NCT00269672已完成2 期
A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 915 人开始时间: 2005年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 915
- 主要终点
- Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
研究概览
简要总结
There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adults 65 years of age and older.
- •Determined by medical history, physical examination, and clinical judgment to be eligible for the study.
- •Expected to be available for the duration of the trial (up to approximately 13 months).
排除标准
- •Received previous immunization with 23vPS.
- •Serious chronic disorders including metastatic malignancy
- •Known or suspected hypersensitivity to any vaccine or vaccine components
结局指标
主要结局
Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
次要结局
- Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
- Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.
研究者
相似试验
已完成
1 期
Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected AdultsHIV InfectionsNCT01578889National Institute of Allergy and Infectious Diseases (NIAID)100
已完成
2 期
Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk MelanomaHigh-Risk MelanomaNCT00273910National Cancer Institute (NCI)104
终止
2 期
Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver MetastasesColon CancerNCT01505166Gradalis, Inc.3
终止
1 期
Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic VaccineHealthy SubjectsNCT00562237Solvay Pharmaceuticals400
已完成
2 期
A Study of An Adjuvanted Inactivated H7N9 Influenza VaccineH7N9 InfluenzaNCT03755427Shanghai Institute Of Biological Products560