Back to resultsA Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b)
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEDI8897
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory Syncytial Virus, RSV, Preterm Infants, Lower Respiratory Tract Infection
Eligibility Criteria
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
MEDI8897 50 mg
Arm Description
Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
Serum Concentration of MEDI8897
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.
Number of Participants With Positive Anti-drug Antibodies to MEDI8897
The number of participants with positive serum antibodies to MEDI8897 are reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02878330
Brief Title
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
Acronym
MEDI8897 Ph2b
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory Syncytial Virus, RSV, Preterm Infants, Lower Respiratory Tract Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1453 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
Arm Title
MEDI8897 50 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
Intervention Type
Drug
Intervention Name(s)
MEDI8897
Intervention Description
A single IM dose of 50 mg on Day 1 of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
Title
Serum Concentration of MEDI8897
Time Frame
Days 91, 151, and 361
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
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
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.
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
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Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
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United States
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Research Site
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Anaheim
State/Province
California
ZIP/Postal Code
92805
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United States
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Research Site
City
Downey
State/Province
California
ZIP/Postal Code
90241
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United States
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Research Site
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Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
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Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
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United States
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Research Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
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Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
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United States
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Research Site
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West Covina
State/Province
California
ZIP/Postal Code
91790
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United States
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Research Site
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Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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United States
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Research Site
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
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United States
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Research Site
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Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
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United States
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Research Site
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Gainesville
State/Province
Florida
ZIP/Postal Code
32607
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United States
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Research Site
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Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
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Research Site
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South Miami
State/Province
Florida
ZIP/Postal Code
33143
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United States
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Research Site
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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United States
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Research Site
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Augusta
State/Province
Georgia
ZIP/Postal Code
30912
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United States
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Research Site
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Chicago
State/Province
Illinois
ZIP/Postal Code
60611
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United States
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Research Site
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Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60068
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United States
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Research Site
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Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
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United States
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Research Site
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South Bend
State/Province
Indiana
ZIP/Postal Code
46601
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United States
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Research Site
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Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
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United States
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Detroit
State/Province
Michigan
ZIP/Postal Code
48201
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United States
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Research Site
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Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
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United States
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Research Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
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United States
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Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
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United States
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Research Site
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Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
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United States
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Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
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United States
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Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
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United States
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Research Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
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United States
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Research Site
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New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
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United States
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Research Site
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Stony Brook
State/Province
New York
ZIP/Postal Code
11794
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United States
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Syracuse
State/Province
New York
ZIP/Postal Code
13210-2306
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United States
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Research Site
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
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United States
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Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
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United States
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
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United States
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Research Site
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Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
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United States
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Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
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Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
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Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
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Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
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United States
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Research Site
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
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United States
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Research Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
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United States
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Research Site
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Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
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United States
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Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
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United States
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Research Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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United States
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Research Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
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United States
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Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
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United States
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Research Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
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Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
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Research Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
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United States
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Research Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
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United States
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Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
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United States
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Research Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
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United States
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Research Site
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
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Research Site
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Syracuse
State/Province
Utah
ZIP/Postal Code
84075
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United States
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Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
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Research Site
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Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
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United States
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Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
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Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Research Site
City
Bahía Blanca
ZIP/Postal Code
B8001HXM
Country
Argentina
Facility Name
Research Site
City
Guaymallen Mendoza
ZIP/Postal Code
5519
Country
Argentina
Facility Name
Research Site
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
Research Site
City
Subiaco
ZIP/Postal Code
6008
Country
Australia
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Research Site
City
Botucatu
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Research Site
City
Campinas
ZIP/Postal Code
13084-791
Country
Brazil
Facility Name
Research Site
City
Canoas
ZIP/Postal Code
92425-900
Country
Brazil
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Research Site
City
Juiz de Fora
ZIP/Postal Code
36025-330
Country
Brazil
Facility Name
Research Site
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Research Site
City
Maipu
ZIP/Postal Code
9250000
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8053095
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8380453
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8880465
Country
Chile
Facility Name
Research Site
City
Valdivia
ZIP/Postal Code
5090000
Country
Chile
Facility Name
Research Site
City
Viña del Mar
ZIP/Postal Code
2520594
Country
Chile
Facility Name
Research Site
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
14710
Country
Czechia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Research Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Research Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Research Site
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Research Site
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Research Site
City
Caen Cedex
ZIP/Postal Code
14033
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Research Site
City
Tours CEDEX 9
ZIP/Postal Code
37044
Country
France
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1131
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Research Site
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Research Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Research Site
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Research Site
City
Nyireyghaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Research Site
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Research Site
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16100
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Research Site
City
Jekabpils
ZIP/Postal Code
LV-5201
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV1002
Country
Latvia
Facility Name
Research Site
City
Valmiera
ZIP/Postal Code
4200
Country
Latvia
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Otahuhu
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Research Site
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85168
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80402
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Research Site
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Research Site
City
Claremont
ZIP/Postal Code
7708
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Pietermaritzburg
ZIP/Postal Code
3201
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
0087
Country
South Africa
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Research Site
City
Boadilla del Monte
ZIP/Postal Code
28660
Country
Spain
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Research Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Research Site
City
San Juan de Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Research Site
City
Sant Cugat del Valles
ZIP/Postal Code
8190
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Research Site
City
Adana
ZIP/Postal Code
1260
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Research Site
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35210
Country
Turkey
Facility Name
Research Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Research Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Research Site
City
Oxford
ZIP/Postal Code
OX3 7EJ
Country
United Kingdom
Facility Name
Research Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32726528
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. Erratum In: N Engl J Med. 2020 Aug 13;383(7):698.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5290C00003&attachmentIdentifier=b9e98653-9f94-46e7-a735-9a742e555af6&fileName=D5290C00003_Redacted_protocol-amendment-1_Red16JLU19.pdf&versionIdentifier=
Description
D5290C00003_Redacted_protocol-amendment-1_Red16JLU19
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5290C00003&attachmentIdentifier=f0ccb086-5c35-4e3c-9dde-0fefc3989cd9&fileName=D5290C00003_MEDI8897-Combined_SAP_PDFAv1.0.pdf&versionIdentifier=
Description
D5290C00003_MEDI8897-Combined SAP_PDFAv1.0
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
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