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临床试验/NCT00500266
NCT00500266已完成3 期

A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment

Pfizer59 个研究点 分布在 2 个国家目标入组 1,053 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
1,053
试验地点
59
主要终点
Percentage of Participants With Pre-specified Local Reactions

研究概览

简要总结

To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
68 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of Participants With Pre-specified Local Reactions

时间窗: Days 1 through 14

Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters\[cm\]); moderate(5.1-10.0 cm); severe(\>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.

Percentage of Participants With Pre-specified Systemic Events

时间窗: Days 1 through 14

Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(\>=38 degrees Celsius\[C\]), chills, rash, vomiting(mild:1-2 times daily; moderate:\>2 times daily; severe:prevents daily activity) decreased appetite \& diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:\>=6 loose stools/day) reported. Participants may be represented in \>1 category.

Percentage of Participants Taking Pain or Antipyretic Medication

时间窗: Days 1 through 14

Use of pain or antipyretic medication was collected by the participants using an electronic diary.

次要结局

未报告次要终点

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (59)

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