Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Condition: Acellular Pertussis; Tetanus; Poliomyelitis; Diphtheria; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Intervention: Infanrix hexa; Prevnar13
Intervention description: • All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh.; • All subjects will receive Infanrix hexa co-administered with Prevenar13* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. *In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 601.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 14 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women
      who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if
      the presence of transplacentally transferred maternal antibodies interfere with the immune
      response to primary vaccination with Infanrix hexa and a co-administered pneumococcal
      conjugate vaccine given as a part of this study in infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
             of the investigator, can and will comply, with the requirements of the protocol (e.g.
             completion of the diary cards, return for follow-up visits).

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
             performing any study specific procedure.

          -  A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and
             including 14 weeks and 6 days of age) at the time of the first vaccination.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].

          -  Medically stable* prematurely born infants, born after a gestation period of 27-36
             weeks may be enrolled in the study at the discretion of the investigator.

               -  Medically stable refers to the condition of premature infants who do not require
                  significant medical support or ongoing management for debilitating disease and
                  who have demonstrated a clinical course of sustained recovery by the time they
                  receive the first dose of study vaccine.

        Exclusion Criteria:

          -  Child in care

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs during the period starting at birth prior to the first
             vaccine dose. For corticosteroids, this will mean prednisone ≥0.5mg/kg/day, or
             equivalent. Inhaled and topical steroids are allowed.

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period (e.g. infliximab).

          -  Administration of any chronic drug therapy to be continued during the study period.

          -  A vaccine not foreseen by the study protocol administered during the period starting
             from 30 days before each dose of vaccine and ending 30 days after*, with the exception
             of inactivated influenza vaccine and other vaccines given as a part of the
             national/regional immunisation schedule, that are allowed at any time during the study
             period.

               -  In case an emergency mass vaccination for an unforeseen public health threat
                  (e.g.: a pandemic) is organised by the public health authorities, outside the
                  routine immunisation program, the time period described above can be reduced if
                  necessary for that vaccine provided it is licensed and used according to its SPC
                  or package insert (PI) and according to the local governmental recommendations
                  and provided a written approval of the Sponsor is obtained.

          -  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 vaccine/product (pharmaceutical product or device).

          -  Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or
             poliovirus since birth.

          -  History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis
             B diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             severe combined immunodeficiency disease (SCID), 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 vaccine.

          -  Major congenital defects

          -  Serious chronic illness.

          -  History of any neurological disorders or seizures.

          -  Acute disease and/or fever at the time of enrolment.

               -  Fever is defined as temperature ≥37.5°C/99.5°F for oral, axillary or tympanic
                  route, or ≥38.0°C/100.4°F for rectal route.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may, be enrolled at the discretion of the investigator.

          -  Administration of immunoglobulins and/or any blood products during the period starting
             at birth before the first dose of study vaccines or planned administration during the
             study period.

          -  Hypersensitivity to latex.