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
- Conditions
- The vaccine in this healthy volunteer trial is indicated to prevent poliomyelitis.
- Registration Number
- EUCTR2009-015175-27-NL
- Lead Sponsor
- etherlands Vaccine Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
•IPV booster dose after 10 years of age
•OPV dose
•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
•Pregnancy
•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
•OPV dose
•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
•Pregnancy
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method