Trials / Completed
CompletedNCT05576623
Safety and Immunogenicity of AdCLD-CoV19-1 OMI as a Booster: A SARS-CoV-2 (COVID-19) Preventive Vaccine
A Phase I/II (Single Center, Open, Phase I and Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Phase II) Trial to Evaluate the Safety and Immunogenicity of the AdCLD-CoV19-1 OMI Administered as a Booster to Healthy Adults Aged 19 Years Old and Above
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 320 (actual)
- Sponsor
- Cellid Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
Summary
The safety and immunogenicity 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AdCLD-CoV19-1 OMI (Part A) | 20 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle |
| BIOLOGICAL | AdCLD-CoV19-1 OMI (Part B) | 250 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular injection in the deltoid muscle |
| OTHER | Placebo (Part B) | 50 participants will receive placebo via intramuscular injection in the deltoid muscle |
Timeline
- Start date
- 2022-09-14
- Primary completion
- 2023-03-10
- Completion
- 2024-02-28
- First posted
- 2022-10-12
- Last updated
- 2024-07-17
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05576623. Inclusion in this directory is not an endorsement.