PoliomyelitisPhase 3NCT05166031
Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine
A Phase 3 study testing bOPV and nOPV2 in people with Poliomyelitis, run by Fidec Corporation.
Trial summary
The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis. Read more about this study
- Who is it for?
- Ages 7 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- bOPV and nOPV2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to 18 Oct 2021
- 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 7 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 8 weeks (-1, + 2 weeks) with birth weight >2,500 gm.
- Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject to be in 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
- Infants who have received previous vaccination according to the National Immunization Program (NIP) (i.e. vaccination against poliomyelitis and/or receipt of diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b [DTPw-HB-Hib vaccine]).
- Infants with anyone under 10 years of age in their household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic NIP.
- Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
- Infants having a member of their household (living in the same house or apartment unit) who has received oral polio vaccine (OPV) in the previous 3 months before study vaccine administration.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
- Family history of congenital or hereditary immunodeficiency.
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- 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, that share molecular composition with the nOPV2 vaccines.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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 inclusion criteria are met.).
- 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 III Study to Evaluate the Immunogenicity and Safety of Concomitant Administration of Two Doses of a Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine in Healthy Infants
The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.
- Conditions
- Poliomyelitis
- Being tested
- bOPV and nOPV2
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bOPV and nOPV2Biological
Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.
| Study group | Role | What they receive |
|---|---|---|
| bOPV dose | Active comparator | Naïve infants to receive two doses of bOPV at 2 and 3 months of age. Receives: Biological: bOPV and nOPV2 |
| nOPV2 dose | Active comparator | Naïve infants to receive two doses of nOPV2 at 2 and 3 months of age. Receives: Biological: bOPV and nOPV2 |
| bOPV + nOPV2 dose | Experimental | Naïve infants to receive two doses of nOPV2 and bOPV at 2 and 3 months of age. Receives: Biological: bOPV and nOPV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
Assessment and comparison of seroconversion rate to poliovirus types 1, 2 and 3 28 days following co-administration of two doses of nOPV2 and bOPV with two doses of nOPV2 or two doses of bOPV
Measured: 2 months
Incidence of serious adverse reactions (SARs) , important medical reactions (IMRs) and severe solicited adverse reactions (ARs)
Number of serious adverse reactions, important medical reactions and severe solicited adverse reactions following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV
Measured: 6 months
Secondary outcomes (7)
Immunogenicity to poliovirus type 2
Assessment and comparison of geometric mean neutralizing antibody titers against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
Measured: 2 months
Immunogenicity to poliovirus type 2
Assessment and comparison of seroconversion rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
Measured: 2 months
Immunogenicity to poliovirus type 2
Assessment and comparison of seroprotection rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
Measured: 2 months
Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Assessment and comparison of the seroprotection rates against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV.
Measured: 2 months
Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Assessment and comparison of the geometric mean neutralizing against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV.
Measured: 2 months
Assesment of SAEs, IMEs and any AEs
Number, severity and causality of any serious adverse event (SAE), any solicited AE, any unsolicited AE and any important medical events (IME) following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV
Measured: 6 months
Assessment and comparison of viral shedding
Assessment and comparison of viral shedding in stool at fixed time points following administration of nOPV2, bOPV or the co-administration of nOPV2 and bOPV.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study startDec 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completion18 Oct 2021 (estimated)
Why it stopped: Sponsor decided not to conduct it
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidec Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166031
- Sponsor's protocol ID
- nOPV2-001-ABMG
- Status last verified
- Dec 2021
- First submitted
- 26 Oct 2020
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Evaluate the Immunogenicity and Safety of Concomitant Administration of Two Doses of a Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine in Healthy Infants
- ClinicalTrials.gov ID
- NCT05166031
- Acronym / sponsor ID
- nOPV2-001-ABMG
- Conditions
- Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided not to conduct it
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fidec CorporationUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Dec 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- 18 Oct 2021 (estimated)
- First posted
- 21 Dec 2021 (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 study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bOPV dose | Active comparator | Biological: bOPV and nOPV2Naïve infants to receive two doses of bOPV at 2 and 3 months of age. |
| nOPV2 dose | Active comparator | Biological: bOPV and nOPV2Naïve infants to receive two doses of nOPV2 at 2 and 3 months of age. |
| bOPV + nOPV2 dose | Experimental | Biological: bOPV and nOPV2Naïve infants to receive two doses of nOPV2 and bOPV at 2 and 3 months of age. |
Who may qualify
- Ages
- 7 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged 8 weeks (-1, + 2 weeks) with birth weight >2,500 gm.
- Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject to be in 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 (11 listed)
- Infants who have received previous vaccination according to the National Immunization Program (NIP) (i.e. vaccination against poliomyelitis and/or receipt of diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b [DTPw-HB-Hib vaccine]).
- Infants with anyone under 10 years of age in their household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic NIP.
- Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
- Infants having a member of their household (living in the same house or apartment unit) who has received oral polio vaccine (OPV) in the previous 3 months before study vaccine administration.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
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 |
|---|---|---|
| bOPV and nOPV2Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses. | Biological | bOPV + nOPV2 dose, bOPV dose, nOPV2 dose |
Primary outcome
Seroconversion rate
Time frame: 2 months
Assessment and comparison of seroconversion rate to poliovirus types 1, 2 and 3 28 days following co-administration of two doses of nOPV2 and bOPV with two doses of nOPV2 or two doses of bOPV
Incidence of serious adverse reactions (SARs) , important medical reactions (IMRs) and severe solicited adverse reactions (ARs)
Time frame: 6 months
Number of serious adverse reactions, important medical reactions and severe solicited adverse reactions following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV
7 secondary outcomes
Immunogenicity to poliovirus type 2
Time frame: 2 months
Immunogenicity to poliovirus type 2
Time frame: 2 months
Immunogenicity to poliovirus type 2
Time frame: 2 months
Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Time frame: 2 months
Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Time frame: 2 months
Assesment of SAEs, IMEs and any AEs
Time frame: 6 months
Assessment and comparison of viral shedding
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bOPV and nOPV2 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 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: withdrawn, as of the sponsor's last update on 14 Jan 2022. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Seroconversion rate (time frame: 2 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?
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 2022.