Trial Outcomes & Findings for Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) (NCT NCT04938830)
NCT ID: NCT04938830
Last Updated: 2026-05-08
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1003 participants
Primary outcome timeframe
Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
Results posted on
2026-05-08
Participant Flow
Part 1 (blinded dose) is Day 1 through Day 60 of respiratory syncytial virus (RSV) Season 1. Part 2 (unblinded dose) began on Day 60. A subset of participants from the RSV Season 1 entered RSV Season 2.
Participant milestones
| Measure |
Clesrovimab 105 mg (Season 1)
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
|---|---|---|---|---|
|
RSV Season 1
Dose 5 (Day 120)
|
0
|
324
|
0
|
0
|
|
RSV Season 1
STARTED
|
502
|
501
|
0
|
0
|
|
RSV Season 1
Dose 1 (Day 1)
|
498
|
499
|
0
|
0
|
|
RSV Season 1
Dose 2 (Day 28)
|
484
|
494
|
0
|
0
|
|
RSV Season 1
Dose 3 (Day 60)
|
0
|
485
|
0
|
0
|
|
RSV Season 1
Dose 4 (Day 90)
|
0
|
398
|
0
|
0
|
|
RSV Season 1
RSV Season 1 All Participants as Treated (APaT) Population
|
497
|
499
|
0
|
0
|
|
RSV Season 1
COMPLETED
|
465
|
462
|
0
|
0
|
|
RSV Season 1
NOT COMPLETED
|
37
|
39
|
0
|
0
|
|
RSV Season 2
STARTED
|
0
|
0
|
138
|
138
|
|
RSV Season 2
Season 2 Day 1 Dose
|
0
|
0
|
138
|
138
|
|
RSV Season 2
COMPLETED
|
0
|
0
|
137
|
134
|
|
RSV Season 2
NOT COMPLETED
|
0
|
0
|
1
|
4
|
Reasons for withdrawal
| Measure |
Clesrovimab 105 mg (Season 1)
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
|---|---|---|---|---|
|
RSV Season 1
Withdrawal by parent/guardian
|
17
|
20
|
0
|
0
|
|
RSV Season 1
Physician Decision
|
2
|
1
|
0
|
0
|
|
RSV Season 1
Lost to Follow-up
|
9
|
13
|
0
|
0
|
|
RSV Season 1
Death
|
8
|
4
|
0
|
0
|
|
RSV Season 1
Randomized by mistake without study treatment
|
1
|
1
|
0
|
0
|
|
RSV Season 2
Withdrawal by parent/guardian
|
0
|
0
|
1
|
2
|
|
RSV Season 2
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
RSV Season 2
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
Baseline characteristics by cohort
| Measure |
Clesrovimab 105 mg (Season 1)
n=502 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=501 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
Total
n=1003 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
0.3 Years
STANDARD_DEVIATION 0.2 • n=41 Participants
|
0.3 Years
STANDARD_DEVIATION 0.2 • n=40 Participants
|
0.3 Years
STANDARD_DEVIATION 0.2 • n=81 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
55 Participants
n=41 Participants
|
55 Participants
n=40 Participants
|
110 Participants
n=81 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
447 Participants
n=41 Participants
|
446 Participants
n=40 Participants
|
893 Participants
n=81 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=41 Participants
|
251 Participants
n=40 Participants
|
498 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
255 Participants
n=41 Participants
|
250 Participants
n=40 Participants
|
505 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
152 Participants
n=41 Participants
|
157 Participants
n=40 Participants
|
309 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
336 Participants
n=41 Participants
|
336 Participants
n=40 Participants
|
672 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=41 Participants
|
8 Participants
n=40 Participants
|
22 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=41 Participants
|
9 Participants
n=40 Participants
|
14 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
90 Participants
n=41 Participants
|
86 Participants
n=40 Participants
|
176 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=41 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
81 Participants
n=41 Participants
|
85 Participants
n=40 Participants
|
166 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
254 Participants
n=41 Participants
|
256 Participants
n=40 Participants
|
510 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
66 Participants
n=41 Participants
|
63 Participants
n=40 Participants
|
129 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Region at Randomization
Northern Hemisphere
|
355 Participants
n=41 Participants
|
353 Participants
n=40 Participants
|
708 Participants
n=81 Participants
|
|
Region at Randomization
Southern Hemisphere
|
147 Participants
n=41 Participants
|
148 Participants
n=40 Participants
|
295 Participants
n=81 Participants
|
|
Participant Condition
CLD
|
139 Participants
n=41 Participants
|
142 Participants
n=40 Participants
|
281 Participants
n=81 Participants
|
|
Participant Condition
CHD
|
55 Participants
n=41 Participants
|
52 Participants
n=40 Participants
|
107 Participants
n=81 Participants
|
|
Participant Condition
Neither CLD nor CHD <29 weeks gestational age
|
41 Participants
n=41 Participants
|
39 Participants
n=40 Participants
|
80 Participants
n=81 Participants
|
|
Participant Condition
Neither CLD nor CHD ≥29 weeks gestational age
|
267 Participants
n=41 Participants
|
268 Participants
n=40 Participants
|
535 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)Population: All randomized participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
Injection site erythema
|
31 Participants
|
32 Participants
|
|
Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
Injection site pain
|
39 Participants
|
54 Participants
|
|
Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1
Injection site swelling
|
31 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)Population: All randomized participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.
Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F. The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Solicited Daily Body Temperatures With Fever in RSV Season 1
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)Population: All randomized participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Sesason 1 APaT population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 1 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Solicited Systemic AEs in RSV Season 1
Decreased appetite
|
67 Participants
|
66 Participants
|
|
Number of Participants With Solicited Systemic AEs in RSV Season 1
Irritability
|
143 Participants
|
168 Participants
|
|
Number of Participants With Solicited Systemic AEs in RSV Season 1
Somnolence
|
94 Participants
|
110 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days in RSV Season 1Population: All randomized participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Anaphylaxis/Hypersensitivity AEs of Special Interest (AESI) in RSV Season 1
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days in RSV Season 1Population: All randomized participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included urticaria and drug eruption. The number of participants with rash AESI in RSV Season 1 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Rash AESI in RSV Season 1
Urticaria
|
2 Participants
|
0 Participants
|
|
Number of Participants With Rash AESI in RSV Season 1
Drug eruption
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days in RSV Season 1Population: All participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with nonserious AEs in RSV Season 1 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Nonserious AEs in RSV Season 1
|
353 Participants
|
379 Participants
|
PRIMARY outcome
Timeframe: Up to 365 days in RSV Season 1Population: All randomized participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.
An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The number of participants with SAEs in RSV Season 1 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Serious AEs (SAEs) Through the Duration of Participation in RSV Season 1
|
122 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: Up to 150 days in RSV Season 1Population: All randomized participants who received at least 1 dose of study intervention and without deviations from the protocol that could impact the results. Deviations include but are not limited to the following: study intervention administered out of time window, improperly stored study intervention, and NP swab not obtained.
Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal (NP) sample. The number of cases of outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1. For each participant, only the first occurrence of the case is counted for the analysis.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=495 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=485 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1
|
15 Number of Cases
|
16 Number of Cases
|
SECONDARY outcome
Timeframe: Up to 150 days in RSV Season 1Population: All randomized participants who received at least 1 dose of study intervention and without deviations from the protocol that could impact the results. Deviations include but are not limited to the following: study intervention administered out of time window, improperly stored study intervention, and NP swab not obtained.
RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR NP sample. The number of cases of RSV-associated hospitalization in RSV Season 1 is reported. For each participant, only the first occurrence of the case is counted for the analysis.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=495 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=485 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Cases of RSV-associated Hospitalization in RSV Season 1
|
5 Number of Cases
|
8 Number of Cases
|
SECONDARY outcome
Timeframe: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)Population: All randomized participants who received at least 1 dose of study intervention in RSV Season 2.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 2 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=138 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=138 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Solicited Injection-site AEs in RSV Season 2
Injection site erythema
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection-site AEs in RSV Season 2
Injection site pain
|
7 Participants
|
5 Participants
|
|
Number of Participants With Solicited Injection-site AEs in RSV Season 2
Injection site swelling
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)Population: All randomized participants who received at least 1 dose of study intervention in RSV Season 2.
Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F. The number of participants with solicited daily body temperature of fever in RSV Season 2 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=138 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=138 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Solicited Daily Body Temperature With Fever in RSV Season 2
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days postdose in RSV Season 2 (Up to ~400 days)Population: All randomized participants who received at least 1 dose of study intervention in RSV Season 2.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 2 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=138 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=138 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Solicited Systemic AEs in RSV Season 2
Decreased appetite
|
12 Participants
|
7 Participants
|
|
Number of Participants With Solicited Systemic AEs in RSV Season 2
Irritability
|
12 Participants
|
24 Participants
|
|
Number of Participants With Solicited Systemic AEs in RSV Season 2
Somnolence
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)Population: All randomized participants who received at least 1 dose of study intervention in RSV Season 2.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 2 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=138 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=138 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Anaphylaxis/Hypersensitivity AESI in RSV Season 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)Population: All randomized participants who received at least 1 dose of study intervention in RSV Season 2.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included urticaria and drug eruption. The number of participants with rash AESI in RSV Season 2 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=138 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=138 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Rash AESI in RSV Season 2
Drug eruption
|
0 Participants
|
3 Participants
|
|
Number of Participants With Rash AESI in RSV Season 2
Urticaria
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days postdose in RSV Season 2 (Up to ~440 days)Population: All randomized participants who received at least 1 dose of study intervention in RSV Season 2.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with nonserious AEs in RSV Season 2 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=138 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=138 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With Nonserious AEs in RSV Season 2
|
85 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: Up 180 days postdose in RSV Season 2 (Up to ~575 days)Population: All randomized participants who received at least 1 dose of study intervention in RSV Season 2.
