Trial Outcomes & Findings for Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection (NCT NCT00192504)

NCT ID: NCT00192504

Last Updated: 2021-10-08

Results Overview

Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 31 participants
• Primary outcome timeframe: From the start of treatment to 30 days after dosing
• Results posted on: 2021-10-08

Participant Flow

The screening period occurred within 24 hours before randomization. All subjects who were screened were randomized into the study.

Participant milestones

Measure	Motavizumab (MEDI-524), 3 mg/kg Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo Placebo, as a single intravenous dose administered on Day 0
Overall Study STARTED	5	5	6	15
Overall Study COMPLETED	4	5	5	15
Overall Study NOT COMPLETED	1	0	1	0

Reasons for withdrawal

Measure	Motavizumab (MEDI-524), 3 mg/kg Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo Placebo, as a single intravenous dose administered on Day 0
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Dosing window missed	0	0	1	0

Baseline Characteristics

Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

Baseline characteristics by cohort

Measure	Motavizumab (MEDI-524), 3 mg/kg n=5 Participants Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 Participants Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 Participants Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 Participants Placebo, as a single intravenous dose administered on Day 0	Total n=30 Participants Total of all reporting groups
Age, Continuous	8.84 months STANDARD_DEVIATION 6.62 • n=5 Participants	3.18 months STANDARD_DEVIATION 1.56 • n=7 Participants	10.78 months STANDARD_DEVIATION 9.07 • n=5 Participants	7.43 months STANDARD_DEVIATION 7.69 • n=4 Participants	7.51 months STANDARD_DEVIATION 7.19 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants	20 Participants n=21 Participants
Race/Ethnicity, Customized White/Non-Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants	27 Participants n=21 Participants
Region of Enrollment Chile	4 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants	27 participants n=21 Participants
Region of Enrollment United States	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Weight	8.728 Kilograms STANDARD_DEVIATION 1.392 • n=5 Participants	5.516 Kilograms STANDARD_DEVIATION 0.891 • n=7 Participants	9.194 Kilograms STANDARD_DEVIATION 3.43 • n=5 Participants	7.386 Kilograms STANDARD_DEVIATION 3.218 • n=4 Participants	7.599 Kilograms STANDARD_DEVIATION 2.903 • n=21 Participants

PRIMARY outcome

Timeframe: From the start of treatment to 30 days after dosing

Population: All patients who recieved study drug were included in the analysis of safety.

Safety and tolerability of motavizumab (MEDI-524) was measured by adverse events through 30 days after dosing

Outcome measures

Measure	Motavizumab (MEDI-524), 3 mg/kg n=5 Participants Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 Participants Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 Participants Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 Participants Placebo, as a single intravenous dose administered on Day 0
Number of Subjects Reporting Adverse Events Through 30 Days After Dosing	3 Participants	5 Participants	3 Participants	6 Participants

PRIMARY outcome

Timeframe: From the start of treatment to 30 days after dosing

Safety and tolerability of motavizumab (MEDI-524) was measured by serious adverse events through 30 days after dosing

Outcome measures

Measure	Motavizumab (MEDI-524), 3 mg/kg n=4 Participants Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 Participants Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 Participants Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 Participants Placebo, as a single intravenous dose administered on Day 0
Number of Subjects Reporting Serious Adverse Events Through 30 Days After Dosing	0 participants	0 participants	1 participants	1 participants

PRIMARY outcome

Timeframe: From the start of treatment to 30 days after dosing

Population: All patients who recieved study drug were included in the analysis of safety.

Safety and tolerability of motavizumab (MEDI-524) was measured by the occurrence of increased toxicity grade from baseline as determined by laboratory evaluations (complete blood count, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and urinalysis) at baseline and at each study collection time point following dosing

Outcome measures

Measure	Motavizumab (MEDI-524), 3 mg/kg n=5 Participants Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 Participants Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 Participants Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 Participants Placebo, as a single intravenous dose administered on Day 0
The Occurrence of Increased Toxixity Grade From Baseline as Determined by Laboratory Evaluations	0 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 2 and Day 30

Population: All patients who recieved a full dose of study drug were included in the analysis of trough serum concentrations. One patient in the 3 mg/kg group was not assessed for serum trough levels at either Day 2 or Day 30.

Mean trough serum concentrations of motavizumab (MEDI-524) were collected on Day 2 and on Day 30. Serum concentrations of MEDI-524 were analysed using a qualified enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Motavizumab (MEDI-524), 3 mg/kg n=4 Participants Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 Participants Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 Participants Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 Participants Placebo, as a single intravenous dose administered on Day 0
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30 Trough Serum Concentration at Day 2	61.78 Micrograms per mililiter Standard Deviation 20.09	170.8 Micrograms per mililiter Standard Deviation 38.43	333.2 Micrograms per mililiter Standard Deviation 99.86	0 Micrograms per mililiter Standard Deviation 0
To Describe the Mean Trough Serum Concentrations of Motavizumab (MEDI-524) Administered as a Single Intravenous Dose at Day 2 and Day 30 Trough Serum Concentration at Day 30	16.63 Micrograms per mililiter Standard Deviation 13.08	59.18 Micrograms per mililiter Standard Deviation 12.72	80.28 Micrograms per mililiter Standard Deviation 27.34	0 Micrograms per mililiter Standard Deviation 0

SECONDARY outcome

Timeframe: Immediately before dosing on Day 0

Population: All patients who received a full dose of study drug were included in the analysis of immunogenicity.

The serum anti-motavizumab antibody titers were measured in subjects on Day 0 (before dosing). Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.

Outcome measures

Measure	Motavizumab (MEDI-524), 3 mg/kg n=5 Participants Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 Participants Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 Participants Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 Participants Placebo, as a single intravenous dose administered on Day 0
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 0	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 30

Population: All patients who received a full dose of study drug were included in the analysis of immunogenicity. One patient in the 3 mg/kg group was not assessed for immunogenicity.

The serum anti-motavizumab antibody titers were measured in subjects on Day 30. Anti-motavizumab antibody assays were performed at MedImmune using a qualified assay.

Outcome measures

Measure	Motavizumab (MEDI-524), 3 mg/kg n=4 Participants Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 Participants Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 Participants Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 Participants Placebo, as a single intravenous dose administered on Day 0
To Describe the Immunogenicity of Motavizumab (MEDI-524) Following a Single IV Dose at Day 30	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Motavizumab (MEDI-524), 3 mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Motavizumab (MEDI-524), 15 mg/kg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Motavizumab (MEDI-524), 30 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Motavizumab (MEDI-524), 3 mg/kg n=5 participants at risk Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 participants at risk Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 participants at risk Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 participants at risk Placebo, as a single intravenous dose administered on Day 0
Infections and infestations Epstein-Barr virus infection	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.

Other adverse events

Measure	Motavizumab (MEDI-524), 3 mg/kg n=5 participants at risk Motavizumab, 3 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 15 mg/kg n=5 participants at risk Motavizumab, 15 mg/kg as a single intravenous dose administered on Day 0	Motavizumab (MEDI-524), 30 mg/kg n=5 participants at risk Motavizumab, 30 mg/kg as a single intravenous dose administered on Day 0	Placebo n=15 participants at risk Placebo, as a single intravenous dose administered on Day 0
Investigations Alanine aminotransferase increased	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Respiratory, thoracic and mediastinal disorders Allergic respiratory symptom	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Bronchitis	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	40.0% 2/5 • Number of events 2 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 3/15 • Number of events 3 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Investigations Cardiac murmur	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Injury, poisoning and procedural complications Contusion	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Gastrointestinal disorders Disbacteriosis	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Eye disorders Eyelid oedema	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Genital infection fungal	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Vascular disorders Haemodynamic instability	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Haemophilus infection	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Skin and subcutaneous tissue disorders Heat rash	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Vascular disorders Hypertension	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	13.3% 2/15 • Number of events 2 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Lower respiratory tract infection	40.0% 2/5 • Number of events 2 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	13.3% 2/15 • Number of events 2 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Nasopharyngitis	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
General disorders Oedema	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Otitis media	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Otitis media acute	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
General disorders Pyrexia	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 3/15 • Number of events 4 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Skin and subcutaneous tissue disorders Rash erythematous	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Skin and subcutaneous tissue disorders Skin erosion	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Superinfection bacterial	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Urinary tract infection	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Infections and infestations Viral skin infection	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/15 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	20.0% 1/5 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	0.00% 0/5 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.	6.7% 1/15 • Number of events 1 • Adverse events were collected from the time of the first administration of motavizumab (MEDI-524) to 30 days after dosing.

Additional Information

Genevieve A. Losonsky, MD/VP Clinical Development

MedImmune, LLC

Phone: 301-398-0000

Email: losonskyG@medimmune.com

Results disclosure agreements

• Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
• Publication restrictions are in place

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