A Phase 4 interventional study of nOPV2 in Poliomyelitis, sponsored by Fidec Corporation. Completed at 1 site in Bangladesh. Open to participants aged 5 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fidec Corporation · Phase 4, Interventional, and Prevention
The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants
In the light of the switch from OPV to IPV and the continued presence of cVDPV2 in many countries, it is important to understand and quantify the impact of IPV on pharyngeal mucosal immunity, to inform whether and to what extent the mucosal and humoral immune response following IPV could reduce transmission and spread.
This study will assess the effect of vaccination with IPV in parallel with poliovirus type-2 naïve infants (infants having received bOPV) on the pharyngeal and fecal shedding and the induction of immunity following type-2 poliovirus challenge. This understanding would provide critical information on the potential use of IPV in specific settings to interrupt transmission / reduce spread. The results from this study may potentially have important consequences on public health policy in countries which use IPV for infant priming, as they will help to show the extent to which a type-2 mucosal immunity gap remains following a primary series of IPV.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's enrollment of 501 is close to the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Fidec Corporation is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
Biological: nOPV2
Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.
Biological: nOPV2
Vaccination
Number of Participants Shedding Detectable Levels of Poliovirus Type-2 by RT PCR.
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
Time frame: 1 month
Pharyngeal Neutralizing Antibodies (NAbs) to Poliovirus Type-2.
To assess and compare the pharyngeal NAbs poliovirus type-2 activity on D0, D14 and D28 in both groups.
Time frame: 1 month
Seroprotection Rate to Poliovirus Type-2 on D0, D28 and D56 in Both Groups.
To assess the humoral immunogenicity to poliovirus type-2 at D0, 4 and 8 weeks following administration of a challenge dose of nOPV2 in both groups. Seroprotection is defined as neutralizing type-2 poliovirus antibody specific titers ≥1:8.
Time frame: 2 months
Number of Participants That Experienced Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
To assess the number of subjects experiencing SAEs and IMEs following administration of IPV, bOPV and nOPV2 throughout the whole study period.
Time frame: 5 months
Pharyngeal Poliovirus Type-2-specific Immunoglobulin A (IgA) Concentrations
To asses and compare the pharyngeal mucosal immunoglobulin class-specific immune response to poliovirus type-2 at Day 0, 2 and 4 weeks following administration of a challenge dose of nOPV2 in both groups.This is measured in geometric mean concentrations (GMCs) in nasal samples on D0, D14 and D28 in both groups.
Time frame: 1 month
| Milestone | IPV-primed Group | bOPV-primed Group |
|---|---|---|
| Started | 250 | 250 |
| Completed | 238 | 232 |
| Not completed | 12 | 18 |
To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.
| Participants | IPV-primed Group | bOPV-primed Group |
|---|---|---|
| Number of Participants Shedding Detectable Levels of Poliovirus Type-2 by RT PCR. | 4 | 6 |
To assess and compare the pharyngeal NAbs poliovirus type-2 activity on D0, D14 and D28 in both groups.
| mcg/ml | IPV-primed Group | bOPV-primed Group |
|---|---|---|
| Day 0 | 2.07 (1.48 to 2.91) | 0.07 (0.00 to 5.24) |
| Day 14 | 7.54 (5.12 to 11.09) | 0.63 (0.32 to 1.25) |
| Day 28 | 7.72 (5.39 to 11.05) | 0.82 (0.46 to 1.47) |
To assess the humoral immunogenicity to poliovirus type-2 at D0, 4 and 8 weeks following administration of a challenge dose of nOPV2 in both groups. Seroprotection is defined as neutralizing type-2 poliovirus antibody specific titers ≥1:8.
| percentage of participants | IPV-primed Group | bOPV-primed Group |
|---|---|---|
| Day 0 | 99.1 (96.9 to 99.9) | 20.6 (15.6 to 26.5) |
| Day 28 | 99.1 (96.9 to 99.9) | 73.6 (67.3 to 79.2) |
| Day 56 | 97.8 (94.9 to 99.3) | 68.8 (62.2 to 74.8) |
To assess the number of subjects experiencing SAEs and IMEs following administration of IPV, bOPV and nOPV2 throughout the whole study period.
| Participants | IPV-primed Group | bOPV-primed Group |
|---|---|---|
| Number of Participants That Experienced Serious Adverse Events (SAEs) and Important Medical Events (IMEs) | 5 | 2 |
To asses and compare the pharyngeal mucosal immunoglobulin class-specific immune response to poliovirus type-2 at Day 0, 2 and 4 weeks following administration of a challenge dose of nOPV2 in both groups.This is measured in geometric mean concentrations (GMCs) in nasal samples on D0, D14 and D28 in both groups.
| mcg/ml | IPV-primed Group | bOPV-primed Group |
|---|---|---|
| D0 | 857.66 (756.53 to 972.32) | 919.34 (797.95 to 1059.20) |
| D14 | 886.20 (783.75 to 1002.04) | 888.07 (774.03 to 1018.90) |
| D28 | 769.36 (674.75 to 877.24) | 849.08 (752.85 to 957.61) |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IPV-primed Group | 0/250 (0%) | 5/250 (2%) | 0/250 (0%) |
| bOPV-primed Group | 0/250 (0%) | 2/250 (0.8%) | 0/250 (0%) |
| Event | IPV-primed Group | bOPV-primed Group |
|---|---|---|
| PneumoniaRespiratory, thoracic and mediastinal disorders | 3/250 | 0/250 |
| GastroenteritisGastrointestinal disorders | 1/250 | 0/250 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 0/250 | 1/250 |
| DiarrhoeaGastrointestinal disorders | 1/250 | 0/250 |
| Febrile convulsionNervous system disorders | 0/250 | 1/250 |
| Age, Categorical(Participants) | IPV-primed Group | bOPV-primed Group | Total |
|---|---|---|---|
| <=18 years | 250 | 250 | 500 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | IPV-primed Group | bOPV-primed Group | Total |
|---|---|---|---|
| Female | 134 | 120 | 254 |
| Male | 116 | 130 | 246 |
| Race (NIH/OMB)(Participants) | IPV-primed Group | bOPV-primed Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 250 | 250 | 500 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | IPV-primed Group | bOPV-primed Group | Total |
|---|---|---|---|
| Bangladesh | 250 | 250 | 500 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2023 to primary completion in Feb 2024, 3 months.
Results were first posted in Sep 2026, 2 years 6 months after primary completion.
Of 30 phase 4 interventional studies under Poliomyelitis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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