Clinical trial NCT01389687: Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Official title: Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Poliomyelitis
Polio
Keywords: Poliomyelitis
Inactivated polio vaccine
Polio
Poliovirus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 74
Sex: ALL
Minimum age (years): 3
Maximum age (years): 68
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination
timeFrame: 1 month post-vaccination 3
Secondary outcomes:
measure: 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.
timeFrame: Day 0 and 1 month post-vaccination
measure: Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV
timeFrame: Day 0 up to 12 months post-vaccination
measure: 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.
timeFrame: 1 month post-booster vaccination
Other outcomes:
Locations:
city: Fukui City
country: Japan
state: Fukui Prefecture
city: Sapporo City
country: Japan
state: Hokkaido
Study officials:
affiliation: Sanofi Aventis K.K.
name: Medical Director
role: STUDY_DIRECTOR
References: