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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 )

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 9, 2013
Results First Submitted Date  ICMJE March 17, 2015
Results First Posted Date  ICMJE March 30, 2015
Last Update Posted Date March 30, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
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 ]
Anti-Poliovirus types 1, 2, and 3 titers will be measured by neutralization assay.
Change History Complete list of historical versions of study NCT02005536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
  • 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 ]
    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 ]
    Anti-Poliovirus types 1, 2, and 3 titers will be measured by neutralization assay.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
Official Title  ICMJE Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Poliomyelitis
  • Polio
Intervention  ICMJE Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Other Names:
  • SP059
  • IMOVAX POLIO®
Study Arms  ICMJE Experimental: Study Group
Participants will receive one booster dose of SP059 (IMOVAX POLIO®)
Intervention: Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005536
Other Study ID Numbers  ICMJE IPV46 (EFC13614)
U1111-1143-8561 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi K.K.
PRS Account Sanofi
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP