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
NCT00980655
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Vaccines, Pneumococcal Conjugate Vaccine | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1
Interventions:
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Publications * | Cordonnier C, Ljungman P, Juergens C, Maertens J, Selleslag D, Sundaraiyer V, Giardina PC, Clarke K, Gruber WC, Scott DA, Schmoele-Thoma B; 3003 Study Group. Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged ?2 years: an open-label study. Clin Infect Dis. 2015 Aug 1;61(3):313-23. doi: 10.1093/cid/civ287. Epub 2015 Apr 13. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 251 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | May 16, 2013 | |||
Actual Primary Completion Date | May 16, 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 2 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, Czechia, France, Germany, Netherlands, Poland, Spain, Sweden, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00980655 | |||
Other Study ID Numbers ICMJE | 6115A1-3003 B1851022 ( Other Identifier: Alias Study Number ) 2009-012087-13 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |