A new inactivated polio vaccine based on attenuated poliovirus strains was developed to transfer the technology to manufacturers in low- and middle-income countries. This vaccine was produced in different dosages and in different formulations. In healthy adults the safety of the highest dose was comparable to that of the existing inactivated polio vaccine. The purpose of this trial is to determine the safety of the different dosages and formulations of the vaccine in infants. The second goal of this study is to analyse the immune response after three doses in infants.
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 infants. * The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and adjuvanted Sabin-IPV in infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
NZOZ Centrum Zdrowia "Błonie"
Bydgoszcz, Poland
Specjalistyczna Poradnia Medyczna "Przylądek Zdrowia"
Krakow, Poland
Szpital im. Jana Pawła II
Krakow, Poland
Samodzielny Publiczny ZOZ
Lubartów, Poland
Number of adverse reactions following vaccination
Time frame: 5 days or until adverse reactions have resolved
Level of virus neutralizing titers in serum
Time frame: 28 days after last vaccination
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NZOZ Praktyka Lekarza Rodzinnego "Eskulap"
Lublin, Poland
NZLA Michałkowice Jarosz i Partnerzy Spółka Lekarsk
Siemianowice Śląskie, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp z o.o.
Tarnów, Poland