A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation); Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation); DTPw-HBV/Hib
Intervention description: 4 doses by intramuscular injection in the right left anterolateral thigh; 4 doses by intramuscular injection in the right anterolateral thigh; 3 doses by intramuscular injection in the left anterolateral thigh
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 320.0
Sex: All
Minimum age: 42 Days
Maximum age: 76 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Invasive disease by Streptococcus pneumoniae (S. pneumoniae) (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media); Infants; Multidose; Haemophilus influenzae; Streptococcus pneumoniae; Preservative; Safety; Pneumonia; Immunogenicity; Pneumococcal conjugate vaccine; Acute otitis media caused by non-typeable Haemophilus influenzae (NTHi).; Respiratory tract infections

Summary:

      The primary aim of the study is to demonstrate that an investigational 4-dose presentation of
      the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of
      Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal
      serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first
      secondary objective), after administration of a 3-dose primary vaccination course at 6, 10
      and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at
      6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).

      In addition, the study will also assess the safety, reactogenicity, immunogenicity and
      antibody persistence (approximately 7 months following primary vaccination) of the 4-dose
      presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18
      weeks of age followed by a booster dose at 38 weeks.

      This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose
      presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9
      months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects for whom, in the opinion of the investigator, the parent(s)/Legally
             Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the
             protocol (e.g., return for vaccination and follow-up visits).

          -  A male or female between, and including 6-10 weeks (42-76 days) of age at the time of
             the first vaccination.

          -  Written or oral, signed or thumb-printed informed consent obtained from the
             parent(s)/LAR(s) of the subject. For all subjects, the consent form should be
             countersigned by a witness.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Born full-term (i.e., after a gestation period from 37 to 42 weeks).

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, 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. Inhaled and topical steroids are allowed.

          -  Planned administration of long-acting immune-modifying drugs at any time during the
             study period (e.g., infliximab).

          -  Administration or planned administration of a vaccine not foreseen by the study
             protocol administered during the period starting from 30 days before each dose of
             study vaccines and ending 30 days after with the following exceptions:

          -  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, H. influenzae type b
             and/or S. pneumoniae.

          -  History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H.
             influenzae type b disease.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  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.

          -  Major congenital defects or 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 on rectal route. The preferred route for recording temperature in this study
             will be axillary.

          -  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 (Hepatitis B immunoglobulins at birth are
             allowed).

          -  Any medical condition which might interfere with the assessment of the study
             objectives in the opinion of the investigator.