EUCTR2009-015175-27-NL
Active, not recruiting
Not Applicable
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 sitesOctober 29, 2009
Drugspoliomyelitisvaccin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- etherlands Vaccine Institute
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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