Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Syncytial Virus Infections
Intervention: Suptavumab 30 mg/kg; Placebo Matched to Suptavumab; Suptavumab 30 mg/kg- 1 Dose; Suptavumab 30 mg/kg - 2 Doses
Intervention description: Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.; Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.; Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.; Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1177.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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