Trials / Completed
CompletedNCT01960686
RSV F Dose-Ranging Study in Women
A Phase II Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F Particle Vaccine With Aluminum, in Healthy Women of Child-Bearing Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 720 (actual)
- Sponsor
- Novavax · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | |
| BIOLOGICAL | Dose 4 of Aluminum Adjuvant | |
| BIOLOGICAL | Placebo |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2013-10-11
- Last updated
- 2016-05-26
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01960686. Inclusion in this directory is not an endorsement.