Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
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.
- 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).
- 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan|
- A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination [ Time Frame: 1 month post-vaccination 3 ] [ Designated as safety issue: No ]Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.
- Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination. [ Time Frame: Day 0 and 1 month post-vaccination ] [ Designated as safety issue: No ]
- Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV [ Time Frame: Day 0 up to 12 months post-vaccination ] [ Designated as safety issue: No ]Solicited injection site: Tenderness (3 to 23 months); Pain (2 to 11 years), Redness, and Swelling. Solicited Systemic reaction: 3 to 23 month olds: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability: 2 to 11 year olds: Fever (Temperature), Headache, Malaise, and Myalgia.
- Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination. [ Time Frame: 1 month post-booster vaccination ] [ Designated as safety issue: No ]Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.
|Study Start Date:||July 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Experimental: Study Group||
Biological: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Other Name: SP059
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389687
|Fukui City, Fukui Prefecture, Japan|
|Sapporo City, Hokkaido, Japan|
|Study Director:||Medical Director||Sanofi Aventis K.K.|