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Keep this study
Lead
Gilead Sciences
Pediatric participants will be enrolled as follows:
* Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to \< 40 kg
* Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg
Age
0–5
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants assigned male or female at birth, from birth to \< 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
* Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 3 kg to \< 40 kg (Part A) and ≥ 1.5 kg to \< 3 kg (Part B)
* Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg
RSV infection diagnosis ≤ 3 days prior to randomization.
Negative test for influenza A/B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection) ≤ 7 days prior to randomization.
Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.
You may not be if
Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
Not expected to survive the current RSV-related illness.
Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
History of asthma or recurrent wheezing.
Neuromuscular disease that affects swallowing.
Cystic fibrosis.
Participants who are immunocompromised.
Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
Abnormal renal function.
Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
Participant whose mother received RSV vaccination during pregnancy and who is \< 1 year old prior to randomization.
