CompletedNCT05644184Updated Sep 25, 2026

Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh

A Phase 2 interventional study of Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) and Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1) in Poliomyelitis, sponsored by PATH. Completed at 1 site in Bangladesh. Open to participants aged 0 Days to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by PATH · Phase 2, Interventional, and Prevention

Updated Sep 25, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 2,232
Allocation: Randomized
Ages: 0 Days to 4 Years
Sex: All

Study summary

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).

Read the detailed description

This single-center trial is the first clinical assessment of nOPV1 in a pediatric population. It will be a 15-arm, randomized, observer-blind, controlled trial, with Sabin monovalent type 1 vaccine (mOPV1) serving as the control. Enrollment in this pediatric study will be staggered into three age-descending cohorts, Cohort 1 composed of 192 healthy young children 1 to less than 5 years of age who have completed their full routine polio immunization series, Cohort 2 composed of 720 healthy infants 6 weeks of age (+6 days) who will receive only one dose of inactivated poliomyelitis vaccine (IPV) on Day 1, and finally Cohort 3, composed of 1320 healthy poliomyelitis unvaccinated neonates (day of birth +3 days). Participants will receive two or three doses of either nOPV1 at dose levels of 10\^5.5 CCID50, 10\^6.0 CCID50, 10\^6.5 CCID50, 10\^7.0 CCID50 or 10\^7.5 CCID50 or the mOPV control vaccine. The second and third doses of vaccine will be given 28 days following the prior dose. In order to demonstrate the vaccine's ability to reduce fecal shedding following a challenge with the Sabin type 1 strain, the infant cohort will be challenged with mOPV 8 weeks after their last dose of nOPV. Participants will be followed until 28 weeks (young children and neonates) or 32 weeks (infants) after their Day 1 vaccination.

Conditions studied

Poliomyelitis

Browse trials for

Poliomyelitis 274

Keywords

Vaccine tolerability
Vaccine safety
Vaccine reactogenicity
Vaccine viral shedding
Vaccine immunogenicity

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's enrollment of 2,232 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

PATH is the lead sponsor of 113 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Browse PATH studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 0 Days to 4 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy, as defined by the absence of any medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator
Parent(s) or guardian(s) willing and able to provide written prior to performance of any study-specific procedure
Resides in study area and parent understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator)
Parent agrees for participant to receive all routine infant and childhood immunizations as per the approved protocol-adjusted schedule

Inclusion Criteria for Cohort 1 (young children) participants only:

Male or female child from 1 to less than 5 years of age at the time of initial study vaccination
Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing OPV (may have also received IPV), with last dose received more than 3 months prior to initial study vaccination

Inclusion Criteria for Cohort 2 (infants) participants only:

Male or female infant expected to be 6 weeks of age (43rd to 49th day of life [with day of birth being the first day of life], inclusive+ 6-day window), at the time of initial study vaccination
Prior to study vaccination has received no doses of IPV or OPV, based on no evidence of such vaccination per available documentation.

Inclusion Criteria for Cohort 3 (neonates) participants only:

Male or female newborn (1st day of life+ 3-day window, inclusive), at the time of initial study vaccination
Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based on no evidence of such vaccination per available documentation.

Exclusion criteria

Exclusion Criteria for all participants:

For all participants, the presence of anyone under 10 years of age in the participant's 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. For household members younger than 10 years of age, "age appropriate" vaccination is complete series of trivalent Oral Poliovirus Vaccine (tOPV) or at least three doses of bivalent (types 1 and 3) Oral Poliovirus Vaccine (bOPV) plus a booster fractional dose of IPV (fractional dose Inactivated Polio Vaccine; fIPV). Note: A vaccination series of tOPV or at least three doses of bOPV with our without a booster fractional dose of IPV will be considered sufficient.
For all participants, having a member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration.
Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.
Moderate or severe (grade ≥ 2) acute illness at the time of enrollment/first study vaccination - temporary exclusion. Participant with mild (grade 1) acute illnesses may be enrolled at the discretion of the investigator.
Presence of fever on the day of enrollment/first study vaccination (axillary temperature ≥37.5˚C) - (Temporary exclusion for Cohorts 1 and 2)
A known allergy, , or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)
Evidence of a congenital or genetic defect as judged by the investigator
History of chronic administration (defined as more than 14 days) of medications, including (> 0.5mg/kg/day of prednisolone (or equivalent)). Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the infant/young child)
Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including infection) in the participant or household member (living under the same roof/in the same building rather than in the same compound)
Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study of study participants or a household member
Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection
Presence of sever malnutrition [weight-for-length/height z-score greater than or equal to -3 SD median (per WHO published growth standards)] - temporary exclusion if marginal and subsequently gains weight.
Participation in another product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior tot he first administration of study vaccine, or planned use during the study period.
Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned use during the study period.
Parent or participant has any condition that in the opinion of the investigator would increase the participant's health risks in the study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments.)

Exclusion Criteria for Cohort 2 \& 3 participants only:

Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500g (up to and including 2499b) at the time of birth or by the time of enrolment.
Premature birth (less than 37 weeks gestation)
From multiple birth (due to increased risk of OPV transmission between siblings)

Terms in these criteria, in plain language(7)

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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

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.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 2,232 participants (actual)

Study arms

Experimental
Group 1: Young Children, nOPV1 10^5.5 CCID50
48 young children aged 1 to \<5 years will receive 2 doses of nOPV1 at a dose level of 10\^5.5 CCID50 on Day 1 and Day 29
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Experimental
Group 3: Young Children, nOPV1 10^6.0 CCID50
48 young children aged 1 to \<5 years will receive 2 doses of nOPV1 at a dose level of 10\^6.0 CCID50 on Day 1 and Day 29
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Experimental
Group 5: Young Children, nOPV1 10^6.5 CCID50
48 young children aged 1 to \<5 years will receive 2 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 1 and Day 29
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Active comparator
Groups 2, 4 and 6: Young Children, mOPV1
48 young children aged 1 to \<5 years will receive 2 doses of mOPV1 at a dose level of ≥ 10\^6.0 CCID50 on Day 1 and Day 29
Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Experimental
Group 7: Infants, nOPV1 10^5.5 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10\^5.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Experimental
Group 9: Infants, nOPV1 10^6.0 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10\^6.0 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Experimental
Group 11: Infants, nOPV1 10^6.5 CCID50
48 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 2 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 29 and Day 57, and a challenge dose of mOPV on Day 113.
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Experimental
Group 11b: Infants, nOPV1 10^6.5 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Experimental
Group 13: Infants, nOPV1 10^7.0 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^7.0 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Experimental
Group 15: Infants, nOPV1 10^7.5 CCID50
96 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1, then 3 doses of nOPV1 at a dose level of 10\^7.5 CCID50 on Day 29, Day 57 and Day 85, and a challenge dose of mOPV on Day 141.
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Active comparator
Groups 8, 10, 12, 12b, 14, 16: Infants mOPV1
192 infants aged 6 weeks (+6 days) will receive 1 dose of IPV on Day 1 then 2 to 3 doses of mOPV1 at a dose level of ≥10\^6.0 CCID50 on Day 29, Day 57, Day 85 (groups 12b, 14 \& 16 only) and a challenge dose of mOPV on Day 113 (groups 8, 10 \& 12) on Day 141 (groups 12b, 14 \& 16)
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1) · Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
Experimental
Group 17: Neonates, nOPV1 10^6.5 CCID50
330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^6.5 CCID50 on Day 1, Day 29 \& Day 57
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Experimental
Group 19: Neonates, nOPV1 10^7.0 CCID50
330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^7.0 CCID50 on Day 1, Day 29 \& Day 57
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Experimental
Group 21: Neonates, nOPV1 10^7.5 CCID50
330 neonates (day of birth +3 days) will receive 3 doses of nOPV1 at a dose level of 10\^7.5 CCID50 on Day 1, Day 29 \& Day 57
Biological: Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Active comparator
Groups 18, 20 & 22: Neonates, mOPV1
330 neonates (day of birth +3 days) will receive 3 doses of mOPV1 at a dose level of ≥ 10\^6.0 CCID50 on Day 1, Day 29 \& Day 57
Biological: Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)

Interventions

BiologicalNovel Live Attenuated Type 1 Oral Poliomyelitis Vaccine (nOPV1)
Drop counts of nOPV vaccine will be varied to achieve approximately 10\^5.5, 10\^6.0, 10\^6.5 CCID50 or 10\^7.0, 10\^7.5 dose levels.
BiologicalSabin Monovalent Oral Poliomyelitis Vaccine Type 1 (mOPV1)
The Sabin Monovalent Oral Poliomyelitis Vaccine Type 1 control and challenge vaccine (mOPV1) contains ≥ 10\^6.0 CCID50 per 0.1 mL (2 drops) dose.

What researchers measure

Primary outcomes

Frequency of serious adverse events (SAEs) from the time of first study vaccination through the end of the study
Serious adverse event is any adverse event that results in any of the following outcomes: 1. Death 2. Is life-threatening (life-threatening means that the study participant was, in the opinion of the site PI or PATH, at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions 5. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event
Time frame: From Day 1 to end of study, up to Day 197 (young children and neonates) or Day 225 (infants)
Frequency of solicited adverse events (AEs) for 7 days (day of vaccination and 6 following days) after each vaccination
Solicited AEs are pre-specific AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. The following specific solicited AEs will be monitored for this trial: * Fever (axillary temperature ≥ 37.5°C) * Vomiting * Diarrhea * Irritability * Decreased feeding or appetite * Fatigue or decreased activity
Time frame: From vaccination to 7 days post vaccination
Frequency of unsolicited AEs for 28 days (day of vaccination and 27 following days) after each vaccination
Unsolicited AEs are any AEs reported spontaneously by the participant's parent, observed by the study personnel during study visits or identified during review of medical records or source documents. In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant will be reported as an AE.
Time frame: From vaccination to 28 days post vaccination
Post-vaccination frequency of seroconversion of type 1 anti-polio serum neutralizing antibody (NAb).
Following two doses of nOPV1, at dose levels of 10\^6.5 and 10\^7.0 CCID50/dose, compared to mOPV1, in healthy neonates. For unvaccinated neonates, seroconversion will be defined as either a minimum 4-fold higher antibody titer relative to the expected level of maternal antibody and seropositivity (reciprocal titer ≥ 8) at the post-vaccination time point among those initially seropositive, or post-vaccination seropositivity among those initially seronegative.
Time frame: 28 days post second vaccination

