Trial Outcomes & Findings for Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine (NCT NCT05512949)
NCT ID: NCT05512949
Last Updated: 2025-04-20
Results Overview
Venous blood was collected at Study Day 43 and the serum was analyzed via the PRNT assay to determine if GMT of the intradermal regimen of 2 x 10\^7 TCID50 MVA-BN and 1 x 10\^7 TCID50 MVA- BN were non-inferior to that of the licensed regimen of 1 x 10\^8 TCID50 MVA-BN administered subcutaneously.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
229 participants
Primary outcome timeframe
Day 43
Results posted on
2025-04-20
Participant Flow
Participants were healthy, non-pregnant, non-breastfeeding adults 18 to 50 years old recruited from the communities at large surrounding 8 clinical sites throughout the U.S. The enrollment period occurred between 09SEP2022 and 12OCT2022.
Participant milestones
| Measure |
2 x 10^7 ID MVA-BN
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10\^8 to 3.95 x 10\^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Intradermal vaccination is administered in the volar aspect (inner side) of the forearm.
|
1 x 10^7 ID MVA-BN
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10\^8 to 3.95 x 10\^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Intradermal vaccination is administered in the volar aspect (inner side) of the forearm.
|
1 x 10^8 SC MVA-BN
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10\^8 to 3.95 x 10\^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Subcutaneous vaccination is administered in the deltoid region.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
78
|
76
|
|
Overall Study
COMPLETED
|
69
|
68
|
71
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
5
|
Reasons for withdrawal
| Measure |
2 x 10^7 ID MVA-BN
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10\^8 to 3.95 x 10\^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Intradermal vaccination is administered in the volar aspect (inner side) of the forearm.
|
1 x 10^7 ID MVA-BN
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10\^8 to 3.95 x 10\^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Intradermal vaccination is administered in the volar aspect (inner side) of the forearm.
|
1 x 10^8 SC MVA-BN
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
JYNNEOS: JYNNEOS is FDA-approved and licensed as a smallpox and monkeypox vaccine in the United States. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. Each 0.5 mL dose is formulated to contain 0.5 x 10\^8 to 3.95 x 10\^8 infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7. Subcutaneous vaccination is administered in the deltoid region.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
Completion status unknown
|
1
|
3
|
0
|
Baseline Characteristics
Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
Baseline characteristics by cohort
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
229 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
31.6 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
32.7 years
STANDARD_DEVIATION 9.1 • n=27 Participants
|
32.2 years
STANDARD_DEVIATION 8.9 • n=483 Participants
|
|
Sex/Gender, Customized
Cisgender Man
|
40 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
112 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Cisgender Woman
|
29 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
107 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Genderqueer
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Gender Non-binary
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Gender Non-conforming
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Transgender Man/Trans Man
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Transgender Woman/Trans Woman
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Decline to state
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
112 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
117 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
182 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
148 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=93 Participants
|
78 participants
n=4 Participants
|
76 participants
n=27 Participants
|
229 participants
n=483 Participants
|
|
HIV Status
HIV Negative
|
73 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
221 Participants
n=483 Participants
|
|
HIV Status
HIV Positive
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Sexual Identity
Heterosexual or straight
|
46 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
148 Participants
n=483 Participants
|
|
Sexual Identity
Lesbian or gay
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Sexual Identity
Bisexual
|
13 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Sexual Identity
Queer
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Sexual Identity
Pansexual
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Sexual Identity
Asexual
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Sexual Identity
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sexual Identity
Decline to state
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 43Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood sample for immunogenicity testing for which valid results were reported. Participants are analyzed according to the study product that they received.
Venous blood was collected at Study Day 43 and the serum was analyzed via the PRNT assay to determine if GMT of the intradermal regimen of 2 x 10\^7 TCID50 MVA-BN and 1 x 10\^7 TCID50 MVA- BN were non-inferior to that of the licensed regimen of 1 x 10\^8 TCID50 MVA-BN administered subcutaneously.
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=74 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=75 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at Day 43
|
203.2 titer
Interval 164.5 to 250.9
|
113.2 titer
Interval 90.3 to 141.9
|
288.9 titer
Interval 222.4 to 375.2
|
SECONDARY outcome
Timeframe: Day 1 through Day 365Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood sample for immunogenicity testing for which valid results were reported. Participants are analyzed according to the study product that they received.
Blood was collected at baseline and multiple timepoints post vaccination for evaluation in a vaccinia virus Western Reserve PRNT assay. For each participant, the highest assessment post vaccination was determined as their peak response. For each arm, the geometric mean of peak responses was determined.
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=77 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Individual Peak GMT Through Day 365
|
215.8 Titer
Interval 174.8 to 266.2
|
127.0 Titer
Interval 100.1 to 161.1
|
312.0 Titer
Interval 238.5 to 408.2
|
SECONDARY outcome
Timeframe: Day 1 through Day 365Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood sample for immunogenicity testing for which valid results were reported. Participants are analyzed according to the study product that they received.
Blood was collected at baseline and multiple timepoints post vaccination for evaluation in a vaccinia virus Western Reserve PRNT assay. Geometric means were determined for each timepoint.
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=77 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 1
|
10.2 Titer
Interval 9.8 to 10.5
|
10.4 Titer
Interval 9.8 to 11.1
|
11.2 Titer
Interval 9.8 to 12.8
|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 15
|
38.6 Titer
Interval 29.9 to 50.0
|
20.8 Titer
Interval 16.8 to 25.8
|
39.7 Titer
Interval 29.0 to 54.3
|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 29
|
43.7 Titer
Interval 33.8 to 56.4
|
24.4 Titer
Interval 19.8 to 30.0
|
42.3 Titer
Interval 31.0 to 57.6
|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 43
|
203.2 Titer
Interval 164.5 to 250.9
|
113.2 Titer
Interval 90.3 to 141.9
|
288.9 Titer
Interval 222.4 to 375.2
|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 57
|
115.5 Titer
Interval 92.2 to 144.7
|
75.6 Titer
Interval 61.0 to 93.6
|
175.3 Titer
Interval 135.1 to 227.5
|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 90
|
60.2 Titer
Interval 48.7 to 74.5
|
36.8 Titer
Interval 29.3 to 46.1
|
91.3 Titer
Interval 69.0 to 120.8
|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 181
|
25.1 Titer
Interval 20.4 to 30.9
|
17.3 Titer
Interval 14.2 to 21.1
|
39.7 Titer
Interval 28.8 to 54.6
|
|
Vaccinia Virus Specific PRNT GMT at Study Day 1, 15, 29, 43, 57, 90, 181, and 365
Day 365
|
25.4 Titer
Interval 20.2 to 31.9
|
21.7 Titer
Interval 16.6 to 28.4
|
41.2 Titer
Interval 30.3 to 55.9
|
SECONDARY outcome
Timeframe: Day 43 through Day 365Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of vaccine and contributed both pre- and at least one post-vaccination venous blood sample for immunogenicity testing for which valid results were reported. Participants are analyzed according to the study product that they received.
Half-life, defined as the time from expected peak response (Day 43) to 50% maximal response, was estimated using the first participant visit with titer results less than or equal to half the titer results at Day 43.
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=74 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=75 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=75 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Vaccinia Virus Specific PRNT Half-life (t ½)
|
44 days
Interval 11.0 to 326.0
|
43 days
Interval 12.0 to 322.0
|
43 days
Interval 9.0 to 352.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 43Population: The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Systemic AEs solicited on a memory aid provided to participants included fever, chills, nausea, headache, fatigue, change in appetite, myalgia, and arthralgia. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29-43 for Dose 2).
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic AEs Through 14 Days After Each Study Vaccination
|
59 Participants
|
55 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 43Population: The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Local AEs solicited on a memory aid provided to participants included pain at injection site, erythema/redness, induration/swelling (functional grade based on interference with daily activity and any measure value greater than 2.5 cm) and pruritis at injection site. Participants are considered reporting the local AE if they reported mild or greater severity at any time through 14 days after each study vaccination (Day 1 through Day 15 for Dose 1 and Day 29 through 43 for Dose 2).
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Local AEs Through 14 Days After Each Study Vaccination
|
73 Participants
|
75 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 57Population: The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Frequency of all unsolicited non-serious AEs from day of each study vaccination through 28 days after each vaccination (Day 1 through Day 29 for Dose 1 and Day 29 through Day 57 for Dose 2).
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Related and Unrelated Adverse Events (AEs) Through 28 Days After Each Vaccination
Related AEs
|
64 Participants
|
62 Participants
|
37 Participants
|
|
Number of Participants Reporting Unsolicited Related and Unrelated Adverse Events (AEs) Through 28 Days After Each Vaccination
Unrelated AEs
|
31 Participants
|
26 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 181Population: The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
An MAAE is an unsolicited AE that results in unscheduled medical attention such as a hospitalization for less than 24 hours, an emergency room visit, or an otherwise unscheduled healthcare visit for any reason. All MAAEs were collected from Study Day 1 through Study Day 57, and all MAAEs deemed related to the vaccine were collected through Study Day 181.
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Number of Participants Reporting Related and Unrelated Medically Attended Adverse Events (MAAEs)
Related MAAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Related and Unrelated Medically Attended Adverse Events (MAAEs)
Unrelated MAAEs
|
11 Participants
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 181Population: The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
SAEs included any untoward medical occurrence that resulted in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All SAEs were collected from Study Day 1 through Study Day 57, and all SAEs deemed related to the vaccine were collected through Study Day 181.
