Clesrovimab (MK-1654) in Infants and Children at Increase... | NCT04938830

NCT04938830

ID	Type	Description
MK-1654-007	Other Identifier	MSD
jRCT2031210664	Registry Identifier	jRCT
2022-500752-39-00	Registry Identifier	EU CT
U1111-1278-0093	Registry Identifier	UTN
2020-005996-11	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clesrovimab	Experimental	Participants will receive intramuscular (IM) injections of clesrovimab and placebo	Biological: Clesrovimab Biological: Placebo
Palivizumab	Active Comparator	Participants will receive IM injections.	Biological: Palivizumab

Name	Type	Description	Arm Group Labels	Other Names
Clesrovimab	Biological	IM injection	Clesrovimab	MK-1654

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.	Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
Number of Participants With Solicited Daily Body Temperatures With Fever in RSV Season 1	Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F. The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.	Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
Number of Participants With Solicited Systemic AEs in RSV Season 1	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 1 is reported.	Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)
Number of Participants With Anaphylaxis/Hypersensitivity AEs of Special Interest (AESI) in RSV Season 1	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.	Up to 42 days in RSV Season 1
Number of Participants With Rash AESI in RSV Season 1

Secondary Outcomes

Measure	Description	Time Frame
Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1	Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal (NP) sample. The number of cases of outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1. For each participant, only the first occurrence of the case is counted for the analysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations and meet defined criteria for the Early or Moderate Pre-term Group or the chronic lung disease (CLD)/congenital heart disease (CHD) Group.
Is available to complete the follow-up period.

Additional inclusion criteria for participation in RSV Season 2:

RSV Season 2 participants enrolled in the CLD/CHD Group in RSV Season 1. Participants with CHD must also have the following:
- Hemodynamically significant CHD at the beginning of RSV Season 2, or
- If the participant has had surgically repaired hemodynamically significant CHD that did not include extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass: 1) continues to require medications to manage CHD, or 2) any additional medical intervention related to their CHD.
RSV Season 2 participants enrolled in the Early or Moderate Pre-term Group in RSV Season 1, with the following:
- Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough
- Down Syndrome (trisomy of chromosome 21)
- Cystic fibrosis with nutritional compromise
- Native Americans and Alaskan Indians or other indigenous populations at high risk for severe RSV disease

Exclusion Criteria:

Requires mechanical ventilation at time of enrollment.
Has a life expectancy <6 months.
Has known hepatic or renal dysfunction, or chronic seizure disorder.
Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
Has severe immunodeficiency or is severely immunocompromised.
Has known hypersensitivity to any component of clesrovimab or palivizumab.

Additional exclusion criteria for participation in RSV Season 2:

Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Miller Children's & Women's Hospital Long Beach ( Site 0001)		Long Beach	California	90806	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40961423	Result	Zar HJ, Bont LJ, Manzoni P, Munoz FM, Ramilo O, Chen PY, Novoa JM, Ordonez GA, Tsolia M, Tapiero B, Acuna-Avila MI, Castellanos JM, Meyer M, Morioka I, Chen Z, Railkar RA, Zang X, Maas BM, Likos A, Lee AW, Castagnini LA, Sinha A; SMART (MK-1654-007) Study Group. Clesrovimab in Infants and Children at Increased Risk for Severe RSV Disease. N Engl J Med. 2025 Oct 2;393(13):1343-1345. doi: 10.1056/NEJMc2506107. Epub 2025 Sep 17. No abstract available.
40602662

Label	URL
Merck Clinical Trials Information	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
FG001	Palivizumab (Season 1)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 25, 2024

Arm/Group Information

ID	Title	Description
BG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
BG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age at Randomization

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0000.3± 0.2 BG0010.3± 0.2 BG0020.3± 0.2

Age, Customized

Age at Randomization

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Newborns (0-27 days)	BG00055 BG00155 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000247 BG001251 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000152 BG001157 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0005 BG0019 BG002

Region at Randomization

Region at randomization was categorized as the following: Northern hemisphere and Southern hemisphere.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Northern Hemisphere	BG000355 BG001353

Participant Condition

Participants were categorized by condition: Chronic lung disease (CLD), congenital heart disease (CHD), neither CLD nor CHD <29 weeks gestational age, and neither CLD nor CHD ≥29 weeks gestational age.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
CLD	BG000139 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Solicited Injection-site Adverse Events (AEs) in RSV Season 1

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included erythema, pain, and swelling. The number of participants with solicited injection-site AEs in RSV Season 1 is reported.

All randomized participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.

