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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)

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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

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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: MEDI8897 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 3, 2016
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : December 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. Serum Concentration of MEDI8897 [ Time Frame: Days 91, 151, and 361 ]
  5. 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.

  6. 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.



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Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878330


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Birmingham, Alabama, United States, 35205
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Anaheim, California, United States, 92804
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Sponsors and Collaborators
MedImmune LLC
  Study Documents (Full-Text)

Documents provided by MedImmune LLC:
Study Protocol  [PDF] January 25, 2018
Statistical Analysis Plan  [PDF] November 18, 2016


Additional Information:
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02878330     History of Changes
Other Study ID Numbers: D5290C00003
First Posted: August 25, 2016    Key Record Dates
Results First Posted: October 14, 2019
Last Update Posted: October 14, 2019
Last Verified: September 2019
Keywords provided by MedImmune LLC:
Respiratory Syncytial Virus, RSV
Preterm Infants
Lower Respiratory Tract Infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections