PoliomyelitisPhase 4M3-ABMGNCT02582255
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
A Phase 4 study testing Sabin mOPV2 in people with Poliomyelitis, run by Fidec Corporation.
Trial summary
A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Sabin mOPV2
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 22 Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1 to 5 years of age, previously vaccinated with three or four doses of IPV.
- Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.
Who cannot join
- Previous vaccination against poliovirus outside the national immunization schedule.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines or to any antibiotics.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
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- Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
- Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months.
- Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
About this study
Official title: A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy IPV-vaccinated Children Aged 1 to 5 Years in Lithuania
A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.
Read the detailed description
Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol. After this cessation of OPV2, stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future outbreak. However, there is a risk of cVDPV2 from Sabin 2 in settings of low population immunity. Research is ongoing to develop vaccines that are genetically more stable than the currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability endpoints of mOPV2 in children aged 1 to 5 years for better understanding of the stockpile use of this vaccine, and any potential new polio vaccine with a type 2 component in the future.
- Conditions
- Poliomyelitis
- Being tested
- Sabin mOPV2
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sabin mOPV2Biological
Also called mOPV2
Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate.
One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Sabin mOPV2 1 dose | Experimental | IPV-vaccinated children to receive 1 dose of SABIN mOPV2 (Group 1) Receives: Biological: Sabin mOPV2 |
| SABIN mOPV2 2 doses | Experimental | IPV-vaccinated children to receive 2 doses of SABIN mOPV2 (Group 2) Receives: Biological: Sabin mOPV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAEs and Severe AEs
Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.
Measured: 3 months
Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.
Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.
Measured: 1 month
Secondary outcomes (2)
Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.
Seroprotection rate for type 2 polio neutralizing antibodies measured at D 28 after the secon dose of mOPV2.
Measured: 3 months
Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).
Incidence, severity and relationship) of any serious adverse events (SAEs), any solicited AEs, any unsolicited AEs, and any Important Medical Events (IMEs) with the exception of severe related AEs. (primary objective), as well as any laboratory deviations of one or two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidec Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Vytautas Usonis, Prof, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582255
- Sponsor's protocol ID
- M3-ABMG
- Acronym
- M3-ABMG
- Status last verified
- Jan 2020
- First submitted
- 4 Aug 2015
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bandyopadhyay AS, Gast C, Brickley EB, Ruttimann R, Clemens R, Oberste MS, Weldon WC, Ackerman ME, Connor RI, Wieland-Alter WF, Wright P, Usonis V. A Randomized Phase 4 Study of Immunogenicity and Safety After Monovalent Oral Type 2 Sabin Poliovirus Vaccine Challenge in Children Vaccinated with Inactivated Poliovirus Vaccine in Lithuania. J Infect Dis. 2021 Jan 4;223(1):119-127. doi: 10.1093/infdis/jiaa390.
PubMed 32621741
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy IPV-vaccinated Children Aged 1 to 5 Years in Lithuania
- ClinicalTrials.gov ID
- NCT02582255
- Acronym / sponsor ID
- M3-ABMG / M3-ABMG
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fidec CorporationUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 16 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.
Detailed description
Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol. After this cessation of OPV2, stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future outbreak. However, there is a risk of cVDPV2 from Sabin 2 in settings of low population immunity. Research is ongoing to develop vaccines that are genetically more stable than the currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability endpoints of mOPV2 in children aged 1 to 5 years for better understanding of the stockpile use of this vaccine, and any potential new polio vaccine with a type 2 component in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sabin mOPV2 1 dose | Experimental | Biological: Sabin mOPV2IPV-vaccinated children to receive 1 dose of SABIN mOPV2 (Group 1) |
| SABIN mOPV2 2 doses | Experimental | Biological: Sabin mOPV2IPV-vaccinated children to receive 2 doses of SABIN mOPV2 (Group 2) |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1 to 5 years of age, previously vaccinated with three or four doses of IPV.
- Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.
Key exclusion criteria (9 listed)
- Previous vaccination against poliovirus outside the national immunization schedule.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines or to any antibiotics.
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 |
|---|---|---|
| Sabin mOPV2Also: mOPV2Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate. One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine. | Biological | SABIN mOPV2 2 doses, Sabin mOPV2 1 dose |
Primary outcome
SAEs and Severe AEs
Time frame: 3 months
Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.
Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.
Time frame: 1 month
Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.
2 secondary outcomes
Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.
Time frame: 3 months
Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32621741Bandyopadhyay AS, Gast C, Brickley EB, Ruttimann R, Clemens R, Oberste MS, Weldon WC, Ackerman ME, Connor RI, Wieland-Alter WF, Wright P, Usonis V. A Randomized Phase 4 Study of Immunogenicity and Safety After Monovalent Oral Type 2 Sabin Poliovirus Vaccine Challenge in Children Vaccinated with Inactivated Poliovirus Vaccine in Lithuania. J Infect Dis. 2021 Jan 4;223(1):119-127. doi: 10.1093/infdis/jiaa390.
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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.
Vytautas Usonis, Prof principal investigator
Vilnius University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sabin mOPV2 in people with Poliomyelitis, run by Fidec Corporation.
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 3 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SAEs and Severe AEs (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02582255, 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 Jan 2020.