D5290C00004- A Phase 3 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 Late Preterm and Term Infants (MELODY)

About this Study

This study will access the safety and effectiveness of a single injection of MEDI8897 compared to placebo in infants >35 weeks gestational age in their first RSV season.

Sponsor Protocol ID:D5290C00004
IRB Number:2019-0204
Actively Enrolling
Interventional
Phase 3
November 25, 2019
Eligibility Criteria
Both Male and Female
No
Yes
No

Inclusion CriteriaSubjects must meet all of the following criteria: 

1 Healthy infants in their first year of life and born ≥ 35 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis or Down syndrome with no other risk factors are eligible) 

2 Infants who are entering their first RSV season at the time of screening 

3 Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative prior to performing any protocol-related procedures, including screening evaluations 

4 Subject's parent(s)/legal representative is able to understand and comply with the requirements of the protocol including follow-up and illness visits as judged by the investigator 

5 Subject is available to complete the follow-up period, which will be 17 months after receipt of study drug

Exclusion CriteriaAny of the following would exclude the subject from participation in the study: 

1 Meets national or other local criteria to receive commercial palivizumab 

2 Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or acute illness within 7 days prior to randomization 

3 Any history of LRTI or active LRTI prior to, or at the time of, randomization 

4 Known history of RSV infection or active RSV infection prior to, or at the time of, randomization 

5 Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt during the study with the exception of: a) multivitamins and iron; b) infrequent use of over-the-counter (OTC) medications for the systemic treatment of common childhood symptoms (eg, pain relievers) that may be permitted according to the judgment of the investigator 

6 Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator)

7 History of receipt of blood, blood products, or immunoglobulin products, or expected receipt through the duration of the study 

8 Receipt of any investigational drug 

9 Known renal impairment 

10 Known hepatic dysfunction including known or suspected active or chronic hepatitis infection 

11 History of CLD/bronchopulmonary dysplasia 

12 Clinically significant congenital anomaly of the respiratory tract 

13 Chronic seizure or evolving or unstable neurologic disorder 

14 CHD, except for children with uncomplicated CHD (eg, patent ductus arteriosus, small septal defect) 

15 Prior history of a suspected or actual acute life-threatening event 

16 Known immunodeficiency, including human immunodeficiency virus (HIV) 

17 Mother with HIV infection (unless the child has been proven to be not infected) 

18 Any known allergy, including to immunoglobulin products, or history of allergic reaction 

19 Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination 

20 Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, IV immunoglobulin) 

21 Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results 

22 Concurrent enrollment in another interventional study 

23 Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals

Categories Click category to view its trials.
Lungs/Breathing
Pediatrics
Women's Health
Participating Locations
Batson Children’s Hospital
Contact Information
Contact Name: Sandra Tyler
Phone Number: 601-815-8706
Email: sltyler@umc.edu
Principal Investigator:Bhatt, Abhay, M.D.
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