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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

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
University of Kentucky
Lexington, Kentucky, 40536 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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.

NCT00980655
Pfizer
Completed
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

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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief SummaryPeople 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal Conjugate Vaccine
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: 1
Interventions:
  • Biological: 13vPnC
  • Biological: 23vPS
Publications *Cordonnier C, Ljungman P, Juergens C, Maertens J, Selleslag D, Sundaraiyer V, Giardina PC, Clarke K, Gruber WC, Scott DA, Schmoele-Thoma B; 3003 Study Group. Immunogenicity, safety, and tolerability of 13-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine in recipients of allogeneic hematopoietic stem cell transplant aged ?2 years: an open-label study. Clin Infect Dis. 2015 Aug 1;61(3):313-23. doi: 10.1093/cid/civ287. Epub 2015 Apr 13.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
251
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2009)
300
Actual Study Completion Date  ICMJE May 16, 2013
Actual Primary Completion DateMay 16, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   France,   Germany,   Netherlands,   Poland,   Spain,   Sweden,   United States
Removed Location CountriesCzech Republic
 
Administrative Information
NCT Number  ICMJE NCT00980655
Other Study ID Numbers  ICMJE 6115A1-3003
B1851022 ( Other Identifier: Alias Study Number )
2009-012087-13 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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