MELODY study

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224798

Enrollment

3000

Registered

2019-07-24

Start date

2019-07-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

investigational material(s) Generic name etc : MEDI8897 INN of investigational material : nirsevimab Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K

IQVIA Services Japan G.K. (ICCC)

motoki.hanada@iqvia.com+81-3-6859-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026