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Number of Participants Reporting Related and Unrelated Serious Adverse Events (SAEs)
Unrelated SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Related and Unrelated Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 365Population: The Safety Analysis population includes all participants who received the first study vaccination. Participants are analyzed according to the study product that they received.
Participants could voluntarily withdraw their consent for study participation for any reason at any time. Primary reason for withdrawal was recorded and early termination visits were attempted. Participants who received the first vaccination could choose to discontinue receipt of study vaccine for any reason and could choose to remain in the study (i.e., not withdraw from study). In addition, a participant could be discontinued from receipt of the second vaccination. Discontinuation from vaccination did not mean automatic withdrawal from the study, and participants were monitored for safety and immunogenicity if the participant consented.
Outcome measures
| Measure |
2 x 10^7 ID MVA-BN
n=75 Participants
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 Participants
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 Participants
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Number of Participants Who Withdrew or Discontinued Vaccination
Withdrew
|
6 participants
|
9 participants
|
5 participants
|
|
Number of Participants Who Withdrew or Discontinued Vaccination
Discontinued Vaccination
|
1 participants
|
1 participants
|
0 participants
|
Adverse Events
2 x 10^7 ID MVA-BN
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
1 x 10^7 ID MVA-BN
Serious events: 1 serious events
Other events: 78 other events
Deaths: 0 deaths
1 x 10^8 SC MVA-BN
Serious events: 1 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 x 10^7 ID MVA-BN
n=75 participants at risk
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 participants at risk
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 participants at risk
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Infections and infestations
Cystitis
|
0.00%
0/75 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
1.3%
1/78 • Number of events 1 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
0.00%
0/76 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
0.00%
0/75 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
0.00%
0/78 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
1.3%
1/76 • Number of events 1 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
Other adverse events
| Measure |
2 x 10^7 ID MVA-BN
n=75 participants at risk
0.1 mL of 2 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^7 ID MVA-BN
n=78 participants at risk
0.05 mL of 1 x 10\^7 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered intradermally on Days 1 and 29.
|
1 x 10^8 SC MVA-BN
n=76 participants at risk
0.5 mL of 1 x 10\^8 (50% Tissue Culture Infectious Dose (TCID50) JYNNEOS (Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN)) administered subcutaneously on Days 1 and 29.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
22.7%
17/75 • Number of events 21 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
19.2%
15/78 • Number of events 18 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
25.0%
19/76 • Number of events 21 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Chills
|
20.0%
15/75 • Number of events 15 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
16.7%
13/78 • Number of events 16 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
17.1%
13/76 • Number of events 15 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Fatigue
|
57.3%
43/75 • Number of events 60 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
55.1%
43/78 • Number of events 57 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
69.7%
53/76 • Number of events 75 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Injection site discolouration
|
77.3%
58/75 • Number of events 94 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
76.9%
60/78 • Number of events 103 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
11.8%
9/76 • Number of events 10 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Injection site exfoliation
|
12.0%
9/75 • Number of events 12 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
9.0%
7/78 • Number of events 8 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
0.00%
0/76 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Injection site nodule
|
68.0%
51/75 • Number of events 68 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
59.0%
46/78 • Number of events 59 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
44.7%
34/76 • Number of events 37 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Injection site erythema
|
82.7%
62/75 • Number of events 110 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
71.8%
56/78 • Number of events 89 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
52.6%
40/76 • Number of events 57 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Injection site induration
|
49.3%
37/75 • Number of events 50 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
42.3%
33/78 • Number of events 39 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
52.6%
40/76 • Number of events 60 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Injection site pain
|
65.3%
49/75 • Number of events 69 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
56.4%
44/78 • Number of events 64 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
88.2%
67/76 • Number of events 113 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
General disorders
Injection site pruritus
|
85.3%
64/75 • Number of events 119 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
93.6%
73/78 • Number of events 125 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
55.3%
42/76 • Number of events 62 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
5/75 • Number of events 5 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
3.8%
3/78 • Number of events 3 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
5.3%
4/76 • Number of events 4 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
14.7%
11/75 • Number of events 11 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
21.8%
17/78 • Number of events 21 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
17.1%
13/76 • Number of events 20 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.0%
18/75 • Number of events 21 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
15.4%
12/78 • Number of events 14 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
17.1%
13/76 • Number of events 15 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.0%
24/75 • Number of events 28 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
24.4%
19/78 • Number of events 25 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
43.4%
33/76 • Number of events 47 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
|
Nervous system disorders
Headache
|
48.0%
36/75 • Number of events 45 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
47.4%
37/78 • Number of events 47 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
56.6%
43/76 • Number of events 61 • Solicited events, including local and systemic AEs, were collected from the time of each study vaccination through 14 days after each study vaccination. Unsolicited, non-serious AEs, all SAEs, and all MAAEs were collected from the time of first study vaccination through Study Day 57. All related SAEs and MAAEs were collected from the time of each study vaccination through Study Day 181.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60