TREATMENT ALLOCATION
Beschreibung

RANDOMISATION / TREATMENT ALLOCATION

Record treatment number
Beschreibung

Treatment number

Datentyp

integer

GROUP HBV AT BIRTH
Beschreibung

GROUP HBV AT BIRTH

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Has the EngerixTM-B vaccine been administered at birth?
Beschreibung

ENGERIXTM-B VACCINE; Only for subjects in the HBV+DTPw-HBV/Hib Kft group.

Datentyp

boolean

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Ähnliche Modelle

VISIT 1 (Day 0 Birth)

1 Formulare
  1. StudyEvent: ODM
    1. VISIT 1 (Day 0 Birth)
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
ELIMINATION CRITERIA DURING THE STUDY
Subject Number
Item
Subject Number
text
Elimination Criteria Planned Concomitant Vaccination
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
Elimination Criteria Unplanned Concomitant Medication
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
Elimination Criteria Immunodepressants
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
Elimination Criteria Prior Hepatitis B Vaccine
Item
Hepatitis B vaccine received after the first 72 hours of life.
boolean
Elimination Criteria Prior BCG Vaccine
Item
Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.
boolean
Elimination Criteria Previous Vaccination
Item
Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae or hepatitis B (except if indicated in the group allocation).
boolean
Elimination Criteria History of Diphteria
Item
History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B or Hib diseases.
boolean
Elimination Criteria Immunodeficient condition
Item
Any confirmed immunodeficient condition, based on medical history and physical examination (no laboratory testing is required at study entry).
boolean
Elimination Criteria Allergies
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
Elimination Criteria Immuniglobulins
Item
Administration of immunoglobulins and/ or any blood products during the study period.
boolean
Elimination Criteria Unplanned Concomitant Vaccination
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
Elimination Criteria Immunosuppressants
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
Elimination Criteria Planned Concomitant Vaccination
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
Elimination Criteria Immunoglobulins
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
Elimination Criteria History of Immunodeficiency
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
Anaphylactic reaction
Item
Anaphylactic reaction following the administration of vaccines.
boolean
hypersensitivity to vaccine
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
Encephalopathy
Item
Encephalopathy (not due to another identifiable cause).
boolean
Disease at vaccination time
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
Temperature
Item
Axillary or oral temperature >= 37.5 °C or Rectal temperature >= 38 °C at the time of vaccination.
boolean
Item Group
PRECAUTIONS
Fever
Item
Fever = 40.0 °C (preferable axillary temperature or oral temperature) within 48 hours of vaccination, not due to another identifiable cause.
boolean
Collapse or Shock
Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
boolean
Crying
Item
Persistent crying lasting >= 3 hours, occurring within 48 hours of vaccination.
boolean
Febrile Convulsions
Item
Convulsions with or without fever, occurring within 3 days of vaccination. There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
boolean
Item
Reminder
text
Reminder
Code List
Reminder
CL Item
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of (1)
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 (2)
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. (3)
Item Group
INFORMED CONSENT
Informed Consent
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
Center number
Item
Center number:
integer
Date of birth
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)
Item Group
ELIGIBILITY CHECK
Eligibility Check
Item
Did the subject meet all the entry criteria?
boolean
Item Group
INCLUSION CRITERIA
Reliability of Subjects
Item
Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
Subject's Mother seronegative for HBsAg
Item
Born to a mother known to be seronegative for HBsAg (documented laboratory result of HBsAg assay from a maternal blood sample is available).
boolean
Written Consent Obtained
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
Free of obvious health problems
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
Born after a normal gestation period
Item
Born after a normal gestation period (between 36 and 42 weeks).
boolean
A male or female less than or equal to 3 days (72 hours) of age at the time of the birth dose of Hepatitis B vaccination, if indicated for the group.
Item
A male or female less than or equal to 3 days (72 hours) of age at the time of the birth dose of Hepatitis B vaccination, if indicated for the group.
boolean
Item Group
EXCLUSION CRITERIA
Concomitant Medication
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.
boolean
Immunodificient Condition
Item
Any confirmed immunodeficient condition, based on medical history and physical examination (no laboratory testing is required at study entry).
boolean
Family History of Hereditary Immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
Major congenital defects
Item
Major congenital defects or serious chronic illness.
boolean
History of neurologic disorders/seizures
Item
History of any neurologic disorders or seizures.
boolean
Administration of immunoglobulins
Item
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
Acute disease at the time of enrolment
Item
Acute disease at the time of enrolment. (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
Other conditions
Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
Hepatitis B vaccination given at birth outside the study.
Item
Hepatitis B vaccination given at birth outside the study.
boolean
Item Group
RANDOMISATION / TREATMENT ALLOCATION
Treatment number
Item
Record treatment number
integer
Item Group
GROUP HBV AT BIRTH
Subject Number
Item
Subject Number
integer
Vaccine Administration
Item
Has the EngerixTM-B vaccine been administered at birth?
boolean
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