Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

Wyeth is now a wholly owned subsidiary of Pfizer89 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Invasive Pneumococcal Disease

Interventions

13-valent pneumococcal conjugate vaccine (13vPnC)BIOLOGICAL

0.5 mL intramuscular injection

Blood drawPROCEDURE

Collection of 10 mL of blood

Eligibility

Sex: ALLMin age: 5 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (2)

Landspitali University Hospital

Hringbraut, Reykjavik, Iceland

Midstod Heilsuverndar barna

Reykjavik, Iceland

Outcomes

Primary Outcomes

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

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.

Time frame: Day 28

Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination

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.

Time frame: Day 28

Secondary Outcomes

Antibody Response Measured 1 Month After Vaccination (Avidity Assay)

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).

Time frame: Day 28

Antibody Response Measured 1 Month After Vaccination (OPA)

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.

Time frame: Day 28

Data from ClinicalTrials.gov

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