PoliomyelitisPhase 3NCT00258843
Safety of Imovax Polio in Chinese Infants and Children
A Phase 3 study testing Inactivated Poliomyelitis vaccine in people with Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in China.
Trial summary
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants. Read more about this study
- Who is it for?
- Ages 2 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Inactivated Poliomyelitis vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Nov 2005to Apr 2006
- 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 2 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Group 1: Aged 18 months (18-20 months) on the day of inclusion
- Group 2: Aged 2 months (56-70 days) on the day of inclusion
Who cannot join
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2)
Show all 15Show fewer
- Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2)
- Vaccination planned in the 4 weeks following the trial vaccination
- Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures
- Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.
- Conditions
- Poliomyelitis
- Being tested
- Inactivated Poliomyelitis vaccine
- Keywords
- IMOVAX;, poliomyelitis
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Poliomyelitis vaccineBiological
Also called IMOVAX Polio™ (IPV)
0.5 mL, intramuscular (IM)
Inactivated Poliomyelitis vaccineBiological
Also called IMOVAX Polio ™ (IPV)
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Children at 18 months of age Receives: Biological: Inactivated Poliomyelitis vaccine |
| Group 2 | Experimental | Infants at 2 months of age Receives: Biological: Inactivated Poliomyelitis vaccine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2006
- Study completionApr 2006
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258843
- Sponsor's protocol ID
- IPV17
- Status last verified
- Jan 2014
- First submitted
- 24 Nov 2005
- Last updated
- 22 Jan 2014
- Results posted
- 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
- Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
- ClinicalTrials.gov ID
- NCT00258843
- Acronym / sponsor ID
- IPV17
- Conditions
- Poliomyelitis
- Keywords
- IMOVAX;, poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 28 Nov 2005 (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.
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Inactivated Poliomyelitis vaccineChildren at 18 months of age |
| Group 2 | Experimental | Biological: Inactivated Poliomyelitis vaccineInfants at 2 months of age |
Who may qualify
- Ages
- 2 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Group 1: Aged 18 months (18-20 months) on the day of inclusion
- Group 2: Aged 2 months (56-70 days) on the day of inclusion
Key exclusion criteria (15 listed)
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
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 |
|---|---|---|
| Inactivated Poliomyelitis vaccineAlso: IMOVAX Polio™ (IPV)0.5 mL, intramuscular (IM) | Biological | Group 1 |
| Inactivated Poliomyelitis vaccineAlso: IMOVAX Polio ™ (IPV)0.5 mL, IM | Biological | Group 2 |
Primary outcome
Not reported in the source record.
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.
Clinical Trials study director
Sanofi Pasteur, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactivated Poliomyelitis vaccine in people with Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company 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 2 inclusion and 15 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 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 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.
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.