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

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.

Study Overview

• Status: Completed
• Conditions: Poliomyelitis; Polio
• Intervention / Treatment: Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Hokkaido, Japan
  • Mie, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Participants will receive one booster dose of SP059 (IMOVAX POLIO®)	Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine; 0.5 mL, Subcutaneous; Other Names: SP059; IMOVAX POLIO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®	Anti-polio virus antibodies were assessed by virus neutralization assay.	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®	Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay	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®	Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.	Day 28 post-booster vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®	Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.	Day 0 up to Day 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Medical Director, Sanofi K.K.

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 3, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Polio; Poliovirus; Poliomyelitis; Inactivated polio vaccine; IMOVAX POLIO®
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: IPV46 (EFC13614); U1111-1143-8561 (Other Identifier: WHO)