The primary objective of this study is to evaluate the humoral immune response to CVnCoV in elderly adults aged ≥65 years and younger adults aged 18-45 years, 14 days after the second dose administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Intramuscular (IM) injection
Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum
Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 43
Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulin G (IgG) in Serum
Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Month 6, Month 12 and Month 26
Antibody Concentrations Against SARS-CoV-2 Spike Protein-specific Immunoglobulins in Serum
Antibody concentrations against SARS-CoV-2 spike protein-specific immunoglobulin A (IgA) and immunoglobulin M (IgM) in serum. Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 29, Day 43, Month 6, Month 12 and Month 26
Number of Participants With Neutralizing Antibody Titers Against SARS-CoV-2 Spike Protein in Serum
Measured by an in vitro neutralization assay.
Time frame: Day 29, Day 43, Month 6, Month 12 and Month 26
Number of Participants Who Experience a Solicited Local Adverse Event (AE)
Time frame: Up to 7 days after vaccination
Intensity of Solicited Local Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale
Intensity of solicited local AEs will be graded per the FDA Toxicity Grading Scale at grades 0-3, where higher grades indicate a worse outcome.
Time frame: Up to 7 days after vaccination
Duration of Solicited Local Adverse Events (AEs)
Time frame: Up to 7 days after vaccination
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Number of Participants Who Experience a Solicited Systemic Adverse Event (AE)
Time frame: Up to 7 days after vaccination
Intensity of Solicited Systemic Adverse Events (AEs) per the US Food and Drug Administration (FDA) Toxicity Grading Scale
Intensity of solicited systemic AEs will be graded per the FDA Toxicity Grading Scale at grades 0-3, where higher grades indicate a worse outcome.
Time frame: Up to 7 days after vaccination
Duration of Solicited Systemic Adverse Events (AEs)
Time frame: Up to 7 days after vaccination
Number of Participants Who Experience a Treatment-related Solicited Systemic Adverse Event (AE)
Time frame: Up to 7 days after vaccination
Number of Participants Who Experience an Unsolicited Adverse Event (AE)
Time frame: Up to 28 days after vaccination
Intensity of Unsolicited Adverse Events (AEs) per the Investigator's Assessment
Time frame: Up to 28 days after vaccination
Number of Participants Who Experience a Treatment-related Unsolicited Adverse Event (AE)
Time frame: Up to 28 days after vaccination
Number of Participants Who Experience a Medically Attended Adverse Event (AE)
Time frame: Day 1 up to approximately 26 months
Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event (AE)
Time frame: Day 1 up to approximately 26 months
Number of Participants Who Experience a Medically Attended Serious Adverse Event (SAE)
Time frame: Day 1 up to approximately 26 months
Number of Participants Who Experience a Medically Attended Treatment-related Serious Adverse Event (SAE)
Time frame: Day 1 up to approximately 26 months
Number of Participants Who Experience a Medically Attended Adverse Event of Special Interest (AESI)
Time frame: Day 1 up to approximately 26 months
Number of Participants Who Experience a Treatment-related Medically Attended Adverse Event of Special Interest (AESI)
Time frame: Day 1 up to approximately 26 months
Number of Participants With Virologically-confirmed SARS-CoV-2 Infection
Measured by reverse transcription polymerase chain reaction (RT-PCR).
Time frame: Screening up to approximately 26 months