3003: PH 3, HIGH RISK RECIPIENTS OF ALLOGENEIC HSCT >/= 2 YR

• Register: EUCTR
• Last refreshed on: 22 July 2013
• Main ID: EUCTR2009-012087-13-CZ
• Date of registration: 21/03/2011
• Prospective Registration: Yes
• Primary sponsor: Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company
• Public title: 3003: PH 3, HIGH RISK RECIPIENTS OF ALLOGENEIC HSCT >/= 2 YR
• Scientific 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
• Date of first enrolment: 22/06/2011
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012087-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Open-label Trial Number of treatment arms in the trial: 1

Countries of recruitment

Belgium, Canada, Czech Republic, France, Germany, Netherlands, Poland, Spain, Sweden, United States

Contacts

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Centre
• Affiliation: Pfizer Inc

Key inclusion & exclusion 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 3 months after the last vaccination.
• Negative urine pregnancy test for all female subjects of child bearing potential.
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Pneumococcal infection
MedDRA version: 14.1 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Trade Name: Prevenar 13
Product Code: 13vPnC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal polysaccharide serotype 1
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 3
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 4
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 5
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 6A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 6B
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 8.8-
INN or Proposed INN: Pneumococcal polysaccharide serotype 7F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 9V
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 14
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 18C
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 19A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 4.4-
INN or Proposed INN: Pneumococcal polysaccharide serotype 19F
Concentration unit: µg/ml microgram(s)/milli

Primary Outcome(s)

Main Objective: To evaluate the immune responses 1 month after 3 doses of 13vPnC as measured by fold rises of serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in subjects =2 years of age.

Primary end point(s): The primary immunologic endpoint of interest is the serotype-specific mean IgG fold rise at 1 month after 3 doses of 13vPnC in subjects =2 years of age.

Secondary Objective: • To evaluate the immune responses 1 month after 3 doses of 13vPnC as measured by serotype-specific IgG GMCs in subjects =2 years of age.
• To evaluate the immune responses 1 month after 4 doses of 13vPnC as measured by serotype-specific IgG GMCs and fold rises of IgG GMCs in subjects =2 years of age.
• To evaluate the immune responses 1 month after 3 doses and 1 month after 4 doses of 13vPnC as measured by IgG GMCs and fold rise IgG GMCs in the pediatric subgroup (=2 to <18 years) and by serotype-specific IgG GMCs and fold rise IgG GMCs in the adult subgroup (=18 years).

Timepoint(s) of evaluation of this end point: Evaluate immune responses 1 month after 3 doses of 13vPnC as measured by fold rises in serotype-specific IgG geometric mean concentration (GMCs) in subjects > 2 years of age.

Secondary Outcome(s)

Secondary end point(s): IgG GMCs evaluated 1 month after 3 doses of 13vPnC and after 4 doses of 13vPnC for all subjects, adult (=18 years) and pediatric (=2 to <18 years), will be considered secondary endpoints. Additionally, evaluation of mean IgG fold rise in adults and pediatric subjects
1 month after 3 doses of 13vPnC and after 4 doses of 13vPnC will be considered secondary.

Timepoint(s) of evaluation of this end point: - Evaluate immune responses 1 month after 3 doses of 13vPnC as measured by fold rises in serotype-specific IgG geometric mean concentration (GMCs) in subjects > 2 years of age.
- Evaluate immune responses 1 month after 4 doses of 13vPnC as measured by serotype-specific IgG GMCs and fold rises of IgG GMCs in subjects > 2 years of age.
- Evaluate immune responses 1 month after 3 doses and 1 month after 4 doses of 13vPnC as measured by IgG GMCs and fold rise IgG GMCs in the pediatric subgroup ( >2 to <18 years) and by serotype-specific IgG GMCs in the adult subgroup >18 years).

Secondary ID(s)

B1851022(6115A1-3003-WW)

2009-012087-13-BE

Source(s) of Monetary Support

Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company