Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).

The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.

Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

Inclusion Criteria:

• Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
• Subjects must be in good health as determined by medical history, physical examination and clinical judgment.

Exclusion Criteria:

• Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
• History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
• Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
• Receipt of immune-globulin within the past 3 months.
• Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.