EUCTR2009-015175-27-NL进行中（未招募）不适用
Immunogenicity and safety of intradermal injection of reduced dose Inactivated Poliovirus vaccine (IPV) with a jet injector in healthy adults - Intradermal injection of reduced dose IPV in adults
etherlands Vaccine Institute0 个研究点开始时间: 2009年10月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Subjects have to fulfill all of the following criteria:
- •Age = 18 years
- •Good health according to the investigator
- •Must have received in total 6 combined DTP-IPV vaccinations according to the NIP as a child (before 11 years of age) and must not have received any polio vaccination since then.
- •Willingness and ability to adhere to the study regimen
- •Having a signed informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •Subjects have to fulfill all of the following criteria:
- •Age = 18 years
- •Good health according to the investigator
- •Must have received in total 6 combined DTP-IPV vaccinations according to the NIP as a child (before 11 years of age) and must not have received any polio vaccination since then.
- •Willingness and ability to adhere to the study regimen
- •Having a signed informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
排除标准
- •IPV booster dose after 10 years of age
- •Known or suspected allergy against any of the vaccine components
- •History of unusual or severe reactions to any previous vaccination
- •Known or suspected disease or use of medication that may influence the immune system
- •Administration of plasma or blood products three months prior to the study
- •Any vaccination within one month prior to the study
- •History of any neurological disorder including epilepsy or febrile seizures
- •Evidence of excessive alcohol use or drug use
- •Females not willing to use contraceptives during the first 28 days following vaccination, or if breastfeeding
- •Any infectious disease
- •The exclusion criteria for blood collection are:
- •Bleeding disorders or the usage of anticoagulants
- •Delay criteria
- •If body temperature = 38.0°C this will lead to postponement of participation. Screening may continue when the temperature has normalized.
- •IPV booster dose after 10 years of age
- •Known or suspected allergy against any of the vaccine components
- •History of unusual or severe reactions to any previous vaccination
- •Known or suspected disease or use of medication that may influence the immune system
- •Administration of plasma or blood products three months prior to the study
- •Any vaccination within one month prior to the study
- •History of any neurological disorder including epilepsy or febrile seizures
- •Evidence of excessive alcohol use or drug use
- •Females not willing to use contraceptives during the first 28 days following vaccination, or if breastfeeding
- •Any infectious disease
- •The exclusion criteria for blood collection are:
- •Bleeding disorders or the usage of anticoagulants
- •Delay criteria
- •If body temperature = 38.0°C this will lead to postponement of participation. Screening may continue when the temperature has normalized.
研究者
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