臨床研究等提出・公開システム

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)

MELODY study

HANADA MOTOKI

IQVIA Services Japan G.K. (ICCC)

4-10-18, Takanawa, Minato-ku, Tokyo

motoki.hanada@iqvia.com

IQVIA Services Japan G.K jRCT Inquiry Contact

IQVIA Services Japan G.K. (ICCC)

4-10-18, Takanawa, Minato-ku, Tokyo

+81-3-6859-9500

motoki.hanada@iqvia.com

completed

July. 23, 2019

Interventional

A Phase 3 Randomized, Double-blind, Placebo-controlled Study

prevention purpose

3

- Healthy infants in their first year of life and born > 36 weeks 0 days GA (infants who have an underlying illness such as cystic fibrosis with no other risk factors are eligible)
- Infants who are entering their first RSV season at the time of screening

- Meets national or other local criteria to receive commercial palivizumab
- Any fever (>38.0 degree celsius), regardless of route) or acute illness within 7 days prior to randomization
- Any history of LRTI or active LRTI prior to, or at the time of, randomization
- Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
- Receipt of palivizumab or other RSV mAb or any RSV vaccine, including maternal RSV vaccination

Both

Respiratory Syncytial Virus Infections

investigational material(s)
Generic name etc : MEDI8897
INN of investigational material : nirsevimab
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : MEDI8897 50 mg (if < 5 kg weight at the time of dosing) or 100 mg (if > 5 kg weight at the time of dosing) or placebo will be administered intramuscularly in a single-dose

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
Incidence of medically attended LRTI (inpatient and outpatient) due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)

efficacy
Incidence of hospitalizations due to RT-PCR-confirmed RSV through 150 days after dosing (ie, during a typical 5-month RSV season)
safety
Safety and tolerability of MEDI8897 as assessed by the occurrence of TEAEs, TESAEs, AESIs, and NOCDs
pharmacokinetics
Summary of MEDI8897 serum concentrations and estimated PK parameters (apparent clearance and AUC, if data permit)
other
Incidence of ADA to MEDI8897 in serum

-

June. 24, 2019