Last reviewed · How we verify
A Phase 2, Non-inferiority, Open-label, Randomized Controlled Study to Evaluate the Immunogenicity and Safety of Comvigen (Bivalent) Vaccine as a Booster Dose in Adults Who Have Received a Previous Booster Dose of an Approved COVID-19 Vaccine
This study will assess the safety, reactogenicity and immunogenicity of a single dose of Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine as a booster among healthy males and non-pregnant females aged 18-64 years after receiving a previous booster dose of any approved mRNA COVID-19 vaccine for more than 3 months. The results of Combiven will be compared to BIVALENT Pfizer/BNT vaccine.
Details
| Lead sponsor | Chulalongkorn University |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 450 |
| Start date | 2023-10-09 |
| Completion | 2024-02 |
Conditions
- Safety of a Single Dose of COMVIGEN Vaccine
- Reactogenicity of a Single Dose of COMVIGEN Vaccine
- Immunogenicity of a Single Dose of COMVIGEN Vaccine
- Safety of a Single Dose of BIVALENT Pfizer/BNT Vaccine
- Reactogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine
- Immunogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine
Interventions
- Comvigen (Bivalent, ChulaCov19 BNA159.2)
- BIVALENT Pfizer/BNT vaccine
Primary outcomes
- adverse events — 30 minutes after vaccination
Presence of immediate adverse events within 30 minutes after vaccination - solicited injection site or systemic reactions — within 7 days after vaccination
Presence of solicited injection site or systemic reactions within 7 days after vaccination - unsolicited adverse events — within 28 days after vaccination
Presence of unsolicited adverse events within 28 days after vaccination - serious adverse events (SAEs) — 169 days
Presence of serious adverse events (SAEs) from day 1 to Day 169 - medically attended adverse events (MAAEs) — 169 days
Presence of medically attended adverse events (MAAEs) from day 1 to Day 169 - New Onset Chronic Medical Condition (NOCMCs) — 169 days
Presence of New Onset Chronic Medical Condition (NOCMCs) from day 1 to Day 169
Countries
Thailand