PILOT: Characterization of the Prevnar Infant Long-Term Immune Response Versus a Prevnar-Naïve Cohort

Wyeth Pharmaceuticals, Inc. Acting through its division Wyeth Research, a Pfizer Company0 个研究点目标入组 75 人开始时间: 2015年4月9日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•1.Fully vaccinated per-protocol (4 doses of vaccine given at 2, 4, 6, and 12-15 months of age) subjects enrolled in the Prevnar group of study D118-P8, or fully vaccinated per-protocol subjects from the control group of the same study who did not receive Prevnar after the close of study D118-P8, or at any time following the study.
•2.Enrolled in the Northern California Kaiser Permanente (NCKP) health plan.
•3.Subjects included in either group above 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: 75
•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.Previous receipt of pneumococcal polysaccharide vaccine.
•2.Documented recurrent otitis media or any occurrence of pneumococcal pneumonia within the past 12 months prior to enrollment. The definition of recurrent otitis media is three or more episodes of acute otitis media within 6 months or four episodes within 12 months.
•3.History of documented IPD (defined as a positive culture of Streptococcus pneumoniae from a normally sterile body site).
•4.Known or suspected disease or dysfunction of the immune system, including: Human immunodeficiency virus (HIV) infection, malignancy, receipt of immunosuppressive therapy (excluding children who have a short course (up to 10 days) of prednisone within one week prior to study vaccine administration), sickle cell hemoglobinopathy.
•5.Concomitant vaccination during the study period.
•6.Known hypersensitivity to any component of Prevnar.
•7.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.
•8.Receipt of immune globulin within the past 3 months. Positive pregnancy test for female subjects.
•9.Female subjects who are breastfeeding.
•10.For control subjects, previous receipt of Prevnar at any time.
•11.Unwillingness to avoid the use of herbal supplements during the study period through day 28 (does not include vitamins).

发起方

Wyeth Pharmaceuticals, Inc. Acting through its division Wyeth Research, a Pfizer Company