Clinical trial
A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect…
NCT02624947 · Novavax, Industry · Completed
Key facts
| NCT number | NCT02624947 |
|---|---|
| Title | A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization |
| Official title | A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred… |
| Lead sponsor | Novavax, Industry |
| Collaborators | Bill and Melinda Gates Foundation |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Respiratory Syncytial Virus Infections |
| Intervention type | Biological |
| Interventions | RSV F vaccine with adjuvant, Formulation buffer |
| Enrollment | 4,636 |
| Start date | Dec 1, 2015 |
| Primary completion | Dec 28, 2018 |
| Completion | Jul 12, 2019 |
| First posted | Dec 9, 2015 |
| Last update posted | May 6, 2025 |
| Countries | Argentina, Australia, Bangladesh, Chile, Mexico, New Zealand, Philippines, South Africa, Spain, United Kingdom, United States |
At a glance
- 10–99 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: