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

Completed · Phase 3

Conditions studied: Vaccines, Pneumococcal Conjugate Vaccine

In brief

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.

Key facts

Study ID

NCT00980655

Run by

Pfizer

People needed

251

Starts

2010-01-18

Expected to finish

2013-05-16

Last updated by the study team

2018-12-20

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• Columbia University Medical Center Research Pharmacy — New York, New York, United States
• Columbia University Medical Center-Presbyterian Hospital Building — New York, New York, United States
• Columbia University/Taub Institute Irving Center for Clinical Research — New York, New York, United States
• New York-Presbyterian Morgan Stanley Children's Hospital — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Universitair Ziekenhuis Gent — Belgium, Belgium
• Algemeen Ziekenhuis St.-Jan A.V. — Bruges, Belgium
• Clinical University St Luc — Brussels, Belgium
• Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg — Leuven, Belgium
• CHU Liege — Liège, Belgium
• CancerCare Manitoba — Winnipeg, Manitoba, Canada
• Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Fakultni nemocnice Brno/Interni hematoonkologicka klinika — Bmo, Czechia
• Fakultni nemocnice v Motole — Prague, Czechia
• Hôpital Jean Minjoz — Besançon, France
• Hopital Henri Mondor — Créteil, France
• Hôpital Henri Mondor, Pharmacie — Créteil, France
• Hôpital Saint Louis — Paris, France
• CHRU Robert Debré — Paris, France
• Hopital Robert Debre — Paris, France
• Hopital Saint-Louis — Paris, France

Full record on ClinicalTrials.gov

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