The purpose of this trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.
The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI). * The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human). * The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
45
Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.
Krakow, Poland
Number of adverse reactions following vaccination
Time frame: 4 days or until adverse reactions have resolved
Level of virus neutralizing titers in serum
Time frame: 28 days
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