search
Back to results

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

Primary Purpose

Poliomyelitis, Polio

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
IMOVAX POLIO®: Inactive Poliovirus Vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Poliomyelitis, Poliovirus, Polio, IMOVAX POLIO®, Inactivated polio vaccine

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Participants will receive one booster dose of SP059 (IMOVAX POLIO®)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
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®
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®
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®
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.

Full Information

First Posted
December 3, 2013
Last Updated
March 27, 2015
Sponsor
Sanofi Pasteur, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT02005536
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis, Polio
Keywords
Poliomyelitis, Poliovirus, Polio, IMOVAX POLIO®, Inactivated polio vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Participants will receive one booster dose of SP059 (IMOVAX POLIO®)
Intervention Type
Biological
Intervention Name(s)
IMOVAX POLIO®: Inactive Poliovirus Vaccine
Other Intervention Name(s)
SP059, IMOVAX POLIO®
Intervention Description
0.5 mL, Subcutaneous
Primary Outcome Measure Information:
Title
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Description
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.
Time Frame
Day 28 post-vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Description
Anti-polio virus antibodies were assessed by virus neutralization assay.
Time Frame
Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Title
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Description
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
Time Frame
Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Title
Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
Description
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.
Time Frame
Day 28 post-booster vaccination
Title
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Description
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.
Time Frame
Day 0 up to Day 7 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi K.K.
Official's Role
Study Director
Facility Information:
City
Fukuoka
Country
Japan
City
Hokkaido
Country
Japan
City
Mie
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs