Invasive pneumococcal disease MedDRA version: 9.1 Level: LLT Classification code 10061353 Term: Pneumococcal infection
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fully vaccinated children who participated in the D139-P506 study and received a booster dose of either PPV23 or PCV per the original protocol 2. Subjects must be in good health as determined by medical history, physical examination and clinical judgment Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to any component of PCV7 or PCV13 2. History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site) 3. Any known or suspected disease or dysfunction of the immune system, including but not limited to: • HIV infection • Malignancy • Receipt of immunosuppressive therapy • Sickle cell hemoglobinopathy • Diabetes 4. Concomitant vaccination during study period (see Concomitant Treatment) 5. Receipt of immune globulin within the past 3 months 6. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response 7. Receipt of either PPV23 or PCV7 since the completion of the D139-P506 study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the immune response by ELISA and OPA at approximately one month after vaccination to a single dose of PCV13 challenge in children vaccinated with a primary series (3 or 2 doses) of PCV followed by a booster dose of either PCV or PPV23;Primary end point(s): The coprimary endpoints for each of the pneumococcal serotypes are the proportions of subjects achieving a serotype-specific IgG antibody concentration 0.35µg/mL by ELISA and a titre =1:8 by OPA.;Secondary Objective: • To describe the immune response by avidity assay to a single dose of PCV13 challenge in children previously vaccinated with a primary series (3 or 2 doses) of PCV followed by a booster dose of either PCV or PPV23 • To describe the kinetics of the immune response over the entire observation period after a single dose of PCV13 challenge in children previously vaccinated with a primary series (3 or 2 doses) of PCV followed by a booster dose of either PCV or PPV23 • To evaluate the safety profile of PCV13 as measured by the occurrence of serious adverse events (SAEs), adverse events (AEs), and solicited local and systemic reactions in the two groups. | — |
Countries
Iceland
Outcome results
None listed