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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

August 22, 2016
August 25, 2016
September 27, 2018
November 3, 2016
July 17, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02878330 on ClinicalTrials.gov Archive Site
  • 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.
  • 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).

  • 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.
  • 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.
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
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 and entering their first RSV season.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Respiratory Syncytial Virus Infections
  • Drug: MEDI8897
    Anti-RSV monoclonal antibody with an extended half-life
  • Drug: Placebo
    Commercially available 0.9% (w/v) saline.
  • Experimental: MEDI8897
    Anti-RSV monoclonal antibody with an extended half-life
    Intervention: Drug: MEDI8897
  • Placebo Comparator: Placebo
    Commercially available 0.9% (w/v) saline.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1453
1500
December 5, 2018
July 17, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 365 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
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
Czech Republic,   Ukraine
 
NCT02878330
D5290C00003
Yes
Not Provided
Not Provided
MedImmune LLC
MedImmune LLC
Not Provided
Not Provided
MedImmune LLC
September 2018

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