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NCT05534048UNKNOWNanonymous

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

Sponsor

Source record

Everest Medicines (Singapore) Pte. Ltd.

Phase

Source record

PHASE3

Modality

AI-normalized

RNA therapy

Target

AI-normalized

PTX-COVID19-B, Comirnaty®

Indication / condition

AI-normalized

SARS-CoV-2 Infection

Intervention

Source record

PTX-COVID19-B, Comirnaty®

Source & freshness

Source record

NCT ID

NCT05534048

Original source

ClinicalTrials.gov

Source last updated

Sep 09, 2022

Ingested at

Jun 09, 2026

Internal sync

Jun 09, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT05534048

Title

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

Sponsor

Everest Medicines (Singapore) Pte. Ltd.

Status

UNKNOWN

Phase

PHASE3

Condition raw

SARS-CoV-2 Infection

Condition normalized

SARS-CoV-2 Infection

Modality raw

RNA therapy

Modality normalized

RNA therapy

Target raw

PTX-COVID19-B, Comirnaty®

Target normalized

PTX-COVID19-B, Comirnaty®

Interventions

PTX-COVID19-B, Comirnaty®

Public preview

Source record

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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