Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

Inclusion Criteria:

Inclusion criteria for enrolment at birth

• Written informed consent obtained from the parents or guardians of the subject.
• A male or female infant born after a normal gestation period (between 36 and 42 weeks).
• Born to a mother seronegative for HBsAg.
• Free of obvious health problems as established by clinical examination before entering into the study.

Inclusion criteria for administration of the combined vaccine regimen

• Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study.

Inclusion criteria for administration of the booster dose

• Between, and including, 15 and 18 months of age at the time of the booster vaccination.
• Written informed consent obtained from the parents or guardians of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Completion of the three-dose primary vaccination course.

Exclusion Criteria:

Exclusion criteria for enrolment at birth

• A family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• Major congenital defect(s).

Exclusion criteria for administration of the combined vaccine regimen

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration Immunosuppressants or other immune-modifying drugs since birth.
• Any chronic drug therapy to be continued during the study period.
• Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after.
• Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease.
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Exclusion criteria for administration of the booster dose

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination.
• Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• History of any neurologic disorders or seizures.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period.
• Hypersensitivity reaction due to vaccine in primary course
• Encephalopathy within 7 days of previous vaccination with DTP vaccine