PoliomyelitisPhase 4NCT04448132
Evaluation of Persistence of Immunity in 4-year-old Children Previously Immunised With IPV-Al AJV (Picovax®)
A Phase 4 study testing IPV-Al in people with Poliomyelitis, run by AJ Vaccines A/S at 1 site in Panama.
Trial summary
The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Read more about this study
- Who is it for?
- Ages 4 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- IPV-Al
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 sitePanama
- Study dates
- 20 Nov 2020to 3 May 2021
- 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 4 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials
- Healthy, as assessed from medical history and physical examination
- Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
- Parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records
- Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures
Who cannot join
- Previous vaccination with OPV
- Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials
- Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion.
- Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
- Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol)
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
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- Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial period
- Participating in another interventional clinical trial
- Not suitable for inclusion in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Persistence of the Immunity in 4-year-old Children Previously Immunised With an Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al AJV (Picovax®) by Measuring the Response to an Additional Dose of IPV-Al AJV
The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be investigated one month after administration.
- Conditions
- Poliomyelitis
- Being tested
- IPV-Al
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPV-AlBiological
Also called Picovax®, IPV-Al AJV
adjuvanted reduced dose inactivated polio vaccine
| Study group | Role | What they receive |
|---|---|---|
| IPV-Al AJV | Experimental | One dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle. Receives: Biological: IPV-Al |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3
Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples
Measured: One month after administration of an additional dose of IPV-Al AJV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start20 Nov 2020
- Primary completion3 May 2021
- Study completion3 May 2021
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.
- 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- AJ Vaccines A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448132
- Sponsor's protocol ID
- VIPV-07 E2
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2020
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saez-Llorens X, Chan M, DeAntonio R, Petersen T, Olesen C, Jensen JS, Sorensen C, Ekstrand LM, Czort MK, Kristensen HH, Thulstrup N, Christoffersen DB. Persistence of protective anti-poliovirus antibody levels in 4-year-old children previously primed with Picovax(R), a trivalent, aluminium-adjuvanted reduced dose inactivated polio vaccine. Vaccine. 2022 Sep 22;40(40):5835-5841. doi: 10.1016/j.vaccine.2022.06.084. Epub 2022 Sep 3.
PubMed 36064670
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Persistence of the Immunity in 4-year-old Children Previously Immunised With an Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al AJV (Picovax®) by Measuring the Response to an Additional Dose of IPV-Al AJV
- ClinicalTrials.gov ID
- NCT04448132
- Acronym / sponsor ID
- VIPV-07 E2
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- AJ Vaccines A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 25 Jun 2020 (actual)
- 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 trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be investigated one month after administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPV-Al AJV | Experimental | Biological: IPV-AlOne dose of 0.5 mL of IPV-Al AJV injected intramuscularly perpendicular to the skin in the RIGHT deltoid muscle. |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials
- Healthy, as assessed from medical history and physical examination
- Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
- Parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records
- Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures
Key exclusion criteria (9 listed)
- Previous vaccination with OPV
- Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials
- Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion.
- Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
- Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol)
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 |
|---|---|---|
| IPV-AlAlso: Picovax®, IPV-Al AJVadjuvanted reduced dose inactivated polio vaccine | Biological | IPV-Al AJV |
Primary outcome
Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3
Time frame: One month after administration of an additional dose of IPV-Al AJV
Individual serum titers against poliovirus types 1, 2 and three will be measured in collected serum samples
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 Jun 2021.
- Derived from this study: PubMed 36064670Saez-Llorens X, Chan M, DeAntonio R, Petersen T, Olesen C, Jensen JS, Sorensen C, Ekstrand LM, Czort MK, Kristensen HH, Thulstrup N, Christoffersen DB. Persistence of protective anti-poliovirus antibody levels in 4-year-old children previously primed with Picovax(R), a trivalent, aluminium-adjuvanted reduced dose inactivated polio vaccine. Vaccine. 2022 Sep 22;40(40):5835-5841. doi: 10.1016/j.vaccine.2022.06.084. Epub 2022 Sep 3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IPV-Al in people with Poliomyelitis, run by AJ Vaccines A/S at 1 site in Panama.
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 5 inclusion and 9 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 Jun 2021. 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 Panama. 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?
Seroprotection (titer ≥8) against poliovirus types 1, 2 and 3 (time frame: One month after administration of an additional dose of IPV-Al AJV). 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 NCT04448132, 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 Jun 2021.