Trial Outcomes & Findings for Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004) (NCT NCT04767373)
NCT ID: NCT04767373
Last Updated: 2026-02-11
Results Overview
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 sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
3632 participants
Primary outcome timeframe
From Day 1 (postdose) to Day 150
Results posted on
2026-02-11
Participant Flow
Per protocol, participants received one dose of study treatment on Day 1 during RSV Season 1. Participants did not receive study treatment during RSV Season 2. Study disposition data were not collected separately for RSV season 1 and RSV Season 2.
Participant milestones
| Measure |
Clesrovimab 105 mg
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants will be followed through RSV season 2.
|
Placebo
Participants received a single IM administration of placebo on Day 1. An eligible subset of participants will be followed through RSV season 2.
|
|---|---|---|
|
Overall Study
STARTED
|
2421
|
1211
|
|
Overall Study
Treated
|
2411
|
1203
|
|
Overall Study
Safety Analysis Population
|
2409
|
1202
|
|
Overall Study
Participants Who Entered RSV Season 2
|
1017
|
501
|
|
Overall Study
COMPLETED
|
2257
|
1126
|
|
Overall Study
NOT COMPLETED
|
164
|
85
|
Reasons for withdrawal
| Measure |
Clesrovimab 105 mg
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants will be followed through RSV season 2.
|
Placebo
Participants received a single IM administration of placebo on Day 1. An eligible subset of participants will be followed through RSV season 2.
|
|---|---|---|
|
Overall Study
Death
|
6
|
3
|
|
Overall Study
Lost to Follow-up
|
67
|
35
|
|
Overall Study
Physician Decision
|
15
|
4
|
|
Overall Study
Randomized By Mistake Without Study Treatment
|
0
|
1
|
|
Overall Study
Withdrawal By Parent/Guardian
|
75
|
40
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)
Baseline characteristics by cohort
| Measure |
Clesrovimab 105 mg
n=2421 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants will be followed through RSV season 2.
|
Placebo
n=1211 Participants
Participants received a single IM administration of placebo on Day 1. An eligible subset of participants will be followed through RSV season 2.
|
Total
n=3632 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=1581 Participants
|
0.3 Years
STANDARD_DEVIATION 0.2 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
1187 Participants
n=41 Participants
|
593 Participants
n=1581 Participants
|
1780 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
1234 Participants
n=41 Participants
|
618 Participants
n=1581 Participants
|
1852 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
685 Participants
n=41 Participants
|
335 Participants
n=1581 Participants
|
1020 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1667 Participants
n=41 Participants
|
841 Participants
n=1581 Participants
|
2508 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
69 Participants
n=41 Participants
|
35 Participants
n=1581 Participants
|
104 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
50 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
68 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
646 Participants
n=41 Participants
|
321 Participants
n=1581 Participants
|
967 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
326 Participants
n=41 Participants
|
173 Participants
n=1581 Participants
|
499 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
1085 Participants
n=41 Participants
|
553 Participants
n=1581 Participants
|
1638 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
304 Participants
n=41 Participants
|
139 Participants
n=1581 Participants
|
443 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=41 Participants
|
6 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Region at randomization
Northern Hemisphere
|
1657 Participants
n=41 Participants
|
818 Participants
n=1581 Participants
|
2475 Participants
n=4626 Participants
|
|
Region at randomization
Southern Hemisphere
|
764 Participants
n=41 Participants
|
393 Participants
n=1581 Participants
|
1157 Participants
n=4626 Participants
|
|
Gestational Age
Early and Moderate Preterm Infant (≥29 to <35 weeks)
|
425 Participants
n=41 Participants
|
213 Participants
n=1581 Participants
|
638 Participants
n=4626 Participants
|
|
Gestational Age
Late Preterm and Full-term Infant (≥35 weeks)
|
1996 Participants
n=41 Participants
|
998 Participants
n=1581 Participants
|
2994 Participants
n=4626 Participants
|
|
Age at randomization
<6 months
|
1927 Participants
n=41 Participants
|
964 Participants
n=1581 Participants
|
2891 Participants
n=4626 Participants
|
|
Age at randomization
≥6 months
|
494 Participants
n=41 Participants
|
247 Participants
n=1581 Participants
|
741 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: From Day 1 (postdose) to Day 150Population: All randomized participants who received a dose of study treatment and were protocol compliant.
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 sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2398 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1201 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)
|
60 Participants
|
74 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 (postdose) to Day 5Population: Safety analysis population included all randomized participants who received a dose of protocol specified study treatment. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.
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. Solicited injection-site AEs included redness/erythema, swelling, and pain/tenderness. Per protocol, the percentage of RSV season 1 participants with solicited injection-site AEs were reported.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
|
11.4 Percentage of participants
|
11.7 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 (postdose) to Day 5Population: Safety analysis population included all randomized participants who received a dose of protocol specified study treatment and had temperature data available. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.
Fever was defined as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). Per protocol, the percentage of RSV season 1 participants with fever were reported.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2408 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Percentage of Participants With Fever
|
0.5 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 (postdose) to Day 5Population: Safety analysis population included all randomized participants who received a dose of protocol specified study treatment. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.
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. Solicited systemic AEs included irritability, somnolence/drowsiness, and appetite lost. Per protocol, the percentage of RSV season 1 participants with solicited systemic AEs were reported.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Percentage of Participants With Solicited Systemic AEs
|
30.1 Percentage of participants
|
31.2 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 (postdose) to Day 42Population: Safety analysis population included all randomized participants who received a dose of protocol specified study treatment. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.
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. Anaphylaxis/Hypersensitivity AESI included anaphylaxis, angioedema, bronchospasm, drug hypersensitivity, dyspnea, hypersensitivity, dysphonia, and wheezing. Per protocol, the percentage of RSV season 1 participants with anaphylaxis/hypersensitivity AESI were reported.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 (postdose) to Day 42Population: Safety analysis population included all randomized participants who received a dose of protocol specified study treatment. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.
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 acute generalized exanthematous pustulosis, drug eruption, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, generalized rash of exfoliative nature, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Per protocol, the percentage of RSV season 1 participants with rash AESI were reported.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Percentage of Participants With Rash AESI
|
0.5 Percentage of participants
|
0.3 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 (postdose) to Day 42Population: Safety analysis population included all randomized participants who received a dose of protocol specified study treatment. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.
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. Per protocol, the percentage of RSV season 1 participants with ≥1 nonserious AE were reported.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Percentage of Participants With ≥1 Nonserious AE
|
74.8 Percentage of participants
|
75.5 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515Population: Safety analysis population which included all randomized participants who received a dose of protocol specified study treatment. For safety analysis population, participants with protocol deviation were excluded. Per protocol, a subset of participants from RSV season 1 entered RSV season 2 and SAEs were collected separately for RSV season 1 and RSV Season 2.
An SAE was any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. Per protocol, the percentage of participants in RSV season 1 and RSV season 2 with SAEs were reported.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
n=1017 Participants
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
n=501 Participants
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
11.7 Percentage of participants
|
12.6 Percentage of participants
|
3.1 Percentage of participants
|
4.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 (postdose) to Day 150Population: All randomized participants who received a dose of study treatment and were protocol compliant.
RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR nasopharyngeal sample. Per protocol, the number of participants with RSV-associated hospitalization were reported for RSV season 1.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2398 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1201 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Number of Participants With RSV-Associated Hospitalization
|
9 Participants
|
28 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 (postdose) to Day 180Population: All randomized participants who received a dose of study treatment and were protocol compliant.
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 RT-PCR nasopharyngeal sample. Per protocol, participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.
Outcome measures
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2398 Participants
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1201 Participants
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
RSV Season 1: Number of Participants With RSV-Associated MALRI
|
64 Participants
|
77 Participants
|
—
|
—
|
Adverse Events
RSV Season 1: Clesrovimab 105 mg
Serious events: 282 serious events
Other events: 1432 other events
Deaths: 7 deaths
RSV Season 1: Placebo
Serious events: 151 serious events
Other events: 724 other events
Deaths: 3 deaths
RSV Season 2: Clesrovimab 105 mg
Serious events: 32 serious events
Other events: 0 other events
Deaths: 0 deaths
RSV Season 2: Placebo
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 participants at risk
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 participants at risk
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
n=1017 participants at risk
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
n=501 participants at risk
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.66%
16/2409 • Number of events 17 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.58%
7/1202 • Number of events 7 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
2/1017 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Bronchitis mycoplasmal
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Bronchitis viral
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
COVID-19
|
0.25%
6/2409 • Number of events 6 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.58%
7/1202 • Number of events 7 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.33%
4/1202 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Cellulitis
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Coronavirus pneumonia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Croup infectious
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Dengue fever
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Diarrhoea infectious
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Dysentery
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Enterovirus infection
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Epididymitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Exanthema subitum
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Gastroenteritis
|
0.83%
20/2409 • Number of events 20 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.58%
7/1202 • Number of events 7 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.29%
3/1017 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Gastroenteritis viral
|
0.17%
4/2409 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
HIV infection
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Herpangina
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Impetigo
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Influenza
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Laryngitis
|
0.17%
4/2409 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.54%
13/2409 • Number of events 15 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.33%
4/1202 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.40%
2/501 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Mastoiditis
|
0.04%
1/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Meningitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Metapneumovirus bronchiolitis
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Metapneumovirus pneumonia
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Nasopharyngitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Osteomyelitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Otitis externa bacterial
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Otitis media
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Otitis media acute
|
0.17%
4/2409 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Parainfluenzae viral bronchitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Cardiac disorders
Cardiac failure
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Congenital, familial and genetic disorders
Congenital vesicoureteric reflux
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Eye disorders
Retinopathy of prematurity
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Cricopharyngeal dysfunction
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Gastritis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.21%
5/2409 • Number of events 5 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.42%
5/1202 • Number of events 5 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
General disorders
Death
