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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: Completed Phase 3 study, sponsored by Novavax.
NCT02624947 is a Phase 3 study that has completed, run by Novavax. The registered enrollment target is 4,636 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (501% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120,150, and 180 days of life, as defined by: * The presence of RSV infection confirmed by detection of RSV genome by RT-PCR on respiratory secretions (obtained within the continuous illness episode which fulfills the other criteria listed below); AND * At least one manifestation of lower respiratory tract infection (LRTI) from among the following: cough, nasal flaring, lower chest wall indrawing, subcostal ret
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 |
What the finished NCT02624947 record still lists
NCT02624947 is an interventional study that assigns participants to a tested intervention. Its 4,636 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (501% higher).
The record links to 0 conditions, and to 2 interventions - of which RSV F vaccine with adjuvant is the first listed.
NCT02624947 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02624947's enrollment target sits among peer trials
4,636 54th of 2000 higher than 1,947 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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