Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
2 other identifiers
interventional
60
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2013
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
March 30, 2015
CompletedMarch 30, 2015
March 1, 2015
9 months
December 3, 2013
March 17, 2015
March 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
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.
Day 28 post-vaccination
Secondary Outcomes (4)
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
Study Arms (1)
Study Group
EXPERIMENTALParticipants will receive one booster dose of SP059 (IMOVAX POLIO®)
Interventions
0.5 mL, Subcutaneous
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Fukuoka, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Mie, Japan
Unknown Facility
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 9, 2013
Study Start
December 1, 2013
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
March 30, 2015
Results First Posted
March 30, 2015
Record last verified: 2015-03