PoliomyelitisPhase 3NCT03671616
Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given as a Booster at Age 15-18 Months
A Phase 3 study testing IPV-Al SSI in people with Poliomyelitis, run by Statens Serum Institut at 1 site in Panama.
Trial summary
This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. Read more about this study
- Who is it for?
- Ages 15 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- IPV-Al SSI
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 sitePanama
- Study dates
- 15 May 2018to 3 Oct 2018
- 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 15 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants having completed the VIPV-07 trial
- Healthy 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 granted access to the infant'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
- Previously vaccinated with OPV
- Previously vaccinated with IPV outside the VIPV-07 trial
- Known or suspected immunodeficiency (e.g. leukaemia or lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criterion
- Severe uncontrolled chronic disease (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine)
- Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
- Previous Yellow Fever vaccination
Show all 11Show fewer
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
- In treatment with systemic corticosteroids given p.o., i.v., i.m. ≤ 1 month prior to inclusion or during the trial. Subjects administered corticosteroid topically or by asthma inhalators are eligible for inclusion
- Treatment with a product, which is likely to modify the immune response (e.g blood products and immunoglobulins) ≤ 3 months 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: Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI Given as a Booster Vaccination at the Age of 15-18 Months to Infants Previously Immunised With IPV-Al SSI or IPV SSI
This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.
Read the detailed description
At Visit 1 (screening, blood sample, and vaccination), the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. Information on medical history, and concomitant medication are collected and a physical examination is performed and vital signs are measured (demographics data is captured from the VIPV-07 database). The health assessment of the subject will include measurement of height, weight, temperature, heart rate, respiratory rate (breathing) and a general physical examination (which can include skin, head, eyes, ears, nose, throat, heart, lungs, lymph nodes, abdomen, and the musculoskeletal system). A pre-vaccination blood sample is taken for polio antibody determinations. The subject is vaccinated with IPV-Al (and concomitant vaccine(s) according to national guidelines, if relevant) and subsequently observed for immediate adverse events 30 minutes after the vaccination. An eDiary, a thermometer and a ruler are handed out to the parent(s)/guardian(s) for measurements and recording of temperature, injection site reactions and solicited systemic adverse events (AEs). These activities are performed daily, starting on the day of the vaccination and the following 2 days and until resolved. Any other AEs are recorded in the eDiary as instructed by the trial staff. A contact to the parent(s)/guardian(s) via telephone will be made after the vaccination visit to remind and check if the parent(s)/guardian(s) have any questions regarding how to fill in the eDiary.
At Visit 2 (blood sample and trial completion), 1 month after Visit 1, the eDiary is collected, adverse events and concomitant medications are recorded, a blood sample for poliovirus antibody determination is taken and the end of the trial page is completed.
In addition to the trial vaccine, the trial subjects will receive concomitant routine childhood vaccinations. The trial vaccine is administered in the anterolateral aspect of the right thigh, whereas the other injectable childhood vaccines are administered in the left thigh.
- Conditions
- Poliomyelitis
- Being tested
- IPV-Al SSI
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPV-Al SSIBiological
IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. A single dose of the IPV-Al SSI will be given to infants age 15-18 months.
| Study group | Role | What they receive |
|---|---|---|
| IPV-Al SSI | Experimental | Single arm trial. All subjects will receive the IPV-Al SSI as booster vaccination Receives: Biological: IPV-Al SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Booster effect ratiors of GMT
Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured before and one month after the booster vaccination
Measured: Change from Visit 1 (6-9 months post-3rd vaccination) to one month after booster vaccination (Visit 2)
Secondary outcomes (6)
Seroprotection rates before booster vaccination
Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3 before the booster vaccination.
Measured: 6-9 months post-3rd vaccination
Seroprotection rates after booster vaccination
Subjects with seroprotection (titre ≥ 8) against poliovirus types 1, 2 and 3 one month after the booster vaccination.
Measured: one month after booster vaccination
GMT value before booster vaccination
Geometric mean antibody titres (GMTs) against poliovirus types 1, 2 and 3 before the booster vaccination.
Measured: 6-9 months post-3rd vaccination
GMT value after booster vaccination
GMTs against poliovirus types 1, 2 and 3 one month after the booster vaccination.
Measured: one month after booster vaccination
Number of adverse events
All adverse event
Measured: 6-9 months post-3rd vaccination and one month after booster vaccination
Persistence (tite rates) of antibodies
Persistence of antibodies against poliovirus types 1, 2 and 3 in subjects previously im-munised with IPV-Al SSI or IPV SSI
Measured: 6-9 months post-3rd vaccination and one month after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start15 May 2018
- Primary completion3 Oct 2018
- Study completion3 Oct 2018
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 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Larix A/S, Vaxtrials S.A., AJ Vaccines A/S
- Responsible party
- Sponsor
- Investigators
- Ingrid Kromann, Study director, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671616
- Sponsor's protocol ID
- VIPV-07 E1
- Status last verified
- Nov 2018
- First submitted
- 12 Sep 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: EudraCT
Publications
Saez-Llorens X, Thierry-Carstensen B, Stoey LS, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months. Vaccine. 2020 May 6;38(21):3780-3789. doi: 10.1016/j.vaccine.2020.02.066. Epub 2020 Apr 6.
