Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
Drug: Adjuvanted Sabin-IPV
|Study Design:||Allocation: Randomized
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 ]
- Level of virus neutralizing titers in serum [ Time Frame: 28 days ]
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708720
|Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.|
|Study Director:||Pauline Verdijk, PhD||Institute for Public Health and the Environment|