Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine

Long-term Follow-up Study to Assess Antibody Persistence in Children Previously Vaccinated With Four Doses of Pneumococcal Conjugate Vaccine in Primary Vaccination Study (105553) and Booster Vaccination Study (107046)

This protocol posting deals with objectives & outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).

This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). No study vaccines will be administered within this study.

Inclusion Criteria:

• Male or female between, and including, 28-30 months of age at the time of first blood sampling.
• Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• Written informed consent, covering visits 1, 2 and 3, 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.

Exclusion Criteria:

• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
• Administration of any additional pneumococcal vaccine since end of 107046 study.
• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
• Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
• Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.