Drugs / RTS,S
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | malaria | 2014-07-24 | “GSK announced today that it has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.” gsk.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT00075049 | Dec 2003 → Jan 2006 | malaria | U.S. Army Medical Research and Development Command | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-10-29 | GlaxoSmithKline | Results GSK candidate vaccine demonstrates sustained level of protection against active pulmonary tuberculosis gsk.com ↗
These results demonstrate an overall vaccine efficacy of 50% during the three years after vaccination. |
| 2018-09-25 | GlaxoSmithKline | Results GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults in phase II study gsk.com ↗
Today, GSK and Aeras reported that GSK’s M72/AS01E[1] candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection[2] in an ongoing phase IIb clinical trial testing. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RTS,S | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00075049 ↗ |
| Modality | Vaccine | “RTS,S/AS02A, a pre-erythrocytic Plasmodium falciparum vaccine” PMID 16904798 ↗ Jul 2006 |