Study of SP059 Given Subcutaneously as a Three-Dose Primary and Booster Vaccination in Infants in Japa
- Conditions
- PoliomyelitisTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-005187-42-Outside-EU/EEA
- Lead Sponsor
- Sanofi Aventis K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 74
1) Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion
2) Informed consent form signed by the parent(s) or other legal representative
3) Able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 74
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Fever = 37.5°C (axillary temperature) on the day of inclusion
2) Any serious disease whether acute or chronic
3) History of poliomyelitis infection
4) History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
5) History of anaphylaxis or allergy to any of the study vaccine components
6) Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine
7) Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
8) Participation in another clinical trial preceding the trial inclusion
9) Planned participation in another clinical trial during the present trial period
10) Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins).
11) Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination.
12) Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
13) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection
14) Subject ineligible according to the investigator's clinical judgment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1) 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).<br>;Secondary Objective: 1) 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.<br>2) To describe the safety after each dose of IPV.<br><br>;Primary end point(s): 1) A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination.;Timepoint(s) of evaluation of this end point: 1 month post-vaccination 3
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) 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<br>2) Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV<br>3) 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;Timepoint(s) of evaluation of this end point: 1) Day 0 and 1 month post-vaccination<br>2) Day 0 up to 12 months post-vaccination<br>3) 1 month post-booster vaccination