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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 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 226 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04529538
The ClinicalTrials.gov registry entry for NCT04529538 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PATH, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Novel Oral Polio Vaccine Type 1 (nOPV1) is the first listed.
NCT04529538 reports 0 study locations.
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.
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