PoliomyelitisPhase 4NCT02005536
Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan
A Phase 4 study testing IMOVAX POLIO®: Inactive Poliovirus Vaccine in people with Poliomyelitis and Polio, run by Sanofi Pasteur, a Sanofi Company at 4 sites in Japan.
Trial summary
The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis, Polio
- What is being tested?
- IMOVAX POLIO®: Inactive Poliovirus Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesJapan
- Study dates
- Dec 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 4 to 6 years inclusive on the day of inclusion
- Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
- 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.
Who cannot join
- Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
- Any serious disease whether acute or chronic
- Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
- 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
Show all 16Show fewer
- Congenital or current/previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Participation in another clinical trial within 6 months before the trial inclusion
- Planned participation in another clinical trial during the present trial period
- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- Received antipyretics/analgesics/Non-steroidal anti-inflammatory drugs (considered as a single category) within 4 hours prior to vaccination
- 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 trial vaccination
- Any vaccination with inactivated vaccines within the past 6 days preceding the trial vaccination
- Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- Subject ineligible according to the Investigator's clinical judgment.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Fukuoka
Study site
Hokkaido
Study site
Mie
Study site
Tokyo
About this study
Official title: Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.
Primary Objective:
Read more
- To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster
Secondary Objectives:
- To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR).
- To investigate the safety after dosing of SP059 as 2nd booster.
Read the detailed description
Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination.
Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.
- Conditions
- Poliomyelitis, Polio
- Being tested
- IMOVAX POLIO®: Inactive Poliovirus Vaccine
- Keywords
- Poliomyelitis, Poliovirus, Polio, IMOVAX POLIO®, Inactivated polio vaccine
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMOVAX POLIO®: Inactive Poliovirus VaccineBiological
Also called SP059, IMOVAX POLIO®
0.5 mL, Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants will receive one booster dose of SP059 (IMOVAX POLIO®) Receives: Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
Measured: Day 28 post-vaccination
Secondary outcomes (4)
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Anti-polio virus antibodies were assessed by virus neutralization assay.
Measured: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay
Measured: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.
Measured: Day 28 post-booster vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.
Measured: Day 0 up to Day 7 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005536
- Sponsor's protocol ID
- IPV46 (EFC13614)
- Other IDs
- U1111-1143-8561
- Status last verified
- Mar 2015
- First submitted
- 3 Dec 2013
- Last updated
- 30 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of IMOVAX POLIO® Subcutaneous as a Booster Given in Pre-school Age Children in Japan
- ClinicalTrials.gov ID
- NCT02005536
- Acronym / sponsor ID
- IPV46 (EFC13614)
- Conditions
- Poliomyelitis, Polio
- Keywords
- Poliomyelitis, Poliovirus, Polio, IMOVAX POLIO®, Inactivated polio vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 30 Mar 2015
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 of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.
Primary Objective:
- To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster
Secondary Objectives:
- To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR).
- To investigate the safety after dosing of SP059 as 2nd booster.
Detailed description
Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination.
Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: IMOVAX POLIO®: Inactive Poliovirus VaccineParticipants will receive one booster dose of SP059 (IMOVAX POLIO®) |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 4 to 6 years inclusive on the day of inclusion
- Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
- 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.
Key exclusion criteria (16 listed)
- Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
- Any serious disease whether acute or chronic
- Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
- History of poliomyelitis infection
- History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
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 |
|---|---|---|
| IMOVAX POLIO®: Inactive Poliovirus VaccineAlso: SP059, IMOVAX POLIO®0.5 mL, Subcutaneous | Biological | Study Group |
Primary outcome
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®
Time frame: Day 28 post-vaccination
A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.
4 secondary outcomes
Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®
Time frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®
Time frame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®
Time frame: Day 28 post-booster vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®
Time frame: Day 0 up to Day 7 post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IMOVAX POLIO®: Inactive Poliovirus Vaccine in people with Poliomyelitis and Polio, run by Sanofi Pasteur, a Sanofi Company at 4 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 4 inclusion and 16 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 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® (time frame: Day 28 post-vaccination). 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 30 Mar 2015.