Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Completed · Phase 3 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections

In brief

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

Key facts

Study ID

NCT02325791

Run by

Regeneron Pharmaceuticals

People needed

1177

Starts

2015-07-21

Expected to finish

2017-09-26

Last updated by the study team

2018-11-06

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: accepted.

Where it is running

• Regeneron Study Site — Mobile, Alabama, United States
• Regeneron Study Site — Little Rock, Arkansas, United States
• Regeneron Study Site — Anaheim, California, United States
• Regeneron Study Site — Bell Gardens, California, United States
• Regeneron Study Site — Dinuba, California, United States
• Regeneron Study Site — Downey, California, United States
• Regeneron Study Site — Huntington Beach, California, United States
• Regeneron Study Site — La Puente, California, United States
• Regeneron Study Site — Los Angeles, California, United States
• Regeneron Study Site — Madera, California, United States
• Regeneron Study Site — Palmdale, California, United States
• Regeneron Study Site — Ventura, California, United States
• Regeneron Study Site — West Covina, California, United States
• Regeneron Study Site — Aurora, Colorado, United States
• Regeneron Study Site — Thornton, Colorado, United States
• Regeneron Study Site — Hartford, Connecticut, United States
• Regeneron Study Site — Boynton Beach, Florida, United States
• Regeneron Study Site — Gainesville, Florida, United States
• Regeneron Study Site — Jacksonville, Florida, United States
• Regeneron Study Site — Miami, Florida, United States
• Regeneron Study Site — Orlando, Florida, United States
• Regeneron Study Site — Pensacola, Florida, United States
• Regeneron Study Site — Tampa, Florida, United States
• Regeneron Study Site — Winter Park, Florida, United States
• Regeneron Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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