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
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
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
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)
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
Eligibility Check
Item
Did the subject meet all the entry criteria?
boolean
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
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
Subject Number
Item
Subject Number
integer
Vaccine Administration
Item
Has the EngerixTM-B vaccine been administered at birth?
boolean