3003: PH 3, HIGH RISK RECIPIENTS OF ALLOGENEIC HSCT >/= 2 YR
- Conditions
- Pneumococcal infectionMedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2009-012087-13-SE
- Lead Sponsor
- Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
• 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 3 months after the last vaccination.
• Negative urine pregnancy test for all female subjects of child bearing potential.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method