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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878330
Recruitment Status : Completed
First Posted : August 25, 2016
Results First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE August 22, 2016
First Posted Date  ICMJE August 25, 2016
Results First Submitted Date  ICMJE July 17, 2019
Results First Posted Date  ICMJE October 14, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE November 3, 2016
Actual Primary Completion Date July 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)		 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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2016)		 Incidence of medically attended LRTI due to RT-PCR confirmed RSV [ Time Frame: 150 days post dose ]
The incidence of RSV LRTI (inpatient and outpatient) 150 days post dose will be based on RSV test results (performed centrally via RT-PCR) and objective clinical LRTI criteria and will be summarized by treatment group.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • 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).
  • 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.
  • 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.
  • Serum Concentration of MEDI8897 [ Time Frame: 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2016)
  • Incidence of hospitalization due to RT-PCR confirmed RSV [ Time Frame: 150 days post dose ]
    The incidence of RSV hospitalization 150 days post dose will be summarized by treatment group.
  • Safety and tolerability as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatement emergent serious adverse events (TESAE) [ Time Frame: 360 days post dose ]
    Safety of MEDI88987 will primarily be assessed and measured by the occurrence of all treatment-emergent AEs and SAEs. Other safety assessments will include the occurence of AESIs and NOCDs.
  • Single-dose serum concentrations of MEDI8897 [ Time Frame: 360 days post dose ]
    MEDI8897 serum concentration data will be tabulated by treatment group along with descriptive statistics. Terminal-phase half-life (t1/2) will be estimated using non-compartmental analysis, if data permit.
  • Incidence of anti-drug antibody (ADA) to MEDI8897 in serum [ Time Frame: 360 days post dose ]
    The incidence of ADA to MEDI8897 will be assessed and summarized by number and percentage of subjects that are ADA positive by treatment group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Respiratory Syncytial Virus Infections
Intervention  ICMJE
  • Drug: MEDI8897
    A single IM dose of 50 mg on Day 1 of the study.
  • Drug: Placebo
    A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants will receive a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
    Intervention: Drug: Placebo
  • Experimental: MEDI8897 50 mg
    Participants will receive a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
    Intervention: Drug: MEDI8897
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2018)		 1453
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2016)		 1500
Actual Study Completion Date  ICMJE December 6, 2018
Actual Primary Completion Date July 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 365 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czechia,   Estonia,   Finland,   France,   Hungary,   Italy,   Latvia,   Lithuania,   New Zealand,   Poland,   South Africa,   Spain,   Sweden,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT02878330
Other Study ID Numbers  ICMJE D5290C00003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MedImmune LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MedImmune LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP