Trial Outcomes & Findings for Safety and Efficacy of R0.6C Vaccine (NCT NCT04862416)
NCT ID: NCT04862416
Last Updated: 2025-03-05
Results Overview
The number of serious adverse events and solicited and unsolicited grade 3 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
From first immunization up to 84 days after the last immunization
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
1A 30μg R0.6C Alhydrogel
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
5
|
3
|
3
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
2
|
5
|
4
|
3
|
3
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
1A 30μg R0.6C Alhydrogel
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of R0.6C Vaccine
Baseline characteristics by cohort
| Measure |
1A 30μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
22 years
n=5 Participants
|
50 years
n=7 Participants
|
23 years
n=5 Participants
|
23 years
n=4 Participants
|
27 years
n=21 Participants
|
23 years
n=8 Participants
|
21 years
n=8 Participants
|
21 years
n=24 Participants
|
23 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
5 participants
n=8 Participants
|
5 participants
n=24 Participants
|
30 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Brazilian
|
1 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=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
1 participants
n=42 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
5 participants
n=8 Participants
|
5 participants
n=24 Participants
|
32 participants
n=42 Participants
|
|
Weight (kg)
|
84.6 kg
n=5 Participants
|
69.2 kg
n=7 Participants
|
67.0 kg
n=5 Participants
|
74.0 kg
n=4 Participants
|
82.6 kg
n=21 Participants
|
68.0 kg
n=8 Participants
|
65.4 kg
n=8 Participants
|
63.8 kg
n=24 Participants
|
70.1 kg
n=42 Participants
|
PRIMARY outcome
Timeframe: From first immunization up to 84 days after the last immunizationThe number of serious adverse events and solicited and unsolicited grade 3 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization.
Outcome measures
| Measure |
1A 30μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Serious Adverse Events and Grade 3 Adverse Events
Serious adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Serious Adverse Events and Grade 3 Adverse Events
Grade 3 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
PRIMARY outcome
Timeframe: 14 days after the fourth immunizationThe functional transmission reducing activity in the standard membrane feeding assay of volunteer sera collected two weeks after the fourth R0.6C immunization (I4+14), compared to baseline (I1-1) within each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I4+14 sera by total number of oocysts in mosquitoes fed with I1-1 sera.
Outcome measures
| Measure |
1A 30μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
n=2 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Transmission Reducing Activity
|
17 % transmission reducing activity
Interval 3.0 to 27.0
|
-73 % transmission reducing activity
Interval -81.0 to -64.0
|
-10 % transmission reducing activity
Interval -32.0 to 4.0
|
-3 % transmission reducing activity
Interval -157.0 to 16.0
|
0 % transmission reducing activity
Interval -13.0 to 30.0
|
-14 % transmission reducing activity
Interval -118.0 to 16.0
|
26 % transmission reducing activity
Interval -70.0 to 53.0
|
13 % transmission reducing activity
Interval -10.0 to 22.0
|
SECONDARY outcome
Timeframe: From first immunization up to 84 days after the last immunizationThe number of solicited and unsolicited grade 1 and 2 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization.
Outcome measures
| Measure |
1A 30μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Grade 1 and 2 Adverse Events
|
11 adverse events
|
18 adverse events
|
33 adverse events
|
61 adverse events
|
17 adverse events
|
51 adverse events
|
32 adverse events
|
69 adverse events
|
SECONDARY outcome
Timeframe: 14 days after immunization 1, 2 and 3. One day before immunization 4 and 84 days after immunization 4.Population: TRA data were collected first for time points with highest antibody titres, if no significant TRA was detectable at these time points, TRA data was not collected for other timepoints.
The transmission reducing activity at other timepoint (I1+14, I2+14, I3+14, I3+111 \[I4-1\], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I1+14, I2+14, I3+14, I3+111 \[I4-1\], and I4+84 sera by total number of oocysts in mosquitoes fed with I1-1 sera.
