Trials / Completed
CompletedNCT01704365
RSV-F Vaccine Dose Ranging Study in Young Women
A Phase II Randomized, Observer-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum, in Healthy Women of Child-Bearing Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 330 (actual)
- Sponsor
- Novavax · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Low dose RSV-F Vaccine with Adjuvant | 0.5mL IM Injection |
| BIOLOGICAL | Low dose RSV-F Vaccine without Adjuvant | 0.5ml IM Injection |
| BIOLOGICAL | High dose RSV-F Vaccine with Adjuvant | 0.5mL IM Injection |
| BIOLOGICAL | High dose RSV-F Vaccine without Adjuvant | 0.5mL IM Injection |
| BIOLOGICAL | Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] | 0.5mL IM Injection |
| BIOLOGICAL | Placebo | 0.5mL IM Injection |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-04-01
- Completion
- 2013-05-01
- First posted
- 2012-10-11
- Last updated
- 2014-03-07
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01704365. Inclusion in this directory is not an endorsement.