Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Pneumococcal conjugate vaccine GSK1024850A; Infanrix hexa
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 286.0
Sex: All
Minimum age: 8 Weeks
Maximum age: 16 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccine; Preterm; Safety; Pneumococcal disease; Immunogenicity

Summary:

      This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline
      (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with
      diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio
      virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose
      primary immunization course during the first 6 months of life.

      This protocol posting deals with objectives & outcome measures of the primary study. The
      objectives & outcome measures of the Booster study are presented in a separate protocol
      posting (NCT number = 00609492)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol

          -  A male or female between, and including, 8-16 weeks (56-118 days) of age at the time
             of the first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Born after a gestation period of >27 weeks (at least 189 days).

          -  If full term born, healthy subjects as established by medical history and clinical
             examination before entering into the study

          -  If premature, medically stable condition (not requiring significant medical support or
             ongoing management for debilitating disease and having demonstrated a clinical course
             of sustained recovery).

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccines, or planned
             use during the study period

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs from birth to the first vaccine dose.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol,
             during the period starting from one month before the first dose of vaccines and up to
             Visit 6.

          -  Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B,
             Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae
             with the exception of vaccines where the first dose can be given within the first two
             weeks of life according to the national recommendations

          -  History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio,
             Haemophilus influenzae type b disease, Neisseria meningitidis.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of any neurologic disorders or seizures (this criterion does not apply to
             subjects who have had a single, uncomplicated febrile convulsion in the past).

          -  Acute disease at the time of enrolment.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination

          -  A family history of congenital or hereditary immunodeficiency.

          -  Major congenital defects or serious chronic illness.

          -  Administration of immunoglobulins, with the exception of monoclonal antibodies against
             RSV, and/or any blood products within one month preceding the first dose of study
             vaccines or planned administration during the active phase of the study.