Overview

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

Status:
Completed
Trial end date:
2017-09-26
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Regeneron Pharmaceuticals
Criteria
Key Inclusion Criteria:

1. Preterm, otherwise healthy male or female infant who is ≤6 months of age at the time
of the first dose (i.e., infant must be treated on or before their 6 month birthday)

2. Gestational age is ≤35 weeks, 6 days at birth

3. Parent(s) or legal guardian(s) of the infant is able to understand the study
requirements and willing to provide informed consent

Key Exclusion Criteria:

1. Eligible, recommended and have access to receive palivizumab per AAP or other local
guidelines, standard practice, or by their healthcare provider

2. History of CLD defined as requirement of supplemental oxygen for 28 days after birth

3. Known hemodynamically significant congenital heart disease

4. Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the
airway

5. Known renal or hepatic dysfunction

6. Major congenital malformations, including congenital cleft palate, cytogenetic
abnormalities, or serious chronic disorders

7. Known or suspected impairment of immunological functions or autoimmune diseases

8. History of anaphylaxis

9. Previously received palivizumab or any other investigational RSV prophylaxis or
vaccine product

10. Previous reaction to IV immunoglobulin, blood products or other foreign proteins,
including vaccines and monoclonal antibodies

Note: Other inclusion and exclusion criteria apply