Outcome measures
| Measure |
1A 30μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
n=2 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Transmission Reducing Activity
I3+14
|
3 % transmission reducing activity
Interval -6.0 to 10.0
|
-80 % transmission reducing activity
Interval -99.0 to -61.0
|
-3 % transmission reducing activity
Interval -19.0 to 27.0
|
-9 % transmission reducing activity
Interval -16.0 to 22.0
|
15 % transmission reducing activity
Interval -21.0 to 28.0
|
-42 % transmission reducing activity
Interval -63.0 to 30.0
|
16 % transmission reducing activity
Interval -20.0 to 43.0
|
9 % transmission reducing activity
Interval -69.0 to 51.0
|
SECONDARY outcome
Timeframe: 14 days after each immunization. One day before immunization 4 and 84 days after immunization 4.Population: One subject in group 2B withdrew consent 24 days after vaccination 4, therefore the I4+84 timepoint is only analyzed in 4 out of 5 subjects of group 2B.
The anti-6C antibody quantity in volunteer sera collected two weeks after fourth R0.6C immunization (I4+14) and at other time points (I1+14, I2+14, I3+14, I3+111 \[I4-1\], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant combinations, as determined by ELISA.
Outcome measures
| Measure |
1A 30μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
n=2 Participants
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
n=3 Participants
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
n=5 Participants
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Anti-6C Antibody Quantities
I4+84
|
0.76 ug/mL
Interval 0.0 to 1.51
|
1.96 ug/mL
Interval 0.22 to 3.71
|
0.85 ug/mL
Interval 0.57 to 1.13
|
1.69 ug/mL
Interval -2.09 to 5.48
|
1.04 ug/mL
Interval 0.53 to 1.55
|
1.74 ug/mL
Interval 0.96 to 2.51
|
0.58 ug/mL
Interval -0.1 to 1.26
|
2.10 ug/mL
Interval 0.56 to 3.64
|
|
Anti-6C Antibody Quantities
I4+14
|
1.61 ug/mL
Interval -1.43 to 4.65
|
5.22 ug/mL
Interval 1.22 to 9.22
|
2.31 ug/mL
Interval 1.56 to 3.07
|
4.13 ug/mL
Interval -3.52 to 11.78
|
2.40 ug/mL
Interval -1.34 to 6.14
|
7.57 ug/mL
Interval 3.46 to 11.68
|
1.73 ug/mL
Interval -0.65 to 4.11
|
5.75 ug/mL
Interval 0.26 to 11.24
|
|
Anti-6C Antibody Quantities
I1-1
|
0.20 ug/mL
Interval 0.1 to 0.3
|
0.24 ug/mL
Interval -0.18 to 0.66
|
0.21 ug/mL
Interval 0.1 to 0.33
|
0.09 ug/mL
Interval 0.05 to 0.12
|
0.25 ug/mL
Interval 0.08 to 0.43
|
0.12 ug/mL
Interval 0.09 to 0.14
|
0.11 ug/mL
Interval 0.01 to 0.21
|
0.09 ug/mL
Interval 0.02 to 0.16
|
|
Anti-6C Antibody Quantities
I1+14
|
0.23 ug/mL
Interval 0.14 to 0.31
|
0.21 ug/mL
Interval -0.21 to 0.64
|
0.27 ug/mL
Interval 0.0 to 0.54
|
0.11 ug/mL
Interval 0.05 to 0.17
|
0.20 ug/mL
Interval 0.05 to 0.36
|
0.18 ug/mL
Interval 0.07 to 0.28
|
0.11 ug/mL
Interval -0.01 to 0.22
|
0.21 ug/mL
Interval 0.14 to 0.28
|
|
Anti-6C Antibody Quantities
I2+14
|
0.33 ug/mL
Interval 0.17 to 0.48
|
1.62 ug/mL
Interval 0.2 to 3.03
|
0.42 ug/mL
Interval 0.24 to 0.59
|
4.42 ug/mL
Interval -13.84 to 22.69
|
0.78 ug/mL
Interval 0.11 to 1.45
|
3.26 ug/mL
Interval 2.75 to 3.78
|
0.27 ug/mL
Interval 0.0 to 0.54
|
3.52 ug/mL
Interval -1.13 to 8.18
|
|
Anti-6C Antibody Quantities
I3+14
|
0.87 ug/mL
Interval -0.91 to 2.64
|
2.57 ug/mL
Interval 1.81 to 3.33
|
1.20 ug/mL
Interval -0.98 to 3.38
|
4.39 ug/mL
Interval -6.13 to 14.91
|
1.67 ug/mL
Interval 0.8 to 2.54
|
5.64 ug/mL
Interval 4.12 to 7.17
|
0.59 ug/mL
Interval -0.14 to 1.33
|
5.56 ug/mL
Interval -0.42 to 11.53
|
|
Anti-6C Antibody Quantities
I4-1
|
0.38 ug/mL
Interval 0.3 to 0.46
|
0.58 ug/mL
Interval -0.29 to 1.45
|
0.42 ug/mL
Interval 0.25 to 0.59
|
0.79 ug/mL
Interval -0.21 to 1.79
|
0.46 ug/mL
Interval 0.32 to 0.59
|
0.86 ug/mL
Interval 0.63 to 1.1
|
0.24 ug/mL
Interval 0.01 to 0.47
|
0.73 ug/mL
Interval 0.25 to 1.22
|
Adverse Events
1A 30μg R0.6C Alhydrogel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1B 30μg R0.6C Alhydrogel + Matrix M1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
2A 30μg R0.6C Alhydrogel
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
2B 30μg R0.6C Alhydrogel + Matrix M1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3A 100μg R0.6C Alhydrogel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3B 100μg R0.6C Alhydrogel + Matrix M1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
4A 100μg R0.6C Alhydrogel
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
4B 100μg R0.6C Alhydrogel + Matrix M1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1A 30μg R0.6C Alhydrogel
n=3 participants at risk
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
1B 30μg R0.6C Alhydrogel + Matrix M1
n=3 participants at risk
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2A 30μg R0.6C Alhydrogel
n=5 participants at risk
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
2B 30μg R0.6C Alhydrogel + Matrix M1
n=5 participants at risk
5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3A 100μg R0.6C Alhydrogel
n=3 participants at risk
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
3B 100μg R0.6C Alhydrogel + Matrix M1
n=3 participants at risk
3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4A 100μg R0.6C Alhydrogel
n=5 participants at risk
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
4B 100μg R0.6C Alhydrogel + Matrix M1
n=5 participants at risk