Posted

Count of Participants

Participants

Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Units	Counts
Participants	OG000497 OG001499

Title

Denominators

Categories

Injection site erythema

Title	Measurements
	OG00031 OG00132

Injection site pain

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Injection site erythema					Miettinen & Nurminen method	-0.2			2-Sided	95	-3.3	2.9					Other	Difference in Percentage vs. Palivizumab
OG000 OG001	Injection site pain

Primary

Number of Participants With Solicited Daily Body Temperatures With Fever in RSV Season 1

Fever was defined as maximum rectal temperature ≥102.2 °F (39.0 °C) or maximum axillary temperature ≥101.7 °F. The number of participants with solicited daily body temperature of fever in RSV Season 1 is reported.

Posted

Count of Participants

Participants

Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Units	Counts
Participants

Primary

Number of Participants With Solicited Systemic AEs in RSV Season 1

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 1 is reported.

Posted

Count of Participants

Participants

Up to 5 days after each dose in RSV Season 1 (Up to ~33 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Units	Counts

Primary

Number of Participants With Anaphylaxis/Hypersensitivity AEs of Special Interest (AESI) in RSV Season 1

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with anaphylaxis/hypersensitivity AESI in RSV Season 1 is reported.

Posted

Count of Participants

Participants

Up to 42 days in RSV Season 1

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Units	Counts

Primary

Number of Participants With Rash AESI in RSV Season 1

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included urticaria and drug eruption. The number of participants with rash AESI in RSV Season 1 is reported.

Posted

Count of Participants

Participants

Up to 42 days in RSV Season 1

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Units	Counts
Participants

Primary

Number of Participants With Nonserious AEs in RSV Season 1

All participants who received at least 1 dose of study intervention. One participant in the clesrovimab 105 mg arm received incorrect study intervention at Day 28 and was excluded from the RSV Season 1 APaT population.

Posted

Count of Participants

Participants

Up to 42 days in RSV Season 1

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Units	Counts
Participants

Primary

Number of Participants With Serious AEs (SAEs) Through the Duration of Participation in RSV Season 1

An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The number of participants with SAEs in RSV Season 1 is reported.

Posted

Count of Participants

Participants

Up to 365 days in RSV Season 1

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Secondary

Number of Cases of RSV-associated Medically Attended Lower Respiratory Infection (MALRI) in RSV Season 1

Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal (NP) sample. The number of cases of outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1. For each participant, only the first occurrence of the case is counted for the analysis.

All randomized participants who received at least 1 dose of study intervention and without deviations from the protocol that could impact the results. Deviations include but are not limited to the following: study intervention administered out of time window, improperly stored study intervention, and NP swab not obtained.

Posted

Number

Number of Cases

Up to 150 days in RSV Season 1

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Secondary

Number of Cases of RSV-associated Hospitalization in RSV Season 1

RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR NP sample. The number of cases of RSV-associated hospitalization in RSV Season 1 is reported. For each participant, only the first occurrence of the case is counted for the analysis.

Posted

Number

Number of Cases

Up to 150 days in RSV Season 1

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.
OG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.

Units	Counts

Secondary

Number of Participants With Solicited Injection-site AEs in RSV Season 2

All randomized participants who received at least 1 dose of study intervention in RSV Season 2.

Posted

Count of Participants

Participants

Up to 5 days postdose in RSV Season 2 (Up to ~400 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
OG001	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.

Secondary

Number of Participants With Solicited Daily Body Temperature With Fever in RSV Season 2

All randomized participants who received at least 1 dose of study intervention in RSV Season 2.

Posted

Count of Participants

Participants

Up to 5 days postdose in RSV Season 2 (Up to ~400 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
OG001	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.

Units

Secondary

Number of Participants With Solicited Systemic AEs in RSV Season 2

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included decreased appetite, irritability, and somnolence. The number of participants with solicited systemic AEs in RSV Season 2 is reported.

All randomized participants who received at least 1 dose of study intervention in RSV Season 2.

Posted

Count of Participants

Participants

Up to 5 days postdose in RSV Season 2 (Up to ~400 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
OG001	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.

Secondary

Number of Participants With Anaphylaxis/Hypersensitivity AESI in RSV Season 2

All randomized participants who received at least 1 dose of study intervention in RSV Season 2.

Posted

Count of Participants

Participants

Up to 42 days postdose in RSV Season 2 (Up to ~440 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
OG001	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.

Secondary

Number of Participants With Rash AESI in RSV Season 2

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included urticaria and drug eruption. The number of participants with rash AESI in RSV Season 2 is reported.

