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NCT02624947 · ClinicalTrials.gov registry record · Phase 3
A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
A Phase 3 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,636
- Enrollment target
NCT02624947 is a Phase 3 study that has completed, run by Novavax. The registered enrollment target is 4,636 participants.
The verdict
NCT02624947, a Phase 3 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,636 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and 180 days of life in infants.
Interventions
- BIOLOGICAL RSV F vaccine with adjuvant
- BIOLOGICAL Formulation buffer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,636 participants |
| Start Date | 2015-12 |
| Est. Completion | 2019-07-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02624947
The ClinicalTrials.gov registry entry for NCT02624947 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,636 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RSV F vaccine with adjuvant is the first listed.
NCT02624947 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02624947 about?
NCT02624947 is a clinical study titled "A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization". The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and...
What is the current status of trial NCT02624947?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,636 participants. The study started on 2015-12. Estimated completion is 2019-07-12.
What interventions are being tested in trial NCT02624947?
The interventions under investigation include: RSV F vaccine with adjuvant (BIOLOGICAL), Formulation buffer (BIOLOGICAL).
Who is sponsoring clinical trial NCT02624947?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
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