A Study to Evaluate the Mucosal Intestinal Immunity to Poliovirus Type-2 of nOPV2 at Birth Dose in Healthy IPV Vaccinated Infants
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
2 other identifiers
interventional
740
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedStudy Start
First participant enrolled
December 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 21, 2026
July 24, 2025
July 1, 2025
10 months
May 30, 2025
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From enrollment to the end of the study at Wk 22 of age.
Secondary Outcomes (7)
PV Type 2 neutralizing activity in stool samples
From enrollment to the end of the study at 22 Wks of age.
PV Type 2 seroprotection rate
From enrollment till 18 Wks of age
PV Type 2 seroconversion rate
From enrollment till Wk 18 of age.
PV Type 2 neutralization titers
From enrollment till Wk 18 of age
SAEs and IMEs
From enrollment to the end of the study at Wk 22 of age
- +2 more secondary outcomes
Study Arms (3)
nOPV2 at birth
EXPERIMENTALApproximately 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
EXPERIMENTALApproximately 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 COMPARATORApproximately 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
Interventions
nOPV2 will be administered at birth and Wk 14 of age depending on the study arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fidec Corporationlead
- Bill and Melinda Gates Foundationcollaborator
Study Sites (1)
icddr,b - Matlab Health Research Centre
Chāndpur, Dhaka Division, Bangladesh
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khaelqu Zaman, Dr.
International Centre for Diarrhoeal Disease Research, Bangladesh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2025
First Posted
June 8, 2025
Study Start
December 8, 2025
Primary Completion (Estimated)
September 21, 2026
Study Completion (Estimated)
September 21, 2026
Last Updated
July 24, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share