Trials / Completed
CompletedNCT02753413
Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the safety and reactogenicity of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSV vaccine GSK3003891A | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
| BIOLOGICAL | Boostrix | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2016-06-28
- Completion
- 2016-06-28
- First posted
- 2016-04-27
- Last updated
- 2018-06-26
- Results posted
- 2017-07-11
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02753413. Inclusion in this directory is not an endorsement.