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



Status:Completed
Conditions:Vaccines
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - Any
Updated:12/22/2018
Start Date:January 18, 2010
End Date:May 16, 2013

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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

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.


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.
We found this trial at
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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