An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The number of participants with SAEs in RSV Season 2 is reported.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=138 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=138 Participants
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Number of Participants With SAEs in RSV Season 2
|
25 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At Day 7, Day 150, and Day 240 in RSV Season 1Population: All randomized participants who received at least 1 dose of clesrovimab in RSV Season 1, who had data at the given timepoint, and without deviations from the protocol that could impact the results. Deviations include but are not limited to the following: study intervention administered out of time window, improperly stored study intervention, and sample not obtained.
Blood samples were collected to determine the serum concentration of clesrovimab at Days 7, 150, and 240 in RSV Season 1.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=498 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Concentration of Clesrovimab in RSV Season 1
Day 7
|
148.7 µg/mL
Interval 142.3 to 155.3
|
—
|
|
Concentration of Clesrovimab in RSV Season 1
Day 150
|
11.8 µg/mL
Interval 11.3 to 12.4
|
—
|
|
Concentration of Clesrovimab in RSV Season 1
Day 240
|
2.9 µg/mL
Interval 2.7 to 3.1
|
—
|
SECONDARY outcome
Timeframe: At Day 7 and Day 150 postdose in RSV Season 2Population: All randomized participants who received at least 1 dose of clesrovimab in RSV Season 1, who had data at the given timepoint, and without deviations from the protocol that could impact the results. Deviations include but are not limited to the following: study intervention administered out of time window, improperly stored study intervention, and sample not obtained. Data for clesrovimab 210 mg in RSV Season 2 was reported together as pre-specified per protocol.
Blood samples were collected to determine the serum concentration of clesrovimab at Days 7 and 150 in RSV Season 2. RSV Season 2 began 246-393 days after RSV Season 1 dose 1.
Outcome measures
| Measure |
Clesrovimab 105 mg (Season 1)
n=276 Participants
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
|---|---|---|
|
Concentration of Clesrovimab in RSV Season 2
Day 7 postdose season 2
|
170.0 µg/mL
Interval 165.2 to 174.8
|
—
|
|
Concentration of Clesrovimab in RSV Season 2
Day 150 postdose season 2
|
14.4 µg/mL
Interval 13.5 to 15.4
|
—
|
Adverse Events
Clesrovimab 105 mg (Season 1)
Serious events: 122 serious events
Other events: 290 other events
Deaths: 8 deaths
Palivizumab (Season 1)
Serious events: 137 serious events
Other events: 282 other events
Deaths: 4 deaths
Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)
Serious events: 25 serious events
Other events: 69 other events
Deaths: 1 deaths
Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)
Serious events: 26 serious events
Other events: 69 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 participants at risk
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 participants at risk
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)
n=138 participants at risk
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)
n=138 participants at risk
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Adenovirus infection
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Bacterial infection
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Bordetella infection
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Bronchiolitis
|
6.8%
34/497 • Number of events 38 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.2%
26/499 • Number of events 30 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
3.6%
5/138 • Number of events 5 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
3.6%
5/138 • Number of events 5 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Bronchitis
|
0.40%
2/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.60%
3/499 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Bronchitis viral
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
COVID-19
|
2.2%
11/497 • Number of events 11 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
7/499 • Number of events 7 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Croup infectious
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Dengue fever
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Device related infection
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Dysentery
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Encephalitis enteroviral
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Enterovirus infection
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Exanthema subitum
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
10/497 • Number of events 11 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.6%
13/499 • Number of events 14 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
2/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
2/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.40%
2/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Impetigo
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Influenza
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Laryngitis
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
8/497 • Number of events 8 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
7/499 • Number of events 7 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
2/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Meningitis salmonella
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Metapneumovirus bronchiolitis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Nasopharyngitis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia
|
3.2%
16/497 • Number of events 19 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
4.6%
23/499 • Number of events 27 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.9%
4/138 • Number of events 5 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
3.6%
5/138 • Number of events 5 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia adenoviral
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia aspiration
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.80%
4/499 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
2/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pneumonia viral
|
0.80%
4/497 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.0%
5/499 • Number of events 7 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.9%
4/138 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pulmonary sepsis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.60%
3/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Respiratory tract infection
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.0%
5/499 • Number of events 6 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Rhinovirus infection
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Salmonella sepsis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Scabies
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Sepsis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Tonsillitis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.60%
3/497 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.2%
6/499 • Number of events 7 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
2/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Urinary tract infection
|
0.60%
3/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.8%
9/499 • Number of events 10 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Urosepsis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Viral infection
|
0.60%
3/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.60%
3/499 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Injury, poisoning and procedural complications
Child maltreatment syndrome
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Cardiac failure
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Congenital, familial and genetic disorders
Congenital laryngeal stridor
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Eye disorders
Retinopathy of prematurity
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.60%
3/499 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.60%
3/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.0%
5/499 • Number of events 5 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Gastrointestinal disorders
Vomiting
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Crying
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Death
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Drug withdrawal syndrome
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Pyrexia
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Investigations
Body temperature increased
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.80%
4/499 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Overfeeding of infant
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Febrile convulsion
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
2/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Hydrocephalus
|
0.20%
1/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Partial seizures
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Seizure like phenomena
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Psychiatric disorders
Breath holding
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.60%
3/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.80%
4/499 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Brief resolved unexplained event
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal cyst
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.20%
1/497 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.20%
1/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/499 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Vascular disorders
Cyanosis
|
0.40%
2/497 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Vascular disorders
Hypotension
|
0.00%
0/497 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.20%
1/499 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.00%
0/138 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
Other adverse events
| Measure |
Clesrovimab 105 mg (Season 1)
n=497 participants at risk
Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
|
Palivizumab (Season 1)
n=499 participants at risk
Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
|
Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)
n=138 participants at risk
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)
n=138 participants at risk
At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
8/497 • Number of events 10 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.40%
2/499 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.1%
7/138 • Number of events 7 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.2%
3/138 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Injection site erythema
|
6.2%
31/497 • Number of events 38 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.2%
26/499 • Number of events 27 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.2%
3/138 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
1.4%
2/138 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Injection site pain
|
7.8%
39/497 • Number of events 56 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
8.2%
41/499 • Number of events 61 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.1%
7/138 • Number of events 15 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
3.6%
5/138 • Number of events 9 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
General disorders
Injection site swelling
|
6.4%
32/497 • Number of events 38 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
4.6%
23/499 • Number of events 26 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.9%
4/138 • Number of events 5 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Gastroenteritis
|
0.60%
3/497 • Number of events 3 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.80%
4/499 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 2 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.8%
8/138 • Number of events 8 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
12/497 • Number of events 15 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
4.0%
20/499 • Number of events 22 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.1%
7/138 • Number of events 8 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
10.1%
14/138 • Number of events 15 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Respiratory tract infection
|
3.0%
15/497 • Number of events 16 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
3.4%
17/499 • Number of events 18 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
6.5%
9/138 • Number of events 10 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
7.2%
10/138 • Number of events 16 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
60/497 • Number of events 68 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
13.6%
68/499 • Number of events 83 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
11.6%
16/138 • Number of events 18 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
15.9%
22/138 • Number of events 26 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Investigations
Body temperature increased
|
6.0%
30/497 • Number of events 33 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.4%
27/499 • Number of events 27 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
6.5%
9/138 • Number of events 9 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
4.3%
6/138 • Number of events 7 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.7%
68/497 • Number of events 89 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
9.4%
47/499 • Number of events 58 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
8.7%
12/138 • Number of events 14 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
5.8%
8/138 • Number of events 8 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Nervous system disorders
Somnolence
|
19.1%
95/497 • Number of events 135 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
16.8%
84/499 • Number of events 117 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
10.9%
15/138 • Number of events 18 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
6.5%
9/138 • Number of events 10 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Psychiatric disorders
Irritability
|
29.6%
147/497 • Number of events 228 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
27.9%
139/499 • Number of events 208 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
8.7%
12/138 • Number of events 12 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
18.1%
25/138 • Number of events 30 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
9/497 • Number of events 9 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.8%
14/499 • Number of events 15 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
7.2%
10/138 • Number of events 12 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
2.9%
4/138 • Number of events 4 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.6%
13/497 • Number of events 13 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
3.8%
19/499 • Number of events 21 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
8.0%
11/138 • Number of events 12 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
0.72%
1/138 • Number of events 1 • RSV Season 1: Nonserious adverse events (NSAEs) - Up to 42 days, SAEs and all-cause mortality (ACM) - Up to 365 days; RSV Season 2: NSAEs - Up to 42 days postdose in season 2 (Up to ~440 days), SAEs and ACM - Up to 180 days postdose in season 2 (Up to ~575 days)
ACM was reported for all randomized participants. One participant completed the study and died 133 days after study completion. SAEs and NSAEs were reported for the APaT population, which consists of all randomized participants who received at least 1 dose of study intervention, excluding a participant in the clesrovimab 105 mg (season 1) arm who received incorrect study intervention at Day 28.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER