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

• Antibody titres against all investigational vaccine antigen components [ Time Frame: One month after first combined vaccine dose, two months after Dose 1, one month after third combined vaccine dose prior to booster vaccination and one month post-booster vaccination. ] [ Designated as safety issue: No ]
• Occurrence of solicited symptoms [ Time Frame: During the 4-day follow-up period after each dose ] [ Designated as safety issue: No ]
• Occurrence of unsolicited symptoms [ Time Frame: During the 30-day follow-up period after each dose of study vaccine ] [ Designated as safety issue: No ]
• Occurrence of Serious Adverse Events [ Time Frame: From the birth dose of hepatitis B vaccine and ending with the last study visit or performance of the last study procedure or a minimum of 30 days following the third dose of the mixed vaccines and from the start of booster dose and ending a minimum of 3 ] [ Designated as safety issue: No ]

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.

• Diphtheria
• Tetanus
• Whooping Cough
• Hepatitis B
• Poliovirus
• Haemophilus Influenzae Type b Disease

• Biological: DTPa-IPV/Hib vaccine
  Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
• Biological: EngerixTM-B
  The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.
• Biological: DTPa-HBV-IPV/Hib vaccine
  Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.

• Experimental: Group A
  Intervention: Biological: DTPa-HBV-IPV/Hib vaccine
• Experimental: Group B
  Interventions:

  • Biological: DTPa-IPV/Hib vaccine
  • Biological: EngerixTM-B

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