Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan

Sanofi Pasteur, a Sanofi Company0 sites60 target enrollmentDecember 2013

ConditionsPoliomyelitis Polio

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Poliomyelitis
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 60
Primary Endpoint: Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

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

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)