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

Phase 3

Completed

• Conditions: Poliomyelitis; Polio
• Interventions: Biological: Inactive Poliovirus Vaccine

• Registration Number: NCT01389687
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-06
• Study First Posted: 2011-07-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-28
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion
• 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

Exclusion Criteria

• Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
• Any serious disease whether acute or chronic
• History of poliomyelitis infection
• History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
• History of anaphylaxis or allergy to any of the study vaccine components
• Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine
• Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
• Participation in another clinical trial preceding the trial inclusion
• Planned participation in another clinical trial during the present trial period
• Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins).
• Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination.
• Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
• Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection
• Subject ineligible according to the investigator's clinical judgment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Inactive Poliovirus Vaccine	-

Primary Outcome Measures

Name	Time	Method
A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination	1 month post-vaccination 3	Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.

Secondary Outcome Measures

Name	Time	Method
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.	Day 0 and 1 month post-vaccination
Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV	Day 0 up to 12 months post-vaccination	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.	1 month post-booster vaccination	Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.