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

• Immune responses 1 month after 3 doses of 13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs). [ Time Frame: 1 month after 3 doses of 13vPnC ] [ Designated as safety issue: No ]
• Safety of 13vPnC measured by local reactions. [ Time Frame: 14 days post-vaccination, doses 1- 4 ] [ Designated as safety issue: Yes ]
• Safety of 13vPnC measured by systemic events. [ Time Frame: 14 days post-vaccination, doses 1- 4 ] [ Designated as safety issue: Yes ]
• Safety of 13vPnC measured by adverse events. [ Time Frame: Ongoing through study ] [ Designated as safety issue: Yes ]

• Immune responses 1 month after 3 doses of 13vPnC as measured by serotype-specific IgG GMCs. [ Time Frame: 1 month after 3 doses ] [ Designated as safety issue: No ]
• Immune responses 1 month after 4 doses of 13vPnC as measured by serotype-specific IgG GMCs. [ Time Frame: 1 month after 4 doses ] [ Designated as safety issue: No ]

People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.

• Biological: 13vPnC

  0.5mL 13vPnC dose will be administered intramuscularly into the left limb at visits 1,2,3 and 5.

  Starting 3-6 months after HSCT 3 doses given at monthly intervals. 4th dose given 6 months after 3rd dose.

• Biological: 23vPS
  0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.

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 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.

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 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.