A Phase 3, Open-label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years and Older

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

*Male or female subject *2 years of age. *Allogeneic HSCT for hematologic disorder. *Allogeneic HSCT with full myeloablative conditioning or reduced intensity conditioning. *Allogeneic HSCT approximately 3 to 6 months (91 days to 203 days) before enrollment. *Stable engraftment (absolute neutrophil count (ANC) >1000/µl; platelet count >50,000/µl). *Complete hematologic remission of underlying disease. *Subject or parent/legal guardian expected to be available for the entire study and can be contacted by telephone. *Subject or parent/legal guardian must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation. * All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control for 3 months after the last vaccination. * Negative urine pregnancy test for all female subjects of child bearing potential.

Exclusion Criteria

*Autologous HSCT. *Receipt of donor lymphocyte infusions during the 28 days preceding enrollment. *Uncontrolled GVHD that in the opinion of the investigator would prevent the subject from participating in the study. *Lansky/Karnofsky Score *60%. *Receipt of plasma products or immunoglobulins during the 60 days preceding enrollment. *Receipt of rituximab since HSCT. *Receipt of chemotherapy since HSCT. *Human immunodeficiency virus (HIV) infection. *Lymphoproliferative disorder since HSCT. *Chronic illnesses with cardiac, pulmonary, renal, or liver failure that in the opinion of the investigator would prevent the subject participating in the study. *Vaccination with any licensed or experimental pneumococcal vaccine since HSCT. *Previous anaphylactic reaction to any vaccine or vaccine-related component. *Bleeding diathesis or condition associated with prolonged bleeding time that would in the opinion of the investigator contraindicate intramuscular injection. *Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study. *Participation in another study with ongoing use of a licensed investigational product that in the opinion of the investigator would interfere with the evaluation of the study objectives. *Permanent residence in a nursing home or other residential care facility. *Pregnant or breastfeeding female subject. *Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or is a member of the study personnel.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective: To evaluate the immune responses 1 month after 3 doses of<br /><br>13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG)<br /><br>geometric mean concentrations (GMCs) in subjects 2 years of age. </p><br>

Secondary Outcome Measures

Name	Time	Method

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