drugset / Trial / NCT04992182
Reactogenicity, Safety, and Immunogenicity of Covid-19 Vaccine Booster
Phase 2
Unknown
534 enrolled
Universidad del Desarrollo
Ministry of Health, Chile · collabPontificia Universidad Catolica de Chile · collabUniversity of Chile · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Preliminary data suggest that inactivated vaccine-induced neutralizing antibodies against SARS-CoV-2 decrease at six months after vaccination. Observational, unpublished data also indicate that vaccine effectiveness against Covid-19 wanes over time. Thus, the investigators aimed to determine the reactogenicity, safety, and immunogenicity of a homologous or heterologous booster of SARS-CoV-2 vaccines among people already immunized with an inactivated SARS-CoV-2 vaccine. The study focuses on the elderly population and healthcare workers.
Timeline
- Start
- 2021-07-08
- Primary completion
- 2021-08-31
- Completion
- 2022-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT162b2 | Messenger RNA (mRNA) | 0.3 ml | Intramuscular |
| Subject | ChAdOx1 | Vaccine | 0.5 ml | Intramuscular |
| Subject | CoronaVac | Vaccine | 0.5 ml | Intramuscular |