Last updated on November 2018

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

Brief description of study

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of REGN2222 in infants born no more than 35 wGA (weeks 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 will conduct this study during the RSV season using dosing regimens that are expected to be effective.

Detailed Study Description

This study occurs in two parts: Part A and Part B. The status of Part A is 'Complete'. The status of Part B is 'Recruiting.' Part A of the study is an open-label, PK evaluation of intramuscular (IM) administered REGN2222 in preterm infants for whom palivizumab is not recommended to enable the selection of dosing regimens for Part B. Part B of the study is randomized, double-blind, and placebo-controlled, designed to evaluate efficacy, safety, serum concentration and immunogenicity of IM administration of REGN2222 in preterm infants for whom palivizumab is not recommended. The total duration of Part B will be up to 265 days (includes a 28-day screening period, 57-day treatment period and 180-day follow-up period). Up to 1515 subjects are planned to be included in Part B of the study. Participants will be randomly assigned to 1 of 3 different groups, each with 505 infants; 1 group will get 1 dose of REGN2222 and 1 dose of placebo, the second group will receive 2 doses of REGN2222, and the third group will receive 2 doses of placebo. There is a separate genetic testing sub study.

Clinical Study Identifier: NCT02325791

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Clinical Trials Administrator

Regeneron Study Site
Kingsport, TN United States

Recruitment Status: Closed

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