PoliomyelitisPhase 3NCT00348387
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
A Phase 3 study testing Poliomyelitis Vaccine inactivated and Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) in people with Poliomyelitis and Polio, run by Sanofi Pasteur, a Sanofi Company at 2 sites in China.
Trial summary
This study is intended to support the registration of IMOVAX Polio in China. The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. Read more about this study
- Who is it for?
- Ages 60 to 70 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis, Polio
- What is being tested?
- Poliomyelitis Vaccine inactivated and Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2006to Dec 2008
- 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 60 to 70 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 2 months (60-70 days) on the day of inclusion into the study
- Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more
- Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
- Able to attend all planned clinic appointment and obey and follow all study instructions
Who cannot join
- Taking part in another clinical trial during the 4 weeks before the first trial vaccination
- Have plans to take part in another clinical trial d during this trial period
- Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
- Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
- Prolonged or long time illness that could interfere with study or full participation
- Received blood or blood-derived products since birth
Show all 14Show fewer
- Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)
- Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)
- Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine
- History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)
- Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV)
- Bleeding disorder or a low platelet which do not allow vaccination into the muscle
- Had seizures in the past
- Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion
Trial locations and contacts
2 sites in 1 country.
About this study
This study is intended to support the registration of IMOVAX Polio in China.
The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.
- Conditions
- Poliomyelitis, Polio
- Being tested
- Poliomyelitis Vaccine inactivated, Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
- Keywords
- Imovax polio, poliomyelitis
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poliomyelitis Vaccine inactivatedBiological
Also called IMOVAX Polio ™
0.5 mL, Intramuscular
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)Biological
Also called Poliomyelitis Vaccine in Dragee Candy
1g dragee, oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: Poliomyelitis Vaccine inactivated |
| Group 2 | Active comparator | Not described Receives: Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine
Measured: 1 month post-vaccination 3
Secondary outcomes (1)
To provide information concerning the safety of IMOVAX Polio™ vaccine
Measured: Entire study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2008
- Study completionDec 2008
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 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 Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348387
- Sponsor's protocol ID
- IPV13
- Status last verified
- Jan 2014
- First submitted
- 3 Jul 2006
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
- ClinicalTrials.gov ID
- NCT00348387
- Acronym / sponsor ID
- IPV13
- Conditions
- Poliomyelitis, Polio
- Keywords
- Imovax polio, poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Jul 2006 (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 intended to support the registration of IMOVAX Polio in China.
The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Poliomyelitis Vaccine inactivated |
| Group 2 | Active comparator | Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) |
Who may qualify
- Ages
- 60 to 70 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 2 months (60-70 days) on the day of inclusion into the study
- Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more
- Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
- Able to attend all planned clinic appointment and obey and follow all study instructions
Key exclusion criteria (14 listed)
- Taking part in another clinical trial during the 4 weeks before the first trial vaccination
- Have plans to take part in another clinical trial d during this trial period
- Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
- Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
- Prolonged or long time illness that could interfere with study or full participation
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 |
|---|---|---|
| Poliomyelitis Vaccine inactivatedAlso: IMOVAX Polio ™0.5 mL, Intramuscular | Biological | Group 1 |
| Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)Also: Poliomyelitis Vaccine in Dragee Candy1g dragee, oral | Biological | Group 2 |
Primary outcome
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine
Time frame: 1 month post-vaccination 3
1 secondary outcome
To provide information concerning the safety of IMOVAX Polio™ vaccine
Time frame: Entire study period
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 22 Jan 2014.
- 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 Inc.
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 Poliomyelitis Vaccine inactivated and Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell) in people with Poliomyelitis and Polio, run by Sanofi Pasteur, a Sanofi Company at 2 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 14 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 22 Jan 2014. 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 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 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?
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine (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 22 Jan 2014.