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Trial Outcomes & Findings for Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial (NCT NCT03699124)

NCT ID: NCT03699124

Last Updated: 2021-05-27

Results Overview

Vaccinia-specific neutralizing antibody titers below the lower limit of quantitation are given a value 10, i.e., half of the PRNT lower limit of quantitation of 20.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1129 participants

Primary outcome timeframe

Two weeks post second vaccination; approximately Week 6.

Results posted on

2021-05-27

Participant Flow

Participant milestones

Participant milestones
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Overall Study
STARTED
377
375
377
Overall Study
COMPLETED
332
335
337
Overall Study
NOT COMPLETED
45
40
40

Reasons for withdrawal

Reasons for withdrawal
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Overall Study
Adverse Event
6
5
2
Overall Study
Death
0
2
0
Overall Study
Lost to Follow-up
20
16
15
Overall Study
Protocol Violation
1
0
0
Overall Study
Withdrawal by Subject
13
14
13
Overall Study
Other reasons
5
3
10

Baseline Characteristics

Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Total
n=1129 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
377 Participants
n=99 Participants
375 Participants
n=107 Participants
377 Participants
n=206 Participants
1129 Participants
n=7 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Continuous
30.7 years
STANDARD_DEVIATION 7.31 • n=99 Participants
30.6 years
STANDARD_DEVIATION 7.29 • n=107 Participants
30.7 years
STANDARD_DEVIATION 7.50 • n=206 Participants
30.7 years
STANDARD_DEVIATION 7.36 • n=7 Participants
Sex: Female, Male
Female
210 Participants
n=99 Participants
213 Participants
n=107 Participants
207 Participants
n=206 Participants
630 Participants
n=7 Participants
Sex: Female, Male
Male
167 Participants
n=99 Participants
162 Participants
n=107 Participants
170 Participants
n=206 Participants
499 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
28 Participants
n=99 Participants
20 Participants
n=107 Participants
25 Participants
n=206 Participants
73 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
348 Participants
n=99 Participants
354 Participants
n=107 Participants
349 Participants
n=206 Participants
1051 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
1 Participants
n=107 Participants
3 Participants
n=206 Participants
5 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
8 Participants
n=7 Participants
Race (NIH/OMB)
Asian
17 Participants
n=99 Participants
13 Participants
n=107 Participants
13 Participants
n=206 Participants
43 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
2 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
58 Participants
n=99 Participants
55 Participants
n=107 Participants
59 Participants
n=206 Participants
172 Participants
n=7 Participants
Race (NIH/OMB)
White
292 Participants
n=99 Participants
295 Participants
n=107 Participants
293 Participants
n=206 Participants
880 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
n=99 Participants
9 Participants
n=107 Participants
8 Participants
n=206 Participants
24 Participants
n=7 Participants
Region of Enrollment
United States
377 participants
n=99 Participants
375 participants
n=107 Participants
377 participants
n=206 Participants
1129 participants
n=7 Participants

PRIMARY outcome

Timeframe: Two weeks post second vaccination; approximately Week 6.

Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results.

Vaccinia-specific neutralizing antibody titers below the lower limit of quantitation are given a value 10, i.e., half of the PRNT lower limit of quantitation of 20.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=327 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=331 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=330 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT)
252.7 Titer
Interval 231.3 to 276.0
269.9 Titer
Interval 243.2 to 299.7
242.0 Titer
Interval 219.5 to 266.8

SECONDARY outcome

Timeframe: Two weeks post second vaccination; approximately Week 6.

Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results.

Vaccinia-specific total antibody titers below the lower limit of quantitation are given a value 100, i.e., half of the ELISA lower limit of quantitation of 200.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=327 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=331 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=330 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Vaccinia-Specific Total Antibodies Measured by Enzyme-Linked Immunosorbant Assay (ELISA)
1222 Titer
Interval 1123.3 to 1329.4
1311 Titer
Interval 1195.7 to 1437.5
1226.1 Titer
Interval 1118.1 to 1344.6

SECONDARY outcome

Timeframe: Two weeks post second vaccination; approximately Week 6.

Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results. Only subjects who had both a baseline and two weeks post second vaccination titer results are included.

Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for PRNT is 20.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=326 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=331 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=330 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Seroconversion Rates for Vaccinia-Specific Neutralizing Antibodies by PRNT
325 Participants
328 Participants
327 Participants

SECONDARY outcome

Timeframe: Two weeks post second vaccination; approximately Week 6.

Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results. Only subjects who had both a baseline and two weeks post second vaccination titer results are included.

Seroconversion is defined as either the appearance of antibody titers \>= LLOQ for subjects with a titer below LLOQ at baseline, or a doubling (or more) of the antibody titer compared to the baseline titer for subjects with a titer equal or above the LLOQ at baseline. The LLOQ for ELISA is 200.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=326 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=331 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=330 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Seroconversion Rates for Vaccinia-Specific Total Antibodies by ELISA
323 Participants
325 Participants
326 Participants

SECONDARY outcome

Timeframe: Two weeks post second vaccination; approximately Week 6.

Population: The Per Protocol Set includes all randomized subjects who received at least one vaccination and had no major protocol deviations that might have a substantial impact on the immunogenicity results.

Pearson correlation coefficient calculated on the log10 PRNT vs. ELISA titers at 2 weeks post second vaccination.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=327 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=331 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=330 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Pearson Correlation Coefficient Between the log10 Transformed PRNT Titers and the log10 Transformed ELISA Titers
0.657 Correlation Coefficient
Interval 0.5901 to 0.7142
0.657 Correlation Coefficient
Interval 0.591 to 0.7142
0.656 Correlation Coefficient
Interval 0.5893 to 0.7131

SECONDARY outcome

Timeframe: Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Occurrence is defined as the number of participants who experienced an SAE. Related SAEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial
Any Serious Adverse Event
1 Participants
7 Participants
1 Participants
Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial
Related Serious Adverse Event
0 Participants
0 Participants
0 Participants
Occurrence, Relationship and Intensity of Any Serious Adverse Event (SAE) at Any Time During the Trial
Serious Adverse Event >= Grade 3
0 Participants
5 Participants
1 Participants

SECONDARY outcome

Timeframe: Overall study, ie from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Occurrence is defined as the number of participants who experienced an event falling in the system organ class of "Cardiac disorders" per MedDRA version 22.0. Related cardiac signs and symptoms are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial.
Any Cardiac Sign or Symptom
1 Participants
2 Participants
1 Participants
Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial.
Any Related Cardiac Sign or Symptom
0 Participants
0 Participants
0 Participants
Occurrence, Relationship and Intensity of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis at Any Time During the Trial.
Any Cardiac Sign or Symptom >=Grade 3
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Related AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where Grade 3 is Severe and Grade 4 is Potentially Life Threatening.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Occurrence of Any Grade 3 or 4 Unsolicited AEs Probably, Possibly or Definitely Related to the Trial Vaccine
2 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Within 28 days (and up to 35 days) after each vaccination, ie, from Visit 1 to Visit 3 for the first vaccination and from Visit 3 to Visit 5 for the second vaccination based on the protocol scheduled visits.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Occurrence is defined as the number of participants who experienced an unsolicited AE. Related unsolicited AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, published September 2007, where \>= Grade 3 is either Severe or Potentially Life Threatening.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Occurrence, Relationship and Intensity of Unsolicited AEs
Any Unsolicited AE
88 Participants
110 Participants
98 Participants
Occurrence, Relationship and Intensity of Unsolicited AEs
Any Related Unsolicited AE
33 Participants
38 Participants
37 Participants
Occurrence, Relationship and Intensity of Unsolicited AEs
Any Unsolicited AE >= Grade 3
6 Participants
8 Participants
7 Participants

SECONDARY outcome

Timeframe: During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Occurrence is defined as the number of participants who experienced a solicited local AE. Intensity is defined per the protocol for each local event type. For injection site erythema, swelling, and induration the intensity is graded based on the maximum diameter as Grade 1: \< 30mm, Grade 2: \>= 30 - \< 100mm, Grade 3: \>= 100mm. Intensity for pruritis is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. Intensity for injection site pain is defined as Grade 1: Painful on touch, Grade 2: Painful when moving the limb, Grade 3: Spontaneously painful/prevents normal activity. If a participant experienced the local event after both vaccinations, the maximum intensity is presented.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Any Solicited Local AEs
338 Participants
348 Participants
344 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Any Redness
271 Participants
283 Participants
272 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Redness Grade 1
84 Participants
110 Participants
87 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Redness Grade 2
143 Participants
131 Participants
156 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Redness Grade 3
44 Participants
42 Participants
29 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Any Swelling
215 Participants
233 Participants
236 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Swelling Grade 1
88 Participants
121 Participants
118 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Swelling Grade 2
110 Participants
87 Participants
106 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Swelling Grade 3
17 Participants
25 Participants
12 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Any Induration
215 Participants
226 Participants
229 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Induration Grade 1
98 Participants
126 Participants
123 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Induration Grade 2
106 Participants
92 Participants
100 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Induration Grade 3
11 Participants
8 Participants
6 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Any Pruritis
210 Participants
230 Participants
198 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Pruritis Grade 1
160 Participants
181 Participants
159 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Pruritis Grade 2
40 Participants
42 Participants
29 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Pruritis Grade 3
10 Participants
7 Participants
10 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Any Injection Site Pain
325 Participants
330 Participants
329 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Injection Site Pain Grade 1
118 Participants
112 Participants
124 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Injection Site Pain Grade 2
161 Participants
173 Participants
162 Participants
Occurrence and Intensity of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Injection Site Pain Grade 3
46 Participants
45 Participants
43 Participants

SECONDARY outcome

Timeframe: Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Number of days from the start of the local event to resolution. If a participant experienced the local event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Redness
7.1 Days
Standard Deviation 6.53
6.5 Days
Standard Deviation 5.06
6.6 Days
Standard Deviation 5.39
Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Swelling
6.7 Days
Standard Deviation 6.47
6 Days
Standard Deviation 5.04
5.9 Days
Standard Deviation 4.52
Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Induration
18 Days
Standard Deviation 24.04
13.9 Days
Standard Deviation 13.12
15 Days
Standard Deviation 15.01
Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Pruritis
5 Days
Standard Deviation 5.7
4.4 Days
Standard Deviation 3.24
4.4 Days
Standard Deviation 3.87
Duration of Solicited Local AEs (Redness, Swelling, Induration, Pruritus and Pain).
Pain
6.9 Days
Standard Deviation 4.41
7.1 Days
Standard Deviation 4.44
6.7 Days
Standard Deviation 3.64

