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

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389687
• Other study ID #: IPV35 (EFC12403)
• Secondary ID: U1111-1120-1735
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2011
• Last updated: March 28, 2013
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 68 Months

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Polio
• Poliomyelitis

Intervention

Biological:
• Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination	Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.	1 month post-vaccination 3	No
Secondary	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	No
Secondary	Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV	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.	Day 0 up to 12 months post-vaccination	No
Secondary	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.	Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.	1 month post-booster vaccination	No

External Links

•   Link
•   Link