Eligibility check
Inclusion Criteria
Tick "No" for any inclusion criteria subject failed
text
1.Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
boolean
2.Administration of one dose of hepatitis B vaccine at birth (within 72 hours after birth)
boolean
3.A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
boolean
4.Written informed consent obtained from parent or guardian of the subject.
boolean
5.Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
6.Born after a normal gestation period (36 to 42 weeks).
boolean
Exclusion Criteria
Tick "Yes" for any of the exclusion criteria that disqualified the subject from entry
text
7.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.
boolean
9.Planned administration/Administration of vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exeption of oral polio vaccine (OPV).
boolean
10.Bacille-Calmette-Guérin (BCG) vaccine received after the first 6 weeks of life.
boolean
11. Previous vaccination against diphtheria, tetanus, and/or pertussis.
boolean
12.History of diphtheris, tetanus, pertussis and/or hepatitis B disease.
boolean
13.Known exposure to diphtheria, tetanus, pertussis and/or hepatitis B disease since birth.
boolean
warrants deferral of the vacination
boolean
15.Any confirmed or suspected immunosuppresive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
boolean
16.A family history of congenital or hereditary immunodeficiency.
boolean
17.History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
boolean
18.Major congenital defects or serious chronic illness.
boolean
19.History of any neurologic disorders or seizures
boolean
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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.r. axillary temperature <37.5°C/rectal temperature <38°C
boolean
21.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
22.Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
Randomisation/Treatment allocation