Safety and Immunogenicity of a New Inactivated Polio Vaccine 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.
Drug: Adjuvanted Sabin-IPV
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults|
- Number of adverse reactions following vaccination [ Time Frame: 4 days or until adverse reactions have resolved ] [ Designated as safety issue: Yes ]
- Level of virus neutralizing titers in serum [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, and 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose
Experimental: Adjuvanted Sabin-IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, and 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose, adjuvanted with 0.5 mg aluminium hydroxide
|Drug: Adjuvanted Sabin-IPV|
Active Comparator: IPV
Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose
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.
|Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.|
|Study Director:||Pauline Verdijk, PhD||Institute for Public Health and the Environment|