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Vaccines, Pneumococcal Conjugate VaccinePhase 3NCT00980655

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

A Phase 3 study testing 13vPnC and 23vPS in people with Vaccines, Pneumococcal Conjugate Vaccine, run by Pfizer at 47 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Vaccines, Pneumococcal Conjugate Vaccine
What is being tested?
13vPnC and 23vPS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
47 sitesin 10 countries
Study dates
18 Jan 2010to 16 May 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

47 sites in 10 countries.

47 sites in 10 countries

United States9 sites

  • Texas Children's Hospital

    Houston, Texas, 77030

  • University of Kentucky

    Lexington, Kentucky, 40536

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

    New Hyde Park, New York, 11040

  • Columbia University Medical Center Research Pharmacy

    New York, New York, 10032

  • Columbia University Medical Center-Presbyterian Hospital Building

    New York, New York, 10032

  • Columbia University/Taub Institute Irving Center for Clinical Research

    New York, New York, 10032

  • New York-Presbyterian Morgan Stanley Children's Hospital

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

France8 sites

  • Hôpital Jean Minjoz

    Besançon, 25000

  • Hopital Henri Mondor

    Créteil, 94000

  • Hôpital Henri Mondor, Pharmacie

    Créteil, 94010

  • Hôpital Saint Louis

    Paris, 75010

  • CHRU Robert Debré

    Paris, 75019

  • Hopital Robert Debre

    Paris, 75019

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Robert Debre - Service Pharmacie

    Paris, 75935

Other trials in France

Germany8 sites

  • Charite Universitaetsmedizin

    Berlin, 13353

  • Clinical Trial Center North MediGate GmbH

    Hamburg, 20246

  • Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie

    Hamburg, 20246

  • Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH

    Hamburg, 20246

  • Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

    Hamburg, 20246

  • Universitatsklinikum Jena

    Jena, 07740

  • "Universitaetsklinikum Muenster,

    Münster, 48149

  • Universitaetsklinikum Muenster

    Münster, 48149

Other trials in Germany

Belgium5 sites

  • Universitair Ziekenhuis Gent

    Belgium, 9000

  • Algemeen Ziekenhuis St.-Jan A.V.

    Bruges, 8000

  • Clinical University St Luc

    Brussels, 1200

  • Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg

    Leuven, 3000

  • CHU Liege

    Liège, 4000

Other trials in Belgium

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Karolinska Universitetssjukhuset Huddinge

    Huddinge, 141 86

  • Universitetssjukhuset i Lund, Barnonkologen Avd 64

    Lund, 221 85

  • Karolinska University Hospital Huddinge

    Stockholm, 141 86

  • Akademiska Sjukhuset, Infektionskliniken

    Uppsala, 751 85

Other trials in Sweden

Spain4 sites

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario Infantil Niño Jesús

    Madrid, 28009

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Poland3 sites

  • Klinika Hematologii i Transplantologii

    Gdansk, 80-952

  • NZOZ "HIPOKRATES-II" Sp. z o.o.

    Krakow, 31-223

  • Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej

    Wroclaw, 50-345

Other trials in Poland

Canada2 sites

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Czechia2 sites

  • Fakultni nemocnice Brno/Interni hematoonkologicka klinika

    Bmo, 625 00

  • Fakultni nemocnice v Motole

    Prague, 15006

Other trials in Czechia

Netherlands1 site

  • UMC Utrecht, Wilhelmina Kinder Ziekenhuis

    Utrecht, 3584 EA

Other trials in Netherlands

About this study

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

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.

Being tested
13vPnC, 23vPS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 13vPnCBiological

    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.

  • 23vPSBiological

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

Study groups in NCT00980655
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Biological: 13vPnC; Biological: 23vPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

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

    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

    Measured: 1 month after 13vPnC Dose 3

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

    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

    Measured: 1 month after 13vPnC Dose 4

  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 3 in Pediatric and Adult 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. 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.

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

  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 4 in Pediatric, Adult and 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 4 were computed using the logarithmically transformed assay results. 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 4 blood draws.

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

  5. 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

    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. 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 after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2009 (estimated)
  2. Study start18 Jan 2010
  3. Primary completion16 May 2013
  4. Study completion16 May 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomised
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00980655
Sponsor's protocol ID
6115A1-3003
Other IDs
B1851022, 2009-012087-13, 2009
Status last verified
Nov 2018
First submitted
18 Sep 2009
Last updated
20 Dec 2018
Data monitoring committee
Yes

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.

    PubMed 25870329

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13vPnC and 23vPS in people with Vaccines, Pneumococcal Conjugate Vaccine, run by Pfizer at 47 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, France, Germany, Belgium, Sweden and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00980655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.

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