Safety of Imovax Polio in Chinese Infants and Children

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Treatments

Biological: Inactivated Poliomyelitis vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00258843

IPV17

Details and patient eligibility

About

To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.

Enrollment

40 patients

Sex

All

Ages

2 to 18 months old

Volunteers

Accepts Healthy Volunteers

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