A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type b
MeSH terms: Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria
Intervention: Infanrix-IPV/Hib
Intervention description: Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 3 Months
Maximum age: 19 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary dose; Reactogenicity; Immunogenicity; Booster dose; Combined vaccine; Russian Infants; Infanrix®-IPV/Hib

Summary:

      The purpose of this study is to evaluate the immune response, safety and reactogenicity after
      receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination
      course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian
      healthy children according to the Russian immunisation schedule
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally Acceptable Representatives [LARs] who, in the opinion of
             the investigator, can and will comply with the requirements of the protocol.

          -  A male or female child between 3 and 4 months of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the parents/LARs 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.

        Exclusion Criteria:

          -  Child in care

          -  Use of any investigational or non-registered product other than the study vaccine
             during the period starting 30 days before the first dose of study vaccine, or planned
             use during the study period.

          -  Any medical condition that in the judgment of the investigator would make
             intramuscular injection unsafe.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs during
             the period starting since birth. For corticosteroids, this will mean prednisone ≥ 0.5
             mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             in the period starting 30 days before the first dose and ending 30 days after the last
             dose of vaccine administration, with the exception of hepatitis B and other vaccines
             given as part of the national immunisation schedule and as part of routine vaccination
             practice, that are allowed at any time during the study period. Seasonal or pandemic
             influenza vaccine can be given at any time during the study, and according to the
             Summary of Product Characteristics and national recommendations.

          -  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

          -  Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Hib
             diseases.

          -  History of diphtheria, tetanus, pertussis, poliomyelitis and Hib diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  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 for oral, axillary or tympanic route, or
                  ≥38.0°C for rectal route.

               -  Subjects with a minor illness without fever may be enrolled at the discretion of
                  the investigator.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.