NCT01389687

Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 3 Months – 68 Months
• Healthy volunteers: Accepted

Summary

The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months. Primary objective: * To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV). Secondary objective: * To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination. * To describe the safety after each dose of IPV.

Detailed description

Study participants will receive three doses of inactivated polio vaccine (IPV) (at each visit and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. Subjects will be observed by the Investigator or sub-Investigator for 30 minutes following the vaccine injection. The duration of each participant's participation in the trial will be approximately 1 year.

Conditions

• Poliomyelitis
• Polio

Interventions

Type	Name	Description
BIOLOGICAL	Inactive Poliovirus Vaccine	0.5 mL, Subcutaneous

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-07-08
• Last updated: 2013-03-29

Locations

2 sites across 1 country: Japan