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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00980655
First received: September 18, 2009
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Vaccines, Pneumococcal Conjugate Vaccine
Biological: 13vPnC
Biological: 23vPS
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Further study details as provided by Pfizer:

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 ]

Enrollment: 251
Study Start Date: January 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 13vPnC

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.

Biological: 23vPS
0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980655

  Show 36 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00980655     History of Changes
Other Study ID Numbers: 6115A1-3003, B1851022
Study First Received: September 18, 2009
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014