Trials / Active Not Recruiting
Active Not RecruitingNCT05993325
Immunogenicity and Safety of AdCLD-CoV19-1 OMI As a Booster: a COVID-19 Preventive Vaccine in Healthy Volunteers
A Phase III Multinational, Multicenter, Observer-Blinded, Randomized, Active-Controlled Trial to Evaluate the Immunogenicity and Safety of the Preventive COVID-19 Vaccine AdCLD-CoV19-1 OMI Administered As a Booster to Adults Aged 19 Years Old and Above
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,000 (estimated)
- Sponsor
- Cellid Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-11-27
- Primary completion
- 2025-03-01
- Completion
- 2025-11-01
- First posted
- 2023-08-15
- Last updated
- 2024-11-15
Locations
17 sites across 2 countries: Philippines, South Korea
Source: ClinicalTrials.gov record NCT05993325. Inclusion in this directory is not an endorsement.