NCT01389687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

6 months

First QC Date

July 5, 2011

Last Update Submit

March 28, 2013

Conditions

PoliomyelitisPolio

Keywords

PoliomyelitisInactivated polio vaccinePolioPoliovirus

Outcome Measures

Primary Outcomes (1)

  • A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination

    Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.

    1 month post-vaccination 3

Secondary Outcomes (3)

  • 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.

    Day 0 and 1 month post-vaccination

  • Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV

    Day 0 up to 12 months post-vaccination

  • 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.

    1 month post-booster vaccination

Study Arms (1)

Study Group

EXPERIMENTAL
Biological: Inactive Poliovirus Vaccine

Interventions

Inactive Poliovirus VaccineBIOLOGICAL

0.5 mL, Subcutaneous

Also known as: SP059
Study Group

Eligibility Criteria

Age3 Months - 68 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent form signed by the parent(s) or other legal representative

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Fukui-shi, Fukui, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Related Links

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Medical Director

    Sanofi Aventis K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 8, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

JP(2)