- 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 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.
- 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
- 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.