NCT02005536

Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Poliomyelitis
• Polio

Interventions

Type	Name	Description
BIOLOGICAL	IMOVAX POLIO®: Inactive Poliovirus Vaccine	0.5 mL, Subcutaneous

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2013-12-09
• Last updated: 2015-03-30
• Results posted: 2015-03-30

Locations

4 sites across 1 country: Japan