PolioPhase 4NCT01278433
A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
A Phase 4 study testing IMOVAX Polio™: Inactivated Poliomyelitis Vaccine in people with Polio and Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company at 15 sites in China.
Trial summary
The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China. Objective: To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China. Read more about this study
- Who is it for?
- Ages 60 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Polio, Poliomyelitis
- What is being tested?
- IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,007 participants
- Where
- 15 sitesChina
- Study dates
- Dec 2010to Jun 2012
- 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 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
- Subject's parent /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 by 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 (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
- Acute medical illness with or without fever within the last 72 hours.
- Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
- Participation in another clinical trial at the same time.
- Contraindications to vaccination according to IMOVAX Polio™ leaflet.
- Subject plan to leave the study sites for at least three months after inclusion.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Study site
Beijing, Beijing Municipality, 100050
Study site
Changsha
Study site
Chengdu
Study site
Chongqing
Study site
Hangzhou
Study site
Jinan
Study site
Kunming
Study site
Nanjing
Study site
Qingdao
Study site
Shenyang
Study site
Shenzhen
Study site
Tianjin
Study site
Wuhan
Study site
Xi'an
Study site
Zheng Zho
About this study
Official title: Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study
The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China.
Objective:
To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.
Read the detailed description
Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.
- Conditions
- Polio, Poliomyelitis
- Being tested
- IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
- Keywords
- Polio, Poliovirus, IMOVAX 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 Poliomyelitis VaccineBiological
Also called IMOVAX Polio™
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants receiving their first dose of polio vaccine Receives: Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.
Measured: Up to 30 days after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolioStudies 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
- 5,007 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 Pasteur China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278433
- Sponsor's protocol ID
- IPV34
- Other IDs
- UTN: U1111 1115 6566
- Status last verified
- Mar 2013
- First submitted
- 14 Jan 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
- Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study
- ClinicalTrials.gov ID
- NCT01278433
- Acronym / sponsor ID
- IPV34
- Conditions
- Polio, Poliomyelitis
- Keywords
- Polio, Poliovirus, IMOVAX Polio™
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,007 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Jan 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 collect post marketing safety data on IMOVAX Polio vaccine in China.
Objective:
To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.
Detailed description
Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.
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™: Inactivated Poliomyelitis VaccineParticipants receiving their first dose of polio vaccine |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
- Subject's parent /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 by 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 (6 listed)
- Subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
- Acute medical illness with or without fever within the last 72 hours.
- Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
- Participation in another clinical trial at the same time.
- Contraindications to vaccination according to IMOVAX Polio™ leaflet.
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 Poliomyelitis VaccineAlso: IMOVAX Polio™0.5 mL, Intramuscular | Biological | Study Group |
Primary outcome
Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
Time frame: Up to 30 days after each vaccination
A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.
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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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
15 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™: Inactivated Poliomyelitis Vaccine in people with Polio and Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company at 15 sites 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 6 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 15 sites 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?
Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. (time frame: Up to 30 days after each 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 29 Mar 2013.