Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants
Condition: Rotavirus
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Squarekids; Rotarix
Intervention description: Three doses administered subcutaneously in the upper arm or thigh; Two doses administered orally
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 292.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Japanese infants; Safety; Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) vaccine; Vaccination; Oral HRV liquid vaccine; Immunogenicity

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria,
      tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with
      or without the GSK Biologicals' liquid Rotarix (HRV) vaccine, in healthy Japanese infants
      aged 6 - 12 weeks. GSK Biologicals' liquid HRV vaccine Rotarix is licensed in Japan since
      2011. Although the concomitant administration of GSK Biologicals' DTP-IPV vaccine has been
      evaluated during the clinical development of the HRV vaccine, the vaccine differed in
      composition and route of administration from the DPT-IPV vaccine Squarekids manufactured in
      Japan. Hence, as requested by the Japanese regulatory authorities, this post-licensure study
      will evaluate the immunogenicity of the DPT-IPV vaccine manufactured in Japan when
      co-administered with the liquid HRV vaccine
    

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.

          -  A male or female between, and including, 6 and 12 weeks of age at the time of the
             first dose of HRV vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
             performing any study specific procedure.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born full-term as per the delivery records.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days before the first dose of study vaccine, or planned use during the study
             period.

          -  Chronic administration 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.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period.

          -  Planned administration/administration of a vaccine not fore-seen by the study protocol
             within the period starting 30 days before the first dose of HRV vaccine administration
             and ending at Visit 7, with the exception of other routinely administered vaccines
             like PCV, Hib, BCG, hepatitis B, meningococcal vaccine and inactivated influenza
             vaccines, which are allowed at any time during the study, if administered at sites
             different from the sites used to administer the DPT-IPV vaccine.

          -  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.

          -  Uncorrected congenital malformation of the gastrointestinal tract that would
             predispose for Intussusception (IS).

          -  History of IS.

          -  Family history of congenital or hereditary immunodeficiency.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Major congenital defects or serious chronic illness.

          -  Previous vaccination against rotavirus, diphtheria, tetanus, pertussis and/ or
             poliovirus.

          -  Previous confirmed occurrence of RV GE, diphtheria, tetanus, pertussis, and/ or polio
             disease.

          -  GE within 7 days preceding the HRV vaccine administration.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the HRV or DPT-IPV vaccines.

          -  Hypersensitivity to latex.

          -  History of any neurological disorders or seizures.

          -  History of SCID.

          -  Acute disease and/or fever at the time of enrollment.

               -  Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic
                  setting, or ≥ 38.0°C /100.4°F on rectal setting.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.