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

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ClinicalTrials.gov Identifier: NCT02005536
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Polio Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

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Arms and Interventions
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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®


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO® [ Time Frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination ]
    Anti-polio virus antibodies were assessed by virus neutralization assay.

  2. Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO® [ Time Frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination ]
    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

  3. Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO® [ Time Frame: Day 28 post-booster vaccination ]
    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.

  4. Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO® [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005536


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

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02005536    
Other Study ID Numbers: IPV46 (EFC13614)
U1111-1143-8561 ( Other Identifier: WHO )
First Posted: December 9, 2013    Key Record Dates
Results First Posted: March 30, 2015
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Poliomyelitis
Poliovirus
Polio
IMOVAX POLIO®
Inactivated polio vaccine
Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
 Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases