Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan (IPV46)

Sanofi K.K.0 sites60 target enrollmentApril 19, 2016

Overview

No summary available.

Registry

who.int

Start Date

April 19, 2016

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Aged 4 to 6 years inclusive on the day of inclusion
•\- Subjects who received 4 times an IPV\-containing vaccine (DTaP\-IPV or IPV) during first (3 doses) and second year of life (one dose)
•\- Informed consent form signed by the parent(s) or other legal representative
•\- Able to attend all scheduled visits and to comply with all trial procedures
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•\- Fever \= 37\.5°C (axillary temperature) on the day of inclusion
•\- Any serious disease whether acute or chronic
•\- Past or current medical history of Guillain\-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
•\- History of poliomyelitis infection
•\- History of a life threatening reaction to a vaccine containing the same substances of the study vaccine (Inactivated poliovirus types 1, 2, and 3, 2\-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
•\- History of anaphylaxis or allergy to any of the study vaccine components ((Inactivated poliovirus types 1, 2, and 3, 2\-Phenoxyethanol, Formaldehyde, M199 Hanks medium)
•\- Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long\-term systemic corticosteroids therapy\*
•\- Participation in another clinical trial within 6 months before the trial inclusion\*\*
•\- Planned participation in another clinical trial during the present trial period
•\- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw