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 - MEDI8897 1b

Study identifier:D5290C00002

ClinicalTrials.gov identifier:NCT02290340

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Respiratory Syncytial Virus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Placebo, MEDI8897 10 mg, MEDI8897 25 mg, MEDI8897 50 mg

Sex

All

Actual Enrollment

151

Study type

Interventional

Age

0 Months - 12 Months

Date

Study Start Date: 13 Jan 2015

Primary Completion Date: 28 Sept 2016

Study Completion Date: 28 Sept 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Sept 2018 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Syracuse, NY, United States

Location

Research Site

Ontario, CA, United States

Location

Research Site

Anaheim, CA, United States

Location

Research Site

Charleston, SC, United States

Location

Research Site

St. George, UT, United States

Location

Research Site

Cleveland, OH, United States

Location

Research Site

Marshfield, WI, United States

Location

Research Site

East London, South Africa

Arms	Assigned Interventions
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.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 151 participants were screened in the study, of which 89 participants were randomized and treated.

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Participant Flow: Overall Study

	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
STARTED	18	8	31	32
COMPLETED	16	8	31	30
NOT COMPLETED	2	0	0	2
Lost to Follow-up	0	0	0	1
Withdrawal by Subject	1	0	0	0
Unspecified	1	0	0	1

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

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

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Baseline Measures

	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg	Total
Number of Participants [units: Participants]	18	8	31	32	89
Age Continuous [units: Months] Mean ± Standard Deviation	7.0 ± 2.6	4.2 ± 2.1	6.7 ± 2.7	6.9 ± 2.5	6.6 ± 2.6
Gender, Male/Female [units: Participants]
Female	11	4	19	19	53
Male	7	4	12	13	36
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0	1	1
Asian	0	0	1	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	10	1	19	21	51
White	4	6	0	2	12
More than one race	0	1	0	1	2
Unknown or Not Reported	4	0	11	7	22

Outcome Measures

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

Measure Type	Primary
Measure Name	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Measure 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)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug.

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	18	8	31	32
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [units: Participants]
TEAEs	17	5	31	30
TESAEs	0	0	1	2

No statistical analysis provided for Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

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

Measure Type	Primary
Measure Name	Number of Participants With Treatment-Emergent Adverse Events of Special Interest
Measure 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)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug.

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	18	8	31	32
Number of Participants With Treatment-Emergent Adverse Events of Special Interest [units: Participants]	0	0	0	0

No statistical analysis provided for Number of Participants With Treatment-Emergent Adverse Events of Special Interest

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

Measure Type	Primary
Measure Name	Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events
Measure 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)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug.

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	18	8	31	32
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events [units: Participants]
Anaemia	6	0	8	4
Microcytic anaemia	0	0	0	3
Neutropenia	0	0	0	1

No statistical analysis provided for Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events

4. Secondary Outcome Measure: Time to Reach Maximum Observed Serum Concentration (Tmax) 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 ]

Measure Type	Secondary
Measure Name	Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Reporting Groups

	Description
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	5	29	31
Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897 [units: Day] Mean (Standard Deviation)	7.04 (0.0683)	7.04 (0.394)	6.93 (0.549)

No statistical analysis provided for Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897

5. Secondary Outcome Measure: Maximum Observed Serum Concentration (Cmax) 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 ]

Measure Type	Secondary
Measure Name	Maximum Observed Serum Concentration (Cmax) of MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Reporting Groups

	Description
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	5	29	31
Maximum Observed Serum Concentration (Cmax) of MEDI8897 [units: microgram per milliliter (mcg/mL)] Mean (Standard Deviation)	23.2 (9.28)	30.9 (10.4)	71.7 (15.9)

No statistical analysis provided for Maximum Observed Serum Concentration (Cmax) of MEDI8897

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

Measure Type	Secondary
Measure Name	Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Reporting Groups

	Description
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	5	29	31
Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897 [units: Day*mcg/mL] Mean (Standard Deviation)	1940 (809)	2260 (881)	5470 (1440)

No statistical analysis provided for Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897

7. Secondary Outcome Measure: Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) 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 ]

Measure Type	Secondary
Measure Name	Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Reporting Groups

	Description
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	1	6	14
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897 [units: Day*mcg/mL] Mean (Standard Deviation)	2450 (NA)^[1]	4320 (1070)	7510 (1870)

No statistical analysis provided for Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897

8. Secondary Outcome Measure: Terminal Elimination Half Life (t1/2) 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 ]

Measure Type	Secondary
Measure Name	Terminal Elimination Half Life (t1/2) of MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Reporting Groups

	Description
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	1	6	14
Terminal Elimination Half Life (t1/2) of MEDI8897 [units: Day] Mean (Standard Deviation)	72.9 (NA)^[1]	66.2 (7.83)	62.5 (9.35)

No statistical analysis provided for Terminal Elimination Half Life (t1/2) of MEDI8897

9. Secondary Outcome Measure: Extravascular Clearance (CL/F) 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 ]

Measure Type	Secondary
Measure Name	Extravascular Clearance (CL/F) of MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Reporting Groups

	Description
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	1	6	14
Extravascular Clearance (CL/F) of MEDI8897 [units: mL/day] Mean (Standard Deviation)	4.08 (NA)^[1]	6.05 (1.31)	7.01 (1.57)

No statistical analysis provided for Extravascular Clearance (CL/F) of MEDI8897

10. Secondary Outcome Measure: Extravascular Volume of Distribution (Vz/F) 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 ]

Measure Type	Secondary
Measure Name	Extravascular Volume of Distribution (Vz/F) of MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included all participants who received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure.

Reporting Groups

	Description
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	1	6	14
Extravascular Volume of Distribution (Vz/F) of MEDI8897 [units: mL] Mean (Standard Deviation)	429 (NA)^[1]	581 (159)	633 (168)

No statistical analysis provided for Extravascular Volume of Distribution (Vz/F) of MEDI8897

11. Secondary Outcome Measure: Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 [ Time Frame: Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose ]

Measure Type	Secondary
Measure Name	Number of Participants Positive for Anti-Drug Antibodies to MEDI8897
Measure 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
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The As-treated Population included participants who received any study drug.

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Measured Values

	Placebo	MEDI8897 10 mg	MEDI8897 25 mg	MEDI8897 50 mg
Number of Participants Analyzed [units:participants]	18	8	31	32
Number of Participants Positive for Anti-Drug Antibodies to MEDI8897 [units: participants]
Baseline	1	0	0	0
Day 31	0	2	0	0
Day 151	0	0	0	0
Day 361	0	1	7	10

No statistical analysis provided for Number of Participants Positive for Anti-Drug Antibodies to MEDI8897

Serious Adverse Events

Time Frame	From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Additional Description	No text entered.

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Serious Adverse Events

Placebo

MEDI8897 10 mg

MEDI8897 25 mg

MEDI8897 50 mg

Total, serious adverse events

# participants affected / at risk

0/18 (0.00%)

0/8 (0.00%)

1/31 (3.23%)

2/32 (6.25%)

Infections and infestations

Lower respiratory tract infection¹,^†

# participants affected / at risk

0/18 (0.00%)

0/8 (0.00%)

1/31 (3.23%)

1/32 (3.13%)

# events

Nervous system disorders

Febrile convulsion¹,^†

# participants affected / at risk

0/18 (0.00%)

0/8 (0.00%)

0/31 (0.00%)

2/32 (6.25%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 19.0

Other Adverse Events

Time Frame	From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	4%

Reporting Groups

	Description
Placebo	Participants received placebo intramuscularly.
MEDI8897 10 mg	Participants received a single dose of MEDI8897 10 milligram (mg) intramuscularly.
MEDI8897 25 mg	Participants received a single dose of MEDI8897 25 mg intramuscularly.
MEDI8897 50 mg	Participants received a single dose of MEDI8897 50 mg intramuscularly.

Other Adverse Events

Placebo

MEDI8897 10 mg

MEDI8897 25 mg

MEDI8897 50 mg

Total, other (not including serious) adverse events

# participants affected / at risk

17/18 (94.44%)

5/8 (62.50%)

31/31 (100.00%)

28/32 (87.50%)

Blood and lymphatic system disorders

Anaemia¹,^†

# participants affected / at risk

6/18 (33.33%)

0/8 (0.00%)

8/31 (25.81%)

4/32 (12.50%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

2/18 (11.11%)

2/8 (25.00%)

6/31 (19.35%)

1/32 (3.13%)

# events

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

0/18 (0.00%)

0/8 (0.00%)

2/31 (6.45%)

2/32 (6.25%)

# events

General disorders and administration site conditions

Pyrexia¹,^†

# participants affected / at risk

3/18 (16.67%)

3/8 (37.50%)

8/31 (25.81%)

5/32 (15.63%)

# events

Infections and infestations

Bronchiolitis¹,^†

# participants affected / at risk

1/18 (5.56%)

3/8 (37.50%)

3/31 (9.68%)

6/32 (18.75%)

# events

Infections and infestations

Candida nappy rash¹,^†

# participants affected / at risk

1/18 (5.56%)

0/8 (0.00%)

9/31 (29.03%)

2/32 (6.25%)

# events

Infections and infestations

Conjunctivitis¹,^†

# participants affected / at risk

0/18 (0.00%)

0/8 (0.00%)

2/31 (6.45%)

4/32 (12.50%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

4/18 (22.22%)

2/8 (25.00%)

11/31 (35.48%)

8/32 (25.00%)

# events

Infections and infestations

Impetigo¹,^†

# participants affected / at risk

2/18 (11.11%)

0/8 (0.00%)

2/31 (6.45%)

3/32 (9.38%)

# events

Infections and infestations

Lower respiratory tract infection¹,^†

# participants affected / at risk

3/18 (16.67%)

0/8 (0.00%)

4/31 (12.90%)

2/32 (6.25%)

# events

Infections and infestations

Nasopharyngitis¹,^†

# participants affected / at risk

2/18 (11.11%)

0/8 (0.00%)

0/31 (0.00%)

3/32 (9.38%)

# events

Infections and infestations

Oral candidiasis¹,^†

# participants affected / at risk

1/18 (5.56%)

0/8 (0.00%)

5/31 (16.13%)

5/32 (15.63%)

# events

Infections and infestations

Otitis media¹,^†

# participants affected / at risk

4/18 (22.22%)

3/8 (37.50%)

7/31 (22.58%)

5/32 (15.63%)

# events

Infections and infestations

Otitis media acute¹,^†

# participants affected / at risk

1/18 (5.56%)

0/8 (0.00%)

1/31 (3.23%)

3/32 (9.38%)

# events

Infections and infestations

Pharyngitis¹,^†

# participants affected / at risk

2/18 (11.11%)

1/8 (12.50%)

0/31 (0.00%)

1/32 (3.13%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

12/18 (66.67%)

4/8 (50.00%)

23/31 (74.19%)

22/32 (68.75%)

# events

Infections and infestations

Viral rash¹,^†

# participants affected / at risk

1/18 (5.56%)

0/8 (0.00%)

3/31 (9.68%)

1/32 (3.13%)

# events

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

4/18 (22.22%)

1/8 (12.50%)

11/31 (35.48%)

6/32 (18.75%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal congestion¹,^†

# participants affected / at risk

1/18 (5.56%)

3/8 (37.50%)

3/31 (9.68%)

2/32 (6.25%)

# events

Respiratory, thoracic and mediastinal disorders

Nasal obstruction¹,^†

# participants affected / at risk

2/18 (11.11%)

0/8 (0.00%)

6/31 (19.35%)

5/32 (15.63%)

# events

Respiratory, thoracic and mediastinal disorders

Rhinorrhoea¹,^†

# participants affected / at risk

3/18 (16.67%)

0/8 (0.00%)

9/31 (29.03%)

3/32 (9.38%)

# events

Skin and subcutaneous tissue disorders

Dermatitis¹,^†

# participants affected / at risk

0/18 (0.00%)

0/8 (0.00%)

1/31 (3.23%)

3/32 (9.38%)

# events

Skin and subcutaneous tissue disorders

Dermatitis contact¹,^†

# participants affected / at risk

1/18 (5.56%)

1/8 (12.50%)

4/31 (12.90%)

0/32 (0.00%)

# events

Skin and subcutaneous tissue disorders

Dermatitis diaper¹,^†

# participants affected / at risk

1/18 (5.56%)

1/8 (12.50%)

6/31 (19.35%)

4/32 (12.50%)

# events

Skin and subcutaneous tissue disorders

Dry skin¹,^†

# participants affected / at risk

3/18 (16.67%)

0/8 (0.00%)

4/31 (12.90%)

1/32 (3.13%)

# events

Skin and subcutaneous tissue disorders

Eczema¹,^†

# participants affected / at risk

3/18 (16.67%)

0/8 (0.00%)

8/31 (25.81%)

6/32 (18.75%)

# events

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

0/18 (0.00%)

1/8 (12.50%)

4/31 (12.90%)

0/32 (0.00%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 19.0

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact

Name/Title:	M. Pamela Griffin
Organization:	MedImmune, LLC
Phone	301-398-4095
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Trial Results Summaries