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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01389687
First received: July 5, 2011
Last updated: March 28, 2013
Last verified: March 2013

July 5, 2011
March 28, 2013
July 2011
January 2012   (final data collection date for primary outcome measure)
A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination [ Time Frame: 1 month post-vaccination 3 ] [ Designated as safety issue: No ]
Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.
Same as current
Complete list of historical versions of study NCT01389687 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV [ Time Frame: Day 0 up to 12 months post-vaccination ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 month post-booster vaccination ] [ Designated as safety issue: No ]
    Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.
  • 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 ] [ Designated as safety issue: No ]
  • Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV [ Time Frame: Day 0 up to 12 months post-vaccination ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Poliomyelitis
  • Polio
Biological: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Other Name: SP059
Experimental: Study Group
Intervention: Biological: Inactive Poliovirus Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
3 Months to 68 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01389687
IPV35 (EFC12403), U1111-1120-1735
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Aventis K.K.
Sanofi
March 2013

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