PubMed 32273184
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI Given as a Booster Vaccination at the Age of 15-18 Months to Infants Previously Immunised With IPV-Al SSI or IPV SSI
- ClinicalTrials.gov ID
- NCT03671616
- Acronym / sponsor ID
- VIPV-07 E1
- Conditions
- Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Larix A/S, Vaxtrials S.A., AJ Vaccines A/S
- Study start
- 15 May 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 14 Sep 2018 (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.
This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.
Detailed description
At Visit 1 (screening, blood sample, and vaccination), the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. Information on medical history, and concomitant medication are collected and a physical examination is performed and vital signs are measured (demographics data is captured from the VIPV-07 database). The health assessment of the subject will include measurement of height, weight, temperature, heart rate, respiratory rate (breathing) and a general physical examination (which can include skin, head, eyes, ears, nose, throat, heart, lungs, lymph nodes, abdomen, and the musculoskeletal system). A pre-vaccination blood sample is taken for polio antibody determinations. The subject is vaccinated with IPV-Al (and concomitant vaccine(s) according to national guidelines, if relevant) and subsequently observed for immediate adverse events 30 minutes after the vaccination. An eDiary, a thermometer and a ruler are handed out to the parent(s)/guardian(s) for measurements and recording of temperature, injection site reactions and solicited systemic adverse events (AEs). These activities are performed daily, starting on the day of the vaccination and the following 2 days and until resolved. Any other AEs are recorded in the eDiary as instructed by the trial staff. A contact to the parent(s)/guardian(s) via telephone will be made after the vaccination visit to remind and check if the parent(s)/guardian(s) have any questions regarding how to fill in the eDiary.
At Visit 2 (blood sample and trial completion), 1 month after Visit 1, the eDiary is collected, adverse events and concomitant medications are recorded, a blood sample for poliovirus antibody determination is taken and the end of the trial page is completed.
In addition to the trial vaccine, the trial subjects will receive concomitant routine childhood vaccinations. The trial vaccine is administered in the anterolateral aspect of the right thigh, whereas the other injectable childhood vaccines are administered in the left thigh.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPV-Al SSI | Experimental | Biological: IPV-Al SSISingle arm trial. All subjects will receive the IPV-Al SSI as booster vaccination |
Who may qualify
- Ages
- 15 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants having completed the VIPV-07 trial
- Healthy 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 granted access to the infant'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 (11 listed)
- Previously vaccinated with OPV
- Previously vaccinated with IPV outside the VIPV-07 trial
- Known or suspected immunodeficiency (e.g. leukaemia or lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criterion
- Severe uncontrolled chronic disease (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine)
- Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
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-Al SSIIPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. A single dose of the IPV-Al SSI will be given to infants age 15-18 months. | Biological | IPV-Al SSI |
Primary outcome
Booster effect ratiors of GMT
Time frame: Change from Visit 1 (6-9 months post-3rd vaccination) to one month after booster vaccination (Visit 2)
Booster effect (day 28 / day 0 titres), from individual serum titre values for antibodies against poliovirus types 1, 2 and 3 measured before and one month after the booster vaccination
6 secondary outcomes
Seroprotection rates before booster vaccination
Time frame: 6-9 months post-3rd vaccination
Seroprotection rates after booster vaccination
Time frame: one month after booster vaccination
GMT value before booster vaccination
Time frame: 6-9 months post-3rd vaccination
GMT value after booster vaccination
Time frame: one month after booster vaccination
Number of adverse events
Time frame: 6-9 months post-3rd vaccination and one month after booster vaccination
Persistence (tite rates) of antibodies
Time frame: 6-9 months post-3rd vaccination and one month after booster 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 14 Nov 2018.
- Derived from this study: PubMed 32273184Saez-Llorens X, Thierry-Carstensen B, Stoey LS, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months. Vaccine. 2020 May 6;38(21):3780-3789. doi: 10.1016/j.vaccine.2020.02.066. Epub 2020 Apr 6.
- Individual participant dataSharing planned: Yes. EudraCT
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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.
Ingrid Kromann study director
Statens Serum Institut
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 IPV-Al SSI in people with Poliomyelitis, run by Statens Serum Institut 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 11 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 14 Nov 2018. 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 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?
Booster effect ratiors of GMT (time frame: Change from Visit 1 (6-9 months post-3rd vaccination) to one month after booster vaccination (Visit 2)). 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 NCT03671616, 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 14 Nov 2018.