NCT02005536CompletedPhase 4
Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
Sanofi Pasteur, a Sanofi Company4 sites in 1 country60 target enrollmentStarted: December 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Study Overview
Brief Summary
The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.
Primary Objective:
- To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster
Secondary Objectives:
- To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR).
- To investigate the safety after dosing of SP059 as 2nd booster.
Detailed Description
Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination.
Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 4 to 6 years inclusive on the day of inclusion
- •Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
- •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
- •Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
- •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
- •Congenital or current/previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Participation in another clinical trial within 6 months before the trial inclusion
- •Planned participation in another clinical trial during the present trial period
- •Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- •Received antipyretics/analgesics/Non-steroidal anti-inflammatory drugs (considered as a single category) within 4 hours prior to vaccination
- •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 trial vaccination
- •Any vaccination with inactivated vaccines within the past 6 days preceding the trial vaccination
- •Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- •Subject ineligible according to the Investigator's clinical judgment.
Outcomes
Primary Outcomes
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Time Frame: Day 28 post-vaccination
A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
Secondary Outcomes
- Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®(Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination)
- Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®(Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination)
- Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®(Day 28 post-booster vaccination)
- Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®(Day 0 up to Day 7 post-vaccination)
Investigators
Study Sites (4)
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