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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 : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : September 27, 2018
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 and entering their first 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 gestational age (GA) who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Subjects 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 : 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
Estimated Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life
Drug: MEDI8897
Anti-RSV monoclonal antibody with an extended half-life

Placebo Comparator: Placebo
Commercially available 0.9% (w/v) saline.
Drug: Placebo
Commercially available 0.9% (w/v) saline.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of hospitalization due to Reverse Transcriptase Polymerase Chain Reaction (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.

  2. Safety and tolerability as assessed by the occurrence of all treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE) [ Time Frame: 360 days post dose ]

    Safety of MEDI8897 will primarily be assessed and measured by the occurrence of all treatment-emergent AEs and SAEs.

    Other safety assessments will include the occurence of Adverse Event of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs).


  3. 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.

  4. 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.



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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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Sponsors and Collaborators
MedImmune LLC

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02878330     History of Changes
Other Study ID Numbers: D5290C00003
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Keywords provided by MedImmune LLC:
Respiratory Syncytial Virus, RSV
Preterm Infants
Lower Respiratory Tract Infection

Additional relevant MeSH terms:
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs