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

September 24, 2019 updated by: MedImmune LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1453

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
Time Frame: 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).
From Day 1 through Day 151

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
Time Frame: 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).
From Day 1 through Day 151
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time Frame: 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.
From Day 1 through Day 361
Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
Time Frame: 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.
From Day 1 through Day 361
Serum Concentration of MEDI8897
Time Frame: Days 91, 151, and 361
Days 91, 151, and 361
Elimination Half-life (t1/2) of MEDI8897
Time Frame: 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.
Day 91 through Day 361
Number of Participants With Positive Anti-drug Antibodies to MEDI8897
Time Frame: Days 91, 151, and 361
The number of participants with positive serum antibodies to MEDI8897 are reported.
Days 91, 151, and 361

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5290C00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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