Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine 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.

Inclusion criteria

• Age 8 weeks (56-63 days) at the time of first vaccination
• Infants in good general health, eligible to be vaccinated according to the Polish national vaccination program. The same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with a small increase in temperature (< 38.5° C) or with a common cold (runny nose etc) are seen as children with normal health.
• The parent(s)/legally representative(s) have to be willing and able to allow their child to participate in the trial according to the described procedures
• Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of single-parent family).

Exclusion criteria

• Any IPV or OPV dose
• Known or suspected allergy against any of the vaccine components
• History of unusual or severe reactions to any previous vaccination administration of plasma (including immunoglobulins) or blood products prior and during the study
• Any vaccination less than 14 days before or after each vaccination with the IMP
• History of any neurological disorder including epilepsy or febrile seizures
• Any infectious disease at the time of screening and/or inclusion that might interfere with the results of the study
• Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolones, that might interfere with the results of the study
• Any known or suspected primary or secondary immunodeficiency
• Communication problems interfering in the study realization according to the judgment of the investigator
• Bleeding disorders and use of anticoagulants
• Premature birth (<37 weeks)
• Participation in another clinical trial