Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT01708720|
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : February 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Poliomyelitis||Drug: IPV Drug: Sabin-IPV Drug: Adjuvanted Sabin-IPV||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||February 2012|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708720
|Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.|
|Study Director:||Pauline Verdijk, PhD||Institute for Public Health and the Environment|