PoliomyelitisPhase 2NCT00604058
Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly
A Phase 2 study testing Inactivated Poliomyelitis vaccine (IMOVAX) in people with Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Philippines.
Trial summary
The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly… Read more about this study
- Who is it for?
- Ages 42 to 50 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Inactivated Poliomyelitis vaccine (IMOVAX)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 sitePhilippines
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 2
- 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 42 to 50 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion Criteria to be checked at the screening visit (SC):
- Aged 0 to 7 days on the day of screening
- Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
- Informed consent form signed by the parent(s) or other legally acceptable representative
- Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- Inclusion Criteria to be checked at the randomization visit (V01):
- Aged 42 to 50 days on the day of inclusion
- Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
Who cannot join
- Exclusion Criteria to be checked at the screening visit (SC):
- Planned participation in another clinical trial during the present trial period
- Illness that could interfere with trial conduct or completion, in the opinion of the investigator
- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- History of seizures
- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
Show all 21Show fewer
- Thrombocytopenia or bleeding disorder contraindicating IM injection
- Exclusion Criteria to be checked at the randomization visit (V01):
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except BCG, DTP-Hib or Hepatitis B vaccines, which can not be given within 10 days before or after any study vaccination)
- History of seizures
- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection
- Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants
The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.
- Conditions
- Poliomyelitis
- Being tested
- Inactivated Poliomyelitis vaccine (IMOVAX)
- Keywords
- Poliomyelitis, intradermal
- 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 vaccine (IMOVAX)Biological
Also called IMOVAX Polio (IPV) vaccine
Fractional dose (1/5th) 0.1 mL, intradermally
Inactivated Poliomyelitis vaccine (IMOVAX)Biological
Also called IMOVAX Polio (IPV) vaccine
A full dose, 0.5 mL, intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Inactivated Poliomyelitis vaccine (IMOVAX) |
| Group B | Active comparator | Not described Receives: Biological: Inactivated Poliomyelitis vaccine (IMOVAX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination
Measured: 1 Month Post-vaccination
Secondary outcomes (1)
Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines
Measured: 1 Month post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 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
- NCT00604058
- Sponsor's protocol ID
- IPV25
- Status last verified
- Jan 2014
- First submitted
- 17 Jan 2008
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cadorna-Carlos J, Vidor E, Bonnet MC. Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines. Int J Infect Dis. 2012 Feb;16(2):e110-6. doi: 10.1016/j.ijid.2011.10.002. Epub 2011 Dec 5.
PubMed 22153001
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 Fractional Doses of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine Administered Intradermally vs Full Doses of Inactivated Poliomyelitis Vaccine Administered Intramuscularly in Healthy Philippines Infants
- ClinicalTrials.gov ID
- NCT00604058
- Acronym / sponsor ID
- IPV25
- Conditions
- Poliomyelitis
- Keywords
- Poliomyelitis, intradermal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Jan 2008 (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 present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Inactivated Poliomyelitis vaccine (IMOVAX) |
| Group B | Active comparator | Biological: Inactivated Poliomyelitis vaccine (IMOVAX) |
Who may qualify
- Ages
- 42 to 50 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Inclusion Criteria to be checked at the screening visit (SC):
- Aged 0 to 7 days on the day of screening
- Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
- Informed consent form signed by the parent(s) or other legally acceptable representative
- Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
Key exclusion criteria (21 listed)
- Exclusion Criteria to be checked at the screening visit (SC):
- Planned participation in another clinical trial during the present trial period
- Illness that could interfere with trial conduct or completion, in the opinion of the investigator
- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- History of seizures
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 vaccine (IMOVAX)Also: IMOVAX Polio (IPV) vaccineFractional dose (1/5th) 0.1 mL, intradermally | Biological | Group A |
| Inactivated Poliomyelitis vaccine (IMOVAX)Also: IMOVAX Polio (IPV) vaccineA full dose, 0.5 mL, intramuscular | Biological | Group B |
Primary outcome
The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination
Time frame: 1 Month Post-vaccination
1 secondary outcome
Immunogenicity: To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination Safety: To describe in each group the safety after each dose of the study vaccines
Time frame: 1 Month post-vaccination
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.
- Derived from this study: PubMed 22153001Cadorna-Carlos J, Vidor E, Bonnet MC. Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines. Int J Infect Dis. 2012 Feb;16(2):e110-6. doi: 10.1016/j.ijid.2011.10.002. Epub 2011 Dec 5.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inactivated Poliomyelitis vaccine (IMOVAX) in people with Poliomyelitis, run by Sanofi Pasteur, a Sanofi Company at 1 site in Philippines.
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 8 inclusion and 21 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 Philippines. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination (time frame: 1 Month Post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00604058, which also lists 1 linked publication.
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.