5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168.
R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Ear and labyrinth disorders
Otalgia
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Thoracic pain
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Lightheadedness
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Cut wound
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Hangover
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
60.0%
3/5 • Number of events 5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Eye disorders
Chalazion
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hay fever
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Infections and infestations
Herpes simplex infection
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
3/3 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
5/5 • Number of events 5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Reproductive system and breast disorders
Spotting
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Reproductive system and breast disorders
Trichomonas infection
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Injury, poisoning and procedural complications
Hematoma after venipuncture
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Gastrointestinal disorders
Abdominal cramps
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Infections and infestations
Cough
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Cramp
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Gastrointestinal disorders
Pharyngitis
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Pain at injection site
|
100.0%
3/3 • Number of events 6 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
5/5 • Number of events 14 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 13 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
3/3 • Number of events 9 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
3/3 • Number of events 12 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
5/5 • Number of events 20 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
5/5 • Number of events 20 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Induration at injection site
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
3/3 • Number of events 6 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
60.0%
3/5 • Number of events 8 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Itching at injection site
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 7 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
3/3 • Number of events 6 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
5/5 • Number of events 12 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Erythema at injection site
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
5/5 • Number of events 12 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
100.0%
3/3 • Number of events 7 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 10 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Swelling at injection site
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
60.0%
3/5 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
60.0%
3/5 • Number of events 5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 6 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 6 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Headache
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 34 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 23 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 15 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 6 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 11 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
60.0%
3/5 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Tenderness at injection site
|
66.7%
2/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Drowsiness
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Blood and lymphatic system disorders
Elevated leukocytes
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Tired sensation vaccinated upper arm
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Endocrine disorders
Flushes
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Pain between shoulder blades
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in armpit
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Musculoskeletal and connective tissue disorders
Pain hand
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/3 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
0.00%
0/5 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
|
Infections and infestations
Common cold
|
33.3%
1/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 8 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
80.0%
4/5 • Number of events 9 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 4 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
66.7%
2/3 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
40.0%
2/5 • Number of events 2 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
60.0%
3/5 • Number of events 9 • Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
|
Additional Information
Dr. Matthew McCall
Radboud university medical center
Phone: +31 24 361 43 56
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place