NCT00980655CompletedPhase 3
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
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 251
- Locations
- 89
- Primary Endpoint
- Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Intervention: 23vPS (Biological)
1
Experimental
Intervention: 13vPnC (Biological)
Outcomes
Primary Outcomes
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Time Frame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.
Secondary Outcomes
- Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants(Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3)
- Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants(1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4)
- Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants(Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4)
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants(1 month after 13vPnC Dose 3)
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants(1 month after 13vPnC Dose 4)
Investigators
Study Sites (89)
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