PoliomyelitisPhase 3NCT07010822
A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
A Phase 3 study testing nOPV2 in people with Poliomyelitis, run by Fidec Corporation at 1 site in Bangladesh.
Trial summary
The study will compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age). Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- nOPV2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 740 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Apr 2026to 8 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn infants of maximum 1 week of age with birth weight > 2,500 g.
- 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 from participating in the study as established by medical history and physical examination.
- Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
- Resides in the area and parents willing to adhere to all study procedures.
Who cannot join
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the participant's household.
- Household member who has receive any novel OPV 1 month before birth of this study's participant up through 1 month post-last-dose.
- 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 that share molecular composition with a component of the study vaccines.
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)
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- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute severe febrile illness (≥37.5 °C) on the 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.).
- Participant 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 participant.
- Infants from multiple births or born prematurely (< 37 weeks of gestation).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
icddr,b - Matlab Health Research Centre
Chāndpur, Dhaka Division
Khaelqu Zaman, Dr., +880 1713-047100, kzaman@icddrb.org
Warda Haque, +880 1720-289260, warda.haque@icddrb.org
About this study
Official title: A Phase III, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
The study will compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age).
Read the detailed description
To meet the urgent public health need regarding cVDPV2 outbreaks, a novel type 2 OPV (nOPV2) vaccine was developed using attenuated serotype 2 polioviruses derived from a modified Sabin 2 infectious cDNA clone generated by modifying the Sabin-2 ribonucleic acid (RNA) sequence to improve genetic stability and make the strains less prone to reversion to virulence. Clinical trials in adults, children, and infants demonstrated that nOPV2 vaccine is safe, well tolerated, and immunogenic. These include a phase 2 study of vaccine-naïve neonates in Bangladesh who received either two doses of nOPV2 or two doses of placebo at birth and 4 weeks of age concluded that the vaccine was well tolerated and immunogenic, as 90% of the infants seroconverted at 2 weeks post second dose. Overall 99% of infants had protective levels of neutralizing antibody at this time in contrast to the seroprotection rate of 56% in the placebo group.
Although immunogenic, the effect of nOPV2 on virus transmission is still unclear. This phase 3 study aims to compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge (pre-challenge) and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age).
- Conditions
- Poliomyelitis
- Being tested
- nOPV2
- Keywords
- Polio, nOPV2, immunity
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nOPV2Biological
nOPV2 will be administered at birth and Wk 14 of age depending on the study arm.
| Study group | Role | What they receive |
|---|---|---|
| nOPV2 at birth | Experimental | Approximately 330 subjects to receive 1 dose of nOPV2 at birth followed by a regular IPV schedule at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. Receives: Biological: nOPV2 |
| nOPV2 at birth and Wk 14 of age | Experimental | Approximately 80 subjects to receive 2 doses of nOPV2 at birth and 14 wks of age plus a regular IPV schedule at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. Receives: Biological: nOPV2 |
| Placebo | Placebo comparator | Approximately 330 subjects to receive 2 doses of placebo at birth and 14 wks of age plus a regular IPV schedule at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age Receives: Biological: nOPV2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool viral load
To assess the presence or absence of "transmissible" levels of virus in stool, with presence defined as a log10 CCID50 per gram of ≥4.3 at Visit 7 (Day 126; day of nOPV2 challenge dose administration), Visit 8 (Day 130), Visit 9 (Day 133), Visit 10 (Day 140), and Visit 11 (Day 154) in all groups.
Measured: From enrollment to the end of the study at Wk 22 of age.
Secondary outcomes (7)
PV Type 2 neutralizing activity in stool samples
To assess poliovirus type-2-specific neutralizing activity and total concentrations and poliovirus type-2-specific IgA/IgG mean fluorescence intensities (MFI) in stool samples at Visit 7 (Day 126), Visit 8 (Day 130), Visit 9 (Day 133), Visit 10 (Day 140), and Visit 11 (Day 154) in all groups.
Measured: From enrollment to the end of the study at 22 Wks of age.
PV Type 2 seroprotection rate
To assess the seroprotection (SP) rate to poliovirus type-2 on Day 42 (Visit 4) and Week 18 (Visit 7). SP rate is defined as the percentage of subjects with type 2-specific antibody titers ≥ 1:8 in all groups.
Measured: From enrollment till 18 Wks of age
PV Type 2 seroconversion rate
To assess the seroconversion (SC) rate of poliovirus type-2 neutralizing antibodies on Week 18 (Visit 7) of age in all groups.
Measured: From enrollment till Wk 18 of age.
PV Type 2 neutralization titers
To assess the geometric mean and median poliovirus type-2-specific neutralization titers on Week 6 (Visit 4) and Week 18 (Visit 7) of age in all groups.
Measured: From enrollment till Wk 18 of age
SAEs and IMEs
Incidence of SAEs and IMEs by severity and by causal association from the date of informed consent throughout the study period in all groups.
Measured: From enrollment to the end of the study at Wk 22 of age
Solicited AEs
Incidence of mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine/placebo in all groups.
