Revaccination with Pneumococcal Conjugate Vaccine - Characterization of the Immune Response after Polysaccharide (REPLAY) - REPLAY

Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 sites224 target enrollmentFebruary 16, 2009

Overview

No summary available.

Registry

who.int

Start Date

February 16, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

•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

•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
•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