All randomized participants who received at least 1 dose of study intervention in RSV Season 2.

Posted

Count of Participants

Participants

Up to 42 days postdose in RSV Season 2 (Up to ~440 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
OG001	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.

Secondary

Number of Participants With Nonserious AEs in RSV Season 2

All randomized participants who received at least 1 dose of study intervention in RSV Season 2.

Posted

Count of Participants

Participants

Up to 42 days postdose in RSV Season 2 (Up to ~440 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
OG001	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.

Secondary

Number of Participants With SAEs in RSV Season 2

All randomized participants who received at least 1 dose of study intervention in RSV Season 2.

Posted

Count of Participants

Participants

Up 180 days postdose in RSV Season 2 (Up to ~575 days)

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.
OG001	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.

Secondary

Concentration of Clesrovimab in RSV Season 1

Blood samples were collected to determine the serum concentration of clesrovimab at Days 7, 150, and 240 in RSV Season 1.

All randomized participants who received at least 1 dose of clesrovimab in RSV Season 1, who had data at the given timepoint, and without deviations from the protocol that could impact the results. Deviations include but are not limited to the following: study intervention administered out of time window, improperly stored study intervention, and sample not obtained.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

At Day 7, Day 150, and Day 240 in RSV Season 1

ID	Title	Description
OG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.

Units	Counts
Participants	OG000

Secondary

Concentration of Clesrovimab in RSV Season 2

Blood samples were collected to determine the serum concentration of clesrovimab at Days 7 and 150 in RSV Season 2. RSV Season 2 began 246-393 days after RSV Season 1 dose 1.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

At Day 7 and Day 150 postdose in RSV Season 2

ID	Title	Description
OG000	Clesrovimab 210 mg (Season 2)	Total subset of participants who received clesrovimab 210 mg.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Clesrovimab 105 mg (Season 1)	Participants received clesrovimab 105 mg via intramuscular (IM) injection on Day 1 of RSV Season 1 and placebo on Day 28. Participants were followed up to 365 days.	8	502	122	497	290	497
EG001	Palivizumab (Season 1)	Participants received palivizumab 15 mg/kg body weight via IM injection at least at Days 1, 28, 60 up to Days 90 or 120, and were followed up to 365 days.	4	501	137	499	282	499
EG002	Clesrovimab 105 mg (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Clesrovimab 105 mg (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.	1	138	25	138	69	138
EG003	Palivizumab (Season 1) + Clesrovimab 210 mg (Season 2)	At 246 to 393 days after RSV Season 1 Dose 1, an eligible subset of participants from the Palivizumab (Season 1) arm entered RSV Season 2. On Day 1 of RSV Season 2, the subset received clesrovimab 210 mg via IM injection and were followed for an additional 180 days.	1	138	26	138	69	138

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG0030 events0 affected138 at risk
Anaemia neonatal	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Cardiac dysfunction	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0013 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0021 events1 affected138 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pulmonary valve stenosis	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0021 events1 affected138 at risk EG003
Congenital laryngeal stridor	Congenital, familial and genetic disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Retinopathy of prematurity	Eye disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0013 events3 affected499 at risk EG0020 events0 affected138 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0012 events1 affected499 at risk EG0021 events1 affected138 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected497 at risk EG0015 events5 affected499 at risk EG0020 events0 affected138 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Crying	General disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Death	General disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pyrexia	General disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Sudden infant death syndrome	General disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Abscess jaw	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Adenovirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Bordetella infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00038 events34 affected497 at risk EG00130 events26 affected499 at risk EG0025 events5 affected138 at risk EG003
Bronchitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events2 affected497 at risk EG0013 events3 affected499 at risk EG0020 events0 affected138 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
COVID-19	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00011 events11 affected497 at risk EG0017 events7 affected499 at risk EG0020 events0 affected138 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Croup infectious	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0012 events2 affected499 at risk EG0021 events1 affected138 at risk EG003
Dengue fever	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Device related infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Dysentery	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Encephalitis enteroviral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Endocarditis bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Enterovirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Exanthema subitum	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00011 events10 affected497 at risk EG00114 events13 affected499 at risk EG0022 events2 affected138 at risk EG003
Gastroenteritis bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events2 affected497 at risk EG0011 events1 affected499 at risk EG0021 events1 affected138 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Impetigo	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Influenza	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0021 events1 affected138 at risk EG003
Laryngitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0010 events0 affected499 at risk EG0021 events1 affected138 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0008 events8 affected497 at risk EG0017 events7 affected499 at risk EG0021 events1 affected138 at risk EG003
Lower respiratory tract infection viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Mediastinitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Meningitis salmonella	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Metapneumovirus bronchiolitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Metapneumovirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Mycoplasma infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Oral herpes	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Pneumonia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00019 events16 affected497 at risk EG00127 events23 affected499 at risk EG0025 events4 affected138 at risk EG003
Pneumonia adenoviral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Pneumonia haemophilus	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Pneumonia parainfluenzae viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0014 events4 affected499 at risk EG0022 events2 affected138 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0004 events4 affected497 at risk EG0017 events5 affected499 at risk EG0020 events0 affected138 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected497 at risk EG0012 events2 affected499 at risk EG0021 events1 affected138 at risk EG003
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0021 events1 affected138 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0021 events1 affected138 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0016 events5 affected499 at risk EG0020 events0 affected138 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Rotavirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Salmonella sepsis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Scabies	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Sepsis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Superinfection bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0004 events3 affected497 at risk EG0017 events6 affected499 at risk EG0020 events0 affected138 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected497 at risk EG00110 events9 affected499 at risk EG0021 events1 affected138 at risk EG003
Urosepsis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Viral infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected497 at risk EG0014 events3 affected499 at risk EG0021 events1 affected138 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Child maltreatment syndrome	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Foreign body in respiratory tract	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Shunt occlusion	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0021 events1 affected138 at risk EG003
Body temperature increased	Investigations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0014 events4 affected499 at risk EG0020 events0 affected138 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Overfeeding of infant	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Poor feeding infant	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Growth retardation	Musculoskeletal and connective tissue disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Brain injury	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0002 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Movement disorder	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Myoclonus	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Seizure like phenomena	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Jaundice neonatal	Pregnancy, puerperium and perinatal conditions	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Breath holding	Psychiatric disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0021 events1 affected138 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected497 at risk EG0014 events4 affected499 at risk EG0020 events0 affected138 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0021 events1 affected138 at risk EG003
Brief resolved unexplained event	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Bronchopulmonary dysplasia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0013 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Chronic respiratory disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Idiopathic interstitial pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Laryngeal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0012 events2 affected499 at risk EG0020 events0 affected138 at risk EG003
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0010 events0 affected499 at risk EG0020 events0 affected138 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0003 events1 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0010 events0 affected499 at risk EG0021 events1 affected138 at risk EG003
Cyanosis	Vascular disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003
Hypotension	Vascular disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected497 at risk EG0011 events1 affected499 at risk EG0020 events0 affected138 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG00010 events8 affected497 at risk EG0012 events2 affected499 at risk EG0027 events7 affected138 at risk EG0033 events3 affected138 at risk
Injection site erythema	General disorders	MedDRA 28.1	Systematic Assessment	EG00038 events31 affected497 at risk EG00127 events26 affected499 at risk EG0024 events3 affected138 at risk EG003
Injection site pain	General disorders	MedDRA 28.1	Systematic Assessment	EG00056 events39 affected497 at risk EG00161 events41 affected499 at risk EG00215 events7 affected138 at risk EG003
Injection site swelling	General disorders	MedDRA 28.1	Systematic Assessment	EG00038 events32 affected497 at risk EG00126 events23 affected499 at risk EG0025 events4 affected138 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected497 at risk EG0014 events4 affected499 at risk EG0022 events1 affected138 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00015 events12 affected497 at risk EG00122 events20 affected499 at risk EG0028 events7 affected138 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00016 events15 affected497 at risk EG00118 events17 affected499 at risk EG00210 events9 affected138 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00068 events60 affected497 at risk EG00183 events68 affected499 at risk EG00218 events16 affected138 at risk EG003
Body temperature increased	Investigations	MedDRA 28.1	Systematic Assessment	EG00033 events30 affected497 at risk EG00127 events27 affected499 at risk EG0029 events9 affected138 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG00089 events68 affected497 at risk EG00158 events47 affected499 at risk EG00214 events12 affected138 at risk EG003
Somnolence	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG000135 events95 affected497 at risk EG001117 events84 affected499 at risk EG00218 events15 affected138 at risk EG003
Irritability	Psychiatric disorders	MedDRA 28.1	Systematic Assessment	EG000228 events147 affected497 at risk EG001208 events139 affected499 at risk EG00212 events12 affected138 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0009 events9 affected497 at risk EG00115 events14 affected499 at risk EG00212 events10 affected138 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG00013 events13 affected497 at risk EG00121 events19 affected499 at risk EG00212 events11 affected138 at risk EG003

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins