Poliomyelitis Clinical Trial
Official title:
Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive
Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.
Primary Objective:
- To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3
one month following the vaccination dose with SP059 as 2nd booster
Secondary Objectives:
- To investigate seroprotection rates (percentage of subjects presenting poliovirus
neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points,
Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of
individual titer ratio (GMTR).
- To investigate the safety after dosing of SP059 as 2nd booster.
Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age
from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination)
and at 4-6 weeks post- vaccination.
Safety data including serious adverse events (SAEs) after vaccination will be collected
during the study period.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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