SECONDARY outcome

Timeframe: During the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Occurrence is defined as the number of participants who experienced a solicited general AE. Related solicited general AEs are defined as those for which causality to trial vaccine was considered possible, probable, definite, or was missing. Intensity is defined per the protocol for each general event type. For pyrexia (increased body temperature) grading is defined as Grade 1: ≥ 99.5 - \< 100.4°F (≥ 37.5 - \< 38.0°C), Grade 2:≥ 100.4 - \< 102.2°F (≥ 38.0 - \< 39.0°C), Grade 3:≥ 102.2 - \< 104°F (≥ 39.0 - \< 40.0°C), and Grade 4: ≥ 104°F (≥ 40.0°C). Intensity for headache, myalgia, nausea, fatigue and chills is defined as Grade 1: mild, Grade 2: moderate, Grade 3: severe. If a participant experienced the general event after both vaccinations, the maximum intensity is presented.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Chills
58 Participants
54 Participants
57 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Headache Grade 1
96 Participants
102 Participants
120 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Nausea
75 Participants
81 Participants
78 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Nausea Grade 2
16 Participants
19 Participants
18 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Solicited General AEs
253 Participants
267 Participants
266 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Related Solicited General AEs
246 Participants
256 Participants
252 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Pyrexia
47 Participants
60 Participants
63 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Pyrexia Grade 1
39 Participants
48 Participants
49 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Pyrexia Grade 2
7 Participants
8 Participants
13 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Pyrexia Grade 3
1 Participants
4 Participants
1 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Pyrexia Grade 4
0 Participants
0 Participants
0 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Related Pyrexia
47 Participants
57 Participants
55 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Headache
146 Participants
157 Participants
155 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Headache Grade 2
36 Participants
44 Participants
25 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Headache Grade 3
14 Participants
11 Participants
10 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Related Headache
140 Participants
145 Participants
145 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Myalgia
166 Participants
173 Participants
175 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Myalgia Grade 1
115 Participants
116 Participants
116 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Myalgia Grade 2
38 Participants
47 Participants
39 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Myalgia Grade 3
13 Participants
10 Participants
20 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Related Myalgia
159 Participants
167 Participants
167 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Nausea Grade 1
53 Participants
56 Participants
54 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Nausea Grade 3
6 Participants
6 Participants
6 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Related Nausea
73 Participants
73 Participants
67 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Fatigue
140 Participants
171 Participants
171 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Fatigue Grade 1
82 Participants
111 Participants
99 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Fatigue Grade 2
43 Participants
47 Participants
58 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Fatigue Grade 3
15 Participants
13 Participants
14 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Related Fatigue
135 Participants
163 Participants
161 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Chills Grade 1
43 Participants
28 Participants
38 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Chills Grade 2
10 Participants
22 Participants
13 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Chills Grade 3
5 Participants
4 Participants
6 Participants
Occurrence, Relationship, and Intensity of Solicited General AEs (Pyrexia, Headache, Myalgia, Nausea, Fatigue and Chills).
Any Related Chills
55 Participants
50 Participants
53 Participants

SECONDARY outcome

Timeframe: Starting during the 8 day period (day of vaccination and the following 7 days) after each vaccination, ie, Days 1-8 for the first vaccination and Days 28-35 for the second vaccination based on the protocol scheduled visits, through resolution.

Population: The Full Analysis Set includes all subjects who were randomized and received at least one dose of trial vaccine, regardless of the occurrence of protocol deviations.

Number of days from the start of the general event to resolution. If a participant experienced the general event after both vaccinations, the longer duration is presented. Subjects who had a missing resolution date for the event are not included in the analysis.

Outcome measures

Outcome measures
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 Participants
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Nausea
2.6 Days
Standard Deviation 2.98
2.7 Days
Standard Deviation 2.76
2.7 Days
Standard Deviation 2.5
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Pyrexia
2.3 Days
Standard Deviation 1.87
1.9 Days
Standard Deviation 1.91
1.9 Days
Standard Deviation 1.92
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Headache
3.2 Days
Standard Deviation 2.85
3.1 Days
Standard Deviation 2.49
3.2 Days
Standard Deviation 3.59
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Myalgia
4.1 Days
Standard Deviation 2.8
4 Days
Standard Deviation 3.27
4.1 Days
Standard Deviation 3.3
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Fatigue
3.9 Days
Standard Deviation 5.16
3.1 Days
Standard Deviation 2.7
3.6 Days
Standard Deviation 3.57
Duration of Solicited General AEs (Pyrexia [Body Temperature Increase], Headache, Myalgia, Nausea, Fatigue and Chills)
Chills
2.3 Days
Standard Deviation 2.01
2.3 Days
Standard Deviation 2.71
2.3 Days
Standard Deviation 2.19

