PoliomyelitisPhase 4NCT01244464
A Study of the Safety of IMOVAX Polio™ in China
A Phase 4 study testing IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine in people with Poliomyelitis and Polio, run by Sanofi at 1 site in China.
Trial summary
This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China. Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China. Read more about this study
- Who is it for?
- Ages 60 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis, Polio
- What is being tested?
- IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Dec 2011
- Phase
- Phase 4
- 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 60 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
- Subject's parents/legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio™ according to the schedule: one injection at 2, 3, 4 months old, respectively.
- Informed consent form obtained from the subject's parent/legal representative.
- Subject plan to live in the selected study sites for at least three months after inclusion.
Who cannot join
- Subject with a history of serious illness (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours
- Subject plan to leave the study sites for at least three months after inclusion
- Administration of immune globulin or other blood products within the last three months
- Participation in another clinical trial at the same time
- Contraindication to vaccination according to IMOVAX Polio™ leaflet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study
This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.
Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.
Read the detailed description
Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.
- Conditions
- Poliomyelitis, Polio
- Being tested
- IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
- Keywords
- Poliomyelitis, IMOVAX POLIO™, Polio
- 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™-Inactivated types 1, 2, and 3 poliovirus D vaccineBiological
Also called IMOVAX POLIO™
0.5 mL, at 2, 3, and 4 months; Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.
Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
Measured: Day 0 to Day 30 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionDec 2011
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 SanofiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244464
- Sponsor's protocol ID
- IPV29
- Other IDs
- UTN: U1111-1114-3719
- Status last verified
- Aug 2012
- First submitted
- 17 Nov 2010
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study
- ClinicalTrials.gov ID
- NCT01244464
- Acronym / sponsor ID
- IPV29
- Conditions
- Poliomyelitis, Polio
- Keywords
- Poliomyelitis, IMOVAX POLIO™, Polio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Nov 2010 (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.
This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.
Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.
Detailed description
Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.
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: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
- Subject's parents/legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio™ according to the schedule: one injection at 2, 3, 4 months old, respectively.
- Informed consent form obtained from the subject's parent/legal representative.
- Subject plan to live in the selected study sites for at least three months after inclusion.
Key exclusion criteria (7 listed)
- Subject with a history of serious illness (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours
- Subject plan to leave the study sites for at least three months after inclusion
- Administration of immune globulin or other blood products within the last three months
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™-Inactivated types 1, 2, and 3 poliovirus D vaccineAlso: IMOVAX POLIO™0.5 mL, at 2, 3, and 4 months; Intramuscular | Biological | Study Group |
Primary outcome
The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.
Time frame: Day 0 to Day 30 post-vaccination
Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
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 3 Aug 2012.
- 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 Pasteur China
1 site 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™-Inactivated types 1, 2, and 3 poliovirus D vaccine in people with Poliomyelitis and Polio, run by Sanofi at 1 site in China.
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 7 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 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
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?
The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. (time frame: Day 0 to Day 30 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 3 Aug 2012.