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
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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 |
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Study Group |
Biological: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Other Name: SP059 |
- 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.
- 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 ]
- 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.
- 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.

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

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
Japan | |
Fukui City, Fukui Prefecture, Japan | |
Sapporo City, Hokkaido, Japan |
Study Director: | Medical Director | Sanofi Aventis K.K. |
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 |
Poliomyelitis Inactivated polio vaccine Polio Poliovirus |
Poliomyelitis Myelitis Central Nervous System Infections Infections Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Virus Diseases Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |