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
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: September 18, 2009
Last updated: May 14, 2013
Last verified: May 2013
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.
Vaccines, Pneumococcal Conjugate Vaccine
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||A Phase 3, Open-label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13vPnC Followed by 23vPS in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years and Older.
Primary Outcome Measures:
- Immune responses 1 month after 3 doses of 13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs). [ Time Frame: 1 month after 3 doses of 13vPnC ] [ Designated as safety issue: No ]
- Safety of 13vPnC measured by local reactions. [ Time Frame: 14 days post-vaccination, doses 1- 4 ] [ Designated as safety issue: Yes ]
- Safety of 13vPnC measured by systemic events. [ Time Frame: 14 days post-vaccination, doses 1- 4 ] [ Designated as safety issue: Yes ]
- Safety of 13vPnC measured by adverse events. [ Time Frame: Ongoing through study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immune responses 1 month after 3 doses of 13vPnC as measured by serotype-specific IgG GMCs. [ Time Frame: 1 month after 3 doses ] [ Designated as safety issue: No ]
- Immune responses 1 month after 4 doses of 13vPnC as measured by serotype-specific IgG GMCs. [ Time Frame: 1 month after 4 doses ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
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.
0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.
|Ages Eligible for Study:
||2 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980655
||Pfizer CT.gov Call Center
No publications provided
ClinicalTrials.gov processed this record on May 16, 2013
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 18, 2009
||May 14, 2013
||United States: Food and Drug Administration