PoliomyelitisPhase 3NCT01389687
Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
A Phase 3 study testing Inactive Poliovirus Vaccine in people with Poliomyelitis and Polio, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 68 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis, Polio
- What is being tested?
- Inactive Poliovirus Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesJapan
- Study dates
- Jul 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 68 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Poliomyelitis, Polio
- Being tested
- Inactive Poliovirus Vaccine
- Keywords
- Poliomyelitis, Inactivated polio vaccine, Polio, Poliovirus
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactive Poliovirus VaccineBiological
Also called SP059
0.5 mL, Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Biological: Inactive Poliovirus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month post-vaccination 3
Secondary outcomes (3)
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.
Measured: 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
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.
Measured: Day 0 up to 12 months post-vaccination
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.
Measured: 1 month post-booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Aventis K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389687
- Sponsor's protocol ID
- IPV35 (EFC12403)
- Other IDs
- U1111-1120-1735
- Status last verified
- Mar 2013
- First submitted
- 5 Jul 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
- ClinicalTrials.gov ID
- NCT01389687
- Acronym / sponsor ID
- IPV35 (EFC12403)
- Conditions
- Poliomyelitis, Polio
- Keywords
- Poliomyelitis, Inactivated polio vaccine, Polio, Poliovirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Inactive Poliovirus Vaccine |
Who may qualify
- Ages
- 3 to 68 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactive Poliovirus VaccineAlso: SP0590.5 mL, Subcutaneous | Biological | Study Group |
Primary outcome
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.
3 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Related InfoLink provided by the sponsor.
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Poliomyelitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Aventis K.K.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactive Poliovirus Vaccine in people with Poliomyelitis and Polio, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination (time frame: 1 month post-vaccination 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.