A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF A HUMAN MONOCLONAL ANTIBODY, REGN2222, FOR THE PREVENTION OF MEDICALLY ATTENDED RSV INFECTION IN PRETERM INFANTS
- Conditions
- Respiratory Syncytial Virus infectionrespiratory tract infection1004743810028971
- Registration Number
- NL-OMON45852
- Lead Sponsor
- Regeneron Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
1. Preterm, otherwise healthy male or female infant who has a
chronological age of *6 months of age at the time of the first dose (ie.,
infant must receive the first dose on or before the subject's 6 month
birthday)
2. Gestational age at birth is no more than 35 weeks, 6 days
3. Parent(s) or legal guardian(s) of the infant is able to understand the
study requirements, willing to provide informed consent, and legally able
to provide informed consent.
- Eligible and recommended to receive palivizumab per AAP or other
local guidelines, standard practice, or by their healthcare provider
- Children in whom a single blood draw would exceed 1% of their
estimated total blood volume
- History of CLD defined as requirement of supplemental oxygen for 28
days after birth
- Known hemodynamically significant congenital heart disease
- Known immunodeficiency, neuromuscular disease, or congenital
abnormalities of the airway
- Previously received palivizumab, IV gamma globulin, or any other
investigational RSV prophylaxis or vaccine product
- Previous reaction to IV immunoglobulin, blood products or other
foreign proteins, such as vaccines and monoclonal antibodies, or any of
the components of the investigational product formulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method