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

Conditions: Three dose primary vaccination of healthy infants between 6-16 weeks of age at the time of the first vaccination, followed by a booster dose at 15-18 months.
MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2011-002076-16-Outside-EU/EEA

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 24826

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 CAP, invasive disease and 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24826
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 S. 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 (<2.500g)