Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
Complete hematologic remission of underlying disease with very good partial remission (VGPR) acceptable in the case of lymphoma and myeloma.
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.
Hematological recovery as defined by ANC \>1000/µL; platelet count \>50,000/µL.
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 from signing of the ICF until for 3 months after the last vaccination.
Negative urine pregnancy test for all female subjects of child bearing potential.
You may not be if
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 for relapse of underlying malignant disease 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.
Receipt of advanced therapy medicinal products (ATMP) including gene therapy products, somatic cell therapy products, and tissue engineered products at any time before enrollment.
If information is available, - previous allergic or anaphylactic reaction to any vaccine or vaccine-related component in a stem cell donor.
Clareo Health | Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
