Trials / Completed
CompletedNCT02247726
RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.
A Phase II Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety and Immunogenicity of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum, in Healthy Third-trimester Pregnant Women and to Assess the Impact of Maternal Immunization on Infant Safety Through One Year of Life
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Novavax · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Saline Placebo (0.5mL injection) | |
| DRUG | RSV F vaccine (0.5mL injection) |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2014-09-25
- Last updated
- 2022-05-27
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02247726. Inclusion in this directory is not an endorsement.