Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT02005536
First received: December 3, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Poliomyelitis
Polio
Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of participants with at least a four-fold rise in anti-Polio 1, 2 and 3 antibody titers between the pre-booster and one month after the dose of IPV [ Time Frame: Day 0 (pre-) and 28 post-booster vaccination ] [ Designated as safety issue: No ]
    Anti-Poliovirus types 1, 2, and 3 titers will be measured by neutralization assay.


Secondary Outcome Measures:
  • Description of the safety profile in terms of solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events after a vaccination with IPV [ Time Frame: Day 0 up to Day 28 post-booster vaccination ] [ Designated as safety issue: No ]
    Solicited injection site: Pain, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia; Unsolicited Adverse Event (AE) defined as an observed AE that does not fulfill the conditions pre-listed in the case report form. Serious adverse event defined as: Death, Life threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability incapacity,

  • Immunogenicity in terms of percentage of participants with anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], Geometric Mean Titers and Geometric Mean Titers Ratio) of inactivated polio vaccine (IPV) after the booster vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination ] [ Designated as safety issue: No ]
    Anti-Poliovirus types 1, 2, and 3 titers will be measured by neutralization assay.


Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005536

Locations
Japan
Fukuoka, Japan
Hokkaido, Japan
Mie, Japan
Tokyo, Japan
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02005536     History of Changes
Other Study ID Numbers: IPV46 (EFC13614), U1111-1143-8561
Study First Received: December 3, 2013
Last Updated: June 10, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
Poliomyelitis
Poliovirus
Polio
IMOVAX POLIO®
Inactivated polio vaccine

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014