Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Condition: Tetanus; Diphtheria; Haemophilus Influenzae Type b; Poliomyelitis; Acellular Pertussis; Hepatitis B; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Intervention: GSK2202083A vaccine; 10-valent pneumococcal vaccine (GSK 1024850A); Infanrix hexa™; Menjugate®
Intervention description: Intramuscular, three doses; Intramuscular, three doses; Intramuscular, three doses; Intramuscular, two doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 421.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A
      vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A)
      vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female infant between, and including, 8 and 12 weeks of age at the time of
             the first vaccination.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

          -  Subjects should have received one dose of hepatitis B vaccination at birth as per
             local recommendations.

          -  Subjects who the investigator believes that their parent(s)/LAR can and will comply
             with the requirements of the protocol.

          -  Written informed consent obtained from the parent/LAR of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs since
             birth.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Administration of any vaccine since birth, with exception of HBV and Bacillus
             Calmette-Guérin, or planned administration during the study period.

          -  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.

          -  Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B,
             polio, Hib, pneumococcal and/or MenC disease.

          -  History of seizures or progressive neurological disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  Major congenital defects or serious chronic illness.

        The following condition is temporary or self-limiting, and a subject may be vaccinated once
        the condition has resolved if no other exclusion criteria is met:

        • Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe
        illness within 24 hours of study vaccine administration.