poliomyelitis, polio, vaccination, vaccinatie, intradermal, intradermaal, jet injector, needle-free, naaldloos
Conditions
Interventions
Vaccination with inactivated poliomyelitis vaccine (IPV):
1. Reference: 0.5 ml of IPV intramuscular injection with needle and syringe
2. Group A: 0.5 ml of IPV intramuscular injection with jet injector
3. Group B: 0.1 ml of IPV intramuscular injection with needle and syringe
4. Group C: 0.1 ml of IPV intradermal with jet injector.
Sponsors
Netherlands Vaccine Institute
RIVM, formerly Nederland Vaccine, Institute (NVI)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ¡Ý 18 years; 2. Good health according to the investigator; 3. 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.
Exclusion criteria
Exclusion criteria: 1. IPV booster dose after 10 years of age; 2. OPV dose; 3. Known or suspected allergy against any of the vaccine components; 4. History of unusual or severe reactions to any previous vaccination; 5. Known or suspected disease or use of medication that may influence the immune system; 6. History of any neurological disorder including epilepsy or febrile seizures; 7. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety of injection of IPV with jet injector and of intradermal injection of IPV (local and system reactions); 2. Immunogenicity of intradermal injection of reduced dose IPV versus intramuscular injection of full dose IPV (neutralizing antibody titers in serum). | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity (Neutralizing IgA titers) in saliva and the number of poliospecific IgA-producing B cells in peripheral blood. | — |
Contacts
Public ContactD. Soonawala
P.O. Box 9600
Outcome results
None listed