Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine
Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine
This study will assess immunogenicity, safety and reactogenicity of primary and booster
 vaccination.
"There will be two groups in this study:

 -  one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib
 vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster
 vaccination

 -  the control group will receive a birth dose of hepatitis B vaccine and 3 doses of
 DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine
 as booster vaccination".
Inclusion criteria For the primary vaccination phase

 -  Healthy newborn male or female infant 2 to 5 days old at the time of the first
 vaccination & written informed consent taken from the parents/guardians of the subject

 -  Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy

 -  Birth weight >= 2.5 kg and 5 minute Apgar >= 7

 -  Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster
 vaccination phase

 -  A healthy male or female between, and including, 12 and 23 months of age at the time
 of booster vaccination who has completed the primary vaccination course in the primary
 vaccination phase with written informed consent obtained from the parent or guardian
 of the subject

 Exclusion criteria For the primary vaccination phase

 -  Mother known or suspected to be seropositive for HIV (testing not required for
 inclusion)

 -  Planned use of any investigational or non-registered product (drug or vaccine) other
 than the study vaccines during the study

 -  Planned administration of immuno-suppressants or other immune-modifying drugs,
 administration of immunoglobulins and/or any blood products since birth or planned
 administration during the study.

 -  Administration of immunoglobulins and/or any blood products to the mother during
 pregnancy

 -  Neonatal jaundice requiring parenteral treatment (light therapy for physiological
 jaundice is allowed)

 -  At risk of pneumococcal disease or planning to receive Prevenar™ during the study
 period

 -  Administration or planned administration of BCG vaccination during the study period

 -  Acute disease at the time of vaccination. For the booster vaccination phase

 -  Use of any investigational or non-registered product (drug or vaccine) other than the
 study vaccine within 30 days preceding the booster dose, or planned use during the
 booster phase.

 -  Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib
 booster vaccination since the study conclusion visit of the primary vaccination phase.

 -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
 human immunodeficiency virus (HIV) infection.

 -  Administration/ planned administration of a vaccine not foreseen by the study
 protocol, administration/ planned administration of immunoglobulins and/or any blood
 products during the period starting 30 days before the administration of the booster
 dose and ending 30 days after the booster dose.

 -  Chronic administration of immunosuppressants or other immune-modifying drugs within
 six months prior to the booster vaccine dose."