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NCT04424316 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 14,727
- Enrollment target
NCT04424316 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 14,727 participants.
The verdict
NCT04424316, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 14,727 participants
- Enrollment target
Study Summary
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RSVpreF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,727 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2023-10-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04424316
The ClinicalTrials.gov registry entry for NCT04424316 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 14,727 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04424316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04424316 about?
NCT04424316 is a clinical study titled "A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.". This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
What is the current status of trial NCT04424316?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 14,727 participants. The study started on 2020-06-17. Estimated completion is 2023-10-27.
What interventions are being tested in trial NCT04424316?
The interventions under investigation include: Placebo (BIOLOGICAL), RSVpreF (BIOLOGICAL).
Who is sponsoring clinical trial NCT04424316?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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