Trial Outcomes & Findings for MVA Post-Event: Administration Timing and Boost Study (NCT NCT00437021)
NCT ID: NCT00437021
Last Updated: 2025-09-19
Results Overview
Geometric mean of titers collected 14 days after the second vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
226 participants
Primary outcome timeframe
Day 14 after the second vaccination
Results posted on
2025-09-19
Participant Flow
The study population included adults aged greater than 18 years (and born after 1971) who met all inclusion/exclusion criteria. Participants were recruited from seven sites within the United States. The first participant was enrolled on April 16, 2007, and the last participant was enrolled on April 3, 2008.
Participant milestones
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group C: One Dose Dryvax, Day 0
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
Dryvax®: Dryvax® Vaccinia Vaccine (\~10\^5 \[plaque forming units (pfu)/dose\] given via scarification, titer 10\^8 pfu per mL after reconstitution).
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
Dryvax®: Dryvax® Vaccinia Vaccine (\~10\^5 \[plaque forming units (pfu)/dose\] given via scarification, titer 10\^8 pfu per mL after reconstitution).
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
Dryvax®: Dryvax® Vaccinia Vaccine (\~10\^5 \[plaque forming units (pfu)/dose\] given via scarification, titer 10\^8 pfu per mL after reconstitution).
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
|
Placebo C
Placebo participants from Group C. Placebo administered corresponding to method for active drug administration in Group C.
Placebo (scarification): Physiologic normal saline for injection.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
Placebo (scarification): Physiologic normal saline for injection.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
Placebo (scarification): Physiologic normal saline for injection.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
66
|
8
|
5
|
2
|
63
|
6
|
5
|
0
|
1
|
2
|
7
|
|
Overall Study
COMPLETED
|
59
|
62
|
8
|
5
|
2
|
61
|
5
|
4
|
0
|
1
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group C: One Dose Dryvax, Day 0
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
Dryvax®: Dryvax® Vaccinia Vaccine (\~10\^5 \[plaque forming units (pfu)/dose\] given via scarification, titer 10\^8 pfu per mL after reconstitution).
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
Dryvax®: Dryvax® Vaccinia Vaccine (\~10\^5 \[plaque forming units (pfu)/dose\] given via scarification, titer 10\^8 pfu per mL after reconstitution).
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
Dryvax®: Dryvax® Vaccinia Vaccine (\~10\^5 \[plaque forming units (pfu)/dose\] given via scarification, titer 10\^8 pfu per mL after reconstitution).
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
IMVAMUNE®: IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route at titer 1X10\^8 Tissue Culture Infections Dose50 per 0.5 mL dose.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
|
Placebo C
Placebo participants from Group C. Placebo administered corresponding to method for active drug administration in Group C.
Placebo (scarification): Physiologic normal saline for injection.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
Placebo (scarification): Physiologic normal saline for injection.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
Placebo (scarification): Physiologic normal saline for injection.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
Placebo (subcutaneous): 0.9 percent (weight/volume) sodium chloride injection, United States Pharmacopeia \[Sterile Saline Placebo (SSP)\].
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
0
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
MVA Post-Event: Administration Timing and Boost Study
Baseline characteristics by cohort
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=61 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=66 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=8 Participants
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=5 Participants
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=2 Participants
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
n=63 Participants
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
n=6 Participants
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
n=5 Participants
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
n=1 Participants
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
n=2 Participants
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
n=7 Participants
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
24.7 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 4.3 • n=5 Participants
|
26.4 years
STANDARD_DEVIATION 5.1 • n=4 Participants
|
31.0 years
STANDARD_DEVIATION 4.2 • n=21 Participants
|
24.3 years
STANDARD_DEVIATION 3.9 • n=10 Participants
|
25.2 years
STANDARD_DEVIATION 3.5 • n=115 Participants
|
21.4 years
STANDARD_DEVIATION 2.3 • n=24 Participants
|
24.0 years
STANDARD_DEVIATION NA • n=42 Participants
|
20.5 years
STANDARD_DEVIATION 0.7 • n=42 Participants
|
27.9 years
STANDARD_DEVIATION 4.8 • n=42 Participants
|
24.8 years
STANDARD_DEVIATION 4.2 • n=42 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
105 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
121 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
60 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
217 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
54 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
195 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 14 after the second vaccinationPopulation: The analysis population includes all participants who received two doses of study vaccine and contributed both pre- and post-vaccination blood samples for testing for which valid results were reported. Participants were analyzed "as treated" according to the study product they received.
Geometric mean of titers collected 14 days after the second vaccination.
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=59 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=63 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Bavarian Nordic's (BN) Plaque Reduction Neutralizing Antibody Titer (PRNT) Assay in Groups A and B
|
10.8 titer
Interval 9.0 to 12.9
|
30.2 titer
Interval 22.1 to 41.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14 after the second vaccinationPopulation: The analysis population includes all participants who received two doses of study vaccine and contributed both pre- and post-vaccination blood samples for testing for which valid results were reported. Participants were analyzed "as treated" according to the study product they received.
Geometric mean of titers collected 14 days after the second vaccination.
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=59 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=63 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Saint Louis University's (SLU) PRNT Assay in Group A and Group B
|
27.4 titer
Interval 19.1 to 39.3
|
212.2 titer
Interval 146.6 to 307.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 after first vaccination to study completion through Day 365 after last vaccinationPopulation: The safety population includes all participants who received one dose of vaccine. Participants were analyzed "as treated" according to the study product they received.
The number of participants who experienced at least one SAE throughout the course of the study. A SAE is defined as an AE meeting one of the following conditions: * Death during the study period (from first vaccine until end of surveillance period) * Life-threatening (defined as a participant at immediate risk of death at the time of the event) * Requires inpatient hospitalization or prolongation of existing hospitalization during the period of protocol-defined surveillance * Results in a congenital anomaly or birth defect * Results in a persistent or significant disability/incapacity * Severe adverse event associated with study product
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=61 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=67 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=8 Participants
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=5 Participants
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=2 Participants
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
n=63 Participants
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
n=6 Participants
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
n=4 Participants
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
n=1 Participants
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
n=2 Participants
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
n=7 Participants
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Serious Adverse Events (SAEs)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 after first vaccination through Day 28 after last vaccinationPopulation: The safety population includes all participants who received one dose of vaccine. Participants were analyzed "as treated" according to the study product they received.
The number of participants who experienced at least one unsolicited non-serious AE of any severity from Day 0 after the first vaccination to 28 days after the last vaccination.
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=61 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=67 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=8 Participants
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=5 Participants
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=2 Participants
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
n=63 Participants
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
n=6 Participants
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
n=4 Participants
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
n=1 Participants
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
n=2 Participants
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
n=7 Participants
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Non-Serious AEs
|
32 Participants
|
43 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
26 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 15 after first vaccination; Day 0 through Day 15 after second vaccinationPopulation: The safety population includes all participants who received one dose of vaccine. Participants were analyzed "as treated" according to the study product they received.
Local solicited reactogenicity AEs were collected daily for 15 days post each vaccination using a memory aid. Local events include pain at vaccination site, itchiness at vaccination site, rash at vaccination site underarm pain, underarm swelling, erythema, and induration. Erythema and induration at the vaccination site were measured in millimeters; the remaining events were graded on a subjective scale of Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe).
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=61 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=67 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=5 Participants
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=6 Participants
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=4 Participants
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
n=1 Participants
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Local Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D
Post First Vaccination
|
47 Participants
|
50 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Local Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D
Post Second Vaccination
|
51 Participants
|
53 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 15 after first vaccinationPopulation: The safety population includes all participants who received one dose of vaccine. Participants were analyzed "as treated" according to the study product they received.
Local solicited reactogenicity AEs were collected daily for 15 days post vaccination using a memory aid. Local events include pain at vaccination site, itchiness at vaccination site, rash at vaccination site underarm pain, underarm swelling, erythema, and induration. Erythema and induration at the vaccination site were measured in millimeters; the remaining events were graded on a subjective scale of Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe).
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=8 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=63 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=7 Participants
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Local Solicited Reactogenicity AEs for Groups C and F and Placebo F
|
8 Participants
|
50 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 15 after first vaccinationPopulation: The safety population includes all participants who received one dose of vaccine. Participants were analyzed "as treated" according to the study product they received.
Local solicited reactogenicity AEs were collected daily for 15 days post vaccination using a memory aid. Results are reported by vaccination site (MVA Vaccination or Dryvax Vaccination). Local events included pain at vaccination site, itchiness at vaccination site, rash at vaccination site underarm pain, underarm swelling, erythema, and induration. Erythema and induration at the vaccination site were measured in millimeters; the remaining events were graded on a subjective scale of Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe).
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=2 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=2 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Local Solicited Reactogenicity AEs for Group E and Placebo E
MVA Vaccination
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Local Solicited Reactogenicity AEs for Group E and Placebo E
Dryvax Vaccination
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 15 after first vaccination; Day 0 through Day 15 after second vaccinationPopulation: The safety population includes all participants who received one dose of vaccine. Participants were analyzed "as treated" according to the study product they received.
Systemic solicited reactogenicity AEs were collected daily for 15 days post each vaccination using a memory aid. Systemic events included muscle aches, chills, headache, nausea, feeling tired, change in appetite, joint pain, and elevated oral temperature. Events were graded on a subjective scale of Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe).
