Clinical trial NCT00980655: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-21
Enrollment: 251
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 3
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
timeFrame: 1 month after 13vPnC Dose 4
measure: 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
timeFrame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
measure: 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
timeFrame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4
measure: 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
timeFrame: 1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4
Other outcomes:
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
timeFrame: Within 14 days after 13vPnC Dose 1
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
timeFrame: Within 14 days after 13vPnC Dose 2
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
timeFrame: Within 14 days after 13vPnC Dose 3
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
timeFrame: Within 14 days after 13vPnC Dose 4
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
timeFrame: Within 14 days after 13vPnC Dose 1
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
timeFrame: Within 14 days after 13vPnC Dose 2
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
timeFrame: Within 14 days after 13vPnC Dose 3
measure: Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
timeFrame: Within 14 days after 13vPnC Dose 4
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Hyde Park
country: United States
facility: Steven and Alexandra Cohen Children's Medical Center of New York
state: New York
city: New York
country: United States
facility: Columbia University Medical Center Research Pharmacy
state: New York
city: New York
country: United States
facility: Columbia University Medical Center-Presbyterian Hospital Building
state: New York
city: New York
country: United States
facility: Columbia University/Taub Institute Irving Center for Clinical Research
state: New York
city: New York
country: United States
facility: New York-Presbyterian Morgan Stanley Children's Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Belgium
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis St.-Jan A.V.
city: Brussels
country: Belgium
facility: Clinical University St Luc
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg
city: Liege
country: Belgium
facility: CHU Liege
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Bmo
country: Czechia
facility: Fakultni nemocnice Brno/Interni hematoonkologicka klinika
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Besancon
country: France
facility: Hôpital Jean Minjoz
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Créteil
country: France
facility: Hôpital Henri Mondor, Pharmacie
city: PARIS Cedex 10
country: France
facility: Hopital Saint-Louis
city: Paris Cedex 19
country: France
facility: Hopital Robert Debre
city: PARIS Cedex 19
country: France
facility: Hopital Robert Debre - Service Pharmacie
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: CHRU Robert Debré
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin
city: Hamburg
country: Germany
facility: Clinical Trial Center North MediGate GmbH
city: Hamburg
country: Germany
facility: Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Muenster
country: Germany
facility: "Universitaetsklinikum Muenster,
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Utrecht
country: Netherlands
facility: UMC Utrecht, Wilhelmina Kinder Ziekenhuis
city: Gdansk
country: Poland
facility: Klinika Hematologii i Transplantologii
city: Krakow
country: Poland
facility: NZOZ "HIPOKRATES-II" Sp. z o.o.
city: Wroclaw
country: Poland
facility: Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Infantil Niño Jesús
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Lund
country: Sweden
facility: Universitetssjukhuset i Lund, Barnonkologen Avd 64
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset, Infektionskliniken
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.