COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal
MeSH terms: Pneumonia; Streptococcal Infections; Otitis; Otitis Media
Intervention: Pneumococcal conjugate vaccine GSK1024850A; Havrix; Engerix-B; Infanrix hexa; GSK Biologicals' DTPa-IPV/Hib vaccine
Intervention description: Intramuscular injection, 4 doses; Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group; Intramuscular injection, 3 doses; Intramuscular injection,3 doses; Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Enrollment: 23802.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 16 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Otitis media; Pneumonia; Community acquired pneumonia (CAP); Pneumococcal disease; Booster vaccination; Immunogenicity; Pneumococcal vaccine; Safety; Efficacy; Carriage

Summary:

      This is a study in a large number of healthy children less than 3 years old to measure the
      efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate
      vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection)
      likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of
      otitis media (ear infection) in children under 3 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female between, and including, 6 and 16 weeks of age at the time of the
             first vaccination. Pre-term born infants can be included in the study starting from 8
             weeks of chronological age at the time of first vaccination and up to 16 weeks of
             chronological age

          -  Subjects should be living in the area covered by the surveillance system for community
             acquired pneumonia (CAP), invasive disease and acute otitis media (AOM) •Written
             informed consent obtained from the parent or guardian of the subject.

          -  Free of any known or suspected health problems (as established by medical history and
             clinical examination before entering into the study), that would contraindicate the
             initiation of routine immunizations outside a clinical trial context.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol

        Exclusion Criteria:

          -  Use of any investigational or non-registered drug or planned use during the study
             period.

          -  Use or planned use of any investigational or non-registered vaccine other than the
             study vaccine(s).

          -  Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae
             type b, hepatitis A and/or Streptococcus. pneumoniae . Locally recommended EPI
             vaccines to be given at birth are allowed, but should be administered at least one
             month before the first dose of the study vaccine .Other locally recommended vaccines
             are always allowed, even if concomitantly administered with the study vaccines.
             •Previous or planned vaccination with a registered pneumococcal vaccine such as
             Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the
             presence of a high risk disease for pneumococcal infections for which the Prevnar
             vaccine is made locally available, the subject can not be enrolled in the study and
             should be referred to the specific Prevnar immunization program.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment

          -  For Colombia: infants with low birth weight ( less than (<) 2.500 grams)