EUCTR2009-011564-11-Outside-EU/EEA进行中（未招募）不适用
A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 2 and 3 Doses of 13-valent Pneumococcal Conjugate Vaccine in Human Immunodeficiency Virus-Infected Subjects 6 Years of Age and Older Who Have Not Been Previously Immunized With Pneumococcal Vaccine
Wyeth Pharmaceuticals Inc. (a Pfizer Company)0 个研究点目标入组 300 人开始时间: 2012年1月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female subjects aged 6 years or older at the time of enrollment.
- •2.HIV-infection with viral load <50,000 copies/mL obtained on the most recent 2 occasions within 6 months before article administration.
- •3.CD4+ T cell count = 200 cells/µL obtained on the most recent 2 occasions within 6 months before test article administration.
- •4.Receiving stable dose of HAART for at least 6 weeks before test article administration, or not currently receiving any antiretroviral therapy.
- •5.Subject is naïve to any licensed or experimental pneumococcal vaccine.
- •6.Determined by medical history, physical examination, and clinical judgment to be eligible for the study. (Note: Subjects with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before test article administration, are eligible.)
- •7.Subject or their parent/legal guardian, if appropriate, must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.
- •8.Subject is available for the entire study period (approximately 8 months), and who themselves or, where appropriate, whose parent/legal guardian can be contacted by telephone throughout the study.
- •9.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 from the signing of the informed consent form (ICF) until 3 months after the last dose of test article. A subject is biologically capable of having children even if he or she is using contraceptives, or if his or her sexual partner is sterile or using contraceptives.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1.Subject with active immune deficiency syndrome (AIDS) related illness, including opportunistic infections or malignancy.
- •2.Current illicit substance and/or alcohol abuse.
- •3.History of active chronic viral hepatitis with biochemical evidence of AST or ALT values greater than 5 times higher than the upper limit of normal within 6 months before enrollment.
- •4.Previous anaphylactic reaction to any vaccine or vaccine-related component.
- •5.History of culture-proven invasive disease caused by Streptococcus pneumoniae within 12 months before enrollment.
- •6.In the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm due to insufficient muscle mass.
- •7.Pregnant or breastfeeding females, as defined by history or by positive human chorionic gonadotropin (hCG) urine test. A urine pregnancy test must be performed prior to vaccination for all female subjects who are post-menarche and who are not surgically sterile or post-menopausal (>1 year).
- •8.Subject who is a direct relative (child, grandchild, parent or grandparent) of a study personnel, or is a study personnel.
- •9.Current residence in a nursing home, long-term care facility or other similar institution, or requirement of semi-skilled nursing care. (Note: An ambulatory subject who is a resident of a retirement home or village is eligible for the trial.)
- •10.Evidence of dementia or other severe cognitive impairment.
- •11.Current anticoagulant therapy or a history of bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection (Note: use of antiplatelet drugs such as aspirin and clopidogrel are permitted.)
- •12.Receipt of any blood products, including immunoglobulin, within 42 days before test article administration until the last blood draw for the study (approximately 4 months after the first test article administration).
- •13.Use of immunosuppressive agents, to include systemic corticosteroids and cancer chemotherapeutic agents. Use of systemic corticosteroids for 14 days or more is considered immunosuppressive. (Note: such individuals are not eligible to receive test article until at least 28 days after systemic corticosteroid therapy has been discontinued, or for immunosuppressive agents other than corticosteroids, at least 28 days after levels have been reached that are not associated with immunosuppression. Corticosteroids administered by other routes such as by inhalation, topically or intra-articularly are permitted.)
- •14.Serious chronic disorders or any other disorders that in the investigator’s opinion precludes the subject from participating in the study. (Note: serious chronic disorders include metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease.)
- •15.Participation in another study using an investigational product from 28 days before study enrollment until the end of the study. (Note: participation in purely observational studies is acceptable.)
- •16.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.
- •17.Any major illness/condition that, in the investigator’s judgment, could preclude the evaluation of the subject’s response to vaccination.
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