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NCT01960686 · ClinicalTrials.gov registry record · Phase 2
RSV F Dose-Ranging Study in Women
A Phase 2 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 2
- Development phase
- 720
- Enrollment target
NCT01960686: Completed Phase 2 study, sponsored by Novavax.
NCT01960686 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 720 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (441% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960686, a Phase 2 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 720 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.
Primary Outcome
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include: * Geometric mean concentrations as EU (GMEU) * Geometric mean ratio (GMR) * Geometric mean fold-rise (GMFR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Interventions
- BIOLOGICAL Low dose RSV F Antigen
- BIOLOGICAL High dose RSV F Antigen
- BIOLOGICAL Dose 1 of Aluminum Adjuvant
- BIOLOGICAL Dose 2 of Aluminum Adjuvant
- BIOLOGICAL Dose 3 of Aluminum Adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01960686 record still lists
NCT01960686 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (441% higher).
The record links to 0 conditions, and to 5 interventions - of which Low dose RSV F Antigen is the first listed.
NCT01960686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960686 about?
NCT01960686 is a clinical study titled "RSV F Dose-Ranging Study in Women". The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.
What is the current status of trial NCT01960686?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 720 participants. The study started on 2013-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01960686?
The interventions under investigation include: Low dose RSV F Antigen (BIOLOGICAL), High dose RSV F Antigen (BIOLOGICAL), Dose 1 of Aluminum Adjuvant (BIOLOGICAL), Dose 2 of Aluminum Adjuvant (BIOLOGICAL), Dose 3 of Aluminum Adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT01960686?
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 NCT01960686's enrollment target sits among peer trials
720 45th of 2000 higher than 1,956 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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