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

This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course and as a booster dose in infants born to hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV vaccine.


Eligibility Criteria:
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