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NCT04529538 · ClinicalTrials.gov registry record · Phase 1
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
A Phase 1 study, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 226
- Enrollment target
NCT04529538: Completed Phase 1 study, sponsored by PATH.
NCT04529538 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 226 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (277% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04529538, a Phase 1 study, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 226 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.
Primary Outcome
A serious adverse event is any adverse event that resulted in any of the following outcomes: * Death * Was life-threatening * Required inpatient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * Congenital anomaly or birth defect * Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant an
Interventions
- BIOLOGICAL Novel Oral Polio Vaccine Type 1 (nOPV1)
- BIOLOGICAL Novel Oral Polio Vaccine Type 3 (nOPV3)
- BIOLOGICAL Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)
- BIOLOGICAL Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2023-02-17 |
| Phase | Phase 1 |
What the finished NCT04529538 record still lists
NCT04529538 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (277% higher).
The record links to 0 conditions, and to 4 interventions - of which Novel Oral Polio Vaccine Type 1 (nOPV1) is the first listed.
NCT04529538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04529538 about?
NCT04529538 is a clinical study titled "Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines". The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral po...
What is the current status of trial NCT04529538?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 226 participants. The study started on 2021-03-26. Estimated completion is 2023-02-17.
What interventions are being tested in trial NCT04529538?
The interventions under investigation include: Novel Oral Polio Vaccine Type 1 (nOPV1) (BIOLOGICAL), Novel Oral Polio Vaccine Type 3 (nOPV3) (BIOLOGICAL), Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1) (BIOLOGICAL), Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04529538?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04529538's enrollment target sits among peer trials
226 221st of 2000 higher than 1,778 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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