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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date22 Apr 2020 |
A Phase III Study to Evaluate the Safety and Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination in Previously Vaccinated Adults Aged 18 Years and Older
The purpose of this clinical trial is to Evaluate the Safety and Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination in Previously Vaccinated Adults Aged 18 Years and Older.
This study is seeking participants who are:
Adult males and females 18 years of age or older; In efficacy cohort : Subjects who were previously vaccinated with 2 doses of Comirnaty® administered at least 3 months prior to the booster dose..
All participants in this efficacy cohort will receive 1 of the 2 study vaccines: PTX-COVID19-B or Comirnaty®.
All participants in efficacy cohort will receive a single 40 microgram dose PTX-COVID19-B of the study vaccine or one dose of Comirnaty® at the first study clinic and will return to the study clinic 6 more times. At each clinic visit, a blood sample will be taken. They study is about 6 months long for each participant.
In safety cohort: Subjects who have previously received any primary series approved by WHO Emergency Use Authorization at least 3 months prior to enrollment or subjects who have already received one authorized booster vaccination and planned to receive PTX-COVID19-B as the 4th shot will be enrolled.
All participants in this safety cohort will receive 1 dose vaccines: PTX-COVID19-B.
All participants in safety cohort will receive a single 40 microgram dose of the study vaccine at the first study clinic and will return to the study clinic 5 more times. At each clinic visit, a blood sample will be taken. They study is about 6 months long for each participant.
A Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated With Vaxzevria®
This is a Phase III, Randomized, Observer-Blind Study to Evaluate the Safety and Superiority in Immunogenicity of PTX-COVID19-B Administered as Booster Vaccination Compared to Vaxzevria® in Adults Aged 18 Years and Older Who Were Previously Vaccinated with Vaxzevria®.
This study will be a competitive enrollment process in all participating countries. Once the target number of subjects is reached, the enrollment in all participating countries in the particular phase will be stopped.
An Open-label Extention (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 in China
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).
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