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

Phase 1

Conditions: Pneumococcal infection
MedDRA version: 12.0Level: LLTClassification code 10061353Term: Pneumococcal infection

Registration Number: EUCTR2009-012087-13-FR

Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 247

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.
•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.
•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 for 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>•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.<br>•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).

Secondary Outcome Measures

Name	Time	Method

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