Description
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Randomised double-blinded study
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3 study groups all receiving the same vaccine but stored under different conditions
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The COVID-19 vaccine used is CV0801 - a monovalent modified-nucleoside mRNA COVID-19 vaccine encoding Ancestral D614G spike protein
Trial length
6 months
Participant age
Participant ages can range from 18 and above
Patient eligibility
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Female participants must NOT be pregnant
-
Female participants must NOT be breastfeeding
-
Healthy participants above the age of 18
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No history of immunosuppressive or immunodeficient conditions
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Prior receipt of an mRNA COVID-19 vaccine
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This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine
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The last vaccination must be received at least 3 months prior to randomisation
-
2 onsite visits and 3 scheduled phone calls are required from patients
Follow-up inclusions
Objectives
To assess the immunogenicity of COVID-19 booster vaccines stored in different conditions.
Description
-
Randomised double-blinded study
-
3 study groups all receiving the same vaccine but stored under different conditions
-
The COVID-19 vaccine used is CV0801 - a monovalent modified-nucleoside mRNA COVID-19 vaccine encoding Ancestral D614G spike protein
Trial length
6 months
Participant age
Participant ages can range from 18 and above.
Patient eligibility
-
Female participants must NOT be pregnant
-
Female participants must NOT be breastfeeding
-
Healthy participants above the age of 18
-
No history of immunosuppressive or immunodeficient conditions
-
Prior receipt of an mRNA COVID-19 vaccine
-
This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine
-
The last vaccination must be received at least 3 months prior to randomisation
2 onsite visits and 3 scheduled phone calls are required from patients.
Follow-up inclusions
Objectives
To assess the immunogenicity of COVID-19 booster vaccines stored in different conditions.
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