Trials / Completed
CompletedNCT02360475
Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 507 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations 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 GSK3003895A (formulation 1) | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm |
| BIOLOGICAL | RSV vaccine GSK3003898A (formulation 2) | Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm |
| BIOLOGICAL | RSV vaccine GSK3003899A (formulation 3) | 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
- 2015-03-20
- Primary completion
- 2015-07-02
- Completion
- 2016-06-21
- First posted
- 2015-02-10
- Last updated
- 2018-07-03
- Results posted
- 2017-08-16
Locations
12 sites across 4 countries: United States, Australia, Czechia, Germany
Source: ClinicalTrials.gov record NCT02360475. Inclusion in this directory is not an endorsement.