Clinical trial
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women…
NCT04424316 · Pfizer, Industry · Completed
Key facts
| NCT number | NCT04424316 |
|---|---|
| Title | A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy. |
| Official title | A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY |
| Lead sponsor | Pfizer, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Respiratory Tract Infection |
| Intervention type | Biological |
| Interventions | RSVpreF, Placebo |
| Enrollment | 14,727 |
| Start date | Jun 17, 2020 |
| Primary completion | Oct 27, 2023 |
| Completion | Oct 27, 2023 |
| First posted | Jun 9, 2020 |
| Last update posted | Feb 11, 2025 |
| Countries | Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Japan, Mexico, Netherlands, New Zealand, Philippines and 6 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: