The vaccine in this healthy volunteer trial is indicated to prevent poliomyelitis.
Conditions
Interventions
Trade Name: poliomyelitisvaccin
Pharmaceutical Form: Suspension for injection
Sponsors
Netherlands Vaccine Institute
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •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. ;Exclusion criteria: •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For global eradication of poliomyelitis Inactivated Poliovirus Vaccine (IPV) vaccine needs to become available for developing countries. This requires a lower price and increased availability of vaccine doses. Antigen sparing by reducing the dose to one-fifth of the standard dose will have a positive effect on both. Changing the route of administration from intramuscular to intradermal may improve the immunogenicity of IPV and thereby allow this degree of dose reduction. By using a jet injector instead of a needle and syringe, administration will be both needle-free and need little training, making it especially suitable for developing counties. Primary objective is to compare the immunogenicity and safety (local and systemic reactions) of a reduced dose intradermal IPV (NVI) booster vaccination administered with a jet injector to a standard full dose intramuscular IPV (NVI) booster vaccination administered with a needle and syringe. ;Secondary Objective: Secondary objectives are: 1) to evaluate the safety (local and systemic reactions) and immunogenicity of a full dose intramuscular IPV (NVI) booster vaccination administered with a jet injector compared with a standard full dose intramuscular IPV (NVI) booster vaccination administered with a needle and syringe. 2) to compare the immunogenicity of a reduced dose IPV (NVI) booster after dermal and intramuscular vaccination ;Primary end point(s): The primary endpoint for immunogenicity in this clinical trial is the level of neutralizing antibodies in serum (geometric mean titer (GMT)) at 28 days after vaccination. The primary endpoint for safety is the number of adverse reactions and the number and intensity of local and systemic vaccination site reactions. ;Main Objective: For global eradication of poliomyelitis Inactivated Poliovirus Vaccine (IPV) vaccine needs to become available for developing countries. This requires a lower price and increased availability of vaccine doses. Antigen sparing | — |
Countries
Netherlands
Contacts
Public Contact; ;
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Outcome results
None listed