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=61 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=67 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=5 Participants
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=6 Participants
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=4 Participants
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
n=1 Participants
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Systemic Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D
Post First Vaccination
|
31 Participants
|
41 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Systemic Solicited Reactogenicity AEs for Groups A, B, and D and Placebo A, B, and D
Post Second Vaccination
|
29 Participants
|
23 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 15 after first vaccinationPopulation: The safety population includes all participants who received one dose of vaccine. Participants were analyzed "as treated" according to the study product they received.
Systemic solicited reactogenicity AEs were collected daily for 15 days post vaccination using a memory aid. Systemic events included muscle aches, chills, headache, nausea, feeling tired, change in appetite, joint pain, and elevated oral temperature. Events were graded on a subjective scale of Grade 0 (None), Grade 1 (Mild), Grade 2 (Moderate), and Grade 3 (Severe).
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=8 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=2 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=63 Participants
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=2 Participants
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=7 Participants
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Systemic Solicited Reactogenicity AEs for Groups C, E, and F and Placebo E and F
|
5 Participants
|
2 Participants
|
33 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14 after the second vaccinationPopulation: The analysis population includes all participants who received two doses of study vaccine and contributed both pre- and post-vaccination blood samples for testing for which valid results were reported. Participants were analyzed "as treated" according to the study product they received.
Geometric mean of titers collected 14 days after the second vaccination.
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=59 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=63 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of BN Enzyme Linked Immunosorbent Assay (ELISA) in Groups A and B
|
108.7 titer
Interval 87.7 to 134.8
|
501.7 titer
Interval 364.1 to 691.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14 after the second vaccinationPopulation: The analysis population includes all participants who received two doses of study vaccine and contributed both pre- and post-vaccination blood samples for testing for which valid results were reported. Participants were analyzed "as treated" according to the study product they received.
Geometric mean of titers collected 14 days after the second vaccination.
Outcome measures
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=59 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=63 Participants
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of SLU ELISA in Groups A and B
|
60.5 titer
Interval 51.0 to 71.7
|
510.9 titer
Interval 373.0 to 699.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Group A: Two Doses IMVAMUNE, Days 0, 7
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
Group B: Two Doses IMVAMUNE, Days 0, 28
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
Group C: One Dose Dryvax, Day 0
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group E: IMVAMUNE + Dryvax, Day 0
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group F: IMVAMUNE, Day 0
Serious events: 3 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo E
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo F
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=61 participants at risk
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=67 participants at risk
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=8 participants at risk
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=5 participants at risk
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=2 participants at risk
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
n=63 participants at risk
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
n=6 participants at risk
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
n=4 participants at risk
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
n=1 participants at risk
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
n=2 participants at risk
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
n=7 participants at risk
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.6%
1/61 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.6%
1/63 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.6%
1/63 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Nervous system disorders
Complicated migraine
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.5%
1/67 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Renal and urinary disorders
Ureteral disorder
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.6%
1/63 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Surgical and medical procedures
Breast cosmetic surgery
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.5%
1/67 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.6%
1/63 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
Other adverse events
| Measure |
Group A: Two Doses IMVAMUNE, Days 0, 7
n=61 participants at risk
Standard dose IMVAMUNE® vaccine on Days 0 and 7.
|
Group B: Two Doses IMVAMUNE, Days 0, 28
n=67 participants at risk
Standard dose IMVAMUNE® vaccine on Days 0 and 28.
|
Group C: One Dose Dryvax, Day 0
n=8 participants at risk
Dryvax® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group D: IMVAMUNE, Day 0 + Dryvax, Day 7
n=5 participants at risk
Standard dose IMVAMUNE® vaccine on Day 0 and Dryvax® vaccine on Day 7. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group E: IMVAMUNE + Dryvax, Day 0
n=2 participants at risk
Dryvax® vaccine and standard dose IMVAMUNE® vaccine on Day 0. This arm was discontinued from original protocol. Participants already enrolled in this group continued follow-up per protocol.
|
Group F: IMVAMUNE, Day 0
n=63 participants at risk
Standard dose IMVAMUNE® vaccine on Day 0.
|
Placebo A
n=6 participants at risk
Placebo participants from Group A. Placebo administered corresponding to method for active drug administration in Group A.
|
Placebo B
n=4 participants at risk
Placebo participants from Group B. Placebo administered corresponding to method for active drug administration in Group B.
|
Placebo D
n=1 participants at risk
Placebo participants from Group D. Placebo administered corresponding to method for active drug administration in Group D.
|
Placebo E
n=2 participants at risk
Placebo participants from Group E. Placebo administered corresponding to method for active drug administration in Group E.
