Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults (IPV-004)

This is an interventional prevention trial for Poliomyelitis focused on measuring Poliomyelitis, Vaccine Read More

Inclusion Criteria:

• Healthy adults 18-45 years of age
• Subjects born in Belgium or any other country where mandatory polio vaccination is performed.
• Written informed consent obtained from the subject.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  1. has practiced adequate contraception for 30 days prior to vaccination, and
  2. has a negative pregnancy test on the day of vaccination, and
  3. has agreed to continue adequate contraception for 2 months after vaccination.

Exclusion Criteria:

• Participation in another clinical trial.
• Any polio vaccine within 6 months before study inclusion.
• Any other vaccination in the period starting 14 days before administration of study vaccine and ending 28 days after administration of the study vaccine.
• Previous severe reaction after vaccination with polio vaccine.
• Known hypersensitivity to one or more components of the vaccine.
• Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
• Subjects with an history of malignant disease (cancer)
• Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
• Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
• Pregnant or lactating female. Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.
• Known hypersensitivity to one or more components of the vaccine.
• Uncontrolled, clinically significant neuro-psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic or endocrine disease.
• Subjects with an history of malignant disease (cancer)
• Known human immunodeficiency virus (HIV) positivity or other immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of <20 mg/day, or equivalent, is allowed. Inhaled and topical corticosteroids are allowed.
• Acute disease and/or fever (higher or equal to 37.5°C, measured orally) at the time of enrolment. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory tract infection) without fever may be enrolled at the discretion of the investigator.
• Pregnant or lactating female.
• Subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate for any other reason.