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
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Intervention: 13vPnC; 23vPS
Intervention description: 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.; 0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.