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Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers

NCT05993325 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2024-11-15

No results posted yet for this study

Summary

The immunogenicity and safety of AdCLD-CoV19-1 OMI (5.0x10\^10 VP (0.5 mL)/dose/Vial) administered as a booster in healthy adults aged 19 years old and above will be evaluated. Outcome assessment will be performed in comparison with Comirnaty Bivalent.

Conditions

Interventions

BIOLOGICAL

AdCLD-CoV19-1 OMI

3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle

BIOLOGICAL

Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)

1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle

Sponsors & Collaborators

  • Cellid Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2025-03-31
Completion
2025-11-30

Countries

  • Philippines
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05993325 on ClinicalTrials.gov