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NCT01704365 · ClinicalTrials.gov registry record · Phase 2
RSV-F Vaccine Dose Ranging Study in Young Women
A Phase 2 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 2
- Development phase
- 330
- Enrollment target
NCT01704365: Completed Phase 2 study, sponsored by Novavax.
NCT01704365 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 330 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (148% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01704365, a Phase 2 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 330 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.
Primary Outcome
Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Interventions
- BIOLOGICAL Low dose RSV-F Vaccine with Adjuvant
- BIOLOGICAL Low dose RSV-F Vaccine without Adjuvant
- BIOLOGICAL High dose RSV-F Vaccine with Adjuvant
- BIOLOGICAL High dose RSV-F Vaccine without Adjuvant
- BIOLOGICAL Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT01704365 record still lists
NCT01704365 is an interventional study that assigns participants to a tested intervention. The registered 330 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 (148% higher).
The record links to 0 conditions, and to 5 interventions - of which Low dose RSV-F Vaccine with Adjuvant is the first listed.
NCT01704365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01704365 about?
NCT01704365 is a clinical study titled "RSV-F Vaccine Dose Ranging Study in Young Women". The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.
What is the current status of trial NCT01704365?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 330 participants. The study started on 2012-10. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01704365?
The interventions under investigation include: Low dose RSV-F Vaccine with Adjuvant (BIOLOGICAL), Low dose RSV-F Vaccine without Adjuvant (BIOLOGICAL), High dose RSV-F Vaccine with Adjuvant (BIOLOGICAL), High dose RSV-F Vaccine without Adjuvant (BIOLOGICAL), Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] (BIOLOGICAL).
Who is sponsoring clinical trial NCT01704365?
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 NCT01704365's enrollment target sits among peer trials
330 145th of 2000 higher than 1,855 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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