Measured: From enrollment to Wk 18 of age
Viral shedding
To assess the positivity rate in the poliovirus type-specific RT-PCR assay at Visit 7 (Day 126; day of nOPV2 challenge dose administration), Visit 8 (Day 130), Visit 9 (Day 133), Visit 10 (Day 140), and Visit 11 (Day 154) in all groups.
Measured: From enrollment to the end of the study at Wk 22 of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start30 Apr 2026
- Primary completion8 Mar 2027 (estimated)
- Study completion8 Mar 2027 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidec Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Khaelqu Zaman, Dr., Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010822
- Sponsor's protocol ID
- nOPV2-003
- Other IDs
- INV-081593
- Status last verified
- Sep 2026
- First submitted
- 30 May 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
- ClinicalTrials.gov ID
- NCT07010822
- Acronym / sponsor ID
- nOPV2-003
- Conditions
- Poliomyelitis
- Keywords
- Polio, nOPV2, immunity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- Fidec CorporationUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 8 Jun 2025 (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 compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age).
Detailed description
To meet the urgent public health need regarding cVDPV2 outbreaks, a novel type 2 OPV (nOPV2) vaccine was developed using attenuated serotype 2 polioviruses derived from a modified Sabin 2 infectious cDNA clone generated by modifying the Sabin-2 ribonucleic acid (RNA) sequence to improve genetic stability and make the strains less prone to reversion to virulence. Clinical trials in adults, children, and infants demonstrated that nOPV2 vaccine is safe, well tolerated, and immunogenic. These include a phase 2 study of vaccine-naïve neonates in Bangladesh who received either two doses of nOPV2 or two doses of placebo at birth and 4 weeks of age concluded that the vaccine was well tolerated and immunogenic, as 90% of the infants seroconverted at 2 weeks post second dose. Overall 99% of infants had protective levels of neutralizing antibody at this time in contrast to the seroprotection rate of 56% in the placebo group.
Although immunogenic, the effect of nOPV2 on virus transmission is still unclear. This phase 3 study aims to compare the transmissible levels of poliovirus type-2 detected in stool samples collected at the time of the nOPV2 challenge (pre-challenge) and subsequent timepoints in 3 groups of newborns receiving an nOPV2 dose at birth and primed with 3 doses of IPV (6 - 10 - 14 weeks of age).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nOPV2 at birth | Experimental | Biological: nOPV2Approximately 330 subjects to receive 1 dose of nOPV2 at birth followed by a regular IPV schedule at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. |
| nOPV2 at birth and Wk 14 of age | Experimental | Biological: nOPV2Approximately 80 subjects to receive 2 doses of nOPV2 at birth and 14 wks of age plus a regular IPV schedule at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age. |
| Placebo | Placebo comparator | Biological: nOPV2Approximately 330 subjects to receive 2 doses of placebo at birth and 14 wks of age plus a regular IPV schedule at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborn infants of maximum 1 week of age with birth weight > 2,500 g.
- 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 from participating in the study as established by medical history and physical examination.
- Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
- Resides in the area and parents willing to adhere to all study procedures.
Key exclusion criteria (10 listed)
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the participant's household.
- Household member who has receive any novel OPV 1 month before birth of this study's participant up through 1 month post-last-dose.
- 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 that share molecular composition with a component of the study vaccines.
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 |
|---|---|---|
| nOPV2nOPV2 will be administered at birth and Wk 14 of age depending on the study arm. | Biological | Placebo, nOPV2 at birth, nOPV2 at birth and Wk 14 of age |
Primary outcome
Stool viral load
Time frame: From enrollment to the end of the study at Wk 22 of age.
To assess the presence or absence of "transmissible" levels of virus in stool, with presence defined as a log10 CCID50 per gram of ≥4.3 at Visit 7 (Day 126; day of nOPV2 challenge dose administration), Visit 8 (Day 130), Visit 9 (Day 133), Visit 10 (Day 140), and Visit 11 (Day 154) in all groups.
7 secondary outcomes
PV Type 2 neutralizing activity in stool samples
Time frame: From enrollment to the end of the study at 22 Wks of age.
PV Type 2 seroprotection rate
Time frame: From enrollment till 18 Wks of age
PV Type 2 seroconversion rate
Time frame: From enrollment till Wk 18 of age.
PV Type 2 neutralization titers
Time frame: From enrollment till Wk 18 of age
SAEs and IMEs
Time frame: From enrollment to the end of the study at Wk 22 of age
Solicited AEs
Time frame: From enrollment to Wk 18 of age
Viral shedding
Time frame: From enrollment to the end of the study at Wk 22 of age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
Khaelqu Zaman, Dr. principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
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 nOPV2 in people with Poliomyelitis, run by Fidec Corporation at 1 site in Bangladesh.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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 Bangladesh. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Rüttimann, Dr. (+54 9 11 6118-8536, rruttimann@fidec-online.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool viral load (time frame: From enrollment to the end of the study at Wk 22 of age.). 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 9 Sep 2026.