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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Polio

Treatments

Biological: Inactive Poliovirus Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01389687

IPV35 (EFC12403)

U1111-1120-1735 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

3 to 68 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.