Phase 3
N=251
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
Vaccines, Pneumococcal Conjugate Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT00980655 ↗Enrolled (actual)
251
Serious AEs
13.8%
Results posted
Apr 2014
Primary outcome: Primary: 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 — 17.96; 5.07; 23.85; 2.99 fold rise
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13vPnC (Biological); 23vPS (Biological)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
17.96; 5.07; 23.85; 2.99; 5.35; 5.18 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants |
3.52; 2.05; 2.35; 1.60; 0.62; 0.79 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants |
8.75; 4.67; 5.41; 1.23; 0.91; 0.97 | — |
| SECONDARY 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 |
27.64; 15.54; 7.58; 4.43; 40.83; 19.86 | — |
| SECONDARY 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 |
70.66; 35.81; 42.03; 5.88; 6.41; 6.28 | — |
| SECONDARY 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 |
2.80; 2.16; 2.30; 0.88; 1.32; 1.20 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00980655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.