|
Placebo F
n=7 participants at risk
Placebo participants from Group F. Placebo administered corresponding to method for active drug administration in Group F.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
3.0%
2/67 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Eye disorders
Ear discomfort
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Discomfort
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Injection site bruising
|
3.3%
2/61 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
6.0%
4/67 • Number of events 4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
6.3%
4/63 • Number of events 4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Injection site dermatitis
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Injection site irritation
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Injection site rash
|
1.6%
1/61 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
25.0%
2/8 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
3/61 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
11.9%
8/67 • Number of events 8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.8%
3/63 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
25.0%
1/4 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.5%
1/67 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.8%
3/63 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Infections and infestations
Viral infection
|
3.3%
2/61 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
7.5%
5/67 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.8%
3/63 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
16.7%
1/6 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
16.7%
1/6 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Investigations
Blood pressure increased
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.5%
1/67 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
16.7%
1/6 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
16.7%
1/6 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
3.0%
2/67 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
20.0%
1/5 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.6%
4/61 • Number of events 4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
3.0%
2/67 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.8%
3/63 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
25.0%
1/4 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.3%
2/61 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
3.0%
2/67 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
3.2%
2/63 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
25.0%
1/4 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/61 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
6.0%
4/67 • Number of events 4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Axillary pain
|
11.5%
7/61 • Number of events 8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
13.4%
9/67 • Number of events 9 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
62.5%
5/8 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
7.9%
5/63 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Chills
|
8.2%
5/61 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
7.5%
5/67 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
37.5%
3/8 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.8%
3/63 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Fatigue
|
37.7%
23/61 • Number of events 29 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
35.8%
24/67 • Number of events 29 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
4/8 • Number of events 4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
80.0%
4/5 • Number of events 4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
36.5%
23/63 • Number of events 23 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
33.3%
2/6 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
4/4 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Underarm swelling
|
8.2%
5/61 • Number of events 6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.5%
1/67 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
37.5%
3/8 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
1.6%
1/63 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Vaccination site erythema
|
55.7%
34/61 • Number of events 50 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
58.2%
39/67 • Number of events 53 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
8/8 • Number of events 8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
60.0%
3/5 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
36.5%
23/63 • Number of events 23 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
16.7%
1/6 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Vaccination site pain
|
85.2%
52/61 • Number of events 85 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
88.1%
59/67 • Number of events 94 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
62.5%
5/8 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
80.0%
4/5 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
71.4%
45/63 • Number of events 45 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
2/4 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
14.3%
1/7 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Vaccination site pruritus
|
29.5%
18/61 • Number of events 21 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
22.4%
15/67 • Number of events 20 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
87.5%
7/8 • Number of events 7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
40.0%
2/5 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
17.5%
11/63 • Number of events 11 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
1/1 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
General disorders
Vaccination site swelling
|
47.5%
29/61 • Number of events 39 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
44.8%
30/67 • Number of events 42 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
87.5%
7/8 • Number of events 7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
60.0%
3/5 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
22.2%
14/63 • Number of events 14 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Investigations
Body temperature increased
|
1.6%
1/61 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/67 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/63 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
13.1%
8/61 • Number of events 8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
11.9%
8/67 • Number of events 9 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.5%
1/8 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.8%
3/63 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
2/4 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.2%
5/61 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.5%
3/67 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
62.5%
5/8 • Number of events 5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
4.8%
3/63 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.8%
20/61 • Number of events 25 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
28.4%
19/67 • Number of events 24 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
4/8 • Number of events 4 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
20.6%
13/63 • Number of events 13 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
16.7%
1/6 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
2/4 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/7 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Nervous system disorders
Headache
|
34.4%
21/61 • Number of events 24 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
44.8%
30/67 • Number of events 39 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
25.0%
2/8 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
20.0%
1/5 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
100.0%
2/2 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
38.1%
24/63 • Number of events 24 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
33.3%
2/6 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
2/4 • Number of events 3 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
28.6%
2/7 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
|
Gastrointestinal disorders
Nausea
|
16.4%
10/61 • Number of events 11 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
13.4%
9/67 • Number of events 13 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
25.0%
2/8 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/5 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
50.0%
1/2 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
12.7%
8/63 • Number of events 8 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/6 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
25.0%
1/4 • Number of events 1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/1 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
0.00%
0/2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
28.6%
2/7 • Number of events 2 • AEs collected include solicited AEs, unsolicited AEs, and SAEs. Solicited AEs were collected daily for 15 days post each vaccination. Unsolicited AEs were collected from the first vaccination through 28 days after the last vaccination. SAEs were collected from the first vaccination to study completion (Day 365 after the last vaccination).
Participants were analyzed "as treated" according to the study product they received. One participant enrolled in Group B was randomized to Placebo B but was actually administered two doses IMVAMUNE on Days 0 and 28. For AE results, this participant is counted among those at risk in Group B: Two Doses IMVAMUNE, Days 0, 28.
|
Additional Information
Sharon E. Frey, M.D.
Saint Louis University Medical Center
Phone: 315-977-5500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60