Trial Outcomes & Findings for A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 (NCT NCT04515147)

Last Updated: 2023-09-28

Results Overview

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). By definition, all solicited local AEs occurring from the time of first vaccination were considered related to trial vaccination. For solicited systemic AEs, the Investigator assessed the relationship between trial vaccine and each occurrence of each AE.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

668 participants

Primary outcome timeframe

Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)

Results posted on

2023-09-28

Participant Flow

This trial was performed in Peru and Panama between 21 September 2020 and 21 February 2022.

Of the 1035 participants who were screened, 668 participants were enrolled and received trial vaccine.

Participant milestones

Participant milestones
Measure	CVnCoV 6 μg: Aged 18-60 Years Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Overall Study STARTED	12	11	289	295	31	30
Overall Study COMPLETED	11	10	274	268	28	20
Overall Study NOT COMPLETED	1	1	15	27	3	10

Reasons for withdrawal

Reasons for withdrawal
Measure	CVnCoV 6 μg: Aged 18-60 Years Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Overall Study Withdrawal by Subject	1	0	10	18	1	8
Overall Study Lost to Follow-up	0	1	5	6	2	1
Overall Study Adverse Event	0	0	0	2	0	0
Overall Study Miscellaneous	0	0	0	1	0	1

Baseline Characteristics

A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=11 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=289 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=295 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=31 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=30 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	Total n=668 Participants Total of all reporting groups
Age, Continuous	50.2 years STANDARD_DEVIATION 8.44 • n=5 Participants	65.6 years STANDARD_DEVIATION 4.08 • n=7 Participants	38.1 years STANDARD_DEVIATION 12.08 • n=5 Participants	69.0 years STANDARD_DEVIATION 6.06 • n=4 Participants	31.6 years STANDARD_DEVIATION 12.31 • n=21 Participants	66.7 years STANDARD_DEVIATION 5.07 • n=10 Participants	53.4 years STANDARD_DEVIATION 18.16 • n=115 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	118 Participants n=5 Participants	139 Participants n=4 Participants	12 Participants n=21 Participants	16 Participants n=10 Participants	296 Participants n=115 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	171 Participants n=5 Participants	156 Participants n=4 Participants	19 Participants n=21 Participants	14 Participants n=10 Participants	372 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	283 Participants n=5 Participants	287 Participants n=4 Participants	31 Participants n=21 Participants	30 Participants n=10 Participants	654 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	14 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	14 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Other	12 Participants n=5 Participants	11 Participants n=7 Participants	283 Participants n=5 Participants	284 Participants n=4 Participants	30 Participants n=21 Participants	29 Participants n=10 Participants	649 Participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)

Population: Safety Analysis Set: All participants who received at least 1 dose of trial vaccine and for whom any post-vaccination safety data are available. Only participants with evaluable samples at each visit are included.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=11 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=289 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=295 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=31 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=30 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited local AEs	9 Participants	5 Participants	253 Participants	220 Participants	17 Participants	26 Participants
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited systemic AEs	4 Participants	6 Participants	229 Participants	193 Participants	13 Participants	14 Participants
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any related solicited systemic AEs	4 Participants	5 Participants	228 Participants	190 Participants	13 Participants	14 Participants
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited local AEs	9 Participants	3 Participants	208 Participants	188 Participants	6 Participants	22 Participants
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited systemic AEs	9 Participants	8 Participants	217 Participants	195 Participants	13 Participants	11 Participants
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any related solicited systemic AEs	8 Participants	8 Participants	217 Participants	193 Participants	13 Participants	11 Participants

PRIMARY outcome

Timeframe: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)

Population: The Safety Analysis Set including only participants who experienced solicited local and systemic AEs. Only participants with evaluable samples at each visit are included.

