Evaluation of the Immunogenicity of Low Dose Trivalent Inactivated Influenza Vaccine in Healthy Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 11
研究概览
简要总结
It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season. One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults. The objective of this study is to determine if the immune system responds to a half-dose the same way it responds to a whole dose. This study will use the currently approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.
If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose, this could be a strategy to extend the amount of vaccine that could be available in this age group.
详细描述
Eligible subjects will be randomized to receive a single intramuscular injection of either a half-dose or a whole dose of a currently approved influenza virus vaccine in their arm. Prior to vaccination, subjects will have one tube of blood drawn. Subjects will be given a 3-day diary card to record any symptoms they may experience and asked to return for a second and final visit approximately 21 days following vaccination. A second blood draw will be done.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers may be eligible for this trial if they:
- •Are able to and have given informed consent.
- •Are able to understand and comply with all study procedures and to complete study diary.
- •Are aged 18 to 49 years.
- •Are female, and are not pregnant.
- •Are available for all study visits.
排除标准
- •Volunteers will not be eligible for this trial if they:
- •Are allergic to eggs or egg products.
- •Have a current chronic medical condition for which influenza vaccine is normally recommended.
- •Have received experimental vaccines or medications within 30 days of study entry.
- •Have received parenteral immunoglobulin within 30 days of study entry.