Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
This study has been completed.
Sponsor:
Sanofi Pasteur, a Sanofi Company
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Poliomyelitis Polio |
Biological: Inactive Poliovirus Vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Polio and Post-Polio Syndrome
Drug Information available for:
Poliovirus Vaccines
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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.
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. [ 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.
| Enrollment: | 74 |
| Study Start Date: | July 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Study Group |
Biological: Inactive Poliovirus Vaccine
0.5 mL, Subcutaneous
Other Name: SP059
|
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.
Eligibility| Ages Eligible for Study: | 3 Months to 68 Months |
| Genders Eligible for Study: | Both |
| 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT01389687 History of Changes |
| Other Study ID Numbers: | IPV35 (EFC12403), U1111-1120-1735 |
| Study First Received: | July 5, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by Sanofi:
|
Poliomyelitis Inactivated polio vaccine Polio Poliovirus |
Additional relevant MeSH terms:
|
Poliomyelitis Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013