MEDI8897 Ph2b: A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02878330
• Collaborator: (none)
• Enrollment: 1,453
• Locations: 161
• Arms: 2
• Actual Duration (Months): 25.1
• Patients Per Site: 9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections	Drug: MEDI8897; Drug: Placebo	Phase 2

Detailed Description

This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1453 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 2b Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
• Actual Study Start Date: Nov 3, 2016
• Actual Primary Completion Date: Jul 17, 2018
• Actual Study Completion Date: Dec 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Drug: Placebo; A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
Experimental: MEDI8897 50 mg Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.	Drug: MEDI8897; A single IM dose of 50 mg on Day 1 of the study.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) [From Day 1 through Day 151]

   The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (<) 2 months: greater than or equal to (>=) 60 breaths/min; 2-6 months: >= 50 breaths/min; and for > 6 months - 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes less than or equal to (<=) 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).

Secondary Outcome Measures

1. Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI) [From Day 1 through Day 151]

   A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial).

2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [From Day 1 through Day 361]

   An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

3. Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs) [From Day 1 through Day 361]

   An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant.

4. Serum Concentration of MEDI8897 [Days 91, 151, and 361]

5. Elimination Half-life (t1/2) of MEDI8897 [Day 91 through Day 361]

   Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.

6. Number of Participants With Positive Anti-drug Antibodies to MEDI8897 [Days 91, 151, and 361]

   The number of participants with positive serum antibodies to MEDI8897 are reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 365 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.

2. Infants who are entering their first full RSV season at the time of screening.

Key Exclusion Criteria:

1. Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.

