Pneumococcal infection MedDRA version: 14.1 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
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
Sponsors
Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company
Eligibility
Sex/Gender
All
Inclusion 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: 150 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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 2 years of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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). | — |
Countries
Belgium, Canada, Czech Republic, France, Germany, Netherlands, Poland, Spain, Sweden, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc
Outcome results
None listed