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

NCT00980655 | Completed Phase 3 Results DMC

• 3 other identifiers: 6115A1-3003B18510222009-012087-13
• Study Type: interventional
• Target: 251
• Locations: 10 countries
• Sites: 47

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.

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.

  Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3

Secondary Outcomes (5)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants

  1 month after 13vPnC Dose 3

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants

  1 month after 13vPnC Dose 4

• 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

  Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3

• 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

  Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4

• 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

  1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4

Other Outcomes (8)

• Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1

  Within 14 days after 13vPnC Dose 1

• Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2

  Within 14 days after 13vPnC Dose 2

• Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3

  Within 14 days after 13vPnC Dose 3

Study Arms (1)

1

EXPERIMENTAL

Biological: 13vPnC; Biological: 23vPS

Interventions

13vPnC BIOLOGICAL

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.

1

23vPS BIOLOGICAL

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

1

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (47)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040, United States

Location

Columbia University Medical Center Research Pharmacy

New York, New York, 10032, United States

Location

Columbia University Medical Center-Presbyterian Hospital Building

New York, New York, 10032, United States

Location

Columbia University/Taub Institute Irving Center for Clinical Research

New York, New York, 10032, United States

Location

New York-Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Universitair Ziekenhuis Gent

Belgium, 9000, Belgium

Location

Algemeen Ziekenhuis St.-Jan A.V.

Bruges, 8000, Belgium

Location

Clinical University St Luc

Brussels, 1200, Belgium

Location

Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg

Leuven, 3000, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Fakultni nemocnice Brno/Interni hematoonkologicka klinika

Bmo, 625 00, Czechia

Location

Fakultni nemocnice v Motole

Prague, 15006, Czechia

Location

Hôpital Jean Minjoz

Besançon, 25000, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

Hôpital Henri Mondor, Pharmacie

Créteil, 94010, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

CHRU Robert Debré

Paris, 75019, France

Location

Hopital Robert Debre

Paris, 75019, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Robert Debre - Service Pharmacie

Paris, 75935, France

Location

Charite Universitaetsmedizin

Berlin, 13353, Germany

Location

Clinical Trial Center North MediGate GmbH

Hamburg, 20246, Germany

Location

Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie

Hamburg, 20246, Germany

Location

Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH

Hamburg, 20246, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

Hamburg, 20246, Germany

Location

Universitatsklinikum Jena

Jena, 07740, Germany

Location

"Universitaetsklinikum Muenster,

Münster, 48149, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

UMC Utrecht, Wilhelmina Kinder Ziekenhuis

Utrecht, 3584 EA, Netherlands

Location

Klinika Hematologii i Transplantologii

Gdansk, 80-952, Poland

Location

NZOZ "HIPOKRATES-II" Sp. z o.o.

Krakow, 31-223, Poland

Location

Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej

Wroclaw, 50-345, Poland

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Infantil Niño Jesús

Madrid, 28009, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Huddinge, 141 86, Sweden

Location

Universitetssjukhuset i Lund, Barnonkologen Avd 64

Lund, 221 85, Sweden

Location

Karolinska University Hospital Huddinge

Stockholm, 141 86, Sweden

Location

Akademiska Sjukhuset, Infektionskliniken

Uppsala, 751 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 25870329 DERIVED

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 21, 2009
• Study Start: January 18, 2010
• Primary Completion: May 16, 2013
• Study Completion: May 16, 2013
• Last Updated: December 20, 2018
• Results First Posted: April 21, 2014

Record last verified: 2018-11

Locations

US (9); BE (5); NL (1); PL (3); CA (2); FR (8); DE (8); ES (4); SE (5); CZ (2)