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

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

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

5. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States	35205
2	Research Site	Anaheim	California	United States	92804
3	Research Site	Anaheim	California	United States	92805
4	Research Site	Downey	California	United States	90241
5	Research Site	Long Beach	California	United States	90806
6	Research Site	Los Angeles	California	United States	90027
7	Research Site	Paramount	California	United States	90723
8	Research Site	San Diego	California	United States	92123
9	Research Site	West Covina	California	United States	91790
10	Research Site	Aurora	Colorado	United States	80045
11	Research Site	Colorado Springs	Colorado	United States	80922
12	Research Site	Hartford	Connecticut	United States	06106
13	Research Site	Gainesville	Florida	United States	32607
14	Research Site	Orlando	Florida	United States	32806
15	Research Site	South Miami	Florida	United States	33143
16	Research Site	Atlanta	Georgia	United States	30322
17	Research Site	Augusta	Georgia	United States	30912
18	Research Site	Chicago	Illinois	United States	60611
19	Research Site	Oak Lawn	Illinois	United States	60068
20	Research Site	Park Ridge	Illinois	United States	60068
21	Research Site	South Bend	Indiana	United States	46601
22	Research Site	Woburn	Massachusetts	United States	01801
23	Research Site	Detroit	Michigan	United States	48201
24	Research Site	Jackson	Mississippi	United States	39216
25	Research Site	Columbia	Missouri	United States	65212
26	Research Site	Lincoln	Nebraska	United States	68504
27	Research Site	Omaha	Nebraska	United States	68124
28	Research Site	Omaha	Nebraska	United States	68134
29	Research Site	Omaha	Nebraska	United States	68198
30	Research Site	Mineola	New York	United States	11501
31	Research Site	New Hyde Park	New York	United States	11040
32	Research Site	Stony Brook	New York	United States	11794
33	Research Site	Syracuse	New York	United States	13210-2306
34	Research Site	Boone	North Carolina	United States	28607
35	Research Site	Raleigh	North Carolina	United States	27609
36	Research Site	Cincinnati	Ohio	United States	45229
37	Research Site	Cleveland	Ohio	United States	44109
38	Research Site	Columbus	Ohio	United States	43205
39	Research Site	Columbus	Ohio	United States	43231
40	Research Site	Dayton	Ohio	United States	45414
41	Research Site	Oklahoma City	Oklahoma	United States	73104
42	Research Site	Gresham	Oregon	United States	97030
43	Research Site	Erie	Pennsylvania	United States	16506
44	Research Site	Pittsburgh	Pennsylvania	United States	15224
45	Research Site	Charleston	South Carolina	United States	29425
46	Research Site	North Charleston	South Carolina	United States	29406
47	Research Site	Sioux Falls	South Dakota	United States	57104
48	Research Site	Memphis	Tennessee	United States	38103
49	Research Site	Edinburg	Texas	United States	78539
50	Research Site	Fort Worth	Texas	United States	76107
51	Research Site	Galveston	Texas	United States	77555
52	Research Site	Longview	Texas	United States	75605
53	Research Site	San Antonio	Texas	United States	78249
54	Research Site	Layton	Utah	United States	84041
55	Research Site	Orem	Utah	United States	84057
56	Research Site	Syracuse	Utah	United States	84075
57	Research Site	Seattle	Washington	United States	98105
58	Research Site	Huntington	West Virginia	United States	25701
59	Research Site	Morgantown	West Virginia	United States	26506
60	Research Site	Madison	Wisconsin	United States	53792
61	Research Site	Bahía Blanca		Argentina	B8001HXM
62	Research Site	Guaymallen Mendoza		Argentina	5519
63	Research Site	Parkville		Australia	3052
64	Research Site	Subiaco		Australia	6008
65	Research Site	Gent		Belgium	9000
66	Research Site	Mons		Belgium	7000
67	Research Site	Botucatu		Brazil	18618-970
68	Research Site	Campinas		Brazil	13084-791
69	Research Site	Canoas		Brazil	92425-900
70	Research Site	Curitiba		Brazil	80250-060
71	Research Site	Juiz de Fora		Brazil	36025-330
72	Research Site	Passo Fundo		Brazil	99010-080
73	Research Site	Pleven		Bulgaria	5800
74	Research Site	Plovdiv		Bulgaria	4002
75	Research Site	Ruse		Bulgaria	7002
76	Research Site	Sofia		Bulgaria	1407
77	Research Site	Sofia		Bulgaria	1431
78	Research Site	Montreal	Quebec	Canada	H4A 3J1
79	Research Site	Maipu		Chile	9250000
80	Research Site	Santiago		Chile	8053095
81	Research Site	Santiago		Chile	8380453
82	Research Site	Santiago		Chile	8420383
83	Research Site	Santiago		Chile	8880465
84	Research Site	Valdivia		Chile	5090000
85	Research Site	Viña del Mar		Chile	2520594
86	Research Site	Havlickuv Brod		Czechia	580 22
87	Research Site	Praha 4		Czechia	14059
88	Research Site	Praha 4		Czechia	14710
89	Research Site	Tallinn		Estonia	13419
90	Research Site	Tartu		Estonia	50406
91	Research Site	Tampere		Finland	33100
92	Research Site	Turku		Finland	20520
93	Research Site	Bordeaux		France	33000
94	Research Site	Brest		France	29609
95	Research Site	Bron		France	69677
96	Research Site	Caen Cedex		France	14033
97	Research Site	Dijon		France	21079
98	Research Site	Tours CEDEX 9		France	37044
99	Research Site	Budapest		Hungary	1062
100	Research Site	Budapest		Hungary	1094
101	Research Site	Budapest		Hungary	1131
102	Research Site	Budapest		Hungary	1204
103	Research Site	Gyula		Hungary	5700
104	Research Site	Kecskemét		Hungary	6000
105	Research Site	Miskolc		Hungary	3526
106	Research Site	Nagykanizsa		Hungary	8800
107	Research Site	Nyireyghaza		Hungary	4400
108	Research Site	Sopron		Hungary	9400
109	Research Site	Szeged		Hungary	6720
110	Research Site	Szekszárd		Hungary	7100
111	Research Site	Veszprém		Hungary	8200
112	Research Site	Genova		Italy	16100
113	Research Site	Padova		Italy	35128
114	Research Site	Torino		Italy	10126
115	Research Site	Verona		Italy	37126
116	Research Site	Jekabpils		Latvia	LV-5201
117	Research Site	Riga		Latvia	LV1002
118	Research Site	Valmiera		Latvia	4200
119	Research Site	Kaunas		Lithuania	48259
120	Research Site	Kaunas		Lithuania	50161
121	Research Site	Christchurch		New Zealand	8011
122	Research Site	Otahuhu		New Zealand	2025
123	Research Site	Wellington		New Zealand	6021
124	Research Site	Bydgoszcz		Poland	85168
125	Research Site	Gdansk		Poland	80402
126	Research Site	Krakow		Poland	30-349
127	Research Site	Krakow		Poland	30-663
128	Research Site	Leczna		Poland	21-010
129	Research Site	Cape Town		South Africa	7500
130	Research Site	Cape Town		South Africa	7700
131	Research Site	Claremont		South Africa	7708
132	Research Site	Durban		South Africa	4091
133	Research Site	Johannesburg		South Africa	2013
134	Research Site	Johannesburg		South Africa	2193
135	Research Site	Pietermaritzburg		South Africa	3201
136	Research Site	Pretoria		South Africa	0087
137	Research Site	Alicante		Spain	03010
138	Research Site	Boadilla del Monte		Spain	28660
139	Research Site	Cordoba		Spain	14004
140	Research Site	Granada		Spain	18014
141	Research Site	Lleida		Spain	25198
142	Research Site	Madrid		Spain	28040
143	Research Site	Madrid		Spain	28046
144	Research Site	Málaga		Spain	29011
145	Research Site	San Juan de Alicante		Spain	03550
146	Research Site	Sant Cugat del Valles		Spain	8190
147	Research Site	Santiago de Compostela		Spain	15706
148	Research Site	Valencia		Spain	46017
149	Research Site	Stockholm		Sweden	118 83
150	Research Site	Stockholm		Sweden	171 76
151	Research Site	Adana		Turkey	1260
152	Research Site	Ankara		Turkey	06100
153	Research Site	Antalya		Turkey	07070
154	Research Site	Izmir		Turkey	35100
155	Research Site	Izmir		Turkey	35210
156	Research Site	Kocaeli		Turkey	41380
157	Research Site	Brighton		United Kingdom	BN2 5BE
158	Research Site	Bristol		United Kingdom	BS2 8BJ
159	Research Site	London		United Kingdom	SW17 0RE
160	Research Site	Oxford		United Kingdom	OX3 7EJ
161	Research Site	Southampton		United Kingdom	SO16 6YD

Sponsors and Collaborators

• MedImmune LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 25, 2018
• Statistical Analysis Plan - Nov 18, 2016

More Information

Additional Information:

• D5290C00003_Redacted_protocol-amendment-1_Red16JLU19
• D5290C00003_MEDI8897-Combined SAP_PDFAv1.0

Publications

None provided.

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT02878330
• Other Study ID Numbers: D5290C00003
• First Posted: Aug 25, 2016
• Last Update Posted: Oct 14, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by MedImmune LLC: Respiratory Syncytial Virus, RSV; Preterm Infants; Lower Respiratory Tract Infection
• Additional relevant MeSH terms: Respiratory Syncytial Virus Infections

Study Results

Participant Flow

Recruitment Details	The study was conducted from 03-Nov-2016 to 06-Dec-2018.
Pre-assignment Detail	A total of 1540 participants were screened, out of which 1453 participants were randomized in the study.

Arm/Group Title	Placebo	MEDI8897 50 mg
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Period Title: Overall Study
STARTED	484	969
COMPLETED	455	913
NOT COMPLETED	29	56

Baseline Characteristics

Arm/Group Title	Placebo	MEDI8897 50 mg	Total
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.	Total of all reporting groups
Overall Participants	484	969	1453
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	3.28 (2.31)	3.29 (2.22)	3.29 (2.25)
Sex: Female, Male (Count of Participants)
Female	224 46.3%	468 48.3%	692 47.6%
Male	260 53.7%	501 51.7%	761 52.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	91 18.8%	225 23.2%	316 21.7%
Not Hispanic or Latino	393 81.2%	743 76.7%	1136 78.2%
Unknown or Not Reported	0 0%	1 0.1%	1 0.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%	0 0%	1 0.1%
Asian	10 2.1%	5 0.5%	15 1%
Native Hawaiian or Other Pacific Islander	3 0.6%	8 0.8%	11 0.8%
Black or African American	67 13.8%	189 19.5%	256 17.6%
White	355 73.3%	693 71.5%	1048 72.1%
More than one race	5 1%	12 1.2%	17 1.2%
Unknown or Not Reported	43 8.9%	62 6.4%	105 7.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
Description	The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (<) 2 months: greater than or equal to (>=) 60 breaths/min; 2-6 months: >= 50 breaths/min; and for > 6 months - 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes less than or equal to (<=) 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).
Time Frame	From Day 1 through Day 151

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.

Arm/Group Title	Placebo	MEDI8897 50 mg
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Measure Participants	484	969
Count of Participants [Participants]	46 9.5%	25 2.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MEDI8897 50 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Poisson regression
	Comments
Method of Estimation	Estimation Parameter	Relative Risk Reduction
	Estimated Value	70.1
	Confidence Interval	(2-Sided) 95%; 52.3 to 81.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
Description	A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial).
Time Frame	From Day 1 through Day 151

Outcome Measure Data

Analysis Population Description

The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.

Arm/Group Title	Placebo	MEDI8897 50 mg
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Measure Participants	484	969
Count of Participants [Participants]	20 4.1%	8 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, MEDI8897 50 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Poisson regression
	Comments
Method of Estimation	Estimation Parameter	Relative Risk Reduction
	Estimated Value	78.4
	Confidence Interval	(2-Sided) 95%; 51.9 to 90.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary 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 untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time Frame	From Day 1 through Day 361

Outcome Measure Data

Analysis Population Description

As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.

Arm/Group Title	Placebo	MEDI8897 50 mg
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Measure Participants	479	968
TEAEs	416 86%	834 86.1%
TESAEs	81 16.7%	108 11.1%

4. Secondary Outcome

Title	Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
Description	An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant.
Time Frame	From Day 1 through Day 361

Outcome Measure Data

Analysis Population Description

As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.

Arm/Group Title	Placebo	MEDI8897 50 mg
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Measure Participants	479	968
AESIs	3 0.6%	5 0.5%
NOCDs	4 0.8%	4 0.4%

5. Secondary Outcome

Title	Serum Concentration of MEDI8897
Time Frame	Days 91, 151, and 361

Outcome Measure Data

Analysis Population Description

As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.

Arm/Group Title	MEDI8897 50 mg
Arm/Group Description	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Measure Participants	968
Day 91	35.9 (10.9)
Day 151	18.9 (7.4)
Day 361	2.1 (1.1)

6. Secondary Outcome

Title	Elimination Half-life (t1/2) of MEDI8897
Description	Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.
Time Frame	Day 91 through Day 361

Outcome Measure Data

Analysis Population Description

As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. Participants with sufficient additional pharmacokinetics (PK) samples from unscheduled visits were analysed for this outcome measure.

Arm/Group Title	MEDI8897 50 mg
Arm/Group Description	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Measure Participants	968
Mean (Standard Deviation) [Days]	59.3 (9.6)

7. Secondary Outcome

Title	Number of Participants With Positive Anti-drug Antibodies to MEDI8897
Description	The number of participants with positive serum antibodies to MEDI8897 are reported.
Time Frame	Days 91, 151, and 361

Outcome Measure Data

Analysis Population Description

As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.

Arm/Group Title	Placebo	MEDI8897 50 mg
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.	Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Measure Participants	479	968
Day 91	4 0.8%	11 1.1%
Day 151	6 1.2%	17 1.8%
Day 361	8 1.7%	30 3.1%

Adverse Events

Time Frame	From Day 1 through Day 361
Adverse Event Reporting Description	As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.
Arm/Group Title	Placebo		MEDI8897 50 mg
Arm/Group Description	Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.		Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
All Cause Mortality
	Placebo		MEDI8897 50 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/479 (0.6%)		2/968 (0.2%)
Serious Adverse Events
	Placebo		MEDI8897 50 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/479 (16.9%)		108/968 (11.2%)
Blood and lymphatic system disorders
Anaemia neonatal	1/479 (0.2%)	1	0/968 (0%)	0
Cardiac disorders
Cardiac arrest	0/479 (0%)	0	1/968 (0.1%)	1
Cardiac failure	0/479 (0%)	0	1/968 (0.1%)	1
Cardiac failure congestive	0/479 (0%)	0	1/968 (0.1%)	3
Myocarditis	1/479 (0.2%)	1	0/968 (0%)	0
Pericardial effusion	1/479 (0.2%)	1	0/968 (0%)	0
Congenital, familial and genetic disorders
Muscular dystrophy	0/479 (0%)	0	1/968 (0.1%)	1
Ear and labyrinth disorders
Deafness bilateral	0/479 (0%)	0	1/968 (0.1%)	1
Gastrointestinal disorders
Abdominal pain	0/479 (0%)	0	1/968 (0.1%)	1
Diarrhoea	1/479 (0.2%)	1	2/968 (0.2%)	2
Dysphagia	0/479 (0%)	0	1/968 (0.1%)	1
Enteritis	1/479 (0.2%)	1	1/968 (0.1%)	1
Gastrooesophageal reflux disease	0/479 (0%)	0	1/968 (0.1%)	1
Incarcerated umbilical hernia	0/479 (0%)	0	1/968 (0.1%)	1
Inguinal hernia	6/479 (1.3%)	6	1/968 (0.1%)	1
Malabsorption	0/479 (0%)	0	1/968 (0.1%)	1
Vomiting	0/479 (0%)	0	2/968 (0.2%)	2
General disorders
Death	0/479 (0%)	0	1/968 (0.1%)	1
Pyrexia	1/479 (0.2%)	1	3/968 (0.3%)	3
Hepatobiliary disorders
Jaundice	0/479 (0%)	0	1/968 (0.1%)	1
Immune system disorders
Drug hypersensitivity	0/479 (0%)	0	1/968 (0.1%)	1
Infections and infestations
Abscess limb	0/479 (0%)	0	1/968 (0.1%)	1
Adenovirus infection	1/479 (0.2%)	1	0/968 (0%)	0
Anal abscess	0/479 (0%)	0	1/968 (0.1%)	1
Bronchiolitis	21/479 (4.4%)	26	20/968 (2.1%)	22
Bronchitis	11/479 (2.3%)	11	14/968 (1.4%)	16
Croup infectious	0/479 (0%)	0	2/968 (0.2%)	2
Cytomegalovirus infection	1/479 (0.2%)	1	0/968 (0%)	0
Gastroenteritis	4/479 (0.8%)	5	9/968 (0.9%)	9
Gastroenteritis escherichia coli	1/479 (0.2%)	1	0/968 (0%)	0
Gastroenteritis adenovirus	0/479 (0%)	0	1/968 (0.1%)	1
Gastroenteritis rotavirus	2/479 (0.4%)	2	0/968 (0%)	0
Gastroenteritis salmonella	1/479 (0.2%)	1	1/968 (0.1%)	1
Gastroenteritis viral	1/479 (0.2%)	2	1/968 (0.1%)	1
Influenza	1/479 (0.2%)	1	0/968 (0%)	0
Laryngitis	0/479 (0%)	0	1/968 (0.1%)	1
Lower respiratory tract infection	13/479 (2.7%)	18	14/968 (1.4%)	14
Lower respiratory tract infection viral	3/479 (0.6%)	5	5/968 (0.5%)	5
Meningitis	1/479 (0.2%)	1	0/968 (0%)	0
Meningitis bacterial	1/479 (0.2%)	1	0/968 (0%)	0
Otitis media	0/479 (0%)	0	2/968 (0.2%)	2
Peritonsillar abscess	1/479 (0.2%)	1	0/968 (0%)	0
Pharyngitis	0/479 (0%)	0	1/968 (0.1%)	1
Pneumonia	10/479 (2.1%)	12	13/968 (1.3%)	13
Pneumonia bacterial	1/479 (0.2%)	1	0/968 (0%)	0
Pneumonia parainfluenzae viral	1/479 (0.2%)	1	0/968 (0%)	0
Pneumonia respiratory syncytial viral	2/479 (0.4%)	2	2/968 (0.2%)	2
Pneumonia viral	2/479 (0.4%)	2	7/968 (0.7%)	8
Pseudomonal bacteraemia	1/479 (0.2%)	1	0/968 (0%)	0
Respiratory syncytial virus bronchiolitis	2/479 (0.4%)	2	1/968 (0.1%)	1
Salmonellosis	0/479 (0%)	0	1/968 (0.1%)	1
Sepsis	1/479 (0.2%)	1	2/968 (0.2%)	2
Sepsis neonatal	0/479 (0%)	0	1/968 (0.1%)	1
Staphylococcal scalded skin syndrome	1/479 (0.2%)	1	0/968 (0%)	0
Tonsillitis	0/479 (0%)	0	1/968 (0.1%)	1
Upper respiratory tract infection	3/479 (0.6%)	3	3/968 (0.3%)	3
Urinary tract infection	4/479 (0.8%)	5	0/968 (0%)	0
Viral upper respiratory tract infection	0/479 (0%)	0	1/968 (0.1%)	1
Injury, poisoning and procedural complications
Exposure to toxic agent	0/479 (0%)	0	1/968 (0.1%)	1
Fall	0/479 (0%)	0	1/968 (0.1%)	1
Palate injury	1/479 (0.2%)	1	0/968 (0%)	0
Thermal burn	0/479 (0%)	0	2/968 (0.2%)	2
Metabolism and nutrition disorders
Dehydration	1/479 (0.2%)	1	2/968 (0.2%)	2
Hypoglycaemia	0/479 (0%)	0	1/968 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid haemangioma	0/479 (0%)	0	1/968 (0.1%)	1
Nervous system disorders
Cerebrovascular accident	1/479 (0.2%)	1	0/968 (0%)	0
Febrile convulsion	0/479 (0%)	0	1/968 (0.1%)	1
Hypotonia	1/479 (0.2%)	1	0/968 (0%)	0
Infantile spasms	1/479 (0.2%)	1	0/968 (0%)	0
Intraventricular haemorrhage	1/479 (0.2%)	1	0/968 (0%)	0
Seizure	1/479 (0.2%)	1	0/968 (0%)	0
Psychiatric disorders
Irritability	1/479 (0.2%)	1	0/968 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/479 (0%)	0	2/968 (0.2%)	2
Reproductive system and breast disorders
Penile adhesion	1/479 (0.2%)	1	0/968 (0%)	0
Respiratory, thoracic and mediastinal disorders
Apnoea	1/479 (0.2%)	1	1/968 (0.1%)	1
Asthma	0/479 (0%)	0	1/968 (0.1%)	1
Laryngeal stenosis	1/479 (0.2%)	1	0/968 (0%)	0
Pneumonia aspiration	0/479 (0%)	0	2/968 (0.2%)	2
Pulmonary vein stenosis	0/479 (0%)	0	1/968 (0.1%)	1
Skin and subcutaneous tissue disorders
Dermatitis allergic	1/479 (0.2%)	1	0/968 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		MEDI8897 50 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	402/479 (83.9%)		804/968 (83.1%)
Blood and lymphatic system disorders
Anaemia	17/479 (3.5%)	17	29/968 (3%)	29
Congenital, familial and genetic disorders
Plagiocephaly	3/479 (0.6%)	3	15/968 (1.5%)	15
Gastrointestinal disorders
Abdominal pain	10/479 (2.1%)	10	5/968 (0.5%)	5
Constipation	21/479 (4.4%)	24	34/968 (3.5%)	36
Diarrhoea	49/479 (10.2%)	55	98/968 (10.1%)	113
Gastrooesophageal reflux disease	22/479 (4.6%)	22	37/968 (3.8%)	38
Teething	32/479 (6.7%)	35	62/968 (6.4%)	72
Umbilical hernia	3/479 (0.6%)	3	11/968 (1.1%)	11
Vomiting	15/479 (3.1%)	17	40/968 (4.1%)	46
General disorders
Pyrexia	63/479 (13.2%)	75	109/968 (11.3%)	133
Infections and infestations
Acarodermatitis	8/479 (1.7%)	8	13/968 (1.3%)	15
Bronchiolitis	42/479 (8.8%)	60	83/968 (8.6%)	104
Bronchitis	49/479 (10.2%)	77	91/968 (9.4%)	150
Candida nappy rash	6/479 (1.3%)	6	12/968 (1.2%)	14
Conjunctivitis	39/479 (8.1%)	44	86/968 (8.9%)	94
Croup infectious	6/479 (1.3%)	7	12/968 (1.2%)	13
Ear infection	13/479 (2.7%)	21	23/968 (2.4%)	34
Exanthema subitum	11/479 (2.3%)	11	21/968 (2.2%)	22
Fungal skin infection	8/479 (1.7%)	8	5/968 (0.5%)	5
Gastroenteritis	44/479 (9.2%)	49	115/968 (11.9%)	138
Gastroenteritis viral	5/479 (1%)	5	13/968 (1.3%)	15
Hand-foot-and-mouth disease	14/479 (2.9%)	14	36/968 (3.7%)	36
Impetigo	6/479 (1.3%)	6	12/968 (1.2%)	12
Laryngitis	10/479 (2.1%)	10	24/968 (2.5%)	31
Lower respiratory tract infection	46/479 (9.6%)	65	75/968 (7.7%)	103
Lower respiratory tract infection viral	6/479 (1.3%)	8	9/968 (0.9%)	9
Nasopharyngitis	94/479 (19.6%)	158	164/968 (16.9%)	264
Oral candidiasis	26/479 (5.4%)	26	36/968 (3.7%)	39
Otitis media	42/479 (8.8%)	63	63/968 (6.5%)	87
Otitis media acute	24/479 (5%)	33	51/968 (5.3%)	82
Pharyngitis	27/479 (5.6%)	32	57/968 (5.9%)	68
Rhinitis	50/479 (10.4%)	61	111/968 (11.5%)	145
Tonsillitis	5/479 (1%)	6	16/968 (1.7%)	16
Upper respiratory tract infection	169/479 (35.3%)	337	392/968 (40.5%)	734
Urinary tract infection	7/479 (1.5%)	7	12/968 (1.2%)	12
Varicella	11/479 (2.3%)	11	19/968 (2%)	19
Viral rash	15/479 (3.1%)	16	32/968 (3.3%)	34
Viral upper respiratory tract infection	34/479 (7.1%)	57	48/968 (5%)	75
Injury, poisoning and procedural complications
Arthropod bite	6/479 (1.3%)	6	14/968 (1.4%)	14
Vaccination complication	15/479 (3.1%)	19	23/968 (2.4%)	28
Psychiatric disorders
Irritability	7/479 (1.5%)	14	11/968 (1.1%)	20
Respiratory, thoracic and mediastinal disorders
Cough	15/479 (3.1%)	17	37/968 (3.8%)	45
Nasal congestion	24/479 (5%)	27	71/968 (7.3%)	83
Nasal obstruction	17/479 (3.5%)	17	23/968 (2.4%)	23
Rhinorrhoea	29/479 (6.1%)	34	63/968 (6.5%)	75
Skin and subcutaneous tissue disorders
Dermatitis	15/479 (3.1%)	15	20/968 (2.1%)	26
Dermatitis atopic	8/479 (1.7%)	9	30/968 (3.1%)	34
Dermatitis diaper	36/479 (7.5%)	44	76/968 (7.9%)	94
Eczema	15/479 (3.1%)	15	34/968 (3.5%)	34
Rash	17/479 (3.5%)	18	43/968 (4.4%)	49
Seborrhoeic dermatitis	7/479 (1.5%)	8	17/968 (1.8%)	17

Limitations/Caveats

[Not Specified]

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