Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

This multicenter study is open and consists of a primary and a booster phase. The study has 2 treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase, one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose. In the booster phase, two blood samples will be collected: prior to and one month post booster vaccination.

Inclusion criteria

Primary Phase:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• healthy male or female subject between, and including, 6 and 12 weeks of age at the time of the first vaccination, born after a gestation period between and including 36 and 42 weeks.
• Written informed consent obtained from the parent or guardian of the subject prior to the study entry.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Booster Phase:

• Participation in primary phase of study.

Exclusion criteria

Primary Phase:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) since birth or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth.
• Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with exception of BCG.
• Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio, pneumococcal, Hepatitis B or Hib disease
• History of Haemophilus influenzae type b and /or meningococcal serogroup C disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or 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.

Additional Exclusion criteria for the Booster Phase:

• Previous booster vaccination with Hib and/or MenC and/or DTP containing and/or IPV containing and/or HepB containing vaccine(s).