NCT01708720

Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults

Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Pauline Verdijk · Other Government
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
DRUG	IPV
DRUG	Sabin-IPV
DRUG	Adjuvanted Sabin-IPV

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-09-01
• Completion: 2012-02-01
• First posted: 2012-10-17
• Last updated: 2014-02-21

Locations

1 site across 1 country: Poland