Poliomyelitis Clinical Trial
Official title:
Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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