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

NCT02878330 | Completed Phase 2 Results DMC

• 1 other identifier: D5290C00003
• Study Type: interventional
• Target: 1,453
• Locations: 22 countries
• Sites: 149

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus, RSV; Preterm Infants; Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)

  From Day 1 through Day 151

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  From Day 1 through Day 361

• Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)

  From Day 1 through Day 361

• Serum Concentration of MEDI8897

  Days 91, 151, and 361

• Elimination Half-life (t1/2) of MEDI8897

  Day 91 through Day 361

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.

Drug: Placebo

MEDI8897 50 mg

EXPERIMENTAL

Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.

Drug: MEDI8897

Interventions

MEDI8897 DRUG

A single IM dose of 50 mg on Day 1 of the study.

MEDI8897 50 mg

Placebo DRUG

A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.

Placebo

Eligibility Criteria

• Age: Up to 365 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
• Infants who are entering their first full RSV season at the time of screening.

You may not qualify if:

• Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
• Any fever (\>= 100.4°F \[\>= 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization.
• Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization.
• Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection.
• Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (161)

Research Site

Birmingham, Alabama, 35205, United States

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Anaheim, California, 92804, United States

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Anaheim, California, 92805, United States

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Downey, California, 90241, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90027, United States

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Paramount, California, 90723, United States

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San Diego, California, 92123, United States

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West Covina, California, 91790, United States

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Aurora, Colorado, 80045, United States

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Colorado Springs, Colorado, 80922, United States

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Hartford, Connecticut, 06106, United States

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Gainesville, Florida, 32607, United States

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Orlando, Florida, 32806, United States

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South Miami, Florida, 33143, United States

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Atlanta, Georgia, 30322, United States

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Augusta, Georgia, 30912, United States

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Chicago, Illinois, 60611, United States

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Oak Lawn, Illinois, 60068, United States

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Park Ridge, Illinois, 60068, United States

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South Bend, Indiana, 46601, United States

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Woburn, Massachusetts, 01801, United States

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Detroit, Michigan, 48201, United States

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Jackson, Mississippi, 39216, United States

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Columbia, Missouri, 65212, United States

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Lincoln, Nebraska, 68504, United States

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Omaha, Nebraska, 68124, United States

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Omaha, Nebraska, 68134, United States

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Omaha, Nebraska, 68198, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11040, United States

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Stony Brook, New York, 11794, United States

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Syracuse, New York, 13210-2306, United States

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Boone, North Carolina, 28607, United States

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Raleigh, North Carolina, 27609, United States

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Cincinnati, Ohio, 45229, United States

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Cleveland, Ohio, 44109, United States

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Columbus, Ohio, 43205, United States

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Columbus, Ohio, 43231, United States

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Dayton, Ohio, 45414, United States

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Oklahoma City, Oklahoma, 73104, United States

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Gresham, Oregon, 97030, United States

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Erie, Pennsylvania, 16506, United States

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Pittsburgh, Pennsylvania, 15224, United States

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Charleston, South Carolina, 29425, United States

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North Charleston, South Carolina, 29406, United States

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Sioux Falls, South Dakota, 57104, United States

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Memphis, Tennessee, 38103, United States

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Edinburg, Texas, 78539, United States

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Fort Worth, Texas, 76107, United States

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Galveston, Texas, 77555, United States

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Longview, Texas, 75605, United States

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San Antonio, Texas, 78249, United States

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Layton, Utah, 84041, United States

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Orem, Utah, 84057, United States

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Syracuse, Utah, 84075, United States

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Seattle, Washington, 98105, United States

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Huntington, West Virginia, 25701, United States

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Morgantown, West Virginia, 26506, United States

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Madison, Wisconsin, 53792, United States

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Bahía Blanca, B8001HXM, Argentina

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Guaymallen Mendoza, 5519, Argentina

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Parkville, 3052, Australia

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Subiaco, 6008, Australia

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Ghent, 9000, Belgium

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Mons, 7000, Belgium

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Botucatu, 18618-970, Brazil

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Campinas, 13084-791, Brazil

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Canoas, 92425-900, Brazil

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Curitiba, 80250-060, Brazil

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Juiz de Fora, 36025-330, Brazil

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Passo Fundo, 99010-080, Brazil

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1431, Bulgaria

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Montreal, Quebec, H4A 3J1, Canada

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Maipú, 9250000, Chile

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Santiago, 8053095, Chile

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Santiago, 8380453, Chile

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Santiago, 8420383, Chile

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Santiago, 8880465, Chile

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Valdivia, 5090000, Chile

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Viña del Mar, 2520594, Chile

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Havlíčkův Brod, 580 22, Czechia

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Prague, 14059, Czechia

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Prague, 14710, Czechia

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Tallinn, 13419, Estonia

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Tartu, 50406, Estonia

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Tampere, 33100, Finland

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Turku, 20520, Finland

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Bordeaux, 33000, France

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Brest, 29609, France

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Bron, 69677, France

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Caen, 14033, France

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Dijon, 21079, France

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Tours, 37044, France

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Budapest, 1062, Hungary

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Budapest, 1094, Hungary

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Budapest, 1131, Hungary

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Budapest, 1204, Hungary

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Gyula, 5700, Hungary

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Kecskemét, 6000, Hungary

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Miskolc, 3526, Hungary

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Nagykanizsa, 8800, Hungary

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Nyireyghaza, 4400, Hungary

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Sopron, 9400, Hungary

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Szeged, 6720, Hungary

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Szekszárd, 7100, Hungary

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Veszprém, 8200, Hungary

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Genova, 16100, Italy

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Padua, 35128, Italy

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Torino, 10126, Italy

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Verona, 37126, Italy

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Jēkabpils, LV-5201, Latvia

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Riga, LV1002, Latvia

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Valmiera, 4200, Latvia

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Kaunas, 48259, Lithuania

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Kaunas, 50161, Lithuania

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Christchurch, 8011, New Zealand

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Otahuhu, 2025, New Zealand

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Wellington, 6021, New Zealand

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Bydgoszcz, 85168, Poland

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Gdansk, 80402, Poland

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Krakow, 30-349, Poland

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Krakow, 30-663, Poland

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Łęczna, 21-010, Poland

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Cape Town, 7500, South Africa

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Cape Town, 7700, South Africa

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Claremont, 7708, South Africa

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Durban, 4091, South Africa

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Johannesburg, 2013, South Africa

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Johannesburg, 2193, South Africa

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Pietermaritzburg, 3201, South Africa

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Pretoria, 0087, South Africa

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Alicante, 03010, Spain

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Boadilla del Monte, 28660, Spain

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Córdoba, 14004, Spain

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Granada, 18014, Spain

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Lleida, 25198, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Málaga, 29011, Spain

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Sant Cugat del Vallès, 8190, Spain

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Sant Joan d'Alacant, 03550, Spain

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Santiago de Compostela, 15706, Spain

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Valencia, 46017, Spain

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Stockholm, 118 83, Sweden

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Stockholm, 171 76, Sweden

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Adana, 1260, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Antalya, 07070, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Izmir, 35210, Turkey (Türkiye)

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Kocaeli, 41380, Turkey (Türkiye)

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Brighton, BN2 5BE, United Kingdom

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Bristol, BS2 8BJ, United Kingdom

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London, SW17 0RE, United Kingdom

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Oxford, OX3 7EJ, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Related Publications (3)

• Langer S, Holzapfel S, August L, Badura A, Wellmann S, Mack I. Parental knowledge and attitudes to infant immunization in the context of RSV: All about confidence? Vaccine. 2024 Oct 3;42(23):126050. doi: 10.1016/j.vaccine.2024.06.018. Epub 2024 Jun 19.

  PMID: 38902186 DERIVED

• Ahani B, Tuffy KM, Aksyuk AA, Wilkins D, Abram ME, Dagan R, Domachowske JB, Guest JD, Ji H, Kushnir A, Leach A, Madhi SA, Mankad VS, Simoes EAF, Sparklin B, Speer SD, Stanley AM, Tabor DE, Hamren UW, Kelly EJ, Villafana T. Molecular and phenotypic characteristics of RSV infections in infants during two nirsevimab randomized clinical trials. Nat Commun. 2023 Jul 19;14(1):4347. doi: 10.1038/s41467-023-40057-8.

  PMID: 37468530 DERIVED

• 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.

  PMID: 32726528 DERIVED

Related Links

• D5290C00003\_Redacted\_protocol-amendment-1\_Red16JLU19
• D5290C00003\_MEDI8897-Combined SAP\_PDFAv1.0

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: M. Pamela Griffin
• Organization: MedImmune, LLC

information.center@astrazeneca.com

+1 301-398-4059

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: November 3, 2016
• Primary Completion: July 17, 2018
• Study Completion: December 6, 2018
• Last Updated: October 14, 2019
• Results First Posted: October 14, 2019

Record last verified: 2019-09

Locations

ES (2); US (60); SE (2); CL (7); CA (1); BU (5); AU (2); FI (2); FR (6); LI (2); AR (2); BE (2); BR (6); PL (5); GB (5); NZ (3); HU (13); IT (4); LA (3); TU (6); CZ (3); ZA (8)