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Heterologous CoronaVac/Comirnaty vs Homologous CoronaVac Prime-Boost
NCT05668065Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2021
- Primary completion
- Jan 2022
- Countries
- 1
- Sponsor
- Institut Pasteur de Tunis
- Modality
- Vaccines & Immunotherapeutics, Lipid-based Nanoparticles, mRNA Therapeutics
- Drugs
- tozinameran
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, single-blind trial of tozinameran in coronavirus disease 2019 (COVID-19) (2 arms), sponsored by Institut Pasteur de Tunis. Primary endpoint: Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines. Started Nov 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Homologous (CoronaVac/CoronaVac)
CoronaVac followed by CoronaVac
Heterologous (CoronaVac/Comirnaty)
CoronaVac followed by Comirnaty
03
Who it enrols
Healthy adults aged 18-60 years who are COVID-19 vaccine naïve and have no history of COVID-19 infection.
04
Endpoints
Primary
Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines
Secondary
Immunogenicity parameters (Neutralizing antibody titers)
Immunogenicity parameters (IgG antibody titers)
Safety indexes of adverse reactions
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