ID

35332

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

Keywords

Versions (2)
  1. 2/27/19 2/27/19 -
  2. 2/28/19 2/28/19 -
Copyright Holder

GSK group of companies

Uploaded on

February 28, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

VISIT 1 (Day 0 Birth)

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

ELIMINATION CRITERIA DURING THE STUDY

Subject Number
Description

Subject Number

Data type

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).
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.

Data type

boolean

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

Elimination Criteria Unplanned Concomitant Medication

Data type

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).
Description

Elimination Criteria Immunodepressants

Data type

boolean

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

Elimination Criteria Prior Hepatitis B Vaccine

Data type

boolean

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

Elimination Criteria Prior BCG Vaccine

Data type

boolean

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

Elimination Criteria Previous Vaccination

Data type

boolean

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

Elimination Criteria History of Diphteria

Data type

boolean

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

Elimination Criteria Immunodeficient condition

Data type

boolean

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

Elimination Criteria Allergies

Data type

boolean

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

Elimination Criteria Immuniglobulins

Data type

boolean

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

Data type

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).
Description

Elimination Criteria Immunosuppressants

Data type

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.
Description

Elimination Criteria Planned Concomitant Vaccination

Data type

boolean

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

Elimination Criteria Immunoglobulins

Data type

boolean

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

Elimination Criteria History of Immunodeficiency

Data type

boolean

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Description

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

Anaphylactic reaction following the administration of vaccines.
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 :

Data type

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.
Description

hypersensitivity to vaccine

Data type

boolean

Encephalopathy (not due to another identifiable cause).
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.

Data type

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.)
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.

Data type

boolean

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

Temperature

Data type

boolean

PRECAUTIONS
Description

PRECAUTIONS

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

Data type

boolean

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

Collapse or Shock

Data type

boolean

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

Crying

Data type

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.
Description

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.

Data type

boolean

Reminder
Description

Reminder

Data type

text

INFORMED CONSENT
Description

INFORMED CONSENT

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

Informed Consent

Data type

boolean

Informed Consent Date:
Description

Informed Consent Date

Data type

date

DEMOGRAPHICS
Description

DEMOGRAPHICS

Center number:
Description

Center number

Data type

integer

Date of birth:
Description

Date of birth

Data type

date

Gender:
Description

Gender

Data type

text

Race:
Description

Race

Data type

text

ELIGIBILITY CHECK
Description

ELIGIBILITY CHECK

Did the subject meet all the entry criteria?
Description

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.

Data type

boolean

INCLUSION CRITERIA
Description

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.
Description

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

boolean

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

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

Data type

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.
Description

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

Data type

boolean

EXCLUSION CRITERIA
Description

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.
Description

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

Data type

boolean

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

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

Data type

boolean

A family history of congenital or hereditary immunodeficiency.
Description

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

Data type

boolean

Major congenital defects or serious chronic illness.
Description

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

Data type

boolean

History of any neurologic disorders or seizures.
Description

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

Data type

boolean

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

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

Data type

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).
Description

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

Data type

boolean

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

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

Data type

boolean

Hepatitis B vaccination given at birth outside the study.
Description

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

Data type

boolean

RANDOMISATION / TREATMENT ALLOCATION
Description

RANDOMISATION / TREATMENT ALLOCATION

Record treatment number
Description

Treatment number

Data type

integer

GROUP HBV AT BIRTH
Description

GROUP HBV AT BIRTH

Subject Number
Description

Subject Number

Data type

integer

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

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

Data type

boolean

Back to the top of the page

Similar models

VISIT 1 (Day 0 Birth)

1 forms
  1. StudyEvent: ODM
    1. VISIT 1 (Day 0 Birth)
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial