Trial Outcomes & Findings for Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria (NCT NCT05581641)
NCT ID: NCT05581641
Last Updated: 2025-09-03
Results Overview
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])
Results posted on
2025-09-03
Participant Flow
Participant milestones
| Measure |
Cohort 1: BNT165b1: 3 Micrograms (mcg)
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Placebo
Participants received 3 intramuscular injections of matching placebo of BNT165b vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
12
|
|
Overall Study
Vaccinated With Dose 1 (Day 1)
|
16
|
16
|
16
|
12
|
|
Overall Study
Vaccinated With Dose 2 (Day 57)
|
15
|
15
|
14
|
10
|
|
Overall Study
Vaccinated With Dose 3 (Day 183)
|
15
|
15
|
13
|
9
|
|
Overall Study
COMPLETED
|
14
|
14
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1: BNT165b1: 3 Micrograms (mcg)
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Placebo
Participants received 3 intramuscular injections of matching placebo of BNT165b vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
2
|
1
|
Baseline Characteristics
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
Baseline characteristics by cohort
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 Participants
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 Participants
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively
|
Cohort 3: BNT165b1: 30 mcg
n=16 Participants
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively
|
Placebo
n=12 Participants
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 10.61 • n=99 Participants
|
41.5 years
STANDARD_DEVIATION 10.46 • n=107 Participants
|
35.6 years
STANDARD_DEVIATION 10.14 • n=206 Participants
|
34.2 years
STANDARD_DEVIATION 10.16 • n=7 Participants
|
38.8 years
STANDARD_DEVIATION 10.74 • n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Body Mass Index (BMI)
|
28.05 kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 3.665 • n=99 Participants
|
28.85 kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 3.195 • n=107 Participants
|
26.06 kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 3.954 • n=206 Participants
|
27.28 kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 4.564 • n=7 Participants
|
27.58 kilogram per meter square (kg/m^2)
STANDARD_DEVIATION 3.875 • n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])Population: Analysis was performed on the safety set, i.e., participants who received at least one dose of the IMP. Here, "number analyzed" signified participants who received vaccination at the specified visits.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Outcome measures
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 Participants
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 Participants
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
n=16 Participants
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively
|
Placebo
n=12 Participants
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Local Reactions
Erythema/Redness- Post any vaccination
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Induration/Swelling- Post any vaccination
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Pain at the injection site- Post any vaccination
|
4 Participants
|
6 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Reactions
Erythema/Redness- Post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Induration/Swelling- Post Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Pain at the injection site- Post Dose 1
|
2 Participants
|
4 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Erythema/Redness- Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Induration/Swelling- Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Pain at the injection site- Post Dose 2
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Reactions
Erythema/Redness- Post Dose 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Induration/Swelling- Post Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Pain at the injection site- Post Dose 3
|
3 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Grade >=3 Local Reaction-Post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Grade >=3 Local Reaction-Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Reactions
Grade >=3 Local Reaction-Post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])Population: Analysis was performed on the safety set. Here, "number analyzed" signified participants who received vaccination at the specified visits.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Outcome measures
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 Participants
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 Participants
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
n=16 Participants
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively
|
Placebo
n=12 Participants
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions
Arthralgia- Post any vaccination
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Chills- Post any vaccination
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Diarrhea- Post any vaccination
|
5 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fatigue- Post any vaccination
|
9 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever- Post any vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache- Post any vaccination
|
6 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia- Post any vaccination
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Vomiting- Post any vaccination
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Arthralgia- Post Dose 1
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Chills- Post Dose 1
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Diarrhea- Post Dose 1
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fatigue- Post Dose 1
|
7 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever- Post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache- Post Dose 1
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia- Post Dose 1
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Vomiting- Post Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Arthralgia- Post Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Chills- Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Diarrhea-Post Dose 2
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fatigue- Post Dose 2
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever- Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache- Post Dose 2
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia- Post Dose 2
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Vomiting- Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Arthralgia- Post Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Chills- Post Dose 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Diarrhea- Post Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fatigue- Post Dose 3
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever- Post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache- Post Dose 3
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia- Post Dose 3
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Vomiting- Post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Grade >=3 Systemic Reaction-Post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Grade >=3 Systemic Reaction-Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Grade >=3 Systemic Reaction-Post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85] and Dose 3 [at Day 211])Population: Analysis was performed on the safety set. Here, "number analyzed" signified participants who received vaccination at the specified visits.
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
Outcome measures
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 Participants
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 Participants
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
n=16 Participants
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively
|
Placebo
n=12 Participants
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Post any vaccination
|
4 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)
Post Dose 1
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Grade >= 3 AE: Post Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Post Dose 2
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Grade >= 3 AE: Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Post Dose 3
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Grade >= 3 AE: Post Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 24 weeks after Dose 3 (i.e., up to Day 351)Population: Analysis was performed on the safety set.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Outcome measures
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 Participants
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 Participants
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
n=16 Participants
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively
|
Placebo
n=12 Participants
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85], Dose 3 [at Day 211])Population: Analysis was performed on the safety set. Here, "number analyzed" signified participants who received vaccination at the specified visits.
MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
Outcome measures
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 Participants
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 Participants
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
n=16 Participants
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively
|
Placebo
n=12 Participants
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs)
Post any vaccination
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs)
Post Dose-1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs)
Post Dose-2
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Medically Attended Adverse Events (MAAEs)
Post Dose-3
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Cohort 1: BNT165b1: 3 mcg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: BNT165b1: 10 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3: BNT165b1: 30 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 participants at risk
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 participants at risk
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
n=16 participants at risk
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Placebo
n=12 participants at risk
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
Other adverse events
| Measure |
Cohort 1: BNT165b1: 3 mcg
n=16 participants at risk
Participants received 3 intramuscular injections of 3 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 2: BNT165b1: 10 mcg
n=16 participants at risk
Participants received 3 intramuscular injections of 10 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Cohort 3: BNT165b1: 30 mcg
n=16 participants at risk
Participants received 3 intramuscular injections of 30 mcg of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
Placebo
n=12 participants at risk
Participants received 3 intramuscular injections of matching placebo of BNT165b1 vaccine, one each at Days 1, 57 and 183, respectively.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
General disorders
Chest discomfort
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
General disorders
Fatigue
|
12.5%
2/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
8.3%
1/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
General disorders
Non-cardiac chest pain
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Infections and infestations
COVID-19
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
16.7%
2/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
8.3%
1/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
8.3%
1/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Nervous system disorders
Migraine
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
12.5%
2/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
6.2%
1/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/16 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
0.00%
0/12 • AE data were collected from Day 1 up to 28 days after each vaccination. All SAEs collected throughout the study are reported in the AE section and were reported from Visit 0 (Screening) up to Visit 14 (i.e., 1 year post Dose 3, up to Day 548)
Analysis was performed on the safety set. Per protocol, solicited local and systemic reactions were not included in the AE analysis unless they continued longer than 7 days post-investigational medicinal product (IMP) administration or were a SAE. Solicited local and systemic reactions are presented in the respective outcome measures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators respectively trial sites shall not publish or refer to in writing or orally, in whole or in part, any data, information or materials generated from the study and the services, without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER