Trial Outcomes & Findings for MVA-BN-RSV Vaccine Trial (NCT NCT05238025)
NCT ID: NCT05238025
Last Updated: 2024-10-31
Results Overview
RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
20419 participants
Primary outcome timeframe
From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
MVA-BN-RSV
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection).
Group assignment based on the Full Analysis Set, i.e. participants randomized to MVA-BN-RSV and treated (including 8751 participants with a single randomization to MVA-BN-RSV \[thereof 4 participants actually received Placebo\] and 409 participants \[multiple enrollers\] with their first randomization to MVA-BN-RSV \[thereof 230 participants receiving Placebo as second/later dose\])
|
Placebo
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL).
Group assignment based on the Full Analysis Set, i.e. participants randomized to Placebo and treated (including 8771 participants with a single randomization to Placebo \[thereof 1 participant actually received MVA-BN-RSV\] and 417 participants \[multiple enrollers\] with their first randomization to Placebo \[thereof 232 participants receiving MVA-BN-RSV as second/later dose\])
|
|---|---|---|
|
Overall Study
STARTED
|
9160
|
9188
|
|
Overall Study
COMPLETED
|
1530
|
1535
|
|
Overall Study
NOT COMPLETED
|
7630
|
7653
|
Reasons for withdrawal
| Measure |
MVA-BN-RSV
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection).
Group assignment based on the Full Analysis Set, i.e. participants randomized to MVA-BN-RSV and treated (including 8751 participants with a single randomization to MVA-BN-RSV \[thereof 4 participants actually received Placebo\] and 409 participants \[multiple enrollers\] with their first randomization to MVA-BN-RSV \[thereof 230 participants receiving Placebo as second/later dose\])
|
Placebo
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL).
Group assignment based on the Full Analysis Set, i.e. participants randomized to Placebo and treated (including 8771 participants with a single randomization to Placebo \[thereof 1 participant actually received MVA-BN-RSV\] and 417 participants \[multiple enrollers\] with their first randomization to Placebo \[thereof 232 participants receiving MVA-BN-RSV as second/later dose\])
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
334
|
339
|
|
Overall Study
Withdrawal by Subject
|
203
|
222
|
|
Overall Study
Physician Decision
|
20
|
8
|
|
Overall Study
Protocol Violation
|
6
|
2
|
|
Overall Study
Death
|
38
|
32
|
|
Overall Study
Study terminated by Sponsor
|
6358
|
6358
|
|
Overall Study
Other Reason
|
669
|
690
|
Baseline Characteristics
MVA-BN-RSV Vaccine Trial
Baseline characteristics by cohort
| Measure |
MVA-BN-RSV
n=9160 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=9188 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
Total
n=18348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 5.78 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 5.83 • n=7 Participants
|
70.4 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
|
Age, Customized
60 to 64 years
|
931 Participants
n=5 Participants
|
933 Participants
n=7 Participants
|
1864 Participants
n=5 Participants
|
|
Age, Customized
65 to 74 years
|
6166 Participants
n=5 Participants
|
6164 Participants
n=7 Participants
|
12330 Participants
n=5 Participants
|
|
Age, Customized
75 to 84 years
|
1889 Participants
n=5 Participants
|
1903 Participants
n=7 Participants
|
3792 Participants
n=5 Participants
|
|
Age, Customized
>= 85 years
|
174 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4606 Participants
n=5 Participants
|
4680 Participants
n=7 Participants
|
9286 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4554 Participants
n=5 Participants
|
4508 Participants
n=7 Participants
|
9062 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7786 Participants
n=5 Participants
|
7794 Participants
n=7 Participants
|
15580 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1185 Participants
n=5 Participants
|
1202 Participants
n=7 Participants
|
2387 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
79 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
67 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8445 Participants
n=5 Participants
|
8468 Participants
n=7 Participants
|
16913 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
715 Participants
n=5 Participants
|
720 Participants
n=7 Participants
|
1435 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 monthsPopulation: Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization.
RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)
Outcome measures
| Measure |
MVA-BN-RSV
n=9160 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=9188 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms
|
12 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 monthsPopulation: Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization.
RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 2 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)
Outcome measures
| Measure |
MVA-BN-RSV
n=9160 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=9188 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms
|
25 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 monthsPopulation: Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization.
RSV-associated acute respiratory disease (ARD) is defined by the presence of either one ARD symptom lasting for at least 24 hours or two simultaneously occurring ARD symptoms (irrespective of duration), with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)
Outcome measures
| Measure |
MVA-BN-RSV
n=9160 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=9188 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Occurrence of PCR Confirmed RSV-associated ARD
|
42 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 monthsPopulation: Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization.
RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.
Outcome measures
| Measure |
MVA-BN-RSV
n=9160 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=9188 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Occurrence of Complications Related to PCR-confirmed RSV Disease
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 monthsPopulation: Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization.
Hospitalization due to PCR confirmed RSV disease and/or any complication related to PCR-confirmed RSV disease. RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.
Outcome measures
| Measure |
MVA-BN-RSV
n=9160 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=9188 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 monthsPopulation: Full Analysis Set i.e., all participants who were randomized to any treatment arm and received study vaccine (MVA-BN-RSV or placebo). Participants were analyzed based on the treatment to which they were randomized. Participants who received multiple doses of study vaccine ("multiple enrollers") were included once in this analysis set with group allocation based on their first randomization and with data censored from the time of second randomization.
Severe RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD and at least 1 of the following signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR): 1) hypoxemia (oxygen saturation \<92% at rest in conjunction with an at least 3% decrease from baseline); 2) respiratory rate \>25 breaths/Min; 3) imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia
Outcome measures
| Measure |
MVA-BN-RSV
n=9160 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=9188 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Occurrence of Severe PCR Confirmed RSV-associated LRTD
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From vaccination through study termination, up to 16 monthsPopulation: Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; subjects were analyzed in the placebo arm when having received placebo only.
Number and percentage of study participants reporting any serious adverse events at any time during the trial period.
Outcome measures
| Measure |
MVA-BN-RSV
n=9389 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=8959 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
517 Participants
|
422 Participants
|
SECONDARY outcome
Timeframe: Within 29 days after vaccinationPopulation: Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; subjects were analyzed in the placebo arm when having received placebo only.
Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse events assessed as related to study vaccine
Outcome measures
| Measure |
MVA-BN-RSV
n=9389 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=8959 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Within 8 days after vaccinationPopulation: Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; participants were analyzed in the placebo arm when having received placebo only.
Number and percentage of study participants reporting injection site reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.
Outcome measures
| Measure |
MVA-BN-RSV
n=9389 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=8959 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Number of Participants With Solicited Local Adverse Events
Pain
|
5704 Participants
|
667 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Erythema
|
522 Participants
|
157 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Swelling
|
448 Participants
|
78 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Induration
|
417 Participants
|
74 Participants
|
|
Number of Participants With Solicited Local Adverse Events
Pruritus
|
1718 Participants
|
470 Participants
|
SECONDARY outcome
Timeframe: Within 8 days after vaccinationPopulation: Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; participants were analyzed in the placebo arm when having received placebo only.
Number and percentage of study participants reporting systemic reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.
Outcome measures
| Measure |
MVA-BN-RSV
n=9389 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=8959 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events
Chills
|
1531 Participants
|
490 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Pyrexia
|
550 Participants
|
309 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Headache
|
3144 Participants
|
1737 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Myalgia
|
4558 Participants
|
1480 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Nausea
|
990 Participants
|
551 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events
Fatigue
|
3526 Participants
|
1973 Participants
|
SECONDARY outcome
Timeframe: Within 29 days after vaccinationPopulation: Safety Set i.e., all participants who received study vaccine (MVA-BN-RSV or placebo). Subjects were analyzed based on the treatment they actually received. Subjects who received multiple doses of study vaccine ("multiple enrollers") were analyzed in the MVA-BN-RSV arm when having received the MVA-BN-RSV vaccine at least once; subjects were analyzed in the placebo arm when having received placebo only.
Number and percentage of study participants reporting any unsolicited adverse events within 29 days after vaccination.
Outcome measures
| Measure |
MVA-BN-RSV
n=9389 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=8959 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
607 Participants
|
581 Participants
|
SECONDARY outcome
Timeframe: 1 week after vaccinationRSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks after vaccinationPopulation: Immunogenicity Analysis Set, a subset of the Full Analysis Set, including participants at designated clinical trial sites who signed the informed consent form for collection of serum samples. Number of participants analyzed represent the participants with antibody titer results available at the respective time point.
Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA)
Outcome measures
| Measure |
MVA-BN-RSV
n=309 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=317 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
RSV-specific Serum IgG Antibody Titers
Baseline
|
1510.6 Titer
Interval 1386.4 to 1646.0
|
1590.1 Titer
Interval 1468.3 to 1722.0
|
|
RSV-specific Serum IgG Antibody Titers
Week 2
|
4335.5 Titer
Interval 3963.7 to 4742.2
|
1562.9 Titer
Interval 1440.5 to 1695.6
|
SECONDARY outcome
Timeframe: 2 weeks after vaccinationPopulation: Immunogenicity Analysis Set, a subset of the Full Analysis Set, including participants at designated clinical trial sites who signed the informed consent form for collection of serum samples. Number of participants analyzed represent the participants with antibody titer results available at the respective time point.
Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ
Outcome measures
| Measure |
MVA-BN-RSV
n=309 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=317 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
RSV-specific Serum Neutralizing Antibody Titers (Subtype A)
Week 2
|
482.3 Titer
Interval 436.9 to 532.5
|
307.7 Titer
Interval 276.5 to 342.4
|
|
RSV-specific Serum Neutralizing Antibody Titers (Subtype A)
Baseline
|
275.1 Titer
Interval 249.4 to 303.4
|
310.6 Titer
Interval 280.5 to 343.9
|
SECONDARY outcome
Timeframe: 2 weeks after vaccinationPopulation: Immunogenicity Analysis Set, a subset of the Full Analysis Set, including participants at designated clinical trial sites who signed the informed consent form for collection of serum samples. Number of participants analyzed represent the participants with antibody titer results available at the respective time point.
Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ
Outcome measures
| Measure |
MVA-BN-RSV
n=309 Participants
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection)
|
Placebo
n=317 Participants
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL)
|
|---|---|---|
|
RSV-specific Serum Neutralizing Antibody Titers (Subtype B)
Baseline
|
289.5 Titer
Interval 251.5 to 333.1
|
336.5 Titer
Interval 292.1 to 387.5
|
|
RSV-specific Serum Neutralizing Antibody Titers (Subtype B)
Week 2
|
475.3 Titer
Interval 419.7 to 538.3
|
307.6 Titer
Interval 265.4 to 356.5
|
Adverse Events
MVA-BN-RSV
Serious events: 517 serious events
Other events: 82 other events
Deaths: 41 deaths
Placebo
Serious events: 422 serious events
Other events: 82 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
MVA-BN-RSV
n=9389 participants at risk
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection).
Group assignment based on actual treatment, i.e. participants treated with MVA-BN-RSV (including 8747 Single Enroller participants randomized to MVA-BN-RSV and treated with MVA-BN-RSV + 1 Single Enroller participant randomized to Placebo and treated with MVA-BN-RSV + 179 Multiple Enroller participants randomized to MVA-BN-RSV (first randomization) and treated with MVA-BN-RSV only + 230 Multiple Enroller participants randomized to MVA-BN-RSV (first randomization) and treated with at least one dose of Placebo + 232 Multiple Enroller participants randomized to Placebo (first randomization) and treated with at least one dose of MVA-BN-RSV).
|
Placebo
n=9191 participants at risk
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL).
Group assignment based on actual treatment, i.e. participants treated with Placebo (including 8770 Single Enroller participants randomized to Placebo and treated with Placebo + 4 Single Enroller participants randomized to MVA-BN-RSV and treated with Placebo + 185 Multiple Enroller participants randomized to Placebo (first randomization) and treated with Placebo only (at least 2 doses and up to 4 doses) + 232 Multiple Enroller participants randomized to Placebo (first randomization) and treated with at least one dose of MVA-BN-RSV).
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.39%
37/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.25%
23/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Sepsis
|
0.13%
12/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.10%
9/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Cellulitis
|
0.11%
10/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
COVID-19
|
0.10%
9/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.05%
5/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Urinary tract infection
|
0.10%
9/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.08%
7/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Diverticulitis
|
0.06%
6/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Arthritis infective
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Appendicitis
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Influenza
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Pyelonephritis
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Septic shock
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.04%
4/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Abscess limb
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Atypical pneumonia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Cystitis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Localised infection
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Osteomyelitis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Sinusitis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Abdominal wall abscess
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Abscess intestinal
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Arthritis bacterial
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Bacterial infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Campylobacter infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Clostridium difficile infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Complicated appendicitis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Endocarditis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Epididymitis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Fournier's gangrene
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Gangrene
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Hepatitis A
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Large intestine infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Norovirus infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Pneumonia influenzal
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Postoperative wound infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Staphylococcal infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Urosepsis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Wound infection
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Infected bite
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Scrotal cellulitis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Atrial fibrillation
|
0.22%
21/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.15%
14/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.16%
15/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Myocardial infarction
|
0.12%
11/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.14%
13/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Angina pectoris
|
0.10%
9/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.09%
8/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardiac arrest
|
0.06%
6/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardiac failure
|
0.06%
6/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Coronary artery disease
|
0.06%
6/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardiac failure acute
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Arrhythmia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Arrhythmic storm
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Atrioventricular block
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Bradycardia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Bundle branch block left
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Palpitations
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Pericarditis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Sinus arrest
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Sinus bradycardia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.04%
4/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.16%
15/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.12%
11/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.13%
12/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Syncope
|
0.10%
9/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.09%
8/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Encephalopathy
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Dizziness
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Ischaemic stroke
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Myelopathy
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Presyncope
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Alcoholic seizure
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Altered state of consciousness
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Amnesia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Ataxia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Basal ganglia stroke
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Embolic stroke
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Epilepsy
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Facial paresis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Headache
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Loss of consciousness
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Monoplegia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Paralysis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Seizure
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Speech disorder
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Cervical spinal cord paralysis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Migraine
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Product Issues
Device failure
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Constipation
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Enteritis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Gastritis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Haematemesis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Haematochezia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Proctitis ulcerative
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Vomiting
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
13/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.20%
18/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
10/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
9/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.09%
8/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.14%
13/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery occlusion
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
14/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.26%
24/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Spinal retrolisthesis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Fall
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.04%
4/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.05%
5/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.04%
4/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.04%
4/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal adenocarcinoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal wall
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Marginal zone lymphoma recurrent
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Non-cardiac chest pain
|
0.12%
11/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Death
|
0.10%
9/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.08%
7/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Chest discomfort
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Chest pain
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Gait disturbance
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Malaise
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Peripheral swelling
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Pyrexia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Asthenia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Cardiac death
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Cyst
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Drug withdrawal syndrome
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Injection site erythema
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Injection site pruritus
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Oedema peripheral
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Sudden cardiac death
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Calcinosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Dysplasia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Fatigue
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
General disorders
Pain
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
6/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Deep vein thrombosis
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.04%
4/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Hypertensive crisis
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Aortic stenosis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Hypertension
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Hypertensive emergency
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Hypotension
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Thrombosis
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Arterial occlusive disease
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Arteriosclerosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Bleeding varicose vein
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Extremity necrosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Haematoma
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Internal haemorrhage
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Ischaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Malignant hypertension
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Shock haemorrhagic
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Depression
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Anxiety
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Alcohol use disorder
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Bipolar disorder
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Confusional state
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Delirium
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Depression suicidal
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Mental disorder
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Schizophrenia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Substance use disorder
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.07%
7/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
4/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.07%
6/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
End stage renal disease
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Mixed incontinence
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Renal failure
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Urinary retention
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.05%
5/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
3/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Biliary colic
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.03%
3/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.02%
2/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.04%
4/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Eye disorders
Diplopia
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Eye disorders
Lens dislocation
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Eye disorders
Macular oedema
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Eye disorders
Glaucoma
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Eye disorders
Visual impairment
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Ear and labyrinth disorders
Vertigo
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
Gastrointestinal stoma output increased
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
SARS-CoV-2 test positive
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
Blood potassium increased
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
Cardiac murmur
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
Heart rate increased
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
Heart rate irregular
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Product Issues
Device dislocation
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Product Issues
Device loosening
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.02%
2/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Endocrine disorders
Goitre
|
0.01%
1/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.00%
0/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Surgical and medical procedures
Gallbladder operation
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.01%
1/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
Other adverse events
| Measure |
MVA-BN-RSV
n=9389 participants at risk
Single administration of MVA-BN-RSV vaccine with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL (intramuscular injection).
Group assignment based on actual treatment, i.e. participants treated with MVA-BN-RSV (including 8747 Single Enroller participants randomized to MVA-BN-RSV and treated with MVA-BN-RSV + 1 Single Enroller participant randomized to Placebo and treated with MVA-BN-RSV + 179 Multiple Enroller participants randomized to MVA-BN-RSV (first randomization) and treated with MVA-BN-RSV only + 230 Multiple Enroller participants randomized to MVA-BN-RSV (first randomization) and treated with at least one dose of Placebo + 232 Multiple Enroller participants randomized to Placebo (first randomization) and treated with at least one dose of MVA-BN-RSV).
|
Placebo
n=9191 participants at risk
Single administration of Tris Buffered Saline (TBS) (intramuscular injection; 0.5mL).
Group assignment based on actual treatment, i.e. participants treated with Placebo (including 8770 Single Enroller participants randomized to Placebo and treated with Placebo + 4 Single Enroller participants randomized to MVA-BN-RSV and treated with Placebo + 185 Multiple Enroller participants randomized to Placebo (first randomization) and treated with Placebo only (at least 2 doses and up to 4 doses) + 232 Multiple Enroller participants randomized to Placebo (first randomization) and treated with at least one dose of MVA-BN-RSV).
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.87%
82/9389 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
0.89%
82/9191 • From vaccination through study termination, up to 16 months
SAEs were to be reported from vaccination to study end, non-serious AEs within 4 weeks of vaccination. Participants were analyzed based on their actual treatment. Multiple enrollers with at least 1 dose of MVA-BN-RSV were analyzed in the MVA-BN-RSV group from administration of MVA-BN-RSV onwards. Multiple enrollers receiving Placebo first and at least one dose of MVA-BN-RSV later were also analyzed in the Placebo group starting from administration of Placebo up to administration of MVA-BN-RSV.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place