MEDI8897 1b: A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02290340
• Collaborator: (none)
• Enrollment: 151
• Locations: 13
• Arms: 4
• Actual Duration (Months): 20.5
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy preterm infants.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus	Drug: Placebo; Drug: MEDI8897 10 mg; Drug: MEDI8897 25 mg; Drug: MEDI8897 50 mg	Phase 1

Detailed Description

This Phase 1b/2a study will be a dose-escalation design to begin data collection on PK and safety in children. The population to be enrolled is healthy preterm infants born between 32 weeks 0 days and 34 weeks 6 days gestation who would not receive RSV prophylaxis based on the American Academy of Pediatrics (AAP) or other local guidelines. These subjects will not be receiving palivizumab, allowing for a placebo comparator group to begin collecting data on incidence rates of RSV medically attended lower respiratory illness (MA-LRI) and efficacy. Enrollment is planned at approximately 20 sites in the USA, Chile, and South Africa.

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
• Actual Study Start Date: Jan 13, 2015
• Actual Primary Completion Date: Sep 28, 2016
• Actual Study Completion Date: Sep 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive placebo intramuscularly.	Drug: Placebo; Participants will receive placebo intramuscularly.
Experimental: MEDI8897 10 mg Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Drug: MEDI8897 10 mg; Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
Experimental: MEDI8897 25 mg Participants will receive a single dose of MEDI8897 25 mg intramuscularly.	Drug: MEDI8897 25 mg; Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
Experimental: MEDI8897 50 mg Participants will receive a single dose of MEDI8897 50 mg intramuscularly.	Drug: MEDI8897 50 mg; Participants will receive a single dose of MEDI8897 50 mg intramuscularly.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)]

   An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.

2. Number of Participants With Treatment-Emergent Adverse Events of Special Interest [From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)]

   An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.

3. Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events [From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)]

   Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.

Secondary Outcome Measures

1. Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose]

   The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.

2. Maximum Observed Serum Concentration (Cmax) of MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose]

   The Cmax is the maximum observed serum concentration of MEDI8897.

3. Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose]

   Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).

4. Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose]

   The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.

5. Terminal Elimination Half Life (t1/2) of MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose]

   Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.

6. Extravascular Clearance (CL/F) of MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose]

   Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

7. Extravascular Volume of Distribution (Vz/F) of MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose]

   Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.

8. Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 [Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose]

   A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline. Titers greater than or equal to 50 were considered positive.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

• Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age

• Infants who are entering their first RSV season at the time of screening

Key Exclusion Criteria:

• Gestational age < 32 weeks 0 days and >34 weeks 6 days

• Meets AAP or other local criteria to receive commercial palivizumab

• Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization

• Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization

• Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection

• Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Anaheim	California	United States
2	Research Site	Ontario	California	United States
3	Research Site	Syracuse	New York	United States
4	Research Site	Cleveland	Ohio	United States
5	Research Site	Charleston	South Carolina	United States
6	Research Site	Saint George	Utah	United States
7	Research Site	Marshfield	Wisconsin	United States
8	Research Site	Santiago		Chile
9	Research Site	Valdivia		Chile
10	Research Site	Cape Town		South Africa
11	Research Site	East London		South Africa
12	Research Site	Johannesburg		South Africa
13	Research Site	Pretoria		South Africa

Sponsors and Collaborators

• MedImmune LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT02290340
• Other Study ID Numbers: D5290C00002
• First Posted: Nov 14, 2014
• Last Update Posted: Sep 19, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by MedImmune LLC: Respiratory Syncytial Virus, RSV
• Additional relevant MeSH terms: Virus Diseases

Study Results

Participant Flow

Recruitment Details	Participants were recruited between January 2015 and September 2015 at 10 sites (USA, South Africa, and Chile) and followed for 1 year after dosing.
Pre-assignment Detail	A total of 151 participants were screened in the study, of which 89 participants were randomized and treated.

Arm/Group Title	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received placebo intramuscularly.	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Period Title: Overall Study
STARTED	18	8	31	32
COMPLETED	16	8	31	30
NOT COMPLETED	2	0	0	2

Baseline Characteristics

Arm/Group Title	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg	Total
Arm/Group Description	Participants received placebo intramuscularly.	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.	Total of all reporting groups
Overall Participants	18	8	31	32	89
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	7.0 (2.6)	4.2 (2.1)	6.7 (2.7)	6.9 (2.5)	6.6 (2.6)
Sex: Female, Male (Count of Participants)
Female	11 61.1%	4 50%	19 61.3%	19 59.4%	53 59.6%
Male	7 38.9%	4 50%	12 38.7%	13 40.6%	36 40.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	1 3.1%	1 1.1%
Asian	0 0%	0 0%	1 3.2%	0 0%	1 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	10 55.6%	1 12.5%	19 61.3%	21 65.6%	51 57.3%
White	4 22.2%	6 75%	0 0%	2 6.3%	12 13.5%
More than one race	0 0%	1 12.5%	0 0%	1 3.1%	2 2.2%
Unknown or Not Reported	4 22.2%	0 0%	11 35.5%	7 21.9%	22 24.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Description	An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame	From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug.

Arm/Group Title	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received placebo intramuscularly.	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	18	8	31	32
TEAEs	17 94.4%	5 62.5%	31 100%	30 93.8%
TESAEs	0 0%	0 0%	1 3.2%	2 6.3%

2. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events of Special Interest
Description	An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.
Time Frame	From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug.

Arm/Group Title	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received placebo intramuscularly.	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	18	8	31	32
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Description	Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.
Time Frame	From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug.

Arm/Group Title	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received placebo intramuscularly.	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	18	8	31	32
Anaemia	6 33.3%	0 0%	8 25.8%	4 12.5%
Microcytic anaemia	0 0%	0 0%	0 0%	3 9.4%
Neutropenia	0 0%	0 0%	0 0%	1 3.1%

4. Secondary Outcome

Title	Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Description	The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	5	29	31
Mean (Standard Deviation) [Day]	7.04 (0.0683)	7.04 (0.394)	6.93 (0.549)

5. Secondary Outcome

Title	Maximum Observed Serum Concentration (Cmax) of MEDI8897
Description	The Cmax is the maximum observed serum concentration of MEDI8897.
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	5	29	31
Mean (Standard Deviation) [microgram per milliliter (mcg/mL)]	23.2 (9.28)	30.9 (10.4)	71.7 (15.9)

6. Secondary Outcome

Title	Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
Description	Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	5	29	31
Mean (Standard Deviation) [Day*mcg/mL]	1940 (809)	2260 (881)	5470 (1440)

7. Secondary Outcome

Title	Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
Description	The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	1	6	14
Mean (Standard Deviation) [Day*mcg/mL]	2450 (NA)	4320 (1070)	7510 (1870)

8. Secondary Outcome

Title	Terminal Elimination Half Life (t1/2) of MEDI8897
Description	Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	1	6	14
Mean (Standard Deviation) [Day]	72.9 (NA)	66.2 (7.83)	62.5 (9.35)

9. Secondary Outcome

Title	Extravascular Clearance (CL/F) of MEDI8897
Description	Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	1	6	14
Mean (Standard Deviation) [mL/day]	4.08 (NA)	6.05 (1.31)	7.01 (1.57)

10. Secondary Outcome

Title	Extravascular Volume of Distribution (Vz/F) of MEDI8897
Description	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Arm/Group Title	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	1	6	14
Mean (Standard Deviation) [mL]	429 (NA)	581 (159)	633 (168)

11. Secondary Outcome

Title	Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
Description	A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline. Titers greater than or equal to 50 were considered positive.
Time Frame	Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose

Outcome Measure Data

Analysis Population Description

The As-treated Population included participants who received any study drug.

Arm/Group Title	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Arm/Group Description	Participants received placebo intramuscularly.	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.	Participants received a single dose of MEDI8897 25 mg intramuscularly.	Participants received a single dose of MEDI8897 50 mg intramuscularly.
Measure Participants	18	8	31	32
Baseline	1 5.6%	0 0%	0 0%	0 0%
Day 31	0 0%	2 25%	0 0%	0 0%
Day 151	0 0%	0 0%	0 0%	0 0%
Day 361	0 0%	1 12.5%	7 22.6%	10 31.3%

Adverse Events

Time Frame	From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Arm/Group Title	Placebo		MEDI8897 10 mg		MEDI8897 25 mg		MEDI8897 50 mg
Arm/Group Description	Participants received placebo intramuscularly.		Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.		Participants received a single dose of MEDI8897 25 mg intramuscularly.		Participants received a single dose of MEDI8897 50 mg intramuscularly.
All Cause Mortality
	Placebo		MEDI8897 10 mg		MEDI8897 25 mg		MEDI8897 50 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/8 (0%)		0/31 (0%)		0/32 (0%)
Serious Adverse Events
	Placebo		MEDI8897 10 mg		MEDI8897 25 mg		MEDI8897 50 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/8 (0%)		1/31 (3.2%)		2/32 (6.3%)
Infections and infestations
Lower respiratory tract infection	0/18 (0%)	0	0/8 (0%)	0	1/31 (3.2%)	2	1/32 (3.1%)	1
Nervous system disorders
Febrile convulsion	0/18 (0%)	0	0/8 (0%)	0	0/31 (0%)	0	2/32 (6.3%)	2
Other (Not Including Serious) Adverse Events
	Placebo		MEDI8897 10 mg		MEDI8897 25 mg		MEDI8897 50 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/18 (94.4%)		5/8 (62.5%)		31/31 (100%)		28/32 (87.5%)
Blood and lymphatic system disorders
Anaemia	6/18 (33.3%)	6	0/8 (0%)	0	8/31 (25.8%)	8	4/32 (12.5%)	4
Gastrointestinal disorders
Diarrhoea	2/18 (11.1%)	2	2/8 (25%)	2	6/31 (19.4%)	6	1/32 (3.1%)	1
Vomiting	0/18 (0%)	0	0/8 (0%)	0	2/31 (6.5%)	2	2/32 (6.3%)	2
General disorders
Pyrexia	3/18 (16.7%)	3	3/8 (37.5%)	5	8/31 (25.8%)	8	5/32 (15.6%)	6
Infections and infestations
Bronchiolitis	1/18 (5.6%)	1	3/8 (37.5%)	7	3/31 (9.7%)	3	6/32 (18.8%)	6
Candida nappy rash	1/18 (5.6%)	1	0/8 (0%)	0	9/31 (29%)	9	2/32 (6.3%)	5
Conjunctivitis	0/18 (0%)	0	0/8 (0%)	0	2/31 (6.5%)	2	4/32 (12.5%)	4
Gastroenteritis	4/18 (22.2%)	5	2/8 (25%)	3	11/31 (35.5%)	11	8/32 (25%)	11
Impetigo	2/18 (11.1%)	2	0/8 (0%)	0	2/31 (6.5%)	3	3/32 (9.4%)	3
Lower respiratory tract infection	3/18 (16.7%)	4	0/8 (0%)	0	4/31 (12.9%)	5	2/32 (6.3%)	2
Nasopharyngitis	2/18 (11.1%)	2	0/8 (0%)	0	0/31 (0%)	0	3/32 (9.4%)	3
Oral candidiasis	1/18 (5.6%)	1	0/8 (0%)	0	5/31 (16.1%)	6	5/32 (15.6%)	6
Otitis media	4/18 (22.2%)	4	3/8 (37.5%)	11	7/31 (22.6%)	11	5/32 (15.6%)	6
Otitis media acute	1/18 (5.6%)	1	0/8 (0%)	0	1/31 (3.2%)	1	3/32 (9.4%)	5
Pharyngitis	2/18 (11.1%)	2	1/8 (12.5%)	1	0/31 (0%)	0	1/32 (3.1%)	1
Upper respiratory tract infection	12/18 (66.7%)	26	4/8 (50%)	8	23/31 (74.2%)	47	22/32 (68.8%)	48
Viral rash	1/18 (5.6%)	1	0/8 (0%)	0	3/31 (9.7%)	3	1/32 (3.1%)	1
Respiratory, thoracic and mediastinal disorders
Cough	4/18 (22.2%)	4	1/8 (12.5%)	1	11/31 (35.5%)	11	6/32 (18.8%)	8
Nasal congestion	1/18 (5.6%)	2	3/8 (37.5%)	4	3/31 (9.7%)	3	2/32 (6.3%)	2
Nasal obstruction	2/18 (11.1%)	4	0/8 (0%)	0	6/31 (19.4%)	8	5/32 (15.6%)	5
Rhinorrhoea	3/18 (16.7%)	3	0/8 (0%)	0	9/31 (29%)	14	3/32 (9.4%)	3
Skin and subcutaneous tissue disorders
Dermatitis	0/18 (0%)	0	0/8 (0%)	0	1/31 (3.2%)	1	3/32 (9.4%)	3
Dermatitis contact	1/18 (5.6%)	1	1/8 (12.5%)	1	4/31 (12.9%)	5	0/32 (0%)	0
Dermatitis diaper	1/18 (5.6%)	1	1/8 (12.5%)	1	6/31 (19.4%)	6	4/32 (12.5%)	4
Dry skin	3/18 (16.7%)	3	0/8 (0%)	0	4/31 (12.9%)	4	1/32 (3.1%)	1
Eczema	3/18 (16.7%)	3	0/8 (0%)	0	8/31 (25.8%)	9	6/32 (18.8%)	7
Rash	0/18 (0%)	0	1/8 (12.5%)	1	4/31 (12.9%)	4	0/32 (0%)	0

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going 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.