drugset / Trial / NCT03303625
A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age
RandomizedParallel-groupQuadruple-blindOther
Summary
The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.
Timeline
- Start
- 2017-11-29
- Primary completion
- 2020-04-21
- Completion
- 2020-04-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.RSV.preF | Vaccine | 0.25 ml | Intramuscular |
| Subject | Ad26.RSV.preF | Vaccine | 0.5 ml | Intramuscular |
| Subject | Ad26.RSV.preF | Vaccine | 5e+10 unknown | Intramuscular |
| Subject | Ad26.RSV.preF | Vaccine | 1e+11 unknown | Intramuscular |