Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

Phase 3

Completed

Interventions: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
Procedure: Blood draw

Brief Summary: 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.

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Single	Blood draw	All subjects will receive a single dose of 13vPnC
Single	13-valent pneumococcal conjugate vaccine (13vPnC)	All subjects will receive a single dose of 13vPnC

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination	Day 28	Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination	Day 28	Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Secondary Outcome Measures

Name	Time	Method
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)	Day 28	Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
Antibody Response Measured 1 Month After Vaccination (OPA)	Day 28	Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.