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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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 13, 2026
NCT ID
NCT05534048
Status
UNKNOWN
Phase
PHASE3
Sponsor
Everest Medicines (Singapore) Pte. Ltd.
Executive brief
Investment-Ready Snapshot
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.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT05534048
Indication
SARS-CoV-2 Infection
Modality
RNA therapy
Target
PTX-COVID19-B, Comirnaty®
Intervention
PTX-COVID19-B, Comirnaty®
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.