Immunogenicity and safety of intradermal injection of reduced dose Inactivated Poliovirus vaccine (IPV) with a jet injector in healthy adults
- Conditions
- infantile paralysispolio10047438
- Registration Number
- NL-OMON32437
- Lead Sponsor
- ederlands Vaccin Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
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 National Immunization Programme 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
Any of the following criteria will exclude a volunteer from participation, at start of this study:
•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
•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
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The level of neutralizing antibodies in serum and the number and intensity of<br /><br>local and systemic adverse reactions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The number of B-lymphocytes producing IPV-specific IgA in blood and the level<br /><br>of poliovirus specific IgA antibodies in saliva.</p><br>