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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

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
University of Kentucky
Lexington, Kentucky, 40536 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00980655
Pfizer
Completed
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

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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