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Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004) | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

NCT04767373•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
•For the phase 2b cohort only: Has a chronological age \>2 weeks of age up to 1 year and is entering their first respiratory syncytial virus (RSV) season at the time of obtaining documented informed consent.
•For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
•For participants in South Korea only: Weighs ≥2 kg

Exclusion Criteria

•Is recommended to receive palivizumab per local guidelines or professional society recommendations.
•Has known hypersensitivity to any component of clesrovimab
•Has a bleeding disorder contraindicating IM administration
•Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
•Has received any vaccine or monoclonal antibody for the prevention of RSV
•Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study

Locations (217)

Southeastern Pediatric Associates, P.A. ( Site 0008)

Dothan, Alabama, United States

Northwest Arkansas Pediatric Clinic ( Site 0050)

Fayetteville, Arkansas, United States

Children's Clinic of Jonesboro, PA ( Site 0058)

Jonesboro, Arkansas, United States

Long Beach Memorial Medical Center ( Site 0014)

Long Beach, California, United States

Madera Family Medical Group ( Site 0046)

Madera, California, United States

Orange County Research Institute ( Site 0057)

Ontario, California, United States

Children's Hospital Colorado ( Site 0066)

Aurora, Colorado, United States

Optumcare Colorado Springs, LLC ( Site 0022)

Colorado Springs, Colorado, United States

Children's National Hospital ( Site 0076)

Washington D.C., District of Columbia, United States

MedStar Georgetown Pediatrics ( Site 0047)

Washington D.C., District of Columbia, United States

Key Dates

Start Date

April 7, 2021

Primary Completion Date

July 9, 2024

Completion Date

July 9, 2024

Last Updated

February 11, 2026

Enrollment

3,632

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infection

Interventions

Clesrovimab

BIOLOGICAL

Placebo

DRUG

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children