The Efficacy and Safety of REGN2222 for the Prevention of RSV Infection in Preterm Infants.

Clinical Trial

Offered by: Nemours Children's Specialty Care, Jacksonville
Location: Jacksonville, Fla.

Trial Name

The Efficacy and Safety of REGN2222 for the Prevention of RSV Infection in Preterm Infants

What is the trial about?

To demonstrate the efficacy of REGN2222 in preventing medically attended RSV infections (subjects with either RSV-confirmed hospitalizations or outpatient lower respiratory tract infection). To demonstrate the efficacy of REGN2222 in reducing visits to the Emergency Department, urgent care or pediatric specialty care locations.

Who can participate?

Preterm, otherwise healthy male or female infant who has a chronological age of ≤six months of age at the time of the first dose (i.e., infant must receive the first dose on or before the subject’s six-month birthday). Gestational age at birth is no more than 35 weeks, six days.

What is involved?

Premature infants born less than 35 weeks, six days gestational age and less than six month old at the time of first dose of medication. Immunization will be given on the second visit and fourth visit. The study will last eight months. Seven visits will be at the clinic. Then visits eight, nine and ten will be phone visits. If the infant should get ill and have to see a physician in the Emdergency Department, urgent care or pediatric office there will be an unscheduled visit. Each family will receive $50 for visits one-seven.

Everyone will have two blood draws, some participants will have three blood draws. Everyone will receive two intramuscular immunizations. Everyone will have a physical with six of the visits.

Contact Nemours Clinical Trials

Trial Name: RSV Prevention in Preterm Infants

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org