Pneumococcal vaccine booster study in healthy children 12-18 mths old previously primed with the same vaccines

Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

• A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 and received three doses of pneumococcal conjugate vaccine.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
• Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
• Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
• History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
• 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 and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.