Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
Condition: Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Tetanus; Acellular Pertussis; Hepatitis B
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: Infanrix hexa; Pediarix; ActHIB; Pentacel; Engerix-B; Infanrix; Hiberix; Prevnar13; Rotarix
Intervention description: 3 doses administered intramuscularly in the right thigh.; 3 doses administered intramuscularly in the right thigh; 4 doses administered intramuscularly in the upper left thigh; 4 doses administered intramuscularly in the right thigh; 2 or 3 doses administered intramuscularly in the upper left thigh; 1 dose administered intramuscularly in the right thigh; 1 dose administered intramuscularly in the left thigh; 3 doses administered intramuscularly in the lower left thigh; 2 doses administered orally
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 585.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infants; Safety; Healthy; Infanrix Hexa; Immunogenicity

Summary:

      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and
      6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK
      Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion
             of the investigator, can and will comply, with the requirements of the protocol.

          -  A male or female between, and including, 6 and 12 weeks of age at the time of the
             first vaccination.

          -  Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed
             weeks [259 to 293 days]).

          -  Written informed consent obtained from parent(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Infants who have not received a previous dose of hepatitis B vaccine or those who have
             received only 1 dose of hepatitis B vaccine administered at least 30 days prior to
             enrolment.

        Exclusion Criteria:

          -  Child in care

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccines, or planned
             use during the study period.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs since birth. For corticosteroids, this will mean
             prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within the period starting from 30 days before the first vaccination until 30 days
             after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose
             4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of
             the study:

               -  Inactivated influenza and hepatitis A vaccines are allowed throughout the study.

               -  Routine administration(s) of vaccines are allowed from 30 days after the last
                  dose of primary vaccination until 30 days before the booster dose and after
                  post-booster blood sampling. Routine administration of measles-mumps-rubella
                  vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last
                  dose of primary vaccine until 30 days before booster dose and from post-booster
                  blood sampling, as well as according to the recommended immunization schedule in
                  US.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus
             and hepatitis B diseases.

          -  Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus,
             rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines (including yeast).

          -  Hypersensitivity to latex.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders including seizures.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  History of intussusception or of any uncorrected congenital malformation of the
             gastrointestinal tract that would predispose the infant to intussusception.

          -  History of Severe Combined Immunodeficiency Disease (SCID).

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred
                  route for recording temperature in this study will be rectal for Epoch 001 and
                  axillary for Epoch 002.

               -  Subjects with a minor illness (such as mild diarrhea, mild upper respiratory
                  infection) without fever may, be enrolled at the discretion of the investigator.