Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly

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

Inclusion Criteria:

• Inclusion Criteria to be checked at the screening visit (SC):
• Aged 0 to 7 days on the day of screening
• Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
• Informed consent form signed by the parent(s) or other legally acceptable representative
• Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
• Inclusion Criteria to be checked at the randomization visit (V01):
• Aged 42 to 50 days on the day of inclusion
• Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures

Exclusion Criteria:

• Exclusion Criteria to be checked at the screening visit (SC):
• Planned participation in another clinical trial during the present trial period
• Illness that could interfere with trial conduct or completion, in the opinion of the investigator
• Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
• History of seizures
• Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
• Thrombocytopenia or bleeding disorder contraindicating IM injection
• Exclusion Criteria to be checked at the randomization visit (V01):
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
• Planned participation in another clinical trial during the present trial period
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
• Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
• Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except BCG, DTP-Hib or Hepatitis B vaccines, which can not be given within 10 days before or after any study vaccination)
• History of seizures
• Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
• History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
• Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
• Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection
• Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment