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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: Placebo; Drug: MEDI8897

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 Type: Interventional
• Enrollment (Actual): 1453
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Bahía Blanca, Argentina, B8001HXM
    • Research Site
  • Guaymallen Mendoza, Argentina, 5519
    • Research Site
• Australia
  • Parkville, Australia, 3052
    • Research Site
  • Subiaco, Australia, 6008
    • Research Site
• Belgium
  • Gent, Belgium, 9000
    • Research Site
  • Mons, Belgium, 7000
    • Research Site
• Brazil
  • Botucatu, Brazil, 18618-970
    • Research Site
  • Campinas, Brazil, 13084-791
    • Research Site
  • Canoas, Brazil, 92425-900
    • Research Site
  • Curitiba, Brazil, 80250-060
    • Research Site
  • Juiz de Fora, Brazil, 36025-330
    • Research Site
  • Passo Fundo, Brazil, 99010-080
    • Research Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Research Site
  • Plovdiv, Bulgaria, 4002
    • Research Site
  • Ruse, Bulgaria, 7002
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1407
    • Research Site
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Research Site
• Chile
  • Maipu, Chile, 9250000
    • Research Site
  • Santiago, Chile, 8420383
    • Research Site
  • Santiago, Chile, 8880465
    • Research Site
  • Santiago, Chile, 8380453
    • Research Site
  • Santiago, Chile, 8053095
    • Research Site
  • Valdivia, Chile, 5090000
    • Research Site
  • Viña del Mar, Chile, 2520594
    • Research Site
• Czechia
  • Havlickuv Brod, Czechia, 580 22
    • Research Site
  • Praha 4, Czechia, 14710
    • Research Site
  • Praha 4, Czechia, 14059
    • Research Site
• Estonia
  • Tallinn, Estonia, 13419
    • Research Site
  • Tartu, Estonia, 50406
    • Research Site
• Finland
  • Tampere, Finland, 33100
    • Research Site
  • Turku, Finland, 20520
    • Research Site
• France
  • Bordeaux, France, 33000
    • Research Site
  • Brest, France, 29609
    • Research Site
  • Bron, France, 69677
    • Research Site
  • Caen Cedex, France, 14033
    • Research Site
  • Dijon, France, 21079
    • Research Site
  • Tours CEDEX 9, France, 37044
    • Research Site
• Hungary
  • Budapest, Hungary, 1204
    • Research Site
  • Budapest, Hungary, 1062
    • Research Site
  • Budapest, Hungary, 1094
    • Research Site
  • Budapest, Hungary, 1131
    • Research Site
  • Gyula, Hungary, 5700
    • Research Site
  • Kecskemét, Hungary, 6000
    • Research Site
  • Miskolc, Hungary, 3526
    • Research Site
  • Nagykanizsa, Hungary, 8800
    • Research Site
  • Nyireyghaza, Hungary, 4400
    • Research Site
  • Sopron, Hungary, 9400
    • Research Site
  • Szeged, Hungary, 6720
    • Research Site
  • Szekszárd, Hungary, 7100
    • Research Site
  • Veszprém, Hungary, 8200
    • Research Site
• Italy
  • Genova, Italy, 16100
    • Research Site
  • Padova, Italy, 35128
    • Research Site
  • Torino, Italy, 10126
    • Research Site
  • Verona, Italy, 37126
    • Research Site
• Latvia
  • Jekabpils, Latvia, LV-5201
    • Research Site
  • Riga, Latvia, LV1002
    • Research Site
  • Valmiera, Latvia, 4200
    • Research Site
• Lithuania
  • Kaunas, Lithuania, 48259
    • Research Site
  • Kaunas, Lithuania, 50161
    • Research Site
• New Zealand
  • Christchurch, New Zealand, 8011
    • Research Site
  • Otahuhu, New Zealand, 2025
    • Research Site
  • Wellington, New Zealand, 6021
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85168
    • Research Site
  • Gdansk, Poland, 80402
    • Research Site
  • Krakow, Poland, 30-663
    • Research Site
  • Krakow, Poland, 30-349
    • Research Site
  • Leczna, Poland, 21-010
    • Research Site
• South Africa
  • Cape Town, South Africa, 7700
    • Research Site
  • Cape Town, South Africa, 7500
    • Research Site
  • Claremont, South Africa, 7708
    • Research Site
  • Durban, South Africa, 4091
    • Research Site
  • Johannesburg, South Africa, 2193
    • Research Site
  • Johannesburg, South Africa, 2013
    • Research Site
  • Pietermaritzburg, South Africa, 3201
    • Research Site
  • Pretoria, South Africa, 0087
    • Research Site
• Spain
  • Alicante, Spain, 03010
    • Research Site
  • Boadilla del Monte, Spain, 28660
    • Research Site
  • Cordoba, Spain, 14004
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Lleida, Spain, 25198
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Málaga, Spain, 29011
    • Research Site
  • San Juan de Alicante, Spain, 03550
    • Research Site
  • Sant Cugat del Valles, Spain, 8190
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Valencia, Spain, 46017
    • Research Site
• Sweden
  • Stockholm, Sweden, 118 83
    • Research Site
  • Stockholm, Sweden, 171 76
    • Research Site
• Turkey
  • Adana, Turkey, 1260
    • Research Site
  • Ankara, Turkey, 06100
    • Research Site
  • Antalya, Turkey, 07070
    • Research Site
  • Izmir, Turkey, 35100
    • Research Site
  • Izmir, Turkey, 35210
    • Research Site
  • Kocaeli, Turkey, 41380
    • Research Site
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Research Site
  • Bristol, United Kingdom, BS2 8BJ
    • Research Site
  • London, United Kingdom, SW17 0RE
    • Research Site
  • Oxford, United Kingdom, OX3 7EJ
    • Research Site
  • Southampton, United Kingdom, SO16 6YD
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site
  • California
    • Anaheim, California, United States, 92804
      • Research Site
    • Anaheim, California, United States, 92805
      • Research Site
    • Downey, California, United States, 90241
      • Research Site
    • Long Beach, California, United States, 90806
      • Research Site
    • Los Angeles, California, United States, 90027
      • Research Site
    • Paramount, California, United States, 90723
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
    • West Covina, California, United States, 91790
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
    • Colorado Springs, Colorado, United States, 80922
      • Research Site
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Research Site
  • Florida
    • Gainesville, Florida, United States, 32607
      • Research Site
    • Orlando, Florida, United States, 32806
      • Research Site
    • South Miami, Florida, United States, 33143
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Research Site
    • Augusta, Georgia, United States, 30912
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Research Site
    • Oak Lawn, Illinois, United States, 60068
      • Research Site
    • Park Ridge, Illinois, United States, 60068
      • Research Site
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Research Site
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Research Site
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Research Site
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68504
      • Research Site
    • Omaha, Nebraska, United States, 68198
      • Research Site
    • Omaha, Nebraska, United States, 68124
      • Research Site
    • Omaha, Nebraska, United States, 68134
      • Research Site
  • New York
    • Mineola, New York, United States, 11501
      • Research Site
    • New Hyde Park, New York, United States, 11040
      • Research Site
    • Stony Brook, New York, United States, 11794
      • Research Site
    • Syracuse, New York, United States, 13210-2306
      • Research Site
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • Research Site
    • Raleigh, North Carolina, United States, 27609
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Research Site
    • Cleveland, Ohio, United States, 44109
      • Research Site
    • Columbus, Ohio, United States, 43205
      • Research Site
    • Columbus, Ohio, United States, 43231
      • Research Site
    • Dayton, Ohio, United States, 45414
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Research Site
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Research Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15224
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Research Site
    • North Charleston, South Carolina, United States, 29406
      • Research Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Research Site
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Research Site
  • Texas
    • Edinburg, Texas, United States, 78539
      • Research Site
    • Fort Worth, Texas, United States, 76107
      • Research Site
    • Galveston, Texas, United States, 77555
      • Research Site
    • Longview, Texas, United States, 75605
      • Research Site
    • San Antonio, Texas, United States, 78249
      • Research Site
  • Utah
    • Layton, Utah, United States, 84041
      • Research Site
    • Orem, Utah, United States, 84057
      • Research Site
    • Syracuse, Utah, United States, 84075
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Research Site
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Research Site
    • Morgantown, West Virginia, United States, 26506
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)	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).	From Day 1 through Day 151

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)	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).	From Day 1 through Day 151
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	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.	From Day 1 through Day 361
Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)	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.	From Day 1 through Day 361
Serum Concentration of MEDI8897		Days 91, 151, and 361
Elimination Half-life (t1/2) of MEDI8897	Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.	Day 91 through Day 361
Number of Participants With Positive Anti-drug Antibodies to MEDI8897	The number of participants with positive serum antibodies to MEDI8897 are reported.	Days 91, 151, and 361

Collaborators and Investigators

• Sponsor: MedImmune LLC

Publications and helpful links

General Publications

• Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, Simoes EAF, Esser MT, Khan AA, Dubovsky F, Villafana T, DeVincenzo JP; Nirsevimab Study Group. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med. 2020 Jul 30;383(5):415-425. doi: 10.1056/NEJMoa1913556. Erratum In: N Engl J Med. 2020 Aug 13;383(7):698.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Lower Respiratory Tract Infection; Preterm Infants; Respiratory Syncytial Virus, RSV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: D5290C00003