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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: Completed Phase 3 study, sponsored by Pfizer.
NCT04424316 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 14,727 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1810% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: infant with an MA-RTI visit with age related fast breathing (respiratory rate \[RR\] more than or equal to \[\>=\] 60 breaths per minute \[bpm\] for less than \[\<\] 2 months of age \[\<60 days of age\], \>=50 bpm for \>=2 months to \<12 months of age, or \>=40 bpm for \>=12 months to 24 months of age) or oxygen saturation (SpO2) \<95 percent (%) or chest wall indrawing and RSV positive test results by reverse t
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 |
What the finished NCT04424316 record still lists
NCT04424316 is an interventional study that assigns participants to a tested intervention. Its 14,727 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1810% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04424316 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04424316's enrollment target sits among peer trials
14,727 15th of 2000 higher than 1,986 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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