Poliomyelitis Clinical Trial
Official title:
Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults
The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that
only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that
contains the 3 serotypes of polio). This safety evaluation will be done in young adults.
If the study vaccine appears to be safe, it will be tested at a later stage in the target
group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the
purpose is to use the study vaccine in the future to protect young children against Polio
serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young
children to come to a complete eradication of Polio is needed. The standard use of Imovax to
protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio
vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has
been developed.
The duration of the study will be approximately 6 months. 120 subjects between 18 and 45
years of age will participate in Belgium.
During the study there will be 2 groups of subjects. Subjects will be assigned by chance to
one of these groups. One group will receive one single injection of the study vaccine m-IPV2
HD (which contains only serotype 2), the other group will receive one single injection of
the standard polio vaccine IPV, Imovax (which contains the 3 serotypes).
After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked
to come to the study centre one more time for the second visit (on Day 8, which is 7 days
after the first visit). They will also receive 2 follow-up phone calls for approximately one
month and 6 months after vaccination.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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