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=9 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=8 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=253 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=220 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=17 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=26 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited local AEs · Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited local AEs · Grade 1	9 Participants	5 Participants	191 Participants	203 Participants	16 Participants	25 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited local AEs · Grade 2	0 Participants	0 Participants	61 Participants	17 Participants	1 Participants	1 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited systemic AEs · Grade 1	4 Participants	4 Participants	122 Participants	122 Participants	7 Participants	11 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited systemic AEs · Grade 2	0 Participants	2 Participants	96 Participants	65 Participants	6 Participants	3 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 1: Any solicited systemic AEs · Grade 3	0 Participants	0 Participants	11 Participants	6 Participants	0 Participants	0 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited local AEs · Grade 1	9 Participants	2 Participants	166 Participants	162 Participants	5 Participants	17 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited local AEs · Grade 2	0 Participants	1 Participants	42 Participants	25 Participants	1 Participants	5 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited local AEs · Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited systemic AEs · Grade 1	7 Participants	5 Participants	100 Participants	103 Participants	7 Participants	8 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited systemic AEs · Grade 2	2 Participants	1 Participants	109 Participants	83 Participants	6 Participants	3 Participants
Intensity of Solicited AEs Per US Food and Drug Administration (FDA) Toxicity Grading Scale Occurring on the Day of Vaccination and the Following 7 Days After Dose 1 and Dose 2 Dose 2: Any solicited systemic AEs · Grade 3	0 Participants	2 Participants	8 Participants	9 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 7 days after Dose 1 (Days 1 to 8) and Dose 2 (Days 29 to 36)

Population: The Safety Analysis Set including only participants who experienced solicited local and systemic AEs. Only participants with evaluable samples at each visit are included.

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after day 8 are included.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=9 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=8 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=253 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=220 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=17 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=26 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 Dose 1: Any solicited local AEs	1.3 days Standard Deviation 0.50	1.2 days Standard Deviation 0.45	2.1 days Standard Deviation 1.12	1.8 days Standard Deviation 1.54	1.6 days Standard Deviation 0.87	2.0 days Standard Deviation 1.20
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 Dose 1: Any solicited systemic AEs	1.5 days Standard Deviation 1.00	1.5 days Standard Deviation 0.84	1.9 days Standard Deviation 1.25	2.1 days Standard Deviation 1.42	1.9 days Standard Deviation 0.86	2.4 days Standard Deviation 2.17
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 Dose 2: Any solicited local AEs	2.1 days Standard Deviation 1.27	2.3 days Standard Deviation 1.15	2.2 days Standard Deviation 1.11	1.9 days Standard Deviation 1.33	2.2 days Standard Deviation 1.17	2.2 days Standard Deviation 0.96
Duration of Solicited AEs Occurring on the Day of Vaccination and the Following 7 Days After After Dose 1 and Dose 2 Dose 2: Any solicited systemic AEs	2.1 days Standard Deviation 2.32	2.3 days Standard Deviation 2.43	1.9 days Standard Deviation 1.13	2.1 days Standard Deviation 1.49	2.2 days Standard Deviation 2.45	2.3 days Standard Deviation 2.05

PRIMARY outcome

Timeframe: Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=11 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=289 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=295 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=31 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=30 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 1: Any unsolicited AEs	5 Participants	6 Participants	120 Participants	105 Participants	7 Participants	5 Participants
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 1: Any related unsolicited AEs	2 Participants	1 Participants	33 Participants	26 Participants	0 Participants	1 Participants
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 2: Any unsolicited AEs	4 Participants	3 Participants	77 Participants	75 Participants	10 Participants	7 Participants
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 2: Any related unsolicited AEs	1 Participants	2 Participants	13 Participants	7 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 28 days after Dose 1 (Days 1 to 29) and Dose 2 (Days 29 to 57)

Population: The Safety Analysis Set including only participants who experienced unsolicited AEs. Only participants with evaluable samples at each visit are included.

Diaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories: * Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities. * Moderate: an event that caused sufficient discomfort to interfere with normal everyday activities. * Severe: an event that prevented normal everyday activities.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=5 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=6 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=120 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=105 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=10 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=7 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 2: Unsolicited AEs · Mild	4 Participants	1 Participants	54 Participants	63 Participants	9 Participants	1 Participants
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 2: Unsolicited AEs · Moderate	0 Participants	2 Participants	20 Participants	9 Participants	1 Participants	6 Participants
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 2: Unsolicited AEs · Severe	0 Participants	0 Participants	3 Participants	3 Participants	0 Participants	0 Participants
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 1: Unsolicited AEs · Moderate	2 Participants	0 Participants	21 Participants	15 Participants	1 Participants	1 Participants
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 1: Unsolicited AEs · Mild	3 Participants	6 Participants	94 Participants	88 Participants	6 Participants	4 Participants
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Dose 1 and Dose 2 Dose 1: Unsolicited AEs · Severe	0 Participants	0 Participants	5 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 393

An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=11 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=289 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=295 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=31 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=30 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial Any related SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced a Serious Adverse Event (SAE) During the Trial Any SAEs	0 Participants	1 Participants	8 Participants	6 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to Day 393

AESIs included: * AEs with a suspected immune-medicated etiology. * COVID-19 disease. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. Participants who became unblinded and/or received a licensed/authorized vaccine were censored at the day after unblinding or at the day after receiving the licensed/authorized vaccine, whichever was earlier. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=11 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=289 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=295 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=31 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=30 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial Any AESIs	1 Participants	3 Participants	36 Participants	23 Participants	7 Participants	3 Participants
Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) During the Trial Any related AESIs	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline, Day 29 and Day 43

Population: The Immunogenicity Set including only participants who received Dose 1 and Dose 2 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.

As measured by enzyme-linked immunosorbent assay (ELISA). In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=10 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=233 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=243 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=24 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=23 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 Day 29	0 percentage of participants Interval 0.0 to 26.5	10.0 percentage of participants Interval 0.3 to 44.5	11.6 percentage of participants Interval 7.8 to 16.4	7.8 percentage of participants Interval 4.8 to 11.9	0 percentage of participants Interval 0.0 to 14.2	4.3 percentage of participants Interval 0.1 to 21.9
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein Receptor-Binding Domain (RBD) Antibodies on Day 29 and Day 43 Day 43	83.3 percentage of participants Interval 51.6 to 97.9	80.0 percentage of participants Interval 44.4 to 97.5	93.9 percentage of participants Interval 90.0 to 96.6	80.9 percentage of participants Interval 75.2 to 85.7	0 percentage of participants Interval 0.0 to 16.1	4.8 percentage of participants Interval 0.1 to 23.8

PRIMARY outcome

Timeframe: Day 29 and Day 43

As measured by ELISA. The SARS-CoV-2 spike RBD protein-specific antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=10 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=233 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=243 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=24 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=23 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 Day 29	50.000 titers Standard Deviation 1.0000	57.154 titers Standard Deviation 1.5264	67.221 titers Standard Deviation 2.6624	63.828 titers Standard Deviation 2.6005	56.724 titers Standard Deviation 1.5434	52.112 titers Standard Deviation 1.2195
Geometric Mean Titers (GMTs) of SARS-CoV-2 Spike Protein RBD Antibodies on Day 29 and Day 43 Day 43	462.744 titers Standard Deviation 3.4299	464.788 titers Standard Deviation 4.2969	1733.125 titers Standard Deviation 4.2886	552.782 titers Standard Deviation 5.1208	57.455 titers Standard Deviation 1.5663	62.667 titers Standard Deviation 2.8146

PRIMARY outcome

Timeframe: Baseline, Day 29 and Day 43

As measured by an activity assay. In participants not exposed to SARS-CoV-2 before the trial, seroconversion was defined as any increase in titer in SARS-CoV-2 neutralizing antibodies versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=10 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=180 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=154 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=15 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=16 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 Day 29	0 percentage of participants Interval 0.0 to 26.5	0 percentage of participants Interval 0.0 to 30.8	8.3 percentage of participants Interval 4.7 to 13.4	7.8 percentage of participants Interval 4.1 to 13.2	0 percentage of participants Interval 0.0 to 21.8	0 percentage of participants Interval 0.0 to 20.6
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 Day 43	66.7 percentage of participants Interval 34.9 to 90.1	70.0 percentage of participants Interval 34.8 to 93.3	86.4 percentage of participants Interval 80.5 to 91.1	77.1 percentage of participants Interval 69.6 to 83.5	0 percentage of participants Interval 0.0 to 24.7	0 percentage of participants Interval 0.0 to 21.8

PRIMARY outcome

Timeframe: Day 29 and Day 43

The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=10 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=180 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years n=154 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years n=15 Participants Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years n=16 Participants Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 Day 29	5.000 titers Standard Deviation 1.0000	5.000 titers Standard Deviation 1.0000	5.912 titers Standard Deviation 2.0106	6.234 titers Standard Deviation 2.4723	5.000 titers Standard Deviation 1.0000	5.000 titers Standard Deviation 1.0000
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 Day 43	16.339 titers Standard Deviation 3.6716	20.705 titers Standard Deviation 2.8993	50.298 titers Standard Deviation 4.0175	26.848 titers Standard Deviation 3.9517	5.000 titers Standard Deviation 1.0000	5.000 titers Standard Deviation 1.0000