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
General disorders
Pyrexia
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
General disorders
Sudden infant death syndrome
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.17%
4/2409 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Adenovirus infection
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Bacteraemia
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Bacterial tracheitis
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
2/1017 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Bronchiolitis
|
1.3%
32/2409 • Number of events 33 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
1.6%
19/1202 • Number of events 22 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
2/1017 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pharyngitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia
|
1.8%
43/2409 • Number of events 46 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
2.5%
30/1202 • Number of events 33 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
2/1017 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.60%
3/501 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia bacterial
|
0.25%
6/2409 • Number of events 6 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia escherichia
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia influenzal
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.08%
2/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.67%
8/1202 • Number of events 8 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
2/1017 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pneumonia viral
|
0.29%
7/2409 • Number of events 7 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Pyelonephritis acute
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.21%
5/2409 • Number of events 5 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
1.1%
13/1202 • Number of events 13 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.40%
2/501 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.25%
6/2409 • Number of events 6 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.25%
3/1202 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Respiratory tract infection
|
0.17%
4/2409 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.33%
4/1202 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.40%
2/501 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Rhinolaryngitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Rhinovirus infection
|
0.12%
3/2409 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Sepsis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Streptococcal sepsis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Systemic viral infection
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Tonsillitis
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Tracheitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Tracheobronchitis viral
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.37%
9/2409 • Number of events 9 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
12/2409 • Number of events 14 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.33%
4/1202 • Number of events 4 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Varicella zoster pneumonia
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Viral infection
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Viral rash
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Exposure to SARS-CoV-2
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Fall
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Investigations
Body temperature increased
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Investigations
Weight decreased
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B precursor type acute leukaemia
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Brain injury
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Dyskinesia
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Epilepsy
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Facial paralysis
|
0.08%
2/2409 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Febrile convulsion
|
0.42%
10/2409 • Number of events 14 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.25%
3/1202 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
2/1017 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Hemiparesis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Hydrocephalus
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Motor developmental delay
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Partial seizures
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Seizure
|
0.12%
3/2409 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Status epilepticus
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Subdural effusion
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.10%
1/1017 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
1/501 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.21%
5/2409 • Number of events 5 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.20%
2/1017 • Number of events 3 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Brief resolved unexplained event
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.17%
2/1202 • Number of events 2 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Childhood asthma
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Fibrinous bronchitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Vascular disorders
Hypovolaemic shock
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2409 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.08%
1/1202 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Vascular disorders
Cyanosis
|
0.04%
1/2409 • Number of events 1 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1202 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/1017 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
0.00%
0/501 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
Other adverse events
| Measure |
RSV Season 1: Clesrovimab 105 mg
n=2409 participants at risk
Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
|
RSV Season 1: Placebo
n=1202 participants at risk
Participants received a single IM administration of placebo on Day 1.
|
RSV Season 2: Clesrovimab 105 mg
n=1017 participants at risk
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.
|
RSV Season 2: Placebo
n=501 participants at risk
A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.
|
|---|---|---|---|---|
|
Psychiatric disorders
Irritability
|
24.2%
582/2409 • Number of events 789 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
25.2%
303/1202 • Number of events 417 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
139/2409 • Number of events 155 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
6.4%
77/1202 • Number of events 91 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
General disorders
Injection site pain
|
6.5%
156/2409 • Number of events 159 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
8.0%
96/1202 • Number of events 97 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
139/2409 • Number of events 158 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
6.5%
78/1202 • Number of events 89 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.6%
351/2409 • Number of events 415 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
15.7%
189/1202 • Number of events 212 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Investigations
Body temperature increased
|
8.9%
215/2409 • Number of events 253 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
9.0%
108/1202 • Number of events 123 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
161/2409 • Number of events 176 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
7.7%
93/1202 • Number of events 106 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Nervous system disorders
Somnolence
|
14.4%
347/2409 • Number of events 393 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
16.6%
199/1202 • Number of events 231 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
201/2409 • Number of events 254 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
7.7%
93/1202 • Number of events 133 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.5%
205/2409 • Number of events 256 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
8.2%
98/1202 • Number of events 129 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
170/2409 • Number of events 220 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
6.0%
72/1202 • Number of events 91 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
—
0/0 • RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515
All-cause mortality was reported on all randomized participants. Serious and nonserious AEs were reported in safety analysis population. Per protocol, 3 participants were excluded from the safety analysis population due to protocol deviation. Per protocol, only all-cause mortality and SAEs were collected for RSV season 1 and RSV season 2 separately. No data for nonserious AEs were collected during RSV Season 2.
|
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 results of this study may be published or presented at scientific meetings. The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER