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The trial is taking place at:
R

Road Runner Research, Ltd | San Antonio, TX

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Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting
Phase 3

Conditions

RSV Infection

Treatments

Biological: Placebo
Biological: Clesrovimab
Biological: Palivizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04938830
jRCT2031210664 (Registry Identifier)
MK-1654-007 (Other Identifier)
2020-005996-11 (EudraCT Number)
1654-007

Details and patient eligibility

About

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

Enrollment

1,000 estimated patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
  • Is available to complete the follow-up period.

Exclusion criteria

  • Requires mechanical ventilation at time of enrollment.
  • Has a life expectancy <6 months.
  • Has known hepatic or renal dysfunction, or chronic seizure disorder.
  • Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
  • Has severe immunodeficiency or is severely immunocompromised.
  • Has known hypersensitivity to any component of clesrovimab or palivizumab.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,000 participants in 2 patient groups

Clesrovimab
Experimental group
Description:
Participants will receive intramuscular (IM) injections of clesrovimab and placebo
Treatment:
Biological: Clesrovimab
Biological: Placebo
Palivizumab
Active Comparator group
Description:
Participants will receive IM injections.
Treatment:
Biological: Palivizumab

Trial contacts and locations

146

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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