Clinical trial NCT02878330: A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: Respiratory Syncytial Virus, RSV
Preterm Infants
Lower Respiratory Tract Infection
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2016-08-25
Enrollment: 1453
Sex: ALL
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
timeFrame: From Day 1 through Day 151
Secondary outcomes:
measure: Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
timeFrame: From Day 1 through Day 151
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From Day 1 through Day 361
measure: Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
timeFrame: From Day 1 through Day 361
measure: Serum Concentration of MEDI8897
timeFrame: Days 91, 151, and 361
measure: Elimination Half-life (t1/2) of MEDI8897
timeFrame: Day 91 through Day 361
measure: Number of Participants With Positive Anti-drug Antibodies to MEDI8897
timeFrame: Days 91, 151, and 361
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Anaheim
country: United States
facility: Research Site
state: California
city: Anaheim
country: United States
facility: Research Site
state: California
city: Downey
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
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state: California
city: Paramount
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state: California
city: San Diego
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state: California
city: West Covina
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state: California
city: Aurora
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state: Colorado
city: Colorado Springs
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city: Hartford
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state: Connecticut
city: Gainesville
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city: Orlando
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city: South Miami
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state: Georgia
city: Augusta
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city: Oak Lawn
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city: Park Ridge
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city: South Bend
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city: Omaha
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city: Omaha
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city: Raleigh
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country: Argentina
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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city: Maipu
country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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country: Chile
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city: Havlickuv Brod
country: Czechia
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city: Praha 4
country: Czechia
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city: Praha 4
country: Czechia
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city: Tallinn
country: Estonia
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city: Tartu
country: Estonia
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city: Tampere
country: Finland
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country: Finland
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city: Bordeaux
country: France
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country: France
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country: Hungary
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country: Hungary
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country: Italy
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country: Italy
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country: Latvia
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country: Latvia
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country: Lithuania
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country: Lithuania
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country: New Zealand
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country: Poland
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country: South Africa
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country: South Africa
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country: South Africa
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country: South Africa
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city: Alicante
country: Spain
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city: Boadilla del Monte
country: Spain
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country: Spain
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country: Spain
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country: Spain
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city: Madrid
country: Spain
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country: Spain
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country: Spain
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country: Spain
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city: Santiago de Compostela
country: Spain
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city: Valencia
country: Spain
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city: Stockholm
country: Sweden
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city: Stockholm
country: Sweden
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city: Adana
country: Turkey
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city: Ankara
country: Turkey
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country: Turkey
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country: Turkey
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city: Izmir
country: Turkey
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city: Kocaeli
country: Turkey
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city: Brighton
country: United Kingdom
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country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.