Secondary outcomes

Post-vaccination frequency of seroconversion of type 1 anti-polio serum NAb.
To assess the seroconversion rate elicited by nOPV1 at dose levels of 10\^6.5, 10\^7.0 and 10\^7.5 CCID50/dose following one and three doses in healthy neonates compared to mOPV1. To assess the seroconversion rate elicited by nOPV1 at dose levels of 10\^5.5, 10\^6.0 and 10\^6.5 CCID50/dose following one or two doses in healthy young children compared to mOPV1. To assess the seroconversion rate elicited by nOPV1 at dose levels of 10\^5.5 and 10\^6.0 CCID50/dose following one or two doses in healthy infants compared to mOPV1.
Time frame: Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Median type 1 anti-polio serum NAb titers.
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, and one, two or three doses in infants and neonates.
Time frame: Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Type 1 anti-polio serum NAb Geometric Mean Titer (GMT).
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, and one, two or three doses in infants and neonates.
Time frame: Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Post-vaccination GMT ratios of type 1 anti-polio serum NAb, adjusted for baseline immunity.
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, and one, two or three doses in infants and neonates.
Time frame: Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Seroprotection rate, defined as type 1 anti-polio serum NAb reciprocal titer ≥ 8.
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, and one, two or three doses in infants and neonates.
Time frame: Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Geometric mean fold rise (GMFR) in NAb titer relative to baseline
Elicited by nOPV1, compared to that of mOPV1, following one or two doses in healthy young children, and one, two or three doses in infants and neonates.
Time frame: Baseline and 28 days post vaccination (Day 1 and Day 29 for young children, Day 1, Day 29 and Day 57 for neonates and Day 29, Day 57 and Day 85 for infants)
Proportion of participants shedding type 1 poliovirus at any and at each post-vaccination stool collection, as assessed by polymerase chain reaction (PCR) in infants and neonates.
28 days after the initial dose of nOPV1, compared to mOPV1.
Time frame: Baseline through to 28 days post initial vaccination (Day 29 through to Day 57 for infants; Day 1 through to Day 29 for neonates)
Proportion of participants shedding type 1 poliovirus at any and at each post-challenge stool collection, as assessed by PCR in infants.
28 days after mOPV challenge compared to mOPV1
Time frame: Day of challenge through to 28 days post challenge (Day 113 through to Day 141 or 169, for infants)
Neurovirulence of shed study vaccine virus from select stool samples as measured by a transgenic mouse neurovirulence test in a subset of infants.
Within 28 days of an initial nOPV dose and compared to that of mOPV1.
Time frame: Baseline through to 28 days post initial vaccination (Day 29 through 57 for infants)

Study locations

1 site

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, 1212, Bangladesh

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Sep 2026, 41 months.

Of 12 phase 2 interventional studies under Poliomyelitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 38. This study's 41 months is above that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion May 2026 → Sep 2026 and completion May 2026 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered: Nov 10, 2022
First posted: Dec 9, 2022
StartActual: Mar 27, 2023
Primary completionActual: Sep 22, 2026was May 2026
CompletionActual: Sep 22, 2026was May 2026
Last update: Sep 25, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Status

Recruiting→Completed

changed Sep 25, 2026

Primary completion

May 15, 2026→Sep 22, 2026 (actual)

Sep 25, 2026

Study completion

May 15, 2026→Sep 22, 2026 (actual)

Sep 25, 2026

Show all 1 update

Sep 25, 2026
Recruiting→Completed
Primary completion May 15, 2026→Sep 22, 2026 (now actual)
Study completion May 15, 2026→Sep 22, 2026 (now actual)
+ 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05644184
Lead sponsor: PATH
Collaborators: Bill and Melinda Gates Foundation, PT Bio Farma, Centers for Disease Control and Prevention, DiagnoSearch Life Sciences Pvt. Ltd.
Responsible party: Sponsor
First posted: Dec 9, 2022
Start date: Mar 27, 2023
Primary completion: Sep 22, 2026
Completion: Sep 22, 2026
Last update: Sep 25, 2026

Study contacts

K. Zaman, MBBS, MPH, PhD, FRCP

principal investigator · International Centre for Diarrhoeal Disease Research, Bangladesh

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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