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Phase 3 N=251 Prevention

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

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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