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NCT00980655

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: 2018-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-18

Study Completion Date

2013-05-16

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccines, Pneumococcal Conjugate Vaccine

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

13vPnC

Intervention Type BIOLOGICAL

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.

23vPS

Intervention Type BIOLOGICAL

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

Interventions

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13vPnC

Intervention Type BIOLOGICAL

23vPS

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status