Clinical trial NCT02005536: Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Official title: Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Poliomyelitis
Polio
Keywords: Poliomyelitis
Poliovirus
Polio
IMOVAX POLIO®
Inactivated polio vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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
* 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.

Primary outcomes:
measure: Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
timeFrame: Day 28 post-vaccination
Secondary outcomes:
measure: Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
timeFrame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
measure: Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
timeFrame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
measure: Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
timeFrame: Day 28 post-booster vaccination
measure: Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
timeFrame: Day 0 up to Day 7 post-vaccination
Other outcomes:
Locations:
city: Fukuoka
country: Japan
city: Hokkaido
country: Japan
city: Mie
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Sanofi
name: Medical Director
role: STUDY_DIRECTOR
References: