Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
NCT ID: NCT01389687
Last Updated: 2013-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
74 participants
INTERVENTIONAL
2011-07-31
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Group
Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent form signed by the parent(s) or other legal representative
Exclusion Criteria
* 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.
3 Months
68 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Aventis K.K.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fukui-shi, Fukui, Japan
Sapporo, Hokkaido, Japan
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1120-1735
Identifier Type: OTHER
Identifier Source: secondary_id
IPV35 (EFC12403)
Identifier Type: -
Identifier Source: org_study_id