SECONDARY outcome

Timeframe: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=30 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=30 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=15 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited local AEs	15 Participants	24 Participants	12 Participants	—	—	—
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited systemic AEs	15 Participants	24 Participants	8 Participants	—	—	—
Number of Participants Who Experienced a Solicited Adverse Event (AE) Occurring on the Day of Booster Vaccination and the Following 7 Days Any related solicited systemic AEs	15 Participants	24 Participants	8 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)

Population: The Safety Analysis Set including only participants who experienced solicited local and systemic AEs. Only participants who received a booster vaccination on Day 57 or Day 180 and had evaluable samples at each visit were included.

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Intensity of solicited local AEs and solicited systemic AEs were graded per the FDA Toxicity Grading Scale at Grades 1-3, where higher grades indicate a worse outcome.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=15 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=24 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited local AEs · Grade 1	14 Participants	18 Participants	9 Participants	—	—	—
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited local AEs · Grade 2	1 Participants	5 Participants	3 Participants	—	—	—
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited local AEs · Grade 3	0 Participants	1 Participants	0 Participants	—	—	—
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited systemic AEs · Grade 1	13 Participants	11 Participants	6 Participants	—	—	—
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited systemic AEs · Grade 2	2 Participants	12 Participants	2 Participants	—	—	—
Intensity of Solicited AEs Per FDA Toxicity Grading Scale Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited systemic AEs · Grade 3	0 Participants	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 7 days after booster vaccination (Days 57 to 64 and Days 180 to 187)

Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using a diary (electronic or paper). Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the adverse event.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=15 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=24 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=12 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited local AEs	1.7 days Standard Deviation 0.80	2.0 days Standard Deviation 1.53	1.6 days Standard Deviation 0.79	—	—	—
Duration of Solicited AEs Occurring on the Day of Booster Vaccination and the Following 7 Days Any solicited systemic AEs	2.8 days Standard Deviation 2.18	2.0 days Standard Deviation 1.71	2.0 days Standard Deviation 2.07	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208)

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=30 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=30 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=15 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days Any unsolicited AEs	7 Participants	6 Participants	2 Participants	—	—	—
Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Booster Vaccination and the Following 28 Days Any related unsolicited AEs	1 Participants	4 Participants	2 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 28 days after booster vaccination (Days 57 to 85 and Days 180 to 208)

Population: The Safety Analysis Set including only participants who experienced unsolicited AEs. Only participants who received a booster vaccination on Day 57 or Day 180 and had evaluable samples at each visit were included.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=7 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=6 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=2 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days Mild	6 Participants	5 Participants	2 Participants	—	—	—
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days Moderate	1 Participants	0 Participants	0 Participants	—	—	—
Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Booster Vaccination and the Following 28 Days Severe	0 Participants	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: For participants who received the booster vaccination on Day 57: Baseline, Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Baseline, Day 180, Day 208 and Day 393

Population: The Immunogenicity Set including only participants who received Dose 1, Dose 2 and a booster dose on Day 57 or Day 180 with no protocol deviations with impact to immunogenicity, who did not get exposed to SARS-CoV-2 before the trial, or during the trial before the applicable sample was collected and had a blood sample collected at Day 43.

As measured by ELISA. In participants not exposed to SARS-CoV-2 before the trial seroconversion was defined as any increase in titer in antibodies against SARS-CoV-2 RBD versus baseline. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=28 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=21 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=13 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 57	82.1 percentage of participants Interval 63.1 to 93.9	—	—	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 85	100 percentage of participants Interval 86.3 to 100.0	—	—	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 180	100 percentage of participants Interval 83.9 to 100.0	90.5 percentage of participants Interval 69.6 to 98.8	69.2 percentage of participants Interval 38.6 to 90.9	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 208	—	100 percentage of participants Interval 83.2 to 100.0	100 percentage of participants Interval 69.2 to 100.0	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 393	—	100 percentage of participants Interval 2.5 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=28 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=21 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=13 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 57	516.198 titers Standard Deviation 4.6157	—	—	—	—	—
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 85	2889.963 titers Standard Deviation 2.9473	—	—	—	—	—
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 180	1449.055 titers Standard Deviation 2.1869	445.661 titers Standard Deviation 3.1744	153.160 titers Standard Deviation 2.8146	—	—	—
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 208	—	10094.652 titers Standard Deviation 2.1020	4153.249 titers Standard Deviation 2.2450	—	—	—
GMTs of SARS-CoV-2 Spike Protein RBD Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 393	—	915.460 titers Standard Deviation NA Standard deviation was not estimable as only 1 participant had available data.	—	—	—	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=28 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=21 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=13 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 180	57.1 percentage of participants Interval 34.0 to 78.2	28.6 percentage of participants Interval 11.3 to 52.2	7.7 percentage of participants Interval 0.2 to 36.0	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 208	—	100 percentage of participants Interval 83.2 to 100.0	90.0 percentage of participants Interval 55.5 to 99.7	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 393	—	100 percentage of participants Interval 2.5 to 100.0	—	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 57	75.0 percentage of participants Interval 55.1 to 89.3	—	—	—	—	—
Percentage of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 85	96.0 percentage of participants Interval 79.6 to 99.9	—	—	—	—	—

