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Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
NCT02325791 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Suptavumab 30 mg/kg
- DRUG Placebo Matched to Suptavumab
- DRUG Suptavumab 30 mg/kg- 1 Dose
- DRUG Suptavumab 30 mg/kg - 2 Doses
Study Locations (20)
California
- Regeneron Study Site — Anaheim
- Regeneron Study Site — Bell Gardens
- Regeneron Study Site — Dinuba
- Regeneron Study Site — Downey
- Regeneron Study Site — Huntington Beach
- Regeneron Study Site — La Puente
- Regeneron Study Site — Los Angeles
- Regeneron Study Site — Madera
- Regeneron Study Site — Palmdale
- Regeneron Study Site — Ventura
- Regeneron Study Site — West Covina
Florida
- Regeneron Study Site — Boynton Beach
- Regeneron Study Site — Gainesville
- Regeneron Study Site — Jacksonville
Alabama
- Regeneron Investigational Site — Birmingham
- Regeneron Study Site — Mobile
Colorado
- Regeneron Study Site — Aurora
- Regeneron Study Site — Thornton
Arkansas
- Regeneron Study Site — Little Rock
Connecticut
- Regeneron Study Site — Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,177 participants |
| Start Date | 2015-07-21 |
| Est. Completion | 2017-09-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02325791
The ClinicalTrials.gov registry entry for NCT02325791 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 4 interventions — of which Suptavumab 30 mg/kg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02325791 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02325791 about?
NCT02325791 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants". 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 ...
What is the current status of trial NCT02325791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,177 participants. The study started on 2015-07-21. Estimated completion is 2017-09-26.
What conditions does trial NCT02325791 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02325791?
The interventions under investigation include: Suptavumab 30 mg/kg (DRUG), Placebo Matched to Suptavumab (DRUG), Suptavumab 30 mg/kg- 1 Dose (DRUG), Suptavumab 30 mg/kg - 2 Doses (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02325791?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02325791 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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