Adverse Events

GP 1: Two Doses of FD MVA-BN--Lot 1

Serious events: 1 serious events
Other events: 347 other events
Deaths: 0 deaths

GP 2: Two Doses of FD MVA-BN--Lot 2

Serious events: 7 serious events
Other events: 353 other events
Deaths: 2 deaths

GP 3: Two Doses of FD MVA-BN--Lot 3

Serious events: 1 serious events
Other events: 349 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 participants at risk
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 participants at risk
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 participants at risk
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Gastrointestinal disorders
Alcoholic pancreatitis
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/375 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.27%
1/377 • Number of events 1 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Gastrointestinal disorders
Colitis
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.27%
1/375 • Number of events 1 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Death
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.53%
2/375 • Number of events 2 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Musculoskeletal and connective tissue disorders
Foot deformity
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.27%
1/375 • Number of events 1 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Psychiatric disorders
Depression
0.27%
1/377 • Number of events 1 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/375 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Infections and infestations
Groin abscess
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.27%
1/375 • Number of events 1 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.27%
1/375 • Number of events 1 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Psychiatric disorders
Panic attack
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.27%
1/375 • Number of events 1 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
0.00%
0/377 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).

Other adverse events

Other adverse events
Measure
GP 1: Two Doses of FD MVA-BN--Lot 1
n=377 participants at risk
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 1 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 2: Two Doses of FD MVA-BN--Lot 2
n=375 participants at risk
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 2 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
GP 3: Two Doses of FD MVA-BN--Lot 3
n=377 participants at risk
Healthy, vaccinia-naïve subjects receiving two subcutaneous (SC) vaccinations, four weeks apart with freeze-dried (FD) MVA-BN® - Lot 3 FD MVA-BN: Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
Infections and infestations
Upper respiratory tract infection
5.0%
19/377 • Number of events 19 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
6.7%
25/375 • Number of events 26 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
5.6%
21/377 • Number of events 23 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Gastrointestinal disorders
Nausea
19.9%
75/377 • Number of events 90 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
21.6%
81/375 • Number of events 104 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
20.7%
78/377 • Number of events 96 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Chills
15.4%
58/377 • Number of events 65 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
14.4%
54/375 • Number of events 62 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
15.1%
57/377 • Number of events 63 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Fatigue
37.1%
140/377 • Number of events 186 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
45.6%
171/375 • Number of events 225 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
45.4%
171/377 • Number of events 235 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Injection site erythema
71.9%
271/377 • Number of events 439 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
75.5%
283/375 • Number of events 465 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
72.1%
272/377 • Number of events 459 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Injection site induration
57.0%
215/377 • Number of events 328 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
60.3%
226/375 • Number of events 355 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
60.7%
229/377 • Number of events 346 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Injection site pain
86.2%
325/377 • Number of events 573 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
88.0%
330/375 • Number of events 581 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
87.3%
329/377 • Number of events 576 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Injection site pruritis
55.7%
210/377 • Number of events 303 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
61.3%
230/375 • Number of events 338 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
52.5%
198/377 • Number of events 284 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Injection site swelling
57.0%
215/377 • Number of events 324 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
62.1%
233/375 • Number of events 343 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
62.6%
236/377 • Number of events 360 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
General disorders
Pyrexia
12.5%
47/377 • Number of events 56 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
16.0%
60/375 • Number of events 75 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
16.7%
63/377 • Number of events 72 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Musculoskeletal and connective tissue disorders
Myalgia
44.0%
166/377 • Number of events 225 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
46.1%
173/375 • Number of events 238 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
46.4%
175/377 • Number of events 241 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
Nervous system disorders
Headache
38.7%
146/377 • Number of events 189 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
41.9%
157/375 • Number of events 208 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).
41.1%
155/377 • Number of events 208 • Overall study, ie, from first vaccination at Visit 1 through the Follow-up Visit approximately 32 weeks post first vaccination.
Non-systematic assessments include unsolicited adverse events collected at each visit. Systematic events include solicited adverse events collected in a memory aid for 8 days after the vaccinations at Visit 1 (Days 1-8) and Visit 3 (Days 28-35).

Additional Information

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Phone: 1-844-422-8274

Results disclosure agreements

  • Principal investigator is a sponsor employee The agreement entitles Bavarian Nordic to request the Institution(s) to delay their publication for a period of up to six (6) months from the date of the first submission to Bavarian Nordic.
  • Publication restrictions are in place

Restriction type: OTHER