SECONDARY outcome

Timeframe: For participants who received the booster vaccination on Day 57: Day 57, Day 85 and Day 180. For participants who received the booster vaccination on Day 180: Day 180, Day 208 and Day 393

As measured by an activity assay. The SARS-CoV-2 neutralizing antibodies are expressed as GMT (geometric mean of reciprocal duplicate dilutions). Concentration/titers marked as below the lower limit of quantification (LLOQ) were arbitrary replaced by half of the LLOQ for GMT computations purpose. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/ authorized vaccine.

Outcome measures

Outcome measures
Measure	CVnCoV 6 μg: Aged 18-60 Years n=28 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	CVnCoV 6 μg: Aged >60 Years n=21 Participants Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.	CVnCoV 12 μg: Aged 18-60 Years n=13 Participants Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were between the ages of 18 to 60 years old. CVnCoV was administered again as a booster vaccination on Day 180 in a sub-group of participants in Part 1.	CVnCoV 12 μg: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control - Hepatitis A Vaccine: Aged 18-60 Years Participants in Part 1 and Part 2 were vaccinated with a hepatitis A vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged between 18 and 60 years old.	Active Control - Pneumococcal Vaccine: Aged >60 Years Participants in Part 1 and Part 2 were vaccinated with a pneumococcal vaccine as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. Participants in this group were aged over 60 years old.
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 393	—	28.280 titers Standard Deviation NA Standard deviation was not estimable as only 1 participant had available data.	—	—	—	—
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 57	25.937 titers Standard Deviation 4.4384	—	—	—	—	—
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 85	74.642 titers Standard Deviation 3.0879	—	—	—	—	—
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 180	16.957 titers Standard Deviation 3.3656	7.308 titers Standard Deviation 2.5328	5.867 titers Standard Deviation 1.7802	—	—	—
GMTs of SARS-CoV-2 Neutralizing Antibodies on Day 57, Day 85, Day 180, Day 208 and Day 393 Day 208	—	141.724 titers Standard Deviation 2.0232	54.639 titers Standard Deviation 3.3018	—	—	—

Adverse Events

CVnCoV 6 μg

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

CVnCoV 12 μg

Serious events: 14 serious events

Other events: 567 other events

Deaths: 3 deaths

Active Control

Serious events: 1 serious events

Other events: 59 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	CVnCoV 6 μg n=23 participants at risk Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.	CVnCoV 12 μg n=584 participants at risk Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control n=61 participants at risk Participants in Part 1 and Part 2 were vaccinated with an active control (hepatitis A vaccine if aged 18-60 years old or pneumococcal vaccine if aged over 60 years old) as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
Infections and infestations Appendicitis	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.34% 2/584 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Infections and infestations COVID-19	4.3% 1/23 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Infections and infestations COVID-19 pneumonia	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Eye disorders Extraocular muscle paresis	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Eye disorders Retinal vein occlusion	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/584 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	1.6% 1/61 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.34% 2/584 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Nervous system disorders Ischaemic stroke	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.17% 1/584 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.

