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

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ClinicalTrials.gov Identifier: NCT01389687
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : March 29, 2013
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 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.

Condition or disease Intervention/treatment Phase
Poliomyelitis Polio Biological: Inactive Poliovirus Vaccine Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
Study Start Date : July 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Group Biological: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Other Name: SP059


Outcome Measures
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Primary Outcome Measures :
  1. A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination [ Time Frame: 1 month post-vaccination 3 ]
    Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
    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.

  3. 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 ]
    Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 68 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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): NCT01389687


Locations
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Japan
Fukui City, Fukui Prefecture, Japan
Sapporo City, Hokkaido, Japan
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Aventis K.K.
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01389687    
Other Study ID Numbers: IPV35 (EFC12403)
U1111-1120-1735 ( Other Identifier: WHO )
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Poliomyelitis
Inactivated polio vaccine
Polio
Poliovirus
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