A Phase 2 interventional study of Novel Oral Polio Vaccine Type 1 (nOPV1) and Novel Oral Polio Vaccine Type 2 (nOPV2) in Poliomyelitis, sponsored by PATH. Recruiting at 3 sites in Panama. Open to participants aged 6 Weeks to 7 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by PATH · Phase 2, Interventional, and Prevention
The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.
This is a randomized, double dummy, observer blind, active comparator-controlled study. The study population will comprise healthy infants randomized at 16 weeks of age equally across three study groups, nOPV1 only group (N=225), nOPV2 only group (N=225) and co-administered nOPV1+ nOPV2 group (N=225). The participants in the nOPV1 and nOPV2 groups will receive concomitant oral placebo (sterile water) to blind the study arms for parents.
Participants will be screened (screening period 10 weeks), randomized and administered the first dose of study vaccine(s) at 16 weeks of age. The second and third dose of study vaccine(s) will be administered at 20 and 24 weeks of age, respectively. Participants will be consented and screened at 6 weeks of age and receive their routine Expanded Program on Immunization (EPI) vaccines by the study team. For each group, blood will be collected for immunologic testing at 16 (baseline), 20, 24, and 28 weeks of age. Serum specimens will be tested for humoral responses to vaccination by measurement of serum neutralizing antibody (NAb) according to established World Health Organization (WHO) protocols. Stool samples will be collected at various timepoints to evaluate type-specific shedding of polio virus following vaccination.
Following vaccination, participants will be monitored for at least 30 minutes for any immediate adverse events (AEs). Reactogenicity (solicited AEs) will be assessed during the 7 days (day of vaccination and 6 following days) after each vaccination. Parents will be given a post-immunization memory aid to record any local and systemic solicited reactions. In addition, data for unsolicited AEs will be collected for 28 days (day of study vaccination and 27 following days) after each vaccination. Data for SAEs will be collected throughout the study period following vaccination.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's planned enrollment of 675 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →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.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
nOPV1 and oral placebo (sterile water) given to 225 healthy infants
Biological: Novel Oral Polio Vaccine Type 1 (nOPV1) · Biological: Placebo (Sterile Water)
nOPV2 and oral placebo (sterile water) given to 225 healthy infants
Biological: Novel Oral Polio Vaccine Type 2 (nOPV2) · Biological: Placebo (Sterile Water)
nOPV1 given along with nOPV2 to 225 healthy infants
Biological: Novel Oral Polio Vaccine Type 1 (nOPV1) · Biological: Novel Oral Polio Vaccine Type 2 (nOPV2)
nOPV1 containing \>10\^7.0 CCID50 per dose
nOPV2 containing ≥10\^5.0 CCID50 per dose
Sterile, nonpyrogenic preparation of water which contains no bacteriostat, antimicrobial agent, or added buffer
Frequency of serious adverse events (SAEs)
Serious adverse event is any adverse event that results in any of the following outcomes: 1) Death, 2) Life-threatening, 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, or 5) Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or (and) require medical or surgical intervention to prevent one of the outcomes listed in the above
Time frame: From time of Dose 1 to end of study at Day 113
Frequency of solicited adverse events (AEs)
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. The following solicited AEs will be monitored for this trial: Fever (axillary temperature ≥ 37.5°C), Vomiting, Diarrhea, Irritability or Abnormal Crying, Decreased feeding or appetite, and Fatigue or decreased activity
Time frame: From time of vaccination until 7 days after Dose 1 (Day 8), Dose 2 (Day 36), and Dose 3 (Day 57)
Frequency of unsolicited AEs
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 time of vaccination to 28 days after Dose 1 (Day 29), Dose 2 (Day 57), and Dose 3 (Day 85)
Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum neutralizing antibody (NAb)
Cumulative Seroconversion is defined as type specific minimum 4-fold rise from baseline in those seropositive (NAb titer ≥1:8) at baseline, or post-vaccination seropositivity (titer ≥1:8) among those seronegative at baseline
Time frame: 28 days after Dose 2 (Day 57)
Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum NAb
Cumulative Seroconversion is defined as type specific minimum 4-fold rise from baseline in those seropositive (NAb titer ≥1:8) at baseline, or post-vaccination seropositivity (titer ≥1:8) among those seronegative at baseline
Time frame: 28 days after Dose 3 (Day 85)
Percentage of participants demonstrating cumulative seroconversion of type 1 and 2 anti-polio serum NAb
Cumulative Seroconversion is defined as type specific minimum 4-fold rise from baseline in those seropositive (NAb titer ≥1:8) at baseline, or post-vaccination seropositivity (titer ≥1:8) among those seronegative at baseline.
Time frame: 28 days after Dose 1
Median titer for type 1 and 2 anti-polio serum NAb
Time frame: 28 days after Dose 1, Dose 2, and Dose 3
Geometric mean titer (GMT) for Types 1 and 2 anti-polio serum NAb
Time frame: 28 days after Dose 1, Dose 2, and Dose 3
Post-vaccination GMT ratios of types 1 and 2 anti-polio serum NAb
Time frame: Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3
Type-specific and multitypic seroprotection*** rate.
Seroprotection rate defined as anti-polio serum NAb reciprocal titer ≥ 8.
Time frame: 28 days after Dose 1, Dose 2, and Dose 3
Geometric mean fold rise (GMFR) in NAb titer relative to baseline
For immunogenicity evaluation, baseline is defined as NAb measurement prior to the first nOPV dose at 16 weeks of age
Time frame: Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3
GMFR in NAb titer following each dose relative to the pre-vaccination value.
For immunogenicity evaluation, baseline is defined as NAb measurement prior to the first nOPV dose at 16 weeks of age
Time frame: Pre-vaccination titer compared to 28 days after Dose 1, Dose 2, and Dose 3
Percentage of participants shedding types 1 and/or 2 polioviruses
Assessed by polymerase chain reaction (PCR)
Time frame: At Day 1, Day 8, Day 29, Day 36, Day57, Day 64, Day 85 of the study
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2026, 13 months after the start.
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 planned 13 months is close to that.
How these figures are worked out, and which studies are left out of them.
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