Other adverse events

Additional Information

Clinical Trial Information

CureVac AG

Phone: 0049 6976805870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CVnCoV 6 μg n=23 participants at risk Participants in Part 1 were vaccinated with CVnCoV 6 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.	CVnCoV 12 μg n=584 participants at risk Participants in Part 1 and Part 2 were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. CVnCoV was administered again as a booster vaccination on Day 57 or Day 180 in a sub-group of participants in Part 1.	Active Control n=61 participants at risk Participants in Part 1 and Part 2 were vaccinated with an active control (hepatitis A vaccine if aged 18-60 years old or pneumococcal vaccine if aged over 60 years old) as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
General disorders Injection site pain	73.9% 17/23 • Number of events 30 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	90.1% 526/584 • Number of events 1012 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	77.0% 47/61 • Number of events 75 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
General disorders Fatigue	30.4% 7/23 • Number of events 16 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	53.9% 315/584 • Number of events 555 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	36.1% 22/61 • Number of events 29 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
General disorders Chills	34.8% 8/23 • Number of events 13 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	43.5% 254/584 • Number of events 384 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	16.4% 10/61 • Number of events 12 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
General disorders Pyrexia	17.4% 4/23 • Number of events 4 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	31.2% 182/584 • Number of events 233 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	6.6% 4/61 • Number of events 6 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
General disorders Swelling	8.7% 2/23 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	8.9% 52/584 • Number of events 60 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	13.1% 8/61 • Number of events 8 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
General disorders Discomfort	13.0% 3/23 • Number of events 3 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	2.6% 15/584 • Number of events 18 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
General disorders Injection site swelling	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	1.7% 10/584 • Number of events 10 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	6.6% 4/61 • Number of events 4 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Nervous system disorders Headache	56.5% 13/23 • Number of events 24 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	66.8% 390/584 • Number of events 763 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	54.1% 33/61 • Number of events 46 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Musculoskeletal and connective tissue disorders Myalgia	39.1% 9/23 • Number of events 11 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	53.9% 315/584 • Number of events 505 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	21.3% 13/61 • Number of events 21 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Musculoskeletal and connective tissue disorders Arthralgia	34.8% 8/23 • Number of events 15 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	40.6% 237/584 • Number of events 362 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	19.7% 12/61 • Number of events 15 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Musculoskeletal and connective tissue disorders Back pain	13.0% 3/23 • Number of events 3 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	7.9% 46/584 • Number of events 54 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	4.9% 3/61 • Number of events 3 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Infections and infestations Nasopharyngitis	17.4% 4/23 • Number of events 5 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	26.5% 155/584 • Number of events 217 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	19.7% 12/61 • Number of events 14 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Infections and infestations COVID-19	13.0% 3/23 • Number of events 3 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	18.5% 108/584 • Number of events 109 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	19.7% 12/61 • Number of events 12 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Infections and infestations Upper respiratory tract infection	4.3% 1/23 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	11.6% 68/584 • Number of events 79 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	3.3% 2/61 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Infections and infestations Gastroenteritis	8.7% 2/23 • Number of events 3 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	2.4% 14/584 • Number of events 14 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	1.6% 1/61 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Gastrointestinal disorders Diarrhoea	21.7% 5/23 • Number of events 5 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	18.3% 107/584 • Number of events 140 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	9.8% 6/61 • Number of events 6 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	11.8% 69/584 • Number of events 83 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	6.6% 4/61 • Number of events 4 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Gastrointestinal disorders Vomiting	4.3% 1/23 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	7.7% 45/584 • Number of events 58 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	8.2% 5/61 • Number of events 6 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	8.9% 52/584 • Number of events 66 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	18.0% 11/61 • Number of events 12 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Skin and subcutaneous tissue disorders Erythema	4.3% 1/23 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	5.3% 31/584 • Number of events 34 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	8.2% 5/61 • Number of events 5 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/23 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	5.3% 31/584 • Number of events 31 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	3.3% 2/61 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	8.7% 2/23 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	2.7% 16/584 • Number of events 17 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	1.6% 1/61 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.7% 2/23 • Number of events 3 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	2.4% 14/584 • Number of events 14 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	1.6% 1/61 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Injury, poisoning and procedural complications Muscle rupture	8.7% 2/23 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/584 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Blood and lymphatic system disorders Anaemia	8.7% 2/23 • Number of events 2 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	2.6% 15/584 • Number of events 15 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	1.6% 1/61 • Number of events 1 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.
Blood and lymphatic system disorders Lymphopenia	17.4% 4/23 • Number of events 4 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.68% 4/584 • Number of events 4 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.	0.00% 0/61 • Day 1 to Day 393 Adverse events were collected based on intervention type and were not collected separately for the active control arm.