COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine

Inclusion Criteria:

• A male or female between, and including, 6 and 16 weeks of age at the time of thefirst vaccination. Pre-term born infants can be included in the study starting from 8weeks of chronological age at the time of first vaccination and up to 16 weeks ofchronological age

• Subjects should be living in the area covered by the surveillance system for communityacquired pneumonia (CAP), invasive disease and acute otitis media (AOM) •Writteninformed consent obtained from the parent or guardian of the subject.

• Free of any known or suspected health problems (as established by medical history andclinical examination before entering into the study), that would contraindicate theinitiation of routine immunizations outside a clinical trial context.

• Subjects for whom the investigator believes that their parents/guardians can and willcomply with the requirements of the protocol

Exclusion Criteria:

• Use of any investigational or non-registered drug or planned use during the studyperiod.

• Use or planned use of any investigational or non-registered vaccine other than thestudy vaccine(s).

• Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzaetype b, hepatitis A and/or Streptococcus. pneumoniae . Locally recommended EPIvaccines to be given at birth are allowed, but should be administered at least onemonth before the first dose of the study vaccine .Other locally recommended vaccinesare always allowed, even if concomitantly administered with the study vaccines. •Previous or planned vaccination with a registered pneumococcal vaccine such asPrevnar is not allowed. If Prevnar immunization needs to be initiated, due to thepresence of a high risk disease for pneumococcal infections for which the Prevnarvaccine is made locally available, the subject can not be enrolled in the study andshould be referred to the specific Prevnar immunization program.

• History of allergic disease or reactions likely to be exacerbated by any component ofthe 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)