drugset / Trial / NCT03191383
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women
Timeline
- Start
- 2017-07-11
- Primary completion
- 2017-07-14
- Completion
- 2017-07-14
Outcome
Outcome not reported
Stopped: “Study was canceled due to instability of the PreF antigen during manufacturing. No safety concern has been identified in past or ongoing studies.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK3003891A | Vaccine | 30 ug | Intramuscular |
| Subject | GSK3003891A | Vaccine | 60 ug | Intramuscular |
| Subject | GSK3003891A | Vaccine | 120 ug | Intramuscular |