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

Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 224 人开始时间: 2009年2月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•7. Receipt of either PPV23 or PCV7 since the completion of the D139-P506 study

发起方

Wyeth Research Division of Wyeth Pharmaceuticals Inc.