Safety of Imovax Polio in Chinese Infants and Children
Poliomyelitis
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring IMOVAX;, poliomyelitis
Eligibility Criteria
Inclusion Criteria: Group 1: Aged 18 months (18-20 months) on the day of inclusion Group 2: Aged 2 months (56-70 days) on the day of inclusion Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2) Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2) Vaccination planned in the 4 weeks following the trial vaccination Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1
Group 2
Children at 18 months of age
Infants at 2 months of age