search
Back to results

Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

Primary Purpose

Poliomyelitis, Polio

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
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, Inactivated polio vaccine, Polio, Poliovirus

Eligibility Criteria

3 Months - 68 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion
  • 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
  • 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
  • Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine
  • Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Participation in another clinical trial preceding the trial inclusion
  • Planned participation in another clinical trial during the present trial period
  • 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 first trial vaccination.
  • Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
  • Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus 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

Outcomes

Primary Outcome Measures

A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination
Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.

Secondary Outcome Measures

Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination.
Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV
Solicited injection site: Tenderness (3 to 23 months); Pain (2 to 11 years), Redness, and Swelling. Solicited Systemic reaction: 3 to 23 month olds: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability: 2 to 11 year olds: Fever (Temperature), Headache, Malaise, and Myalgia.
Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination.
Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.

Full Information

First Posted
July 5, 2011
Last Updated
March 28, 2013
Sponsor
Sanofi Pasteur, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT01389687
Brief Title
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Official Title
Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (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 and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months. Primary objective: To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV). Secondary objective: To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination. To describe the safety after each dose of IPV.
Detailed Description
Study participants will receive three doses of inactivated polio vaccine (IPV) (at each visit and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination. Subjects will be observed by the Investigator or sub-Investigator for 30 minutes following the vaccine injection. The duration of each participant's participation in the trial will be approximately 1 year.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Inactive Poliovirus Vaccine
Other Intervention Name(s)
SP059
Intervention Description
0.5 mL, Subcutaneous
Primary Outcome Measure Information:
Title
A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination
Description
Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.
Time Frame
1 month post-vaccination 3
Secondary Outcome Measure Information:
Title
Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination.
Time Frame
Day 0 and 1 month post-vaccination
Title
Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV
Description
Solicited injection site: Tenderness (3 to 23 months); Pain (2 to 11 years), Redness, and Swelling. Solicited Systemic reaction: 3 to 23 month olds: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability: 2 to 11 year olds: Fever (Temperature), Headache, Malaise, and Myalgia.
Time Frame
Day 0 up to 12 months post-vaccination
Title
Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination.
Description
Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.
Time Frame
1 month post-booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
68 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion 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 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 Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Participation in another clinical trial preceding the trial inclusion Planned participation in another clinical trial during the present trial period 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 first trial vaccination. Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination. Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus 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 Aventis K.K.
Official's Role
Study Director
Facility Information:
City
Fukui City
State/Province
Fukui Prefecture
Country
Japan
City
Sapporo City
State/Province
Hokkaido
Country
Japan

12. IPD Sharing Statement

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

Learn more about this trial

Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